The Federal Register

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Mar 29 2013 11:00:00 GMT

Summary: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the b

Draft Guidance for Industry; Availability:

Fri, Mar 29 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for metronidazole vaginal gel.

Medicare and Medicaid Programs:

Fri, Mar 29 2013 11:00:00 GMT

A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

Meetings:

Fri, Mar 29 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Center for Scientific Review Special Emphasis Panel Rheumatology, Dermatology and Osteoclast Biology.

Date: April 30, 2013.

Time: 1:00 p.m. to 3:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call)

Contact Person: Aruna K Behera, Ph.D.,

Fri, Mar 29 2013 11:00:00 GMT

This Special Fraud Alert addresses physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physicianowners for use in procedures the physicianowners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).

Fri, Mar 29 2013 11:00:00 GMT

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 2761243.

Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniq

Thu, Mar 28 2013 11:00:00 GMT

Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 6777276, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 78 FR 5812, dated January 28, 2013) is amended to reflect the reorganization of the Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.

Section CB, Organization and Functions, is hereby amended as follows:

Revise the functional statement for the Office of Science Quality (CASH), as follows:

After item (11), insert the following: (12) Plans, develops, coordinates, and manages policies and/or activities that assure CDC intellectual property transfer, scientific training and technical assistance, critical external laboratory partnerships and the provision of essential laboratory services; (13) transfers and translates research findings,

Prospective Grants of Start-Up Exclusive Licenses:

Thu, Mar 28 2013 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive patent license, to practice the inventions embodied in PCT patent application PCT/US2012/044421, filed June 27, 2012 (HHS Reference E2052010/2PCT01), which is a continuationinpart of U.S. Application No. 13/180,111 (E2052010/1 US01) which claims priority to U.S. provisional application No. 61/ 363,079 (E2052010/0US01), and entitled ``Photosensitizing Antibody Fluorophore Conjugates,'' to Aspyrian Therapeutics, Inc., a company incorporated under the laws of the State of Delaware, having its headquarters in San Diego, California.

The United States of America is the assignee of the rights of the above invention.

The field of use may be limited to ``use of photosensitizing antibodyfluorophore conjugate by itself for Photoimmunotherapy (PIT), or in combination wit

Thu, Mar 28 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Ron Otten, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the col

Cooperative Agreements:

Thu, Mar 28 2013 11:00:00 GMT

Announcement Type: New Limited Competition Cooperative Agreement.

Funding Announcement Number: HHS2013IHSHPR0001.
Catalog of Federal Domestic Assistance Number: 93.970.
Key Dates

Application Deadline Date: April 30, 2013.

Review Date: May 13, 2013.

Earliest Anticipated Start Date: May 30, 2013.

Proof of NonProfit Status Due Date: April 30, 2013. I. Funding Opportunity Description

Statutory Authority

The Indian Health Service (IHS) Office of Clinical and Preventive Services (OCPS) is accepting competitive cooperative agreement applications for support for medical professionals' recruitment and continuing education programs. This program is authorized under the Snyder Act, 25 U.S.C. 13. This program is described in the Catalog of Federal Domestic Assistance under 93.970.

Background

The mission of the IHS is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives (AI/AN) to the highest level. The IHS, an agency within the Departme

Guidance for Industry and Staff; Availability:

Thu, Mar 28 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.'' FDA is issuing this guidance to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to B. burgdorferi. These devices are used to aid in the diagnosis of Lyme disease.

World Trade Center Health Program Eligibility Requirements:

Thu, Mar 28 2013 11:00:00 GMT

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) by adding Title XXXIII, which establishes the World Trade Center (WTC) Health Program. The WTC Health Program is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), and provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, Pennsylvania, and at the Pentagon, and to eligible survivors of the New York City attacks. Section 3311(a)(2)(C) of the PHS Act requires the WTC Program Administrator (Administrator) to develop eligibility criteria for enrollment of Shanksville, Pennsylvania and Pentagon responders. This interim final rule est

Thu, Mar 28 2013 11:00:00 GMT

Meetings:

Thu, Mar 28 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. [[Page 18996]]

Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel, Research Dissemination and Implementation.

Date: April 22, 2013.

Time: 1:00 p.m. to 3:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Crystal City Marriott, 1999 Jefferson Davis Highway, Arlington, VA 22202.

Contact Person: Keith A. Mintzer, Ph.D.,

Thu, Mar 28 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Thu, Mar 28 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Ron Otten, at 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Part C Early Intervention Services Grants:

Thu, Mar 28 2013 11:00:00 GMT

To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide a onetime
noncompetitive Part C funds award to the University of Alabama at Birmingham (UAB).

Thu, Mar 28 2013 11:00:00 GMT

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 10413), the Health Resources
[[Page 18989]]
and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 4431984.

HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be coll

Meetings:

Wed, Mar 27 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Developmental Centers in Benign Urology (P20s, RFADK12022)

Date: May 17, 2013.

Time: 8:30 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814.

Wed, Mar 27 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3955806. Written comments should be received within 30 days of this notice. Proposed Project

Colorectal Cancer Screening Program (OMB No. 09200745, exp. 6/30/ 2013)ExtensionNational Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Of cancers affecting both men and women, colorectal cancer (CRC) is the second leading cause of cancerrelated deaths in the United States. Based on scientific evi

Meetings:

Wed, Mar 27 2013 11:00:00 GMT

[[Page 18595]]

Dated: March 21, 2013.
Ben O'Dell,
Associate Director for Center for Faithbased and Neighborhood Partnerships at U.S. Department of Health and Human Services. [FR Doc. 201307142 Filed 32613; 8:45 am]
BILLING CODE 415407P

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Mar 27 2013 11:00:00 GMT

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the [[Page 18606]]
PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's recordkeeping and registration requirements for shell egg producers.

Wed, Mar 27 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send written comments to Ron Otten, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Wed, Mar 27 2013 11:00:00 GMT

The Department of Health and Human Services (HHS) proposes to revise the fee structure currently used by the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC) to charge respirator manufacturers for the examination, inspection, and testing of respirators which are submitted to NIOSH for the purpose of creating or modifying a certificate of approval. Existing regulations reflect prices for respirator testing and approval that were promulgated in 1972, and have not kept pace with the actual costs of providing these services that benefit respirator manufacturers. This proposed rule is designed to update the regulations.

Meetings:

Wed, Mar 27 2013 11:00:00 GMT

The Food and Drug Administration (FDA) and cosponsor International Color Consortium (ICC) are announcing the following public workshop entitled ``Summit on Color in Medical Imaging: An International Workshop on the Technical Framework for Consistency and Interoperability Approaches for Dealing with Color in Medical Images.'' The purpose of the workshop is to bring together key stakeholders to clearly identify areas of need, investigate solutions, and propose bestpractice approaches. The recommendations of the summit might include the creation of a technical special interest group either as part of the ICC or in some other forum and the establishment of best practice guidelines for industry.

Wed, Mar 27 2013 11:00:00 GMT

Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Ron A. Otten, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Mar 27 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Wed, Mar 27 2013 11:00:00 GMT

Affordable Care Act
Title IQuality, Affordable Health Care for All Americans
Subtitle BImmediate Actions to Preserve and Expand Coverage

Section 1104(c)(1), (2), and (3)The authorities pursuant to Section 1104(c)(1), (2), and (3) of the Affordable Care Act, as amended, to administer rules related to standards and associated operating rules, unique health plan identifiers, standards for electronic funds transfer, and a standard and a single set of associated operating rules for health claims attachments. These provisions relate to administrative simplification under Section 262 of HIPAA.
Title IXRevenue Provisions

Subtitle ARevenue Offset Provisions

Section 9008The authorities pursuant to Section 9008 of the Affordable Care Act, as amended, related to the reporting requirements associated with the imposition of annual fee on branded prescription pharmaceutical manufacturers and importers.
Health Insurance Portability and Accountability Act of 1996

Section 203The authorities pursuant to S

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Mar 27 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Wed, Mar 27 2013 11:00:00 GMT

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of fifteen singlesource program expansion supplement grants to the following ten current grantees, for a total of $47,168,490.
[[Page 18603]]
Organization Location Amount BCFS Health and Human Services.... San Antonio, TX..... $3,039,665 Heartland Human Care Services, Chicago, IL......... 1,659,393 Inc..
Southwest Key, Inc................ Austin, TX.......... 13,431,660 Children's Village................ Dobbs Ferry, NY..... 4,208,741 United States Conference of Washington, DC...... 209,576 Catholic Bishops.
Lutheran Immigration Refugee Baltimore, MD....... 281,452 Services.
US Committee for Refugees and Washington, DC...... 602,690 Immigrants.
International Education Services.. Los Fresnos, TX..... 16,314,360 Lincoln Hall...................... Lincolndale, NY..... 7,0

Wed, Mar 27 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

School Dismissal Monitoring System (OMB Control No. 09200849 Expiration 5/31/2013)RevisionNational Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

In the spring of 2009, the beginning of H1N1 influenza pandemic, illness among schoolaged students (K12) in many states and cities resulted in at least 1,351 school dismissals due to rapidly in

Tue, Mar 26 2013 11:00:00 GMT

HHS gives notice of a determination concerning a petition to add a class of employees from General Steel Industries in Granite City, Illinois, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On March 6, 2013, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

All individuals who worked in any location at the General Steel Industries site, located at 1417 State Street, Granite City, Illinois, from January 1, 1953, through June 30, 1966, and/or during the residual radiation period from July 1, 1966, through December 31, 1992.

Tue, Mar 26 2013 11:00:00 GMT

HHS gives notice of a decision to designate a class of employees from the Baker Brothers site in Toledo, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:

All Atomic Weapons Employees who worked at the Baker Brothers site in Toledo, Ohio, during the period from June 1, 1943, through December 31, 1944, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.

This designation will become effective on April 5, 2013, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to

Tue, Mar 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of April 9, 2007 (72 FR 17397 at 17401) to reflect changes to the Center for Devices and Radiological Health's address. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

Guidance for Industry; Availablity:

Tue, Mar 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility'' dated April 2013. The guidance document provides assistance to blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices. The guidance announced in this document finalizes the draft guidance of the same title dated October 2007.

Prospective Grant of Exclusive License:

Tue, Mar 26 2013 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to Aura BioSciences to practice the inventions embodied in U.S. Provisional Patent Application No. 60/928,495 entitled, ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 8, 2007 [HHS Ref. No. E1862007/0US01], U.S. Provisional Patent Application No. 61/065,897 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed February 14, 2008 [HHS Ref. No. E1862007/1US01], PCT Application No. PCT/US2008/ 062296 ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E1862007/2PCT01], Australian Patent Application No. 2008251615 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E1862007/2AU02], Canadian Patent Application No. 2,686,

Tue, Mar 26 2013 11:00:00 GMT

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federallyfunded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Tue, Mar 26 2013 11:00:00 GMT

HHS gives notice of a decision to designate a class of employees from the Battelle Laboratories King Avenue facility in Columbus, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:

All Atomic Weapons Employees who worked at the King Avenue facility owned by Battelle Laboratories in Columbus, Ohio, during the period from April 16, 1943, through June 30, 1956, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.

This designation will become effective on April 5, 2013, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Fe

Draft Guidance for Industry; Availability:

Tue, Mar 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning.'' The draft guidance, when finalized, will advise primary seafood processors who purchase reef fish how to minimize the risk of ciguatera fish poisoning (CFP) from fish that they distribute. The draft guidance is intended to help protect the public health by reducing the risk of CFP.

Prospective Grant of Start-Up Exclusive License:

Tue, Mar 26 2013 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a startup exclusive license to practice the inventions embodied in U.S. Patent No. 7,854,899, (E0982004/0) filed 08/26/2004 and issued 12/20/2010 entitled ``Template Methods and Device for Preparing Sample Arrays''; by Hewitt et al. (NCI); and U.S. Patent No. 6,951,761 9 (E 0642001/0) filed 08/30/2002 and issued 11/04/2005 ``Measurements of Multiple Molecules Using a Cryoarray'' by Star et al. (NIDDK) to Micatu, Inc. having a place of business at 231 West Water Street, Elmira, NY 14901. The patent rights in this invention have been assigned to the United States of America.

Agency Information Collection Activities; Proposals, Submissions, and

Tue, Mar 26 2013 11:00:00 GMT

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $1.5 million (total costs) for up to five years to the state of Idaho for a Strategic Prevention Framework State Incentive Grant. This is not a formal request for applications. Assistance will be provided only to the state of Idaho based on the receipt of a satisfactory application that is approved by an independent review group.

Funding Opportunity Title: SP13005.

Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.

Authority: Section 516 of the Public Health Service Act, as amended .

Justification: Eligibility for this SPF SIG award is limited to the state of Idaho, the only state receiving a Substance Abuse Prevention and Treatment Block Grant (SABG) that has never been awarded a SPF SIG grant from SAMHSA. The SPF SIG grant has already allowed 49 states to strengthen and consolidate their prevention systems and build greater capacity in their

Tue, Mar 26 2013 11:00:00 GMT

HHS gives notice of a determination concerning a petition to add a class of employees from the Hanford site in Richland, Washington, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On March 6, 2013, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

All personnel who were internally monitored (urine or fecal), who worked at the Plutonium Finishing Plant in the 200 Area at the Hanford site, from January 1, 1987, through December 31, 1989.

Tue, Mar 26 2013 11:00:00 GMT

HHS gives notice of a decision to designate a class of employees from the Joslyn Manufacturing and Supply Company in Fort Wayne, Indiana, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 6, 2013, the Secretary of HHS designated the following class of employees as an addition to the SEC:

All Atomic Weapons Employees who worked for Joslyn Manufacturing and Supply Company at the covered facility in Fort Wayne, Indiana, from March 1, 1943, through December 31, 1947, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.

This designation will become effective on April 5, 2013, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the

Tue, Mar 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.

Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or

Tue, Mar 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) has determined that QUESTRAN (cholestyramine for oral suspension, USP), equivalent to (EQ) 4 grams (g), and QUESTRAN LIGHT (cholestyramine for oral suspension, USP), EQ 4 g, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug applications (ANDAs) that refer to these drugs, and it will allow FDA to approve ANDAs that refer to these drugs as long as they meet relevant legal and regulatory requirements.

Meetings:

Tue, Mar 26 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Operation of a Facility for Testing Malaria Vaccine in Human Subjects.

Date: April 19, 2013.

Time: 11:30 a.m. to 5:00 p.m.

Agenda: To review and evaluate contract proposals.

Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conferenc

Public Workshops:

Mon, Mar 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of January 7, 2013 (78 FR 951). In the notice, FDA requested comments on the public workshop entitled ``Accessible Standardized Medical Device Labeling.'' The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Agency Information Collection Activities; Proposals, Submissions, and

Mon, Mar 25 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Intramural Training & Education/OIR/OD, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection

Title: NIH Office of Intramural Training & Education Application. Type of Information Collection Request: Revision. Form Number: 0925 0299. Expiration Date: March 31, 2014. Need and Use of Information Collection: The Office of Intramural Training & Education (OITE) administers a variety of programs and initiatives to recruit pre college through postdoctoral educational level individuals into the National Institutes of Health Intramural Research Program (NIHIRP) to facilitate develop into future biomedical scientists. The proposed information collection is necessary in order t

Meetings:

Mon, Mar 25 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neuroscience.

Date: April 8, 2013.

Time: 2:00 p.m. to 4:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

Contact Person: Richard D Crosland, Ph.D., Scientific Re

New Animal Drug Approvals:

Mon, Mar 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship for an NADA and ANADA, and a change of a sponsor's drug labeler code.

Agency Information Collection Activities; Proposals, Submissions, and

Mon, Mar 25 2013 11:00:00 GMT

Determinations:

Mon, Mar 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA) has determined that the three drug products listed in this document were not withdrawn from [[Page 17934]]
sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

Fri, Mar 22 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary(OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Medical Gases:

Fri, Mar 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is inviting comments from the public on whether any potential changes to the Federal drug regulations are necessary for medical gases.

Fri, Mar 22 2013 11:00:00 GMT

The National Institutes of Health (NIH) is providing guidance to Public Health Service (PHS) awardee institutions on implementation of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals: 2013 Edition (Guidelines). The NIH is seeking input from the public on any concerns they may have regarding the updated Guidelines.

New Animal Drugs:

Fri, Mar 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 21 approved new animal drug applications (NADAs) and 43 approved abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Bayer HealthCare LLC.

Fri, Mar 22 2013 11:00:00 GMT

Meetings:

Fri, Mar 22 2013 11:00:00 GMT

Name: President's Advisory Council on Faithbased and Neighborhood Partnerships Council Meeting.

Time and Date: Wednesday, April 10th, 2013 9:30 a.m.11:30 a.m. (EDT).

Place: Meeting will be held at a location to be determined in the White House complex, 1600 Pennsylvania Ave NW., Washington, DC. Space is extremely limited. Photo ID and RSVP are required to attend the event. Please RSVP to Ben O'Dell at partnerships@hhs.gov.

The meeting will be available to the public through a conference call line. The callin line is: 18668235144; Passcode: 1375705.

Status: Open to the public, limited only by space available. Conference call limited only by lines available.

Meetings:

Fri, Mar 22 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Arthritis and Musculoskeletal and Skin Diseases Special Emphasis Panel; NIAMS Clinical Trial Outcome Development.

Date: March 29, 2013.

Time: 8:00 a.m. to 5:30 p.m.

Agenda: To review and evaluate grant applications.

Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

[[Page 17680]]

Contact Person: Xi

Fri, Mar 22 2013 11:00:00 GMT

Medicare and Medicaid Programs:

Fri, Mar 22 2013 11:00:00 GMT

This proposed notice with comment period acknowledges the receipt of an application from the American Osteopathic Association/ Healthcare Facilities Accreditation Program (AOA/HFAP) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

Single-Source Grant Awards:

Thu, Mar 21 2013 11:00:00 GMT

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of an urgent single source grant in the amount of $250,000 to the Center for Survivors of Torture (CST) in Dallas, TX to ensure incoming refugee populations in Texas have access to mental health services.

Thu, Mar 21 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Kimberly Lane, 1600 Clifton Road, MS D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3955806. Written comments should be received within 30 days of this notice. [[Page 17410]]

Proposed Project

Prevention Research Centers Program National Evaluation Reporting SystemRevisionDivision of Population Health, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Background and Brief Descripti

Thu, Mar 21 2013 11:00:00 GMT

Development of an Evaluation Plan to Evaluate Grantee Attainment of Selected Activities of Comprehensive Cancer Control PrioritiesNew National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description

The National Comprehensive Cancer Control Program (NCCCP) is administered by the Centers for Disease Control

Thu, Mar 21 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 4431984.
Information Collection Request Title: Organ and Tissue Donor and Recipient Life Stories Form (OMB No. 0915xxxx)NEW

Abstract: HRSA's Division of Transplantation (DoT) is the primary entity in the Department of Health and Human Services (HHS) responsible for the Organ Transplant Program established under the National Organ Transplant Act (Pub. L. 98507, codified at sections 3

Meetings:

Thu, Mar 21 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. This meeting is being rescheduled due to the postponement of the March 7, 2013, PulmonaryAllergy Drugs Advisory Committee meeting due to unanticipated weather conditions.

Name of Committee: PulmonaryAllergy Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 17, 2013, from 8 a.m. to 5 p.m. This meeting is being rescheduled because of a postponed meeting announced in the Federal
[[Page 17414]]
Register of December 14, 2012 (77 FR 74486), originally scheduled for March 7, 2013.

Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 209930002. Information regarding special accommodations due to a disability, visi

Meetings:

Thu, Mar 21 2013 11:00:00 GMT

The meeting announced below concerns EpiCenters for the Prevention of HealthcareAssociated Infections, Antimicrobial Resistance and Adverse Events, Funding Opportunity Announcement (FOA) CK11 0010301SUPP13, initial review.

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date: 1:00 p.m.4:00 p.m., May 8, 2013 (Closed).

Place: Teleconference.

Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92463.

Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ``EpiCenters for the Prevention of Healthcare
Associated Infections, Antimicrobial Resistance and Adverse Events, FO

Thu, Mar 21 2013 11:00:00 GMT

Non-Competitive Replacement Awards:

Thu, Mar 21 2013 11:00:00 GMT

The Health Resources and Services Administration (HRSA) is issuing a noncompetitive replacement award under the Rural Health Information Technology Network Development Grant (RHITND) to Grace Community Health Center in order to continue the effective use of grant funds to achieve the original goals of the project. Grace Community Health Center is familiar with the project activities and will continue to follow the goals and objectives outlined in the grant. The project director will remain the same, and Grace Community Health Center has the facilities and resources necessary to support successful performance of the project.

Safety and Effectiveness Summaries for Premarket Approval Applications;

Thu, Mar 21 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

Meetings:

Thu, Mar 21 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; ZHD1 DSRH (NJ)

Date: April 8, 2013.

Time: 2:00 p.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

Contact Person: Marita R. Hopmann, Ph.D

Thu, Mar 21 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395 5806. Written comments should be received within 30 days of this notice.

Proposed Project

Monitoring and Reporting System For DELTA FOCUS AwardeesNew National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Intimate Partner Violence (IPV) is a serious, preventable public health problem that affects millions of Americans and results in serious consequences for victims, families, and communities. IPV o

Thu, Mar 21 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Vital Statistics Training Application, OMB No. 09200217 (expires May 31, 2013)RevisionNational Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

In the United States, legal authority for the registration of vital events, i.e., births, deaths, marriages, divorces, fetal deaths, and induced terminations of pregnancy, resides individually with the States (as well as citi

Thu, Mar 21 2013 11:00:00 GMT

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 4431984.

Wed, Mar 20 2013 11:00:00 GMT

Title: National Directory of New Hires.

OMB No.: 09700166.

Description: The National Directory of New Hires (NDNH), an automated directory maintained by the Federal
[[Page 17214]]
Office of Child Support Enforcement, was established pursuant to the Personal Responsibility and Work Opportunity Reconciliation Act of 1996. 42 U.S.C. 653(i)(1). In accordance with section 453A(g)(2) of the Social Security Act, employers are required to report information pertaining to newly hired employees to their state directory of new hires (SDNH) and, within three days of receiving employer information, states are required to transmit SDNH information to the NDNH. States are also required to transmit wage and unemployment compensation claims information to the NDNH on a quarterly basis. Federal agencies are required to report new hires and quarterly wage information directly to the NDNH.

The information maintained in the NDNH is collected electronically and assists states administering child suppor

Meetings:

Wed, Mar 20 2013 11:00:00 GMT

Name: President's Advisory Council on Faithbased and Neighborhood Partnerships Council Conference Calls.

Time and Date: Monday, April 2nd, 2013 4:00 p.m.5:30 p.m. (EDT).

Place: All meetings announced herein will be held by conference call. The callin line is: 18668235144, Passcode: 1375705. Space is limited so please RSVP to partnerships@hhs.gov to participate.

Status: Open to the public, limited only by lines available.

Purpose: The Council brings together leaders and experts in fields related to the work of faithbased and neighborhood
organizations in order to: Identify best practices and successful modes of delivering social services; evaluate the need for improvements in the implementation and coordination of public policies relating to faithbased and other neighborhood
organizations; and make recommendations for changes in policies, programs, and practices.

Contact Person for Additional Information: Please contact Ben O'Dell f

Wed, Mar 20 2013 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed changes to the currently approved
[[Page 17211]]
information collection project: ``Medical Expenditure Panel Survey Insurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 35013521, AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on December 26th, 2012 and allowed 60 days for public comment. Two comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

Wed, Mar 20 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary(OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Wed, Mar 20 2013 11:00:00 GMT

The Food and Drug Administration (FDA or we) is correcting a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would amend our regulation for current good manufacturing practice in manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and riskbased preventive controls for human food. That proposed rule also would revise certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' We proposed these actions as part of our announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The document published with several typographical errors, styli

Wed, Mar 20 2013 11:00:00 GMT

This notice announces the availability of the final Toxicological Profile for Uranium prepared by ATSDR.

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Mar 20 2013 11:00:00 GMT

The Administration on Aging (AoA), now part of the Administration for Community Living, is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Wed, Mar 20 2013 11:00:00 GMT

The Food and Drug Administration (FDA or we) is correcting the preamble to a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would establish sciencebased minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA proposed these standards as part of our implementation of the FDA Food Safety Modernization Act. The document published with several technical errors, including some errors in cross references, as well as several errors in reference numbers cited throughout the document. This document corrects those errors. We are also placing a corrected copy of the proposed rule in the docket.

Wed, Mar 20 2013 11:00:00 GMT

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 4431984.

HRSA especially requests comments on: (1) The necessity and utility of the
[[Page 17218]]
proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be coll

Wed, Mar 20 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations regarding advisory committees to address minor technical changes and corrections to statutory citations. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.

Meetings:

Wed, Mar 20 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, ``Limited Competition:
Collaborative Partnership to Advance Global Biomedical Research Programs (U01).''

Date: April 12, 2013.

Time: 1:00 p.m. to 3:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6700B Rockledge Drive, Bethes

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Mar 20 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs.

Tue, Mar 19 2013 11:00:00 GMT

This document makes changes to the notice published in the February 28, 2013 Federal Register entitled ``Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Division of Acquisition; Public Availability of the Department of Health and Human Services FY 2011 Service Contract Inventory.'' The following should be changed: The notice provided an incorrect URL address: http://www.hhs.gov/grants/servicecontractsfy11.html. The correct URL address is as follows: http://www.hhs.gov/grants/servicecontracts/index.html. The FY 2011 needs to be changed to FY 2012 in the TITLE, ACTION, and SUMMARY sections. This document makes these technical corrections.

Tue, Mar 19 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is establishing a public docket to obtain input on recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' recommendations). FDA is establishing this docket to provide an opportunity for all interested parties to comment on the tobacco companies' recommendations and to share information that will improve FDA's understanding of the tobacco industry and its manufacturing operations.

Medicare and Medicaid Programs:

Tue, Mar 19 2013 11:00:00 GMT

This rule adopts, with technical changes, the interim rule that published February 18, 2011. That interim rule revised the requirements that a longterm care (LTC) facility must meet in order to qualify to participate as a skilled nursing facility (SNF) in the Medicare program, or a nursing facility (NF) in the Medicaid program. The requirements implemented section 6113 of the Patient Protection and Affordable Care Act to ensure that, among other things, in the case of an LTC facility closure, individuals serving as administrators of a SNF or NF provide written notification of the impending closure and a plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate.

Meetings:

Tue, Mar 19 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIA.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute on Aging, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Comm

Tue, Mar 19 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Mon, Mar 18 2013 11:00:00 GMT

International Conference on Harmonisation:

Mon, Mar 18 2013 11:00:00 GMT

The Food and Drug Administration (FDA or the Agency) is considering a proposed change to the International Conference on Harmonisation (ICH) Sl guidance on rodent carcinogenicity testing. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which 2 year rodent carcinogenicity studies add value to that assessment. The basis of this proposed change is the retrospective analyses of several datasets that reflect three decades of experience with such studies. The datasets suggest that knowledge of certain pharmacologic and toxicologic data can sometimes provide sufficient information to anticipate the outcome of 2year rodent studies and their potential value in predicting the risk of human carcinogenicity of a given pharmaceutical. FDA is requesting public comment regarding a proposed change in approach to carcinogenicity assessment, on the prospecti

Mon, Mar 18 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on medical policy issues that may be considered by the CDER Medical Policy Council (Council) in FDA's Center for Drug Evaluation and Research (CDER). These comments will help the Agency identify and address medical policy issues that need clarification through guidance, notice and comment procedures, or other means.

Funding Availabilities:

Mon, Mar 18 2013 11:00:00 GMT

Announcement Type: Initial.
[[Page 16686]]

CFDA Numbers: 93.971, 93.123, and 93.972.

Key Dates

Application Deadline: April 14, 2013, for continuing students.

Application Deadline: April 14, 2013, for new students.

Application Review: May 1324, 2013.

Continuation Award Notification Deadline: June 7, 2013.

New Award Notification Deadline: July 5, 2013.

Award Start Date: August 1, 2013.

Acceptance/Decline of Awards Deadline: August 16, 2013. I. Funding Opportunity Description

The Indian Health Service (IHS) is committed to encouraging American Indians and Alaska Natives to enter the health professions and to assuring the availability of Indian health professionals to serve Indians. The IHS is committed to the recruitment of students for the following programs:

The Indian Health Professions Preparatory Scholarship authorized by Section 103 of the Indian Health Care Improvement Act, Public Law 94437 (1976), as amended (IHCIA), codified at 25 U.S.C. 1613(

Meetings:

Mon, Mar 18 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on May 2, 2013, from 8 a.m. to 6 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 3019778900.

Contact Person: Jamie Waterhouse, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee

Agency Information Collection Activities; Proposals, Submissions, and

Mon, Mar 18 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion PumpPremarket Notification [510(k)] Submissions.''

Start-Up Option Exclusive License:

Mon, Mar 18 2013 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to ZoneOne Pharma, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following US Patent (and all foreign counterparts): Serial No. 6,890,917 entitled, ``Geldanamycin Derivative and Method of Treating Cancer Using Same'' [HHS Ref. E0502000/0US 15]. The patent rights in this invention have been assigned to the Government of the United States of America.

The prospective exclusive evaluation option license territory may be worldwide, and the field of use may be limited to:
The pharmaceutical use in humans of 17dimethylaminoethylamino17 demethoxygeldanamycin (``17DMAG'') as a liposomeencapsulated drug, alone or in combination with other agents, for the treatment of the following types of cancer: ovary, pancreas, metastatic skin, head and neck, colon, kidney, nonsmall cel

Withdrawals of Approvals of Bupropion Hydrochloride Extended-Release

Mon, Mar 18 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is withdrawing approval of Bupropion Hydrochloride (HCl) ExtendedRelease Tablets, 300 Milligrams (mg) (Bupropion HCl ExtendedRelease Tablets 300 mg), under Abbreviated New Drug Application (ANDA) 77415, held by Impax Laboratories, Inc. (Impax), 30831 Huntwood Ave., Hayward, CA 94544, and marketed under the name BUDEPRION XL. Impax has voluntarily requested that approval for this product be withdrawn and waived its opportunity for a hearing.

Debarment Orders:

Mon, Mar 18 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Shu Bei Yuan for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Ms. Yuan was convicted of one felony count under Federal law for conduct relating to the importation into the United States of an article of food. Ms. Yuan was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 31, 2012 (30 days after receipt of the notice), Ms. Yuan had not responded. Ms. Yuan's failure to respond constitutes a waiver of her right to a hearing concerning this action.

Medicare Programs:

Mon, Mar 18 2013 11:00:00 GMT

The proposed rule would revise Medicare Part B billing policies when a Part A claim for an hospital inpatient admission is denied as not medically reasonable and necessary.

Prospective Grants of Exclusive Licenses:

Fri, Mar 15 2013 11:00:00 GMT

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving an exclusive license, in the field of use of in vitro diagnostics for dengue virus infection, to practice the inventions listed in the patent applications referred to below to CTK Biotech Inc., having a place of business in San Diego, California. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications(s) to be licensed are:

U.S. Provisional Application 61/049,342, filed 4/30/2008, entitled ``Engineered, Chimeric West Nile/Dengue Viruses;'' PCT Application PCT/US2009/041824, filed 4/27/2009, entitled
``Engineered, Chimeric WN/Flavivirus as Reagents to Enhance Flavivirus Diagnostics and Vaccine Development;'' U.S. National Stage Application 12/990,322, filed 10/29/2010, entitled ``Chi

Meetings:

Fri, Mar 15 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Clinical Trial Implementation.

Date: April 8, 2013.

Time: 12:00 p.m. to 4:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817.

Contact Person: Gregory P. Jarosik, Ph.D., Scientific

Fri, Mar 15 2013 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: Evaluation of Emergency Department Crisis Center FollowUp New

The Substance Abuse and Mental Health Services Administration's (SAMHSA), Center for Mental Health Services (CMHS) will conduct an evaluation to assess the impact of crisis center followup with patients admitted to emergency departments following a suicide attempt.

The overarching purpose of the proposed Evaluation of Emergency Department Crisis Center FollowupNew is to examine the impact of crisis center followup with patients admitted to emergency departments following a suicide attempt on subsequent emergency department readmissions. In total this evaluation effort includes two data colle

Fri, Mar 15 2013 11:00:00 GMT

The delegation of authorities for Title II, Subpart D, Parts 2 and 5 of the Help America Vote Act are being delegated from the Assistant Secretary, Administration for Children and Families, to the Administrator, Administration for Community Living (ACL). This action is necessary to complete the transition of the Administration on Intellectual and Developmental Disabilities to the Administration for Community Living from the Administration for Children and Families, consistent with the Federal Register notice of reorganization as last amended, 77 FR 2325023260, April 18, 2012.

Institutional Review Boards:

Fri, Mar 15 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations regarding institutional review boards to address a minor correction to the regulatory text and to update contact information. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.

Fri, Mar 15 2013 11:00:00 GMT

Requests for Nominations:

Fri, Mar 15 2013 11:00:00 GMT

HHS is soliciting nominations for a new, non-Federal member of the Advisory Council on Alzheimer's Research, Care, and Services to fill the position of representative of a voluntary health association as described in Public Law 111375 (42 U.S.C. 11225). Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.

Fri, Mar 15 2013 11:00:00 GMT

This notice reflects organizational changes to the Health Resources and Services Administration. This notice updates the functional statement for the Bureau of Primary Health Care (RC). Specifically, this notice: (1) Establishes the Office of National Assistance and Special Populations (RCE); (2) abolishes the Office of Training and Technical Assistance Coordination (RCS) and the Office of Special Population Health (RCG); and (3) updates the functional statement for the Office of the Associate Administrator (RC), the Office of Administrative Management (RCM), the Office of Policy and Program Development (RCH), and the Office of Quality and Data (RCK). Chapter RCBureau of Primary Health

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Mar 15 2013 11:00:00 GMT

Proposed Projects

Title: Request for State Data Needed to Determine Amount of a Tribal Family Assistance Grant.

OMB No.: 09700173.

Description: 42 U.S.C. 612 (Section 412 of the Social Security Act) gives federally recognized Indian Tribes the opportunity to apply to operate a Tribal Temporary Assistance for Needy Families (TANF) program. The Act specifies that the Secretary shall use Statesubmitted data to determine the amount of the grant to the Tribe. This form (letter) is used to request those data from the States. ACF is proposing to extend this information collection without change.

Respondents: States that have Indian Tribes applying to operate a TANF program.
Annual Burden Estimates Number of Average Instrument Number of responses per burden hours Total burden

Administrative Hearings:

Fri, Mar 15 2013 11:00:00 GMT

This notice announces an administrative hearing to be held on April 30, 2013, at the CMS Atlanta Regional Office, Atlanta Federal Center, 3rd Floor, 61 Forsyth Street SW., Suite 3B52, Atlanta, Georgia 303038909, to reconsider CMS' decision to disapprove Florida SPA 12 015.

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Mar 15 2013 11:00:00 GMT

Meetings:

Fri, Mar 15 2013 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463, codified at 5 U.S.C. App. 2), notice is hereby given of the following meeting:

Name: Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC).

Date and Time: April 19, 2013, 9:30 a.m. to 3:00 p.m.

Place: Virtual via Webinar.

Status: The meeting is open to the public. Preregistration is required. For more information on registration and webinar details, please visit the SACHDNC Web site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

Purpose: The Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), as authorized by Public Law 106310, which added section 1111 of the Public Health Service Act, codified at 42 U.S.C. 300b10, was established by Congress to advise the Secretary of the Department of Health and Human Se

Fri, Mar 15 2013 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: Opioid Drugs in Maintenance and Detoxification Treatment of Opioid Dependence42 CFR Part 8 and Opioid Treatment Programs (OTPs) (OMB No. 09300206)Revision

42 CFR part 8 establishes a certification program managed by SAMHSA's Center for Substance Abuse Treatment (CSAT). The regulation requires that Opioid Treatment Programs (OTPs) be certified. ``Certification'' is the process by which SAMHSA determines that an OTP is qualified to provide opioid treatment under the Federal opioid treatment standards established by the Secretary of Health and Human Services. To become certified, an OTP must be accredited by a SAMHSA approved accreditation body. The regulatio

Fri, Mar 15 2013 11:00:00 GMT

Authorities under the Developmental Disabilities Assistance and Bill of Rights Act of 2000 are being delegated from the Assistant Secretary, Administration for Children and Families, to the Administrator, Administration for Community Living (ACL). This action is necessary to complete the transition of the Administration on Intellectual and Developmental Disabilities to the Administration for Community Living from the Administration for Children and Families, consistent with the Federal Register notice of reorganization as last amended, 77 FR 2325023260, April 18, 2012.

Meetings:

Fri, Mar 15 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop entitled: ``Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion Transmissible Agents and Blood Cell Antigens in Blood Donations.'' The purpose of this public workshop is to discuss research and development of multiplex assays and the use of these tests in blood donor screening and blood cell antigen typing. The public workshop has been planned in partnership with the AABB (formerly known as the American Association of Blood Banks), Advanced Medical Technology Association (AdvaMed), America's Blood Centers, Department of Defense, Department of Health and Human Services Office of the Assistant Secretary for Health, and the National Heart, Lung and Blood Institute, National Institutes of Health. The public workshop will include presentations and panel discussions by experts from academic institutions, blood

establishments, industry, and government agencies.

Thu, Mar 14 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570, or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3956974. Written comments should be received within 30 days of this notice.

Proposed Project

Application for Training (OMB No. 09200017, Expiration 03/31/ 2013)RevisionScientific Education and Professional Development Program Office (SEPDPO), Office of Surveillance, Epidemiology and Laboratory Services (OSELS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC offers public health training activities to professionals worldwide. Employees of hospitals, universities, medical centers, laborato

Meetings:

Thu, Mar 14 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committees: Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee.

General Function of the Committees: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 18, 2013, from 8 a.m. to 5 p.m.

Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading ``Resources for You,'' click on ``Public Meetings at the FDA White Oak Campus.'' Please note that visitors to th

Meetings:

Thu, Mar 14 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications or the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Cancer Institute Special Emphasis Panel, NCI Provocative Questions.

Date: March 28, 2013.

Time: 7:30 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Hilton Rockville, 1750 Rockville Pike, Rockville, MD 20852.

Contact Person: Peter J. Wirth, Ph.D., Scientific

Thu, Mar 14 2013 11:00:00 GMT

Meetings:

Wed, Mar 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This 3day public conference includes presentations from key FDA officials and industry experts with small group breakout sessions. The conference is intended for companies of all sizes and employees at all levels.

Date and Time: The public conference will be held on May 1, 2013, from 8:30 a.m. to 5 p.m.; May 2, 2013, from 8:30 a.m. to 5 p.m.; and May 3, 2013, from 8:30 a.m. to 1 p.m.

Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513745 3073 or 5137453396.

Contact Persons: For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 5136792700, Fax: 5136792771, Gina.Brackett@fda.hhs.gov.

For informat

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Mar 13 2013 11:00:00 GMT

Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations:

Wed, Mar 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA or ``we'') is reopening the comment period for a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/
[[Page 15895]]
Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility CoLocated on a Farm'' (the draft RA) that we made available for public comment in the Federal Register of January 16, 2013. We are reopening the comment period to update comments and to receive any new information.

Draft Guidance for Industry and Review Staff; Availability:

Wed, Mar 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.'' This guidance is intended to provide recommendations for industry on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and procedural disputes that cannot be resolved at the division level. This guidance describes procedures for formally appealing such disputes to the office or center level and providing information to assist FDA officials in resolving the issue(s) presented. This guidance revises the guidance of the same name issued in February 2000.

Medicare Program:

Wed, Mar 13 2013 11:00:00 GMT

This document corrects technical errors in the correcting document that appeared in the October 3, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers; Correction.''

Requests for Information:

Wed, Mar 13 2013 11:00:00 GMT

The purpose of this Request for Information (RFI) is to seek broad public input on the Fiscal Year (FY) 20132018 Strategic Plan for the Office of Disease Prevention (ODP), National Institutes of Health (NIH).

Guidance for Industry; Availability:

Wed, Mar 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation.'' This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates tablet splitting, which is the practice of breaking or cutting a higherstrength tablet into smaller portions.) Specifically, this guidance recommends guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet; and nomenclature and labeling for approved scored tablets.

This guidance does not address specific finishedproduct release testing, where additional requirements may apply to scored tablets. This guidance does not describe the medical practice conditions under which tablet splitting is consid

Meetings:

Wed, Mar 13 2013 11:00:00 GMT

Pursuant to Public Law 92463, notice is hereby given of the meeting of the Substance Abuse and Mental Health Services
Administration's (SAMHSA) Center for Substance Abuse Treatment National Advisory Council on April 10, 2013.

The meeting is open to the public and will include a discussion of the Center's current administrative, legislative, and program developments. Public comments are welcome. To attend onsite, or request special accommodations for persons with disabilities, please register at SAMHSA Committees' Web site, http://nac.samhsa.gov/Registration/meetingsRegistration.aspx, or contact the Council's Designated Federal Officer, Ms. Cynthia Graham (see contact information below).

Committee Name: Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment National Advisory Council.

Date/Time/Type: April 10, 2013 9:00 a.m.4:30 p.m. (OPEN).

Place: SAMHSA, 1 Choke Ch

Wed, Mar 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award of a cooperative agreement to the Brookings Institution's Engelberg Center for Health Care Reform (ECHCR) in support of efforts to inform major initiatives for process improvement and regulatory science related to FDA commitments under the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA V).

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Mar 13 2013 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Nursing Research (NINR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 26, 2012, page 76053 and allowed 60days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Nursing Research (NINR), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this

Meetings:

Tue, Mar 12 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held by teleconference on April 17, 2013, from 1:30 p.m. to 5 p.m.

Location: Rockwall II Building, 5515 Security Lane, Conference Room 1033, Rockville, MD 20852. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room.

Contact Person: Gail Dapolito (3018271289) or Rosanna Harvey (3018271297), Food and Drug Administration, 1401 Rockville Pike (HFM 71), Rockville, MD 20852, or FDA Advisory Committee Information Line, 180074

Meetings:

Tue, Mar 12 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Center for Scientific Review Special Emphasis Panel Member Conflict: Computational Biophysics.

Date: April 4, 2013.

Time: 8:00 a.m. to 6:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: Mike Radtke, Ph.D., Scientific Review O

Tue, Mar 12 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary(OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the
[[Page 15726]]
public regarding the burden estimate, below, or any other aspect of the ICR.

Draft Guidance for Industry and Staff; Availability:

Mon, Mar 11 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex.'' The purpose of this draft guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container. FDA is concerned that statements submitted for inclusion in medical product labeling such as ``latexfree,'' ``does not contain natural rubber latex,'' or ``does not contain latex'' are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. This draft guidance is not final nor is it in effect at this time.

Requests for Nominations:

Mon, Mar 11 2013 11:00:00 GMT

The CDC is soliciting nominations for membership on the Advisory Committee on Immunization Practices (ACIP). The ACIP consists of 15 experts in fields associated with immunization, who are selected by the Secretary of the United States Department of Health and Human Services (DHHS) to provide advice and guidance to the Secretary, the Assistant Secretary for Health, and the CDC on the control of vaccinepreventable diseases. The role of the ACIP is to provide advice that will lead to a reduction in the incidence of vaccine preventable diseases in the United States, and an increase in the safe use of vaccines and related biological products. The committee also establishes, reviews, and as appropriate, revises the list of vaccines for administration to children eligible to receive vaccines through the Vaccines for Children (VFC) Program.

Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's object

Mon, Mar 11 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Exposure Assessment and Epidemiological Study of U.S. Workers Exposed to Carbon Nanotubes and Carbon NanofibersNewNational Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. The O

Patient Protection and Affordable Care Act:

Mon, Mar 11 2013 11:00:00 GMT

This final rule provides detail and parameters related to: the risk adjustment, reinsurance, and risk corridors programs; costsharing reductions; user fees for Federallyfacilitated Exchanges; advance payments of the premium tax credit; the Federallyfacilitated Small Business Health Option Program; and the medical loss ratio program. Costsharing reductions and advance payments of the premium tax credit, combined with new insurance market reforms, are expected to significantly increase the number of individuals with health insurance coverage, particularly in the individual market. In addition, we expect the premium stabilization programsrisk adjustment, reinsurance, and risk corridorsto protect against the effects of adverse selection. These programs, in combination with the medical loss ratio program and market reforms extending guaranteed availability (also known as guaranteed issue) and prohibiting the use of factors such as health status, medical history, gender, and industry of employment to

Meetings:

Mon, Mar 11 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Center for Scientific Review Special Emphasis Panel; ODCS Small Business.

Date: March 1314, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: YiHsin Liu, Ph.D., Scientific Review Officer, Center for

Meetings:

Mon, Mar 11 2013 11:00:00 GMT

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is announcing a public workshop to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME). FDA has determined that CFS and ME are serious conditions for which there are no approved drug treatments. On April 25, 2013, as part of FDA's PatientFocused Drug Development initiative, patients will provide feedback on disease impact on quality of life and individual experience with current treatment regimens. On April 26, 2013, there will be discussions with academic and Government experts, patient advocates, patients, and clinicians on how to identify sound, quantitative outcome measures that can be used in clinical trials to determine whether disease symptoms improve with specific drug interventions.

Date and Time: The public workshop will be held on April 25, 2013, fr

Mon, Mar 11 2013 11:00:00 GMT

CDC Oral Health Management Information System (OMB No. 09200739, exp. 5/31/2013)ExtensionNational Center for Chronic Disease Prevention and Public Health Promotion (NCDDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The CDC seeks to improve the oral health of the nation by targeting efforts to improve the infrastructure of state and territorial oral health de

Mon, Mar 11 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

National Disease Surveillance Program (OMB No. 09200009 Expiration 4/30/2013)RevisionNational Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention, (CDC).

Background and Brief Description

Formal surveillance of 16 separate reportable diseases has been ongoing to meet the public demand and scientific interest in accurate, consistent, epidemiologic data. These ongoing disease repo

Patient Protection and Affordable Care Act:

Mon, Mar 11 2013 11:00:00 GMT

This proposed rule would implement provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) related to the Small Business Health Options Program (SHOP). Specifically, this proposed rule would amend existing regulations regarding triggering events and special enrollment periods for qualified employees and their dependents and would implement a transitional policy regarding employees' choice of qualified health plans (QHPs) in the SHOP.

Meetings:

Fri, Mar 8 2013 11:00:00 GMT

The meeting announced below concerns Epidemiology, Prevention and Treatment of Influenza and other Respiratory Infections in Panama and Central America Region, Funding Opportunity Announcement (FOA) IP13 002; and Strengthening Global AnimalHuman Interface Activities for Avian Influenza and other Zoonotic Diseases, FOA CK13002, initial review.

Correction: The notice was published in the Federal Register on February 7, 2013, Volume 78, Number 26, Page 9055. The time and date should read as follows:

Time and Date: 1:00 p.m.3:00 p.m., March 26, 2013 (Closed).

Contact Person for More Information: Gregory Anderson, M.S., M.P.H., Scientific Review Officer, CDC, 1600 Clifton Road, NE., Mailstop E60, Atlanta, Georgia 30333, Telephone: (404) 7188833.

Requests for Nominations:

Fri, Mar 8 2013 11:00:00 GMT

The National Institutes of Health and the Interagency Pain Research Coordinating Committee (IPRCC) are seeking nominations for membership of five working groups established to support efforts to create a comprehensive, population health level strategy for pain prevention, treatment, management, and research as recommended in the 2011 Institute of Medicine report titled ``Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.''

Guidance for Industry; Availability:

Fri, Mar 8 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide'' (SECG) which updates an earlier guidance of similar title. Previously, this guidance restated the legal requirements of FDA's administrative detention regulation. This document also at one time served as FDA's guidance for administrative detention. In October 2011, FDA revised an earlier version of this guidance document to be consistent with the changes made by an interim final rule (IFR) issued in the Federal Register of May 5, 2011, and to serve as guidance for industry on administrative detention. FDA has since issued a final rule adopting the IFR as final without changes which was published in the Federal Register of February 5, 2013. Accordingly, FDA is further revising the existing guidance document to provide guidance intended to help any entity comply with the requirements in FDA's admi

Fri, Mar 8 2013 11:00:00 GMT

Meetings:

Fri, Mar 8 2013 11:00:00 GMT

The National Toxicology Program (NTP) announces a public webinar, ``Human cancer studies on exposure to pentachlorophenol (PCP): Differentiating potential cancer effects of PCP exposure from effects due to occupational coexposures or PCP contaminants.'' The Office of the Report on Carcinogens (ORoC), Division of the NTP (DNTP), National Institute of Environmental Health Sciences (NIEHS) will hold the webinar using Adobe[supreg] Connect^TM, and the public can register to attend.

Fri, Mar 8 2013 11:00:00 GMT

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft 5year plan describing the Agency's approach to further developing and implementing a structured framework for benefitrisk assessment in the human drug and biologic review process and the opportunity for public comment on the draft plan. This plan is part of FDA's commitments that were made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). FDA has published the draft plan on its Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.

Fri, Mar 8 2013 11:00:00 GMT

Proposed Projects:

Title: TANF Quarterly Financial Report, ACF196.

OMB No.: 09700247.

Description: This information collection is authorized under Section 411(a)(3) of the Social Security Act. This request is for renewal of approval to use the Administration for Children and Families' (ACF) 196 form for periodic financial reporting under the Temporary Assistance for Needy Families (TANF) program. States participating in the TANF program are required by statute to report financial data on a quarterly basis. This form meets the legal standard and provides essential data on the use of Federal funds. Failure to collect the data would seriously compromise ACF's ability to monitor program expenditures, estimate funding needs, and to prepare budget submissions required by Congress. Financial reporting under the TANF program is governed by 45 CFR part 265.

Respondents: TANF Agencies.
Annual Burden Estimates

Thu, Mar 7 2013 11:00:00 GMT

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 4431984.

HRSA specifically requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4

Thu, Mar 7 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending certain regulations regarding food and color additives to correct minor errors (such as misspelled chemical names) and to update office names and addresses. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

Thu, Mar 7 2013 11:00:00 GMT

HHS seeks input on a series of potential policy and programmatic changes to accelerate electronic health information exchange across providers, as well as new ideas that would be both effective and feasible to implement. To further accelerate and advance interoperability and health information exchange beyond what is currently being done through ONC programs and the EHR Incentive Program, HHS is considering a number of policy levers using existing authorities and programs.

Thu, Mar 7 2013 11:00:00 GMT

HRSA published a document in the Federal Register of January 7, 2013 (FR Doc. 201300032), regarding organizational changes that update the functional statements for the Office of Management. The administrative code for the Division of Information Technology (IT) Security and Records Management was incorrectly written as RBR at four occasions, on pages 956 and 957.

Correction

In the Federal Register of January 7, 2013, in FR Doc. 201300032, on pages 956 and 957, at four occasions, correct the administrative code for the Division of Information Technology (IT) Security and Records Management to read RB5R.
Dated: February 28, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 201305304 Filed 3613; 8:45 am]
BILLING CODE 416515P

Thu, Mar 7 2013 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI)
[[Page 14798]]

has taken final action in the following case:

Adam C. Savine, Washington University in St. Louis: Based on the report from Washington University in St. Louis (WUSTL) and Respondent's admission, ORI found that Mr. Adam C. Savine, former doctoral student, Department of Psychology, WUSTL, engaged in research misconduct in research supported by National Institute of Mental Health (NIMH), National Institutes of Health (NIH), grant R56 MH066078, National Institute on Drug Abuse (NIDA), NIH, grants F31 DA032152 and R21 DA027821, and National Institute on Aging (NIA), NIH, grant T32 AG00030.

ORI found that the Respondent engaged in research misconduct by falsifying data that were included in the following three publications and six conference abstracts:

Publications

1. Savine, A.C., & Braver, T.S. ``Local and global effects of motivation on cognitive control.'' Cogn Affect Behav Neurosci. 12(4):692718, 2012 Dec

Medicare Program:

Thu, Mar 7 2013 11:00:00 GMT

This notice announces changes to the payment adjustment for lowvolume hospitals and to the Medicaredependent hospital (MDH) program under the hospital inpatient prospective payment systems (IPPS) for FY 2013 in accordance with sections 605 and 606, respectively, of the American Taxpayer Relief Act of 2012.

Meetings:

Thu, Mar 7 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing plans for five meetings to provide an opportunity for public dialogue and feedback on challenges faced by the animal agriculture industry and practicing veterinarians as FDA implements its initiative for the judicious use of medically important antimicrobials in medicated feed or drinking water of foodproducing animals. Particular emphasis will be placed on challenges faced by animal producers in areas that may lack access to adequate veterinary services. The meetings are jointly sponsored by FDA and the U.S. Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS).

Meetings:

Thu, Mar 7 2013 11:00:00 GMT

In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled to be held for the [[Page 14799]]
Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: http://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/index.html

Thu, Mar 7 2013 11:00:00 GMT

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 4431984.

Thu, Mar 7 2013 11:00:00 GMT

Title: Community Services Block Grant (CSBG) Program Model Plan Application.

OMB No.: 09700382.

Description: Sections 676 and 677 of the Community Services Block Grant Act require States, including the District of Columbia and the Commonwealth of Puerto Rico, Tribes, Tribal organizations and U.S. territories applying for Community Services Block Grant (CSBG) funds to submit an application and plan (Model Application Plan). The application plan must meet statutory requirements prior to being funded with CSBG funds. Applicants have the option to submit a detailed application annually or biannually. Entities that submit a biannual application must provide an abbreviated application the following year if substantial changes to the initial application will occur. OMB approval is being sought.

Respondents: State Governments, including the District of Columbia and the Commonwealth of Puerto Rico, Tribal Governments, Tribal Organizations, and U.S. territories.

New Animal Drug Applications:

Thu, Mar 7 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is withdrawing approval of 19 new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.

Solicitation of Nominations:

Thu, Mar 7 2013 11:00:00 GMT

The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of the Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to fouryear terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention of HIV disease and AIDS. The functions of the Council are solely advisory in nature.

Meetings:

Thu, Mar 7 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Human Genome Research Institute Special Emphasis Panel: Clinically Relevant Variation Resource RFA.

Date: March 14, 2013.

Time: 11:00 a.m. to 1:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Human Genome Research Institute, 4th Floor Conference Room, 5635 Fishers Lane, Rockville, MD 20852, (Telephone Conference Cal

Wed, Mar 6 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is to reinstate the use of the previously approved information collection assigned OMB control number 40400010, which expired on 08/31/2011. The 40400010 includes the following forms: SF424 Project Abstract form, SF424 Key Contacts form, and SF424 Performance/Site Location form. The SF424 Project Abstract form and the SF424 Key Contacts form were previously assigned to OMB control number 40400003. EGOV seeks to move these two instruments to the OMB control number 40400010. The ICR also requests categorizing the forms as common forms, meaning HHS will only request approval for its own use of the forms rather than aggregating the burden estimate across all Federal Agencies as was done for previous ac

Wed, Mar 6 2013 11:00:00 GMT

Proposed Projects

Title: ADP & Services Conditions for FFP for ACF.

OMB No.: 09920005.

Description: The Advance Planning Document (APD) process, established in the rules at 45 CFR Part 95, Subpart F, is the procedure by which States request and obtain approval for Federal financial participation in their cost of acquiring Automatic Data Processing (ADP) equipment and services. State agencies that submit APD requests provide the Department of Health and Human Services (HHS) with the following information necessary to determine the States' needs to acquire the requested ADP equipment and/or services:
(1) A statement of need;
(2) A requirements analysis and feasibility study;
(3) A procurement plan;
(4) A proposed activity schedule; and,

(5) A proposed budget.

HHS' determination of a State Agency's need to acquire requested ADP equipment or services is authorized at sections 402(a)(5), 452(a)(1), 1902(a)(4) and 1102 of the Social Security Act.

Respondents: States

Wed, Mar 6 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 and send comments to Ron Otten, at 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Debarment Orders:

Wed, Mar 6 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Cheng Yi Liang, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Mr. Liang was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for the development or approval, of a drug product. Mr. Liang was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Liang failed to respond. Mr. Liang's failure to respond constitutes a waiver of his right to a hearing concerning this action.

Wed, Mar 6 2013 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: Substance Abuse Prevention and Treatment Block Grant Synar Report Format, FFY 20142016(OMB No. 09300222)Revision

Section 1926 of the Public Health Service Act [42 U.S.C. 300x26] stipulates that funding Substance Abuse Prevention and Treatment Block Grant (SABG) agreements for alcohol and drug abuse programs for fiscal year 1994 and subsequent fiscal years require states to have in effect a law providing that it is unlawful for any manufacturer, retailer, or distributor of tobacco products to sell or distribute any such product to any individual under the age of 18. This section further requires that states conduct annual, random, unannounced inspections to

Wed, Mar 6 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is to reinstate the use of the previously approved information collection assigned OMB control number 40400004, which expired on 03/31/2012. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Wed, Mar 6 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395 5806. Written comments should be received within 30 days of this notice.

Proposed Project

Formative Research for the Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting ConsumersNewNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The purpose of this study is to conduct interviews and focus groups in four rounds of data collections (exploratory res

Guidance for Industry and Food and Drug Administration Staff;

Wed, Mar 6 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Investigational Device Exemption (IDE) Guidance for Retinal Prostheses.'' This guidance document describes FDA's recommendations for clinical investigations of medical devices indicated for the treatment of visual impairments resulting from retinal diseases.

Meetings:

Wed, Mar 6 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Multigenic Disease Models.

Date: March 20, 2013.

Time: 9:00 a.m. to 11:00 a.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

Contact Person: Cathy J.

Wed, Mar 6 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is to reinstate the use of the previously approved information collection assigned OMB control number 40400003, which expired on 11/30/2011. The 40400003 previously included the Project Abstract and Key Contacts Form. Those forms are no longer included in 40400003 and shall be moved to OMB control number 40400010. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect

Wed, Mar 6 2013 11:00:00 GMT

Meetings:

Tue, Mar 5 2013 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), notice is hereby given of the following meeting:

Name: Advisory Commission on Childhood Vaccines (ACCV).

Date and Time: March 07, 2013, 10:00 a.m. to 4:00 p.m. EDT.

Place: Audio Conference Call.

The ACCV will meet on Thursday, March 7, from 10:00 a.m. to 4:00 p.m. (EDT). The public can join the meeting via audio conference call by dialing 18003693104 on March 7 and providing the following information:

Leader's Name: Dr. Vito Caserta.

Password: ACCV.

Agenda: The agenda items for the March meeting will include, but are not limited to: Updates from the Division of Vaccine Injury Compensation (DVIC), Department of Justice (DOJ), National Vaccine Program Office (NVPO), Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health) and Center for Biologics, Evaluation and Research (Food a

Tue, Mar 5 2013 11:00:00 GMT

Dated: February 22, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 201304946 Filed 3413; 8:45 am]
BILLING CODE 416515P

Draft Guidance for Industry; Availability:

Tue, Mar 5 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry (GFI 116) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R)). This draft revised guidance is a revision of a final guidance on the same topic for which a notice of availability was published in the Federal Register of January 4, 2002, and has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In this draft revised VICH guidance the recommendation for a second test to evaluate the potential of a chemical to produce chromosomal effects is being revised. The draft revised guidance indicates that the potential of a chemical to produce chromosomal effects can be evaluated using one of the the following three tests: An in vitro chromosomal aberrations test using metaphase analysis, which detec

Meetings:

Tue, Mar 5 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Understanding Environmental Control of Epigenetic/Mechanisms.

Date: March 27, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709.

Contact Per

Tue, Mar 5 2013 11:00:00 GMT

Section 30.18 of the Department of Health and Human Services' claims collection regulations (45 CFR part 30) provides that the Secretary shall charge an annual rate of interest, which is determined and fixed by the Secretary of the Treasury after considering private consumer rates of interest on the date that the Department of Health and Human Services becomes entitled to recovery. The rate cannot be lower than the Department of Treasury's current value of funds rate or the applicable rate determined from the ``Schedule of Certified Interest Rates with Range of Maturities'' unless the Secretary waives interest in whole or part, or a different rate is prescribed by statute, contract, or repayment agreement. The Secretary of the Treasury may revise this rate quarterly. The Department of Health and Human Services publishes this rate in the Federal Register.

The current rate of 10\5/8\%, as fixed by the Secretary of the Treasury, is certified for the quarter ended December 31, 2012. This in

Draft Guidance for Industry and Staff; Availability:

Tue, Mar 5 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed in connection with the Medical Device User Fee Amendments of 2012 (MDUFA III) and to incorporate additional types of communication, all of which increase the efficiency of the review process. This draft guidance is not final nor is it in effect at this time.

Tue, Mar 5 2013 11:00:00 GMT

In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing the opening of a docket to provide stakeholders and other interested parties an opportunity to submit comments and information that will help the Agency as it forms its own recommendations, to be contained in the Agency's report to Congress, and as it implements the FSMA provisions relating to the tracking and tracing of food.

Tue, Mar 5 2013 11:00:00 GMT

This notice reflects organizational changes to the Health Resources and Services Administration. This notice updates the functional statement for the Office of Federal Assistance Management (RJ). Specifically, this notice: (1) Moves the grant officer and loan officer function from the Office of the Associate Administrator (RJ) to the Division of Grants Management Operations (RJ3); and (2) moves the electronic grant management system function from the Division of Grants Management Operations (RJ3) to the Office of the Associate Administrator (RJ).
Chapter RJOffice of Federal Assistance Management
Section RJ20, Functions
(1) Delete the functional statement for the Office of the Associate

Guidance for Industry; Availability:

Tue, Mar 5 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (GFI 159) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological Acceptable Daily Intake (ADI),'' (VICH GL36(R)). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide guidance for assessing the human food safety of residues from veterinary antimicrobial drugs with regard to effects on the human intestinal flora.

Debarment Orders:

Tue, Mar 5 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Adrian Vela for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Vela was convicted of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Vela was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 3, 2012 (30 days after receipt of the notice), Mr. Vela had not responded. Mr. Vela's failure to respond constitutes a waiver of his right to a hearing concerning this action.

Mon, Mar 4 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Laboratory Response Network (LRN)09200850Extension (expiration 5/31/13)National Center for Emerging and Zoonotic Infections (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description

The Laboratory Response Network (LRN) was established by the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC) in accordance with Presidential Decision Directive 39, which

Medical Devices:

Mon, Mar 4 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used to provide a means for a person with a mobility impairment caused by injury or other disease to move from one level to another, usually in a wheelchair. This order exempts wheelchair elevators, class II devices, from premarket notification and establishes conditions for exemption for this device that will provide a reasonable assurance of the safety and effectiveness of the device without submission of a premarket notification (510(k)). This exemption from 510(k), subject to these conditions, is immediately in effect for wheelchair elevators. All other devices classified under FDA's wheelchair elevator regulations, including attendantoperated stair climbing devices for wheelchairs and portable platform lifts, continue to require

Determinations that Products were Not Withdrawn from Sale for Reasons of Safety or

Mon, Mar 4 2013 11:00:00 GMT

The Food and Drug Administration (FDA) has determined that GEREF (Sermorelin Acetate)
[[Page 14096]]
injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, if all other legal and regulatory requirements are met.

Mon, Mar 4 2013 11:00:00 GMT

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809).

A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Man

Guidance for Industry and Staff; Availability:

Mon, Mar 4 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Pulse OximetersPremarket Notification Submissions [510(k)s].'' This guidance document pertains to noninvasive pulse oximeters intended for prescription use to measure arterial blood oxygen saturation (SpO2) and pulse rate. This document supersedes the General Guidance Document entitled ``Device: NonInvasive Pulse Oximeter'' issued on September 7, 1992, and represents the Agency's current thinking in regards to information that should be included in a premarket submission for a noninvasive pulse oximeter.

Mon, Mar 4 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Ron Otten, at 1600 Clifton Road, MS D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the [[Page 14093]]
proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the

Meetings:

Mon, Mar 4 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business NonHIV Diagnostics, Food Safety,
Sterilization/Disinfection and Bioremediation.
[[Page 14098]]

Date: March 78, 2013.

Time: 8:00 a.m. to 5:30 p.m.

Agenda: To review and evaluate grant applications.

Place: Hyatt Regency Hotel, Cabinet/Judiciary, One Bethesda Metro Center, Bethesda, MD 2

Mon, Mar 4 2013 11:00:00 GMT

The Food and Drug Administration (FDA or ``we'') is reopening the comment period for the interim final rule entitled ``Use of Materials Derived From Cattle in Human Food and Cosmetics'' that published in the Federal Register of July 14, 2004 (69 FR 42256). The interim final rule prohibited the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. In the Federal Register of September 7, 2005 (70 FR 53063), we amended the interim final rule to make changes, including providing that the small intestine of cattle, formerly prohibited cattle material, could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. Since 2005, peerreviewed studies have been published showing the presence of infectivity in the proximal ileum, jejunum, ileocec

Fri, Mar 1 2013 11:00:00 GMT

Meetings:

Fri, Mar 1 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the NIH Advisory Board for Clinical Research.

The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended to discuss personnel matters, the disclosure of which would constitute a clearly unwarranted invasion of privacy.

Name of Committee: NIH Advisory Board for Clinical Research.

Date: March 18, 2013.

Open: 10:00 a.m. to 1:15 p.m.

Agenda: To review the FY14 Clinical Center Budget.

Place: National Institutes of Health, Building 10, 10 Center Drive, CRC Medical B

Meetings:

Fri, Mar 1 2013 11:00:00 GMT

Pursuant to Public Law 92463, notice is hereby given of the meeting on of the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Mental Health Services (CMHS), National Advisory Council meeting on April 10, 2013.

The meeting is open to the public and will be held at the SAMHSA building, 1 Choke Cherry Road, Rockville, MD 20857 in the Sugarloaf Conference Room. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions should be forwarded to the contact person on or before one week prior to the meeting. Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the contact on or before one week prior to the meeting. Five minutes will be allotted for each presentation.

Substantive program information may be obtained after the meeting by
[[Page 13883]]
accessing the SAMHSA

Draft Guidances for Industry and Review Staff:

Thu, Feb 28 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Pediatric Information Incorporated into Human Prescription Drug and Biological Products Labeling.'' This draft guidance is intended to assist applicants and FDA review staff in making decisions about the placement and content of pediatric information in human prescription drug and biological products labeling in accordance with the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), as well as FDA prescription drug and biological product labeling regulations.

Meetings:

Thu, Feb 28 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel; Program Projects in Drug
Metabolism.

Date: March 22, 2013.

Time: 1:00 p.m. to 4:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Natcher Building, 45 Center Drive, Room 3An.18K, Bethesda, MD 20892 (Telephone Conference Call).

Thu, Feb 28 2013 11:00:00 GMT

Meetings:

Thu, Feb 28 2013 11:00:00 GMT

The meeting announced below concerns Monitoring CauseSpecific School Absenteeism for Estimating Community Wide Influenza Transmission, Funding Opportunity Announcement (FOA) CK13003; and Quantifying Social Contact Rates and Mixing Patterns in the U.S. Population, FOA CK13004, initial review.

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date: 11:00 a.m.5:00 p.m., April 29, 2013 (Closed).

Place: Teleconference.

Matters to Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ``Monitoring CauseSpecific School Absente

Agency Information Collection Activities; Proposals, Submissions, and

Thu, Feb 28 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on
[[Page 13682]]
the estimated reporting, recordkeeping, and thirdparty disclosure burden associated with the Mammography Quality Standards Act requirements.

Prospective Grants of Exclusive Licenses:

Thu, Feb 28 2013 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in (a) U.S. Patent Application 61/717,960 entitled ``M971 Chimeric Antigen Receptors'' [HHS Ref. E2912012/0US01], and (b) U.S. Patent Application 61/042,239 entitled ``Human Monoclonal Antibodies Specific for CD22'' [HHS Ref. E0802008/0US01], PCT Application PCT/US2009/ 124109 entitled ``Human and Improved Murine Monoclonal Antibodies Against CD22'' [HHS Ref. E0802008/0PCT02], US patent application 12/934,214 entitled ``Human Monoclonal Antibodies Specific for CD22 '' [HHS Ref. E0802008/0US03], and all related continuing and foreign patents/patent applications for these technology families, to Neomune, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

Thu, Feb 28 2013 11:00:00 GMT

Title: Parents and Children TogetherDiscussion Guide.

OMB No.: 09700403.

Description: The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing data collection activity as part of the Parents and Children Together (PACT) Evaluation.

The PACT project is a formative evaluation whose overall objective is to document and provide initial assessment of selected Responsible Fatherhood and Healthy Marriage grant programs that were authorized under the 2010 Claims Resolution Act. This information will be critical to informing decisions related to future investments in this kind of programming as well as the design and operation of such services.

To meet the objective of the study, PACT is utilizing three major, interrelated evaluation strategies:
(a) Impact evaluation;
(b) Implementation evaluation; and

(c) Qualitative evaluation.

To collect data for these strat

Thu, Feb 28 2013 11:00:00 GMT

Determinations; Regulatory Review Period of Patent Extensions:

Thu, Feb 28 2013 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for ZYTIGA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

Meetings:

Thu, Feb 28 2013 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), notice is hereby given that the following committee will convene its seventysecond meeting.

Name: National Advisory Committee on Rural Health and Human Services.

Dates and Time: April 3, 2013, 9:00 a.m.5:00 p.m. April 4, 2013, 9:00 a.m.5:00 p.m. April 5, 2013, 8:45 a.m.11:15 a.m.

Place: Hospice & Palliative Care of Western Colorado, 3090 North 12th Street, Unit B, Grand Junction, CO 81506, Web site:
www.hospicewco.com.

Phone: (970) 2412212.

Status: The meeting will be open to the public.

Purpose: The National Advisory Committee on Rural Health and Human Services provides advice and recommendations to the Secretary with respect to the delivery, research, development, and administration of health and human services in rural areas.

Agenda: Wednesday morning, at 9:00 a.m., the meeting will be called to order by the Chairman of the Committee,

Agency Information Collection Activities; Proposals, Submissions, and

Thu, Feb 28 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the
[[Page 13689]]
following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collect

Thu, Feb 28 2013 11:00:00 GMT

In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2011 Service Contract inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2011. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at http://www.whitehouse.gov/sites/default/files/omb/procurement/memo/servicecontractinventoriesguidance11052010.pdf. HHS has posted its inventory and a summary of the inventor

Thu, Feb 28 2013 11:00:00 GMT

Wed, Feb 27 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Prevalence Survey of HealthcareAssociated Infections (HAIs) in Acute Care Hospitals in the United StatesExtension(09200852 exp.5/ 31/13)National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Preventing healthcareassociated infections (HAIs) is a CDC priority. An essential step in reducing the occurrence of HAIs is to estimate accurately the b

Wed, Feb 27 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6395960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395 5806. Written comments should be received within 30 days of this notice.

Proposed Project

Requirements for the Importation of Nonhuman Primates into the United States (formerly Requirements for a Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States) (OMB Control No. 09200263 Exp.6/30/2014)RevisionNational Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description

Meetings:

Wed, Feb 27 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel Research Careers in Environmental Health.

Date: March 19, 2013.

Time: 1:00 p.m. to 4:30 p.m.

Agenda: To review and evaluate grant applications.

Place: NIEHS/National Institutes of Health, Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27709, (Telephone Confer

Prospective Grants of Exclusive Licenses:

Wed, Feb 27 2013 11:00:00 GMT

HHS Ref. No. E0931997/0 ``Food Quality Indicator;'' [[Page 13366]]

Patent application No. Territory Filing date Status 61/052,674......................... US July 16, 1997......... Expired. PCT/US1998/14780................... Int'l July 16, 1998......... Nationalized. 7,014,816.......................... US July 16, 1998......... Issued (expires July 16, 2017). 782088............................. AU July 16, 1998......... Issued (expires July 16, 2018). 1007645160....................... KR July 16, 1998......... Issued (expires July 16, 2

Meetings:

Wed, Feb 27 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 25 and 26, 2013, from 8 a.m. to 6 p.m.

Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. The hotel phone number is 3019488900.

Contact Person: Sara J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 66, rm. 1611, Silver Spring, MD 209930002,
Sara.Anderson@fda.hhs.gov, 3017967047, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area). A notice in the Fed

Medicare Program:

Wed, Feb 27 2013 11:00:00 GMT

This notice announces changes to the meeting date and time, location, and format of the first semiannual public meeting of 2013 that was announced and published in the Federal Register on November 26, 2012, entitled ``Medicare Program; SemiAnnual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP Panel)March 11 and 12, 2013.''

Patient Protection and Affordable Care Act:

Wed, Feb 27 2013 11:00:00 GMT

This final rule implements provisions related to fair health insurance premiums, guaranteed availability, guaranteed renewability, single risk pools, and catastrophic plans, consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The final rule clarifies the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are nonfederal governmental plans. This final rule also amends the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under the federal rate review program, and revises the timeline for states to propose state specific thresholds for review and approval by the Centers for Medicare & Medicaid Services (CMS).

Wed, Feb 27 2013 11:00:00 GMT

Draft Guidance for Industry; Availability:

Tue, Feb 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The draft guidance document provides revised recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The draft guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice replaces the draft guidance entitled, ``Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis,'' dated June 2003. In addition, the draft guidance, when finalized, is intended to supersede the FDA memorandum to registered blood establishments dated December 12, 1991, entitled, ``Clarification of FDA Recommendations for Donor Defer

Tue, Feb 26 2013 11:00:00 GMT

Title: Child Care and Development Fund Plan for States/Territories for FFY 20142015 (ACF118).

OMB No.: 09700114.

Description: The Child Care and Development Fund (CCDF) Plan (the Plan) for States and Territories is required from each CCDF Lead agency in accordance with Section 658E of the Child Care and Development Block Grant Act of 1990, as amended (Pub. L. 101508, Pub. L. 104193, and 42 U.S.C. 9858). The implementing regulations for the statutorily required Plan are set forth at 45 CFR 98.10 through 98.18. The Plan, submitted on the ACF118, is required biennially, and remains in effect for two years. The Plan provides ACF and the public with a description of, and assurance about, the States' and Territories' child care programs. The ACF118 is currently approved through December 31, 2013, making it available to States and Territories needing to submit Plan Amendments through the end of the FY 2013 Plan Period. However, on July 1, 2013, States and Territories will be required to sub

Tue, Feb 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDAregulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.

Guidance for Clinical Investigators, Industry, and Staff; Availability:

Tue, Feb 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the most frequently asked questions regarding financial disclosure by clinical investigators. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2011 and replaces the guidance entitled, ``Guidance for Industry: Financial Disclosure by Clinical Investigators,'' dated March 2001.

Agency Information Collection Activities; Proposals, Submissions, and

Tue, Feb 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's regulations on foreign clinical studies not conducted under an investigational new drug application (IND).

Tue, Feb 26 2013 11:00:00 GMT

Title: Child Care and Development Fund Tribal Plan PreprintACF 118A.

OMB No.: 09700198.

Description: The Child Care and Development Fund (CCDF) Plan (the Plan) for Tribes (Indian Tribes, Tribal consortia and Tribal organizations) is required from each CCDF Lead agency in accordance with Section 658E of the Child Care and Development Block Grant Act of 1990, as amended (Pub. L. 101508, Pub. L. 104193, and 42 U.S.C. 9858). The implementing regulations for
[[Page 13062]]
the statutorily required Plan are set forth at 45 CFR 98.10 through 98.18. The Plan, submitted on the ACF 118A, is required biennially, and remains in effect for two years. The Plan provides ACF and the public with a description of, and assurance about, the Tribal child care program. The ACF 118A is currently approved through May 31, 2014, making it available to Tribes needing to submit Plan Amendments through the end of the FY 2013 Plan Period. However, on July 1, 2013, Tribes will be required to submit their FY 2014201

Tue, Feb 26 2013 11:00:00 GMT

Guidance for Industry; Availability:

Tue, Feb 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of an Acceptable FullLength and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma'' dated February 2013. The guidance document recognizes the standardized fulllength and abbreviated donor history questionnaires and accompanying materials, version 1.2 dated September 2012, as an acceptable mechanism that is consistent with FDA's requirements and recommendations for collecting Source Plasma donor history information. The Plasma Protein Therapeutics Association (PPTA) Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) will provide blood establishments that collect Source Plasma with a specific process for administering questions to Source Plasma donors to determine their eligibility to donate. The guidance announced in this notice finalizes the draft guidance of the sa

Debarment Orders:

Tue, Feb 26 2013 11:00:00 GMT

The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Richard Stowell for a period of 3 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Stowell was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. 335a(l)(1)(B)), of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Stowell was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 14, 2012, Mr. Stowell had not responded. Mr. Stowell's failure to respond constitutes a waiver of his right to a hearing concerning this action.

Tue, Feb 26 2013 11:00:00 GMT

Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposed interpretive rules, general statements of policy, and rules of agency procedure or practice as they relate to the Fiscal Year (FY) 2013 Funding Opportunity Announcements (FOA) for the following programs: (1) Social and Economic Development Strategies (hereinafter referred to as SEDS); (2) Native Asset Building Initiative (hereinafter referred to as NABI); (3) Sustainable Employment and Economic Development Strategies (hereinafter referred to as SEEDS); (4) Native Language Preservation and M

Meetings:

Tue, Feb 26 2013 11:00:00 GMT

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, May 1, 2013. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on selected genetic tests for cancer diagnosis (for cancers of unknown primary site and for cervical cytology findings of uncertain clinical significance). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

Meetings:

Tue, Feb 26 2013 11:00:00 GMT

The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Seventh Annual DIA/FDA Statistics Forum2013.'' The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical investigators who are involved in the development of new drugs and biologics. A primary focus for this meeting will be to establish an ongoing dialogue regarding FDA's ``Critical Path'' initiativeemphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress being made in designing and implementing innovative solutions.

Human Subject Protection:

Mon, Feb 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As p

Guidance for Industry; Withdrawal:

Mon, Feb 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA or we) is announcing the withdrawal of a guidance entitled ``Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act,'' dated April 2006, that was announced in the Federal Register on May 2, 2006. The guidance explained FDA's then current thinking on the labeling of certain uses of lecithin derived from soy under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and was part of FDA's implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA). We are taking this action because the policy stated in the guidance regarding FDA's consideration of the exercise of enforcement discretion no longer reflects our current thinking.

Mon, Feb 25 2013 11:00:00 GMT

Patient Protection and Affordable Care Act:

Mon, Feb 25 2013 11:00:00 GMT

This final rule sets forth standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this final rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This rule also finalizes a timeline for qualified health plans to be accredited in Federallyfacilitated Exchanges and amends regulations providing an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.

Mon, Feb 25 2013 11:00:00 GMT

Pursuant to Public Law 92463, notice is hereby given of the combined meeting on March 15, 2013, from 1:30 p.m. to 3:00 p.m. EST via teleconference, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) four National Advisory Councils (the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC), and the two SAMHSA Advisory Committees (Advisory Committee for Women's Services, and the Tribal Technical Advisory Committee).

The Councils were established to advise the Secretary, Department of Health and Human Services (HHS), the Administrator, SAMHSA, and Center Directors, concerning matters relating to the activities carried out by and through the Centers and the policies respecting such activities.

Under Section 501 of the Public Health Service Act, the Advisory Committee for Women's Services (ACWS) is statutorily mandated to advise the SAMHSA Adm

Guidance for Industry on Labeling for Human Prescription Drug and Biological Products;

Mon, Feb 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological ProductsImplementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the ``Physician Labeling Rule'' (PLR) because it addresses prescription drug labeling that is used by prescribers and other healt

Mon, Feb 25 2013 11:00:00 GMT

Proposed Projects

Title: Annual Survey of Refugees (Form ORR9).

OMB No.: 09700033.

Description: The Annual Survey of Refugees collects information on the social and economic characteristics of a random sample of refugees, Amerasians, and entrants who arrived in the United States in the five years prior to the date of the survey. The survey focuses on employment and other training, labor force participation, and welfare utilization rates. From the responses, the Office of Refugee Resettlement reports on the economic adjustment of refugees to the American economy. These data are used by Congress in its annual deliberations on refugee admissions and funding and by program managers in formulating policies for the future direction of the Refugee Resettlement Program.

Respondents: Refugees, Amerasians, and entrants. Annual Burden Estimates Number of Average

Control of Communicable Diseases:

Mon, Feb 25 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that solicited public comment on updates to the Scope and Definitions for its regulations.

Mon, Feb 25 2013 11:00:00 GMT

The National Toxicology Program (NTP) requests public comments on the Draft Office of Health Assessment and Translation (OHAT) Approach for Systematic Review and Evidence Integration for Literature Based Health AssessmentsFebruary 2013 (available at http://ntp.niehs.nih.gov/go/38138). The NTP also plans to release two protocols to illustrate the application of this framework. These documents were prepared by the OHAT, Division of NTP, National Institute of Environmental Health Sciences (NIEHS). The NTP will hold a public webbased, informational meeting during the publiccomment period to provide an overview of the framework, describe the contents in the casestudy protocols, and respond to questions from the public on any of the documents.

Public Workshops:

Mon, Feb 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), are announcing a public workshop entitled ``Fecal Microbiota for Transplantation.'' The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with fecal microbiota for transplantation (FMT).

[[Page 12764]]

Date and Time: The public workshop will be held on May 2 and 3, 2013, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at Lister Hill Center Auditorium, National Institutes of Health, Bldg. 38A, 8600 Rockville Pike, Bethesda, MD 20894. Preregistered participants will receive additional information on security procedures, parking, and public transportation with their email registration confirmation.

Contact Person: Chris Nguyen, Center for Biologics Evaluation and Resear

Mon, Feb 25 2013 11:00:00 GMT

Title: State SelfAssessment Review and Report.

OMB No.: 09700223.

Description: Section 454(15)(A) of the Social Security Act, as amended by the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, requires each State to annually assess the performance of its child support enforcement program in accordance with standards specified by the Secretary of the Department of Health and Human Services, and to provide a report of the findings to the Secretary. This information is required to determine if States are complying with Federal child support mandates and providing the best services possible. The report is also intended to be used as a management tool to help States evaluate their programs and assess performance.

Respondents: State Child Support Enforcement Agencies or the Department/Agency/Bureau responsible for Child Support Enforcement in each State.
Annual Burden Estimates

Draft Guidance for Industry on Attachment to Guidance on Antiviral Product

Mon, Feb 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Attachment to Guidance on Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data.'' The purpose of this attachment is to assist sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting clinical trials of products in development for the treatment of HCV. HCV resistance data submitted in appropriately formatted datasets is a critical component in the review of investigational antiviral products for the treatment of HCV. The information in this attachment will facilitate the development and regulatory review of antiHCV products.

Mon, Feb 25 2013 11:00:00 GMT

Meetings:

Mon, Feb 25 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Child Health and Human Development Initial Review Group; Pediatrics Subcommittee.

Date: March 14, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Double Tree Hotel Bethesda (Formerly Holiday Inn Select) 8120 Wisconsin Avenue Bethesda, MD 20814.

Contact Person: Rita Anand, Ph.D., Sci

Control of Communicable Diseases:

Mon, Feb 25 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is publishing this document to confirm the effective date of the Direct Final Rule (DFR), published on December 26, 2012 (77 FR 75880).

Mon, Feb 25 2013 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: National Outcome Measures (NOMs) for Substance Abuse Prevention(OMB No. 09300230)Revision

This is a revision to the previously OMB approved instrument for the Center for Substance Abuse Prevention's (CSAP) National Outcome Measures for Substance Abuse Prevention (NOMs). Data are collected from SAMHSA/CSAP grants and contracts where community and participant outcomes are assessed. The analysis of these data helps determine whether progress is being made in achieving SAMHSA/CSAP's mission. The primary purpose of this system is to promote the use among SAMHSA/CSAP grantees and contractors of common National Outcome Measures recommended by SAMHSA/CSAP with si

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Feb 22 2013 11:00:00 GMT

Title: Project LAUNCH CrossSite Evaluation.

OMB No.: 09700373.

Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is collecting data as part of a crosssite evaluation of a Substance Abuse and Mental Health Services Administration(SAMHSA) initiative called Project LAUNCH (Linking Actions for Unmet Needs in Children's Health). Project LAUNCH promotes the healthy development and wellness of children ages birth to eight years. A total of 35 Project LAUNCH grantees are funded to improve coordination among childserving systems, build infrastructure, and improve methods for providing services. Grantees implement a range of public health strategies to support young child wellness in a designated locality.

Grants were awarded in four cohorts. Three of these cohorts will end on a rolling basis over the next three years and one cohort of grantees was recently awarded and will end in five years. Annual estimates of burden take into

Medicare and Medicaid Programs:

Fri, Feb 22 2013 11:00:00 GMT

This proposed notice with comment period acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

Fri, Feb 22 2013 11:00:00 GMT

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Feb 22 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden

Draft Guidance for Industry and Staff:

Fri, Feb 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements.'' This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and identify the reporting requirements for both recalls and product enhancements. This draft guidance is not final nor is it in effect at this time.

Meetings:

Fri, Feb 22 2013 11:00:00 GMT

This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

Fri, Feb 22 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

School Associated Violent Death Surveillance System (09200604, Expiration 1/31/2013)Reinstatement with changeNational Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Division of Violence Prevention (DVP), National Center for Injury Prevention and Control (NCIPC) proposes to maintain a system for the surveillance of schoolassociated homicides a

Regulatory Review Periods for Patent Extensions:

Fri, Feb 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for SAPIEN TRANSCATHETER HEART VALVE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

Medicare Program:

Fri, Feb 22 2013 11:00:00 GMT

This proposed rule would implement medical loss ratio (MLR) requirements for the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program under the Patient Protection and Affordable Care Act.

Applications:

Fri, Feb 22 2013 11:00:00 GMT

This notice announces the application of the Commission on Office Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that COLA meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant COLA deeming authority for a period of 6 years.

Fri, Feb 22 2013 11:00:00 GMT

Meetings:

Fri, Feb 22 2013 11:00:00 GMT

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

Requests for Nominations:

Fri, Feb 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be selfnominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2013.

Meetings:

Thu, Feb 21 2013 11:00:00 GMT

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b21 to b26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Act (at 42 U.S.C. 299b23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR Part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 7073170814. AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow health care providers to voluntarily collect and submit standardized information regarding patient safety events. In order to support the Common Formats, AHRQ has provided technical specifications to promote standardization by ensuring that data collected by PSOs and other entities are clinically

Thu, Feb 21 2013 11:00:00 GMT

The Office of Disease Prevention and Health Promotion published a document in the Federal Register of December 6, 2012, announcing the requirements and criteria for the healthfinder.gov Mobile App Challenge. The document contained inaccurate wording in one subsection of the terms and conditions.

Agency Information Collection Activities; Proposals, Submissions, and

Thu, Feb 21 2013 11:00:00 GMT

Title: Tracking of the Early Head Start Research and Evaluation Project (EHSRET) Sample.

OMB No.: 09700388.

Description: The EHSREP is a longitudinal study originally designed to meet the 1994 requirement for a national evaluation of the Early Head Start program. Child and family assessments were conducted when children were 14 months old, 24 months old, 36 months old, in the spring prior to kindergarten entry, and again in the spring of the sixth year of formal schooling (5th grade for most children). Today, children of the EHSREP are approximately 1417 years of age (depending on their age at the time of enrollment in the study).

The Administration for Children and Families (ACF) within the Department of Health and Human Services (HHS) is proposing to track the children/families who participated in the Early Head Start Research and Evaluation Project (EHSREP) until the children reach 18 years of age. The purpose of tracking these participants is to maintain uptodate contact info

Thu, Feb 21 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is studying the potential effects of extreme weather and natural disasters on medical device safety and quality. FDA is announcing at this time its request for comments on the topic of extreme weather effects on medical device safety and quality.

Meetings:

Thu, Feb 21 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Demographic/Behavioral Population Science.

Date: March 12, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Hotel Lombardy, 2019 Pennsylvania Avenue NW., Washington, DC 20006.

Contact Person: Marita R. Hopmann, Ph.D., Scient

Thu, Feb 21 2013 11:00:00 GMT

Information Collection Request Title: Drug Pricing Program Reporting Requirements (OMB No. 09150176)[Extension].

Abstract: Section 602 of Public Law 102585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act), ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B provides that a manufacturer who s

Meetings:

Thu, Feb 21 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (Agency or FDA). The meeting will be open to the public.

Name of Committee: Device Good Manufacturing Practice Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 11, 2013, from 8 a.m. to 6 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 3019778900.

Contact Person: Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 66, rm. 1544, Silver Spring, MD 209930002, 3017965290,
Natasha.Facey@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area). A notice in the Federal Regis

Meetings:

Thu, Feb 21 2013 11:00:00 GMT

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

Thu, Feb 21 2013 11:00:00 GMT

The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment to the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The ACBTSA is a federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to fouryear terms.

Meetings:

Thu, Feb 21 2013 11:00:00 GMT

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Pesticide Handler Personal Protective Technology Stakeholder Meeting''.

Stakeholder Meeting Time and Date:
4 p.m.6 p.m. EDT, March 25, 2013 [Optional]

8 a.m.6 p.m. EDT, March 26, 2013.

Place: NIOSH, Patriots Plaza 1, 395 E. Street, SW., Room 9000, Washington, DC 20201. This meeting will also be accessible remotely through Live Meeting with advanced registration.

Purpose of the Meeting: This meeting is being held to motivate and educate pesticide handlers and pesticide workers to use best pesticide personal protective equipment practices. This stakeholder meeting allows NIOSH to facilitate focused communication and exchange ideas and solutions between key stakeholder groups. Stakeholder feedback is sought to provide input to future updates of the NIOSH Personal [[Page 12066]]
Protective Technology program research agenda.

Meetings:

Wed, Feb 20 2013 11:00:00 GMT

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110134, notice is hereby given of two 1day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, 640(l)(4)].

Meetings:

Wed, Feb 20 2013 11:00:00 GMT

This document corrects a notice that was published in the Federal Register on February 7, 2013 (78 FR 90559056). The title of the meeting announcement should read as follows: Notice of Meeting of the ICD9CM Coordination and Maintenance Committee. The first sentence of the notice should read as follows: National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff announces the following meeting:

Name: ICD9CM Coordination and Maintenance Committee (C&M) meeting.

Time and Date: 9:00 a.m.5:00 p.m., March 5, 2013.

Place: Centers for Medicare and Medicaid Services (CMS) Auditorium, 7500 Security Boulevard, Baltimore, Maryland 21244.

Meetings:

Wed, Feb 20 2013 11:00:00 GMT

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email acmh@osophs.dhhs.gov.

Meetings:

Wed, Feb 20 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel; Translational Research in Diabetes, Obesity and Endocrinology Disorders.

Date: March 13, 2013.

Time: 8:00 a.m. to 6:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: Nanc

Wed, Feb 20 2013 11:00:00 GMT

Title: Child Support Document Exchange System (CSDES)

OMB No.: New Collection

Description: The federal Office of Child Support Enforcement (OCSE) is implementing a new application, the Child Support Document Exchange System (CSDES), within the Federal Parent Locator Service (FPLS) Child Support Services Portal (CSSP). The CSDES will collect and maintain certain child and spousal support caserelated records provided by a state IVD child support agency to facilitate the dissemination of IVD child and spousal support information to authorized users acting on behalf of a state IVD child support agency.
42 U.S.C. 666(c)(1)(A)(B)(C) and (D) and 42 U.S.C. 653(a)(1).

The purpose of the information collection is to provide technical assistance to the states to help them establish effective systems for collecting child and spousal support.

42 U.S.C. 652(a)(7). This will help state IVD agencies in fulfilling the federal requirement to transmit requests for child support case information a

Wed, Feb 20 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Evaluation of Dating Matters: Strategies to Promote Healthy Teen Relationships^TM (OMB 09200941, Expiration 06/30/ 2015)REVISIONNational Center for Injury Prevention and Control (NCIPC)Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Dating Matters: Strategies to Promote Healthy Teen Relationships^TM is the Centers for Disease Control and Prevention's new teen dating vio

Charter Renewals:

Wed, Feb 20 2013 11:00:00 GMT

This gives notice under the Federal Advisory Committee Act (Pub. L. 92463) of October 6, 1972, that the Board of Scientific Counselors, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2year period through February 3, 2015.

For information, contact Dr. Roger Rosa, Executive Secretary, Board of Scientific Counselors, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Department of Health and Human Services, CDC/Washington Office, HHH Building, 200 Independence Ave SW., Room 715H, MS P12, Washington, DC 20201 telephone 202/2057856 or fax 202/2604464.

Wed, Feb 20 2013 11:00:00 GMT

Title: Child Care and Development Fund Plan for States/Territories for FFY 20122013 (ACF118).

OMB No.: 09700114.

Wed, Feb 20 2013 11:00:00 GMT

Exclusive Licenses:

Wed, Feb 20 2013 11:00:00 GMT

Intellectual Property: U.S. provisional patent application no. 61/582, 723 filed January 3, 2012 entitled ``Native and Agonist CTL Epitopes of the MUC1 Tumor Antigen'' [HHS Ref. No. E0012012/0US 01] as well as all international applications, continuation applications and divisional applications.

The patent rights in these inventions have been assigned to the government of the United States of America.

The prospective exclusive license territory may be worldwide and the field of use will be limited to the use of Licensed Patent Rights for development of Poxvirus based vaccines for bladder cance

Wed, Feb 20 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) have filed a petition requesting that the Agency amend the standard of identity for milk and 17 other dairy products to provide for the use of any safe and suitable sweetener as an optional ingredient. FDA is issuing this notice to request comments, data, and information about the issues presented in the petition.

Meetings:

Tue, Feb 19 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Allogeneic Transplant Recipient Research Resource.

Date: March 7, 2013.

Time: 1:00 p.m. to 4:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Room 7192, Bethesda, MD 20892 (Telephone Conference Call).

Contact Pers

Tue, Feb 19 2013 11:00:00 GMT

The Food and Drug Administration (FDA or ``we'') is extending the comment period for the information collection related to the proposed rule on ``Current Good Manufacturing Practice and Hazard Analysis and RiskBased Preventive Controls for Human Food'' that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.

Request for Information:

Tue, Feb 19 2013 11:00:00 GMT

The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD), National Institutes of Health (NIH), is issuing a Request for Information (RFI) as part of the National Children's Study's (NCS) effort to engage communities and receive public input on specific design questions for incorporation into the Main Study Design of the NCS. The information obtained from RFI responses will be used to guide the construction of decision points or parameters for the Main Study design over the next 1218 months. This RFI was preceded by a workshop with the National Academy of Sciences which posed similar questions. For background information on this workshop, please visit: http://www.nationalchildrensstudy.gov/research/workshops/Pages/nationalacademyofsciencesworkshop.aspx.

Agency Information Collection Activities; Proposals, Submissions, and

Tue, Feb 19 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of
[[Page 11652]]
information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Manufactured Food Regulatory Program Standards.''

Tue, Feb 19 2013 11:00:00 GMT

The Food and Drug Administration (FDA or ``we'') is extending the comment period for the information collection provisions of the proposed rule on ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.

Meetings:

Tue, Feb 19 2013 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), notice is hereby given of the following meeting:

Name: Advisory Committee on Organ Transplantation (ACOT).

Date and Time: March 7, 2013, 10:00 a.m. to 4:00 p.m. Eastern Time.

Place: The meeting will be via audio conference call and Adobe Connect Pro.

Status: The meeting will be open to the public.

Purpose: Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, and 42 CFR 121.12 (2000), ACOT was established to assist the Secretary in enhancing organ donation, ensuring that the system of organ transplantation is grounded in the best available medical science, and assuring the public that the system is as effective and equitable as possible, thereby, increasing public confidence in the integrity and effectiveness of the transplantation system. ACOT is composed of up to 25 members including the Chair. Members are serving as Special Government Em

Draft Guidance for Industry and Staff; Availability:

Tue, Feb 19 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.

Tue, Feb 19 2013 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: Services Accountability Improvement System(OMB No. 0930 0208)Extension

This is an extension to the previously OMB approved instrument. The Services Accountability Improvement System (SAIS), which is a real time, performance management system that captures information on the substance abuse treatment and mental health services delivered in the United States. A wide range of client and program information is captured through SAIS for approximately 600 grantees. Substance abuse treatment facilities submit their data on a monthly and even a weekly basis to ensure that SAIS is an accurate, uptodate reflection on the scope of services delivered and characteristic

Medical Devices; Pediatric Uses of Devices:

Tue, Feb 19 2013 11:00:00 GMT

The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 1, 2010, along with a companion direct final rule. The proposed rule proposed to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. The Agency received significant adverse comment and withdrew the direct final rule. The Agency is issuing this supplemental notice of proposed rulemaking reproposing the amendments reflecting comments received.

Meetings:

Tue, Feb 19 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Neonatal Subcommittee of the Pediatric Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on Friday, March 15, 2013, from 8 a.m. to 4 p.m.

Location: Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910, 3015890800, www.sheratonsilverspring.com. [[Page 11656]]

Contact Person: Walter Ellenberg, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154, Silver Spring, MD 20993, 3017960885, walter.ellenberg@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area). A noti

Tue, Feb 19 2013 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the [[Page 11668]]
Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243.
Project: Transformation Accountability Reporting System(OMB No. 0930 0285) Extension

The Transformation Accountability (TRAC) Reporting System is a realtime, performance management system that captures information on the substance abuse treatment and mental health services delivered in the United States. A wide range of client and program information is captured through TRAC for approximately 700 grantees. This request includes an extension of the currently approved data collection effort.

This information collection will allow SAMHSA to continue to meet the Government Performance and Results Act (GPRA) of 1993 reporting requirements that quantify

Medicare and Medicaid Programs:

Fri, Feb 15 2013 11:00:00 GMT

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2012, relating to the Medicare and Medicaid programs and other programs administered by CMS.

Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers;

Fri, Feb 15 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I.'' The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), requires FDA to establish and publish criteria to reaccredit or deny reaccreditation to persons accredited by FDA under the FD&C Act to perform premarket review of medical devices. This draft guidance describes the accreditation, reaccreditation, and accreditation withdrawal processes, including criteria that will be considered to accredit, reaccredit, deny accreditation to, and deny reaccreditation to third party
[[Page 11205]]
reviewers under the Third Party Review Program. The criteria will facilitate international harmonization and, thereby, in the future, allow us to leverage resources with those of regulating bodies in other countries. This draft guida

Meetings:

Fri, Feb 15 2013 11:00:00 GMT

This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2013 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda.

Guidance for Industry and Staff; Availability:

Fri, Feb 15 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.'' This guidance provides FDA's recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation.

Meetings:

Fri, Feb 15 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Program Project on Intestinal Transport.

Date: April 5, 2013.

Time: 12:00 p.m. to 3:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Confe

Consensus Development Conferences:

Fri, Feb 15 2013 11:00:00 GMT

The National Institutes of Health (NIH) is holding a conference, titled ``Consensus Development Conference: Diagnosing Gestational Diabetes Mellitus.'' The conference will be open to the public.

Meetings:

Fri, Feb 15 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Transmissible Spongiform Encephalopathies Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on March 14, 2013, from 8 a.m. to 4 p.m.

[[Page 11208]]

Location: 5630 Fishers Lane, FDA Conference Room 1066, Rockville, MD 20857. For those unable to attend in person, the meeting will also be Webcast. The Web cast will be available at the following link http://fda.yorkcast.com/webcast/Viewer/?peid=63bc1bd2838040b48eb7db7cbedfc4191d.

Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM71), Food and Drug Administration, 1401 Rockville Pike, Rockville, M

Thu, Feb 14 2013 11:00:00 GMT

Environmental Assessments; Availability, etc.:

Thu, Feb 14 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is extending the comment period for two draft environmental review documents for which a notice of availability appeared in the Federal Register of December 26, 2012. In that notice, FDA made available for comment the Agency's draft environmental assessment (EA) of the proposed conditions of use specified in materials submitted by AquaBounty Technologies, Inc., in support of a new animal drug application (NADA) concerning a genetically engineered (GE) Atlantic salmon and a preliminary finding of no significant impact (FONSI) for those specific conditions of use. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Thu, Feb 14 2013 11:00:00 GMT

The U.S. Department of Health and Human Services announces re- establishment of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (hereafter referred to as ``the Advisory Group''). Authorization to reestablish the Advisory Group is given under Executive Order 13631, dated December 7, 2012.

Thu, Feb 14 2013 11:00:00 GMT

Meetings:

Thu, Feb 14 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of General Medical Sciences Initial Review Group; Training and Workforce Development Subcommittee A.

Date: March 12, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Courtyard by Marriott Chevy Chase, 5520 Wisconsin Avenue, Chevy Chase, MD 20815.

Contact Person: John J. Laffan, Ph.D.,

Meetings:

Wed, Feb 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA), in cosponsorship with the Pharmaceutical Users Software Exchange (PhUSE), is announcing a public conference entitled ``The FDA/PhUSE Annual Computational Science Symposium.'' The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA, industry, and academia, FDA will update participants on current initiatives, and collaborative project groups will address specific challenges in accessing and reviewing data to support product development. These project groups will focus on solutions and practical ways to implement them.

Wed, Feb 13 2013 11:00:00 GMT

To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide onetime noncompetitive Part C funds to the Aaron E. Henry Community Health Center (AEHCHC), Clarksville, Mississippi.

Meetings:

Wed, Feb 13 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Center for Complementary and Alternative Medicine Special Emphasis Panel; Clinical Studies of Complementary and Alternative Medicine.

Date: March 14, 2013.

Time: 1:30 p.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892.

Wed, Feb 13 2013 11:00:00 GMT

Public Workshops:

Wed, Feb 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA) Cincinnati District Office, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled ``Global Quality SystemsAn Integrated Approach to Improving Medical Product Safety.'' This 2day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry.

Wed, Feb 13 2013 11:00:00 GMT

To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will be providing a onetime noncompetitive Part C funds award to DFHS, Lagrange, Georgia.

Wed, Feb 13 2013 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``PatientReported Health Information Technology and Workflow.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 35013521, AHRQ invites the public to comment on this proposed information collection.

Wed, Feb 13 2013 11:00:00 GMT

To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide onetime noncompetitive Part C funds to the Hoboken Community Healthcare, Inc., Hoboken, New Jersey.

Wed, Feb 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is providing public meeting registration information for two FSMA related public meetings announced in the January 31, 2013, Federal Register. These public meetings will be held along with the February 28 to March 1, 2013, Washington, DC public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk based preventive controls for human food (the preventive controls proposed rule). These proposed rules are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meetings is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process

Wed, Feb 13 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the following revised final versions of documents that support making regulatory submissions in
[[Page 10182]]
electronic format using the electronic Common Technical Document (eCTD) specifications: ``The eCTD Backbone Files Specification for Module 1, version 2.1'' (which includes the U.S. regional document type definition, version 3.1), and ``Comprehensive Table of Contents Headings and Hierarchy, version 2.1.'' Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.1 by September 2013 and will give 30 days advanced notice to industry.

Wed, Feb 13 2013 11:00:00 GMT

To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide onetime noncompetitive Ryan White HIV/AIDS Program (Part C) funds to the University of Pittsburgh Medical Center, Presbyterian Shadyside, Pittsburgh, Pennsylvania.

Wed, Feb 13 2013 11:00:00 GMT

Title: Tribal TANF Financial Report (ACF196T).

OMB No.: 09700345.

Description: Tribes use Form ACF196T to report expenditures for the Tribal TANF grant. Authority to collect and report this information is found in the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA), Public Law 104193. Tribal entities with approved Tribal plans for implementation of the TANF program are required by Section 412(h) of the Social Security Act to report financial data. Form ACF196T provides for the collection of data regarding Federal expenditures. Failure to collect this data would seriously compromise the Administration for Children and Families' (ACF) ability to monitor expenditures. This information is also used to estimate outlays and may be used to prepare ACF budget submissions to Congress. Financial management of the program would be seriously compromised if the expenditure data were not collected. 45 CFR part 286 subpart E requires the strictest controls on fundin

Tue, Feb 12 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is amending regulations for the importation of live nonhuman primates (NHPs) by establishing a user fee for filovirus testing of all nonhuman primates that die during the HHS/CDCrequired 31day quarantine period for any reason other than trauma. We are amending the regulations to establish a filovirus testing service at HHS/CDC, because
[[Page 9829]]
testing is no longer being offered by the only private, commercial laboratory that previously performed these tests. This testing service will be funded through user fees.

Tue, Feb 12 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send
[[Page 9920]]
comments to Kimberly Lane, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Agency Information Collection Activities; Proposals, Submissions, and

Tue, Feb 12 2013 11:00:00 GMT

The Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the
[[Page 9928]]
Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to Title III and VII State Program Report.

Tue, Feb 12 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Kimberly Lane, 1600 Clifton Road, MS D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Tue, Feb 12 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 and send comments to Kimberly S. Lane, CDC Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Tue, Feb 12 2013 11:00:00 GMT

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 2761243. Project: Monitoring of National Suicide Prevention Lifeline (OMB No. 09300274)Revision

This proposed project renewal includes the continuation of previously approved data collection activities Monitoring of National Suicide Prevention Lifeline Form (OMB No. 09300274) in an effort to advance the understanding of crisis hotline utilization and its impact. Out of the previously approved 11 data collection instruments and consents, only 6 will be utilized through this revision. The Substance Abuse and Mental Health Services Administration's (SAMHSA), Center for Mental Health Services (CMHS) funds a National Suicide Prevention Lifeline Network, consisting of a tollfree

Meetings:

Tue, Feb 12 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Topics in Microbiology.

Date: February 18, 2013.

Time: 11:00 a.m. to 12:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

Contact Person: Gagan Pandya, Ph.D., Sci

Tue, Feb 12 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Kimberly S. Lane, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Traumatic Brain Injury State Implementation Partnership:

Tue, Feb 12 2013 11:00:00 GMT

The Health Resources and Services Administration (HRSA) will issue funding for a noncompetitive oneyear extension for the State Implementation Partnerships (H21) awards to current grantees whose awards are scheduled to end in fiscal year (FY) 2013. Up to $250,000 per
[[Page 9930]]
grantee will be awarded over a oneyear extended project period.

The HRSA TBI Program was initially authorized by the Traumatic Brain Injury Act of 1996 (Pub. L. 104166) and was most recently reauthorized by the Traumatic Brain Injury Act of 2008 (Pub. L. 110 206). Under this authority, the HRSA TBI Program is charged with improving access to rehabilitation and other services for individuals with traumatic brain injury and their families. The TBI State Implementation Partnership Grants support activities that complement existing state infrastructure to provide needed services following TBI. Through comprehensive and periodic needs and resources assessments, activities supported by grant funds are aligned with the hig

Tue, Feb 12 2013 11:00:00 GMT

To assist the Food and Drug Administration (FDA or Agency) in drafting a strategic plan on drug shortages as required by the Food and Drug Administration Safety and Innovation Act, the Agency is seeking public comment from interested persons on certain questions related to drug and biological product shortages.

Public Conferences:

Mon, Feb 11 2013 11:00:00 GMT

The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom of our industry to create synergies focused on finding solutions which make a difference. Every discussion, exploration, and solution is framed by the goal of delivering increased patient health and safety through topics such as a working session with the Office of the Commissioner on the implementation of the FDA Safety and Innovation Act, Business Impact of Outsourcing, Supplier Management Models that Work, Implementing Quality by Design (QbD) Successfullylike other industries, lunch with global regulators (FDA, Medicine

Mon, Feb 11 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3955806. Written comments should be received within 30 days of this notice. Proposed Project

Evaluation of the National Tobacco Prevention and Control Public Education Campaign (OMB No. 09200923, exp. 2/28/2013)Revision National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description

The Centers for Disease Control and Prevention (CDC) requests a Revision of the current OMB approval for Evaluation

Requests for Nominations:

Mon, Feb 11 2013 11:00:00 GMT

The Health Resources and Services Administration (HRSA) is requesting nominations to fill five (5) vacancies on the National Advisory Council (NAC) on the National Health Service Corps (NHSC). The NAC on NHSC was established in 1978.

Mon, Feb 11 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3956974. Written comments should be received within 30 days of this notice. Proposed Project

Laboratory Medicine Best Practices Project (LMBP) (09200848, exp. 5/31/2013)ExtensionOffice of Surveillance, Epidemiology and Laboratory Services (OSELS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is seeking approval from the Office of Management and Budget (OMB) to collect information from healthcare organizations in order to conduct a systematic review o

Draft FDA/Health Canada Quantitative Risk Assessment:

Mon, Feb 11 2013 11:00:00 GMT

The Food and Drug Administration (FDA or we) is announcing the availability of a draft ``Joint Food and Drug Administration/Health CanadaSant[eacute] Canada Quantitative Assessment of the Risk of Listeriosis From SoftRipened Cheese Consumption in the United States and Canada.'' This draft Quantitative Risk Assessment (the draft QRA) includes an Interpretative Summary, a Technical Report, with Appendixes, and a risk assessment model. The purpose of the draft QRA is to evaluate the effect of factors such as the microbiological status of milk, the impact of cheese manufacturing steps, and conditions during distribution and storage on the overall risk of invasive listeriosis to the consumer in the United States or Canada of soft ripened cheese. The draft QRA makes it possible to evaluate the effectiveness of some process changes and intervention strategies in reducing the risk of listeriosis. We are making the draft QRA available for public comment.

Mon, Feb 11 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Proficiency Testing in US Clinical Laboratories: Perception, Practices and Potential for Expanded UtilityNEWThe Office of Surveillance, Epidemiology and Laboratory Services (OSELS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The primary focus of this project is to conduct a systematic analysis in order to understand which types of laboratories follow Proficiency Testing (PT) and Good Laborat

Draft Guidance for Industry; Availability:

Mon, Feb 11 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Immunogenicity Assessment for Therapeutic Protein Products.'' Therapeutic protein products may elicit immune responses, and these responses may lead to serious or lifethreatening adverse events for the patient or loss of efficacy of the product. This draft guidance is intended to assist manufacturers to develop a riskbased approach in both the preclinical and clinical phases of the development of therapeutic protein products to evaluate and mitigate immune responses that may adversely affect their safety and efficacy.

Mon, Feb 11 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Costs and Cost Savings of Motor Vehicle Injury Prevention: EvidenceBased Policy and Behavioral InterventionsNEWNational Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) is seeking a 1year OMB approval to collect information relating to the costs of implementing motor vehicle injury prevention int

Meetings:

Mon, Feb 11 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR11130: Zebrafish Screens.

Date: March 56, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: John Burch, Ph.D., Scientific Review Officer, Ce

Mon, Feb 11 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Interventions to Reduce Shoulder MSDs in Overhead AssemblyNew National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health
[[Page 9700]]
at work for all people through research and prevention. Under Public Law 91596, sections 20 and 22 (Section

Fri, Feb 8 2013 11:00:00 GMT

Authority: 44 U.S.C. 3101.

Dated: February 4, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 201302900 Filed 2713; 8:45 am]
BILLING CODE 415003P

Draft Guidances for Industry and Staff; Availability:

Fri, Feb 8 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.'' This draft guidance provides responses to questions FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) relating to tobacco products in retail outlets. This draft guidance is not final nor is it in effect at this time.

Medicare, Medicaid, Children's Health Insurance Programs:

Fri, Feb 8 2013 11:00:00 GMT

This final rule will require applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children's Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (``covered recipients''). In addition, applicable manufacturers and applicable group purchasing organizations (GPOs) are required to report annually certain physician ownership or investment interests. The Secretary is required to publish applicable manufacturers' and applicable GPOs' submitted payment and ownership information on a public Web site.

Fri, Feb 8 2013 11:00:00 GMT

International Drug Scheduling; Convention on Psychotropic Substances:

Fri, Feb 8 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/ or public meeting will be considered in preparing the U.S. position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2013. This notice is issued under the Controlled Substances Act (the CSA).

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Feb 8 2013 11:00:00 GMT

Meetings:

Fri, Feb 8 2013 11:00:00 GMT

Name: National Committee on Vital and Health Statistics (NCVHS), Full Committee Meeting.

Time and Date: February 28, 2013, 9:00 a.m.2:45 p.m. EST. March 1, 2013, 9:00 a.m.11:30 a.m. EST.

Place: U.S. Department of Health and Human Services, Hubert H. Humphrey Building, Rm. 705A, 200 Independence Avenue SW.,
Washington, DC 20201.

Status: Open.

Purpose: At this meeting the Committee will hear presentations and hold discussions on several health data policy topics. On the morning of the first day, the Committee will hear updates from the Department (HHS), the Centers for Medicare and Medicaid Services (CMS), the Office of the National Coordinator (ONC), and the Office of Civil Rights (OCR). The Committee will consider plans for 2013 activities and hear from newly appointed Committee members as part of the overview. In preparation for 2013 the Committee will discuss how to maintain the dynamics of working across Subcommittees, as well as how to continue development of its key them

Meetings:

Fri, Feb 8 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; BetaCell Function and Cognition.

Date: March 4, 2013.

Time: 3:00 p.m. to 4:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference

Medical Devices; Ophthalmic Devices:

Fri, Feb 8 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to classify the eyelid weight into class II (special controls). The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure). FDA is also giving notice of its intent to exempt the external eyelid weight device from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device type.

Draft Guidances for Industry; Availability:

Fri, Feb 8 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA's current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that occur before the onset of overt dementia.

Fri, Feb 8 2013 11:00:00 GMT

With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the reopening of a public comment period for a request for information and comment published on October 17, 2012. The request for information sought information and comments from the public regarding whether highly pathogenic avian influenza (HPAI) H5N1 viruses that contain a hemagglutinin (HA) from the Goose/Guangdong/1/96 lineage, and their potential to pose a severe threat to public health and safety. The comment period closed on December 17, 2012. We are reopening the comment period to allow interested persons additional time to prepare and submit comments.

Fri, Feb 8 2013 11:00:00 GMT

Dental Devices:

Thu, Feb 7 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing a proposed order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device ``temporary mandibular condyle reconstruction plate.'' FDA is also issuing the draft special controls guideline, ``Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate,'' which sets forth the special controls that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device.

Medicare Program:

Thu, Feb 7 2013 11:00:00 GMT

This request for information solicits ways in which an eligible professional (EP) might use the clinical quality measures (CQM) data reported to specialty boards, specialty societies, regional health care quality organizations or other nonfederal reporting programs to also report under the Physician Quality Reporting System (PQRS), as well as the Electronic Health Record (EHR) Incentive Program. It also solicits ways by which the entities already collecting CQM data for other reporting programs to submit this data on behalf of EPs and group practices for reporting under the PQRS and the EHR Incentive Program. It also requests information regarding section 601(b) of the American Taxpayer Relief Act of 2012 which provides for treating an EP as satisfactorily reporting data on quality measures if the EP is satisfactorily participating in a qualified clinical data registry. We are requesting information from medical specialty societies, boards, and registries, other third party registry vendors, e

Thu, Feb 7 2013 11:00:00 GMT

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: ``NIOSH Criteria for a Recommended Standard: Occupational Exposure to Hexavalent Chromium'' [2013128].

Thu, Feb 7 2013 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Improving Sickle Cell Transitions of Care through Health Information Technology Phase 1.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 35013521, AHRQ invites the public to comment on this proposed information collection.

Medicare and Medicaid Programs:

Thu, Feb 7 2013 11:00:00 GMT

This proposed rule would reform Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This proposed rule would increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care. This is one of several rules that we are proposing to achieve regulatory reforms under Executive Order 13563 on improving regulation and regulatory review and the Department's plan for retrospective review of existing rules.

Meetings:

Thu, Feb 7 2013 11:00:00 GMT

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Stakeholder Meeting on Respiratory Protection for Healthcare Workers''.

Stakeholder Meeting Time and Date: 8 a.m.5:15 p.m. EDT, June 18, 2013.

Place: CDC Tom Harkin Global Communications Center located at 1600 Clifton Road, Building 19, Atlanta, Georgia 30333. This meeting will also be available by videoconference at select CDC locations.

Purpose of the Meeting: This meeting is being held to exchange ideas and solutions to improve healthcare worker compliance with personal protective technologies (PPT), with a focus on respiratory protection. Stakeholder feedback is sought to (1) provide input to future updates of the NIOSH PPT program research agenda and (2) assess progress toward better respirators for healthcare workers.

This meeting will include presentations and moderated roundtable discussions on ``Improving the E

Requests for Nominations:

Thu, Feb 7 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through December 31, 2013.

FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore encourages nominations of appropriately qualified candidates from these groups.

Thu, Feb 7 2013 11:00:00 GMT

Meetings:

Thu, Feb 7 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

Name of Committee: National Institute of Diabetes and Digestive and Ki

Cooperative Research and Development Agreements and Licensing

Wed, Feb 6 2013 11:00:00 GMT

The National Center for Advancing Translational Sciences (NCATS), the National Institutes of Health (NIH), is seeking Cooperative Research and Development Agreement (CRADA) partners to collaborate in the final stages of lead optimization, in vitro and in vivo evaluation, and preclinical development of a novel series of potent, selective, and orally bioavailable small molecule agonists of the relaxin hormone receptor, RXFP1, for the treatment of heart failure and fibrosis. Interested potential CRADA collaborators will receive detailed information on the current status of the project after signing a confidentiality
[[Page 8545]]
disclosure agreement (CDA) with NCATS.

Wed, Feb 6 2013 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new system of records (SOR) titled, ``Long Term Care Hospitals Quality Reporting Program (LTCH QRP),'' System No. 09700539. The new system will support a new quality reporting program for Long Term Care Hospitals (LTCH) created pursuant to Section 3004 of the Patient Protection and Affordable Care Act of 2010 (ACA) (Pub. L. 111148), amending the Social Security Act (the Act) (42 U.S.C. 1886(m)).

Information Available to Industry:

Wed, Feb 6 2013 11:00:00 GMT

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.

Meetings:

Wed, Feb 6 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group; Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review Committee.

Date: March 1213, 2013.

Time: 8:00 a.m. to 4:00 PM.

Agenda: To review and evaluate grant applications.

Place: Marriott Courtyard Gaithersburg Washingtonian Ctr, 204 Boardwalk Place, Gaithersburg, MD 20

Wed, Feb 6 2013 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new system of records titled, ``Health Insurance Exchanges (HIX) Program,'' to support the CMS Health Insurance Exchanges Program established under provisions of the Affordable Care Act (PPACA) (Pub. L. 111148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111152). The Health Insurance Exchanges (HIX) Program includes Federallyfacilitated Exchanges operated by CMS, CMS support and services provided to all Exchanges and state agencies administering Medicaid, CHIP and the BHP, and CMS administration of advance payment of premium tax credits and costsharing reductions. The system of records will contain personally identifiable information (PII) about certain individuals who apply or on whose behalf an application is filed for eligibility determinations for enrollment in a qualified health plan (QHP) through an Exchange, and for insurance affordability programs. Exchange function

Prescription Drug Labeling Improvement and Enhancement Initiative:

Wed, Feb 6 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive comments on the proposed implementation of FDA's Prescription Drug Labeling Improvement and Enhancement Initiative and on a proposed pilot project relating to the voluntary conversion of labeling to the ``Physician Labeling Rule (PLR)'' format described in the 2006 FDA final rule, ``Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.'' The purpose of the initiative and the pilot project is to enhance the safe and effective use of prescription drugs by facilitating optimal communication through labeling. FDA is seeking public comment on this initiative, and the pilot project, particularly from stakeholders who develop and use prescription drug labeling. Comments received from stakeholders will assist the Agency in identifying and addressing feasibility and implementation issues associated with this initiative.
[[Page 8447]]

Medicare Program:

Wed, Feb 6 2013 11:00:00 GMT

This notice announces a request for applications from organizations to participate in the testing of the Comprehensive End Stage Renal Disease (ESRD) Care Model, a new initiative from the Center for Medicare and Medicaid Innovation (Innovation Center), for a period beginning in 2013 and ending in 2016, with a possible extension into subsequent years.

Wed, Feb 6 2013 11:00:00 GMT

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Feb 6 2013 11:00:00 GMT

Tue, Feb 5 2013 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

Bryan William Doreian, Ph.D., Case Western Reserve University: Based on the admission of the Respondent, ORI found that Dr. Bryan William Doreian, former postdoctoral fellow, Department of Dermatology, Case Western Reserve University (CWRU), engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant T32 HL07887 and National Institute of Neurological Disorders and Stroke (NINDS), NIH, grant R01 NS052123.

ORI found that the Respondent engaged in research misconduct by falsifying data that were included in:

Doreian, B.W. ``Molecular Regulation of the Exocytic Mode in Adrenal Chromaffin Cells.'' Submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy, August 2009; hereafter referred to as the ``Dissertation.''

Doreian, B.W., Fulop,

Tue, Feb 5 2013 11:00:00 GMT

Title: Personal Responsibility Education Program (PREP) Multi Component EvaluationData Collection Related to the Performance Analysis Study and the Impact and the Indepth Implementation Study.

OMB No.: 09700398

Description: The Office of Data Analysis, Research, and Evaluation (HHS/ACF/ACYF/ODARE) in the Administration for Children, Youth and Families (ACYF) and the Office of Planning, Research, and Evaluation (HHS/ACF/OPRE) in the Administration for Children and Families (ACF) propose a data collection activity as part of the Personal Responsibility Education Program (PREP) MultiComponent Evaluation. The goals of the PREP MultiComponent Evaluation are to document how PREP programs are designed and implemented in the field, collect performance measure data for PREP programs, and assess the effectiveness of selected PREPfunded programs.

The PREP MultiComponent Evaluation contains three components: the ``Design and Implementation Study,'' the ``Performance Analysis Study,'' and the

Meetings:

Tue, Feb 5 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications\contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Omnibus Cancer Biology 1.

Date: March 1112, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: Zhiqiang Zou, MD, Ph

Tue, Feb 5 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption'' that published in the Federal Register on May 5, 2011, (the 2011 IFR). This final rule affirms the IFR's change to the criteria for ordering administrative detention of human or animal food as required by the FDA Food Safety Modernization Act (FSMA). Under the new criteria, FDA can order an administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.

Tue, Feb 5 2013 11:00:00 GMT

The U.S. Department of Health and Human Services announces establishment of the 2015 Dietary Guidelines Advisory Committee (hereafter referred to as the Committee or 2015 DGAC). The 2015 DGAC is an expert advisory committee that has been established to assist the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) perform a single, timelimited task.

Tue, Feb 5 2013 11:00:00 GMT

Proposed Projects

Title: CrossSite Evaluation of Children's Bureau's Child Welfare Technical Assistance Implementation Centers and National Child Welfare Resource Centers.

OMB No.: 09700377.

Background and Brief Description: The CrossSite Evaluation of the Child Welfare Implementation Centers (ICs) and National Resource Centers (NRCs) is sponsored by the Children's Bureau, Administration for Children and Families, of the U.S. Department of Health and Human Services and involves the conduct of a multiyear crosssite evaluation that examines the service provision of the ICs' and NRCs' and the relation of their training and technical assistance activities to organizational and systems change in State and Tribal child welfare systems. Additionally, the evaluation examines the degree to which networking, collaboration, information sharing, adherence to common principles, and common messaging occurs across members of the Children's Bureau Training and Technical Assistance (T/TA) Network, w

Input on Recommendations:

Tue, Feb 5 2013 11:00:00 GMT

The National Institutes of Health (NIH) Council of Councils received and adopted the recommendations and Report of the NIH Council of Councils Working Group on the Use of Chimpanzees in NIHSupported Research on January 22, 2013. The report is posted on the NIH Web site at http://dpcpsi.nih.gov/council/working_group_message.aspx. The agency will consider the recommendations contained in the report as the agency formulates policy. The NIH also announces the opening of a Request for Comment (RFC) period to collect input on the
recommendations from interested parties. Comments will be accepted until Saturday, March 23, 2013, via the comment database at http://grants.nih.gov/grants/rfi/rfi.cfm?ID=31. In the interim, NIH will continue to apply its policy on Research Involving Chimpanzees (see NOTOD12025;

Draft Guidances for Industry; Availability, etc.:

Mon, Feb 4 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products'' that appeared in the Federal Register of December 17, 2012 (77 FR 74670). In the document, FDA announced the availability of this draft guidance and explained that the comment period would close on February 15, 2013. The Agency is taking this action to allow interested persons additional time to submit comments.

Meetings:

Mon, Feb 4 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Cancer Institute Initial Review Group; Subcommittee JCareer Development.

Date: March 56, 2013.

Time: 4:30 p.m. to 6:00 p.m.

Agenda: To review and evaluate grant applications

Place: Westin Alexandria, 400 Courthouse Square, Alexandria, VA 22314.

Contact Person: Ilda F. S. Melo, Ph.D. Scientific Review Officer, Resources and Training Review

Mon, Feb 4 2013 11:00:00 GMT

Dated: January 24, 2013.
E.J. Holland, Jr.,
Assistant Secretary for Administration.
[FR Doc. 201302385 Filed 2113; 8:45 am]
BILLING CODE 415037P

International Conference on Harmonisation; Draft Guidances; Availability:

Mon, Feb 4 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S10 Photosafety Evaluation of Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance includes criteria for initiation of and triggers for additional photosafety testing and should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the draft guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals.

Foreign Quarantine:

Mon, Feb 4 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is issuing this final rule amending the regulations regarding the importation of infectious biological agents, infectious substances, and vectors. The amendments improve HHS/CDC's ability to prevent the introduction, transmission, or spread of communicable diseases into the United States.

Mon, Feb 4 2013 11:00:00 GMT

Announcement Type: Initial

CFDA Number: 93.164

Key Dates: February 15, 2013 first award cycle deadline date; August 16, 2013 last award cycle deadline date; September 13, 2013 last award cycle deadline date for supplemental loan repayment program funds; September 30, 2013 entry on duty deadline date.

I. Funding Opportunity Description

The Indian Health Service (IHS) estimated budget request for Fiscal Year (FY) 2013 includes $20,179,074 for the IHS Loan Repayment Program (LRP) for health professional educational loans (undergraduate and graduate) in return for fulltime clinical service as defined in the IHS LRP policy clarifications at http://www.ihs.gov/loanrepayment/documents/LRP_Policy_Updates.pdf, in Indian health programs.

This program announcement is subject to the appropriation of funds. This notice is being published early to coincide with the recruitment activity of the IHS, which competes wi

Mon, Feb 4 2013 11:00:00 GMT

The Food and Drug Administration (FDA or we) is extending to May 13, 2013, the comment period for the notice entitled ``Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket,'' that appeared in the Federal Register of December 14, 2012 (77 FR 74485). In that document, we requested comments relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens as defined in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The document requested comments (including data) that we can use to design and carry out a quantitative risk assessment for establishing regulatory thresholds for major food allergens. We are extending the comment period in response to a request from an industry association.

Mon, Feb 4 2013 11:00:00 GMT

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118);
[[Page 7796]]
April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809).

Fri, Feb 1 2013 11:00:00 GMT

Title: Child Care and Development Fund Financial Report (ACF 696) for States and Territories.

OMB No.: 09700163.

Description: States and Territories use the Financial Report Form ACF696 to report Child Care and Development Fund (CCDF) expenditures. Authority to collect and report this information is found in section 658G of the Child Care and Development Block Grant Act of 1990, as revised. In addition to the Program Reporting Requirements set forth in 45 CFR part 98, subpart H, the regulations at 45 CFR 98.65(g) and 98.67(c)(1) authorize the Secretary to require financial reports as necessary.

The form provides specific data regarding claims and provides a mechanism for States to request Child Care grant awards and to certify the availability of State matching funds. Failure to collect this data would seriously compromise ACF's ability to monitor Child Care and Development Fund expenditures. This information is also used to estimate outlays and may be used to prepare ACF budget

Meetings:

Fri, Feb 1 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel, RFA Panel: Studies in Neonatal Resuscitation.

Date: February 2728, 2013.

Time: 8:00 a.m. to 6:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

Contact Person: Gary Hunnicutt, Ph.D., Scien

Fri, Feb 1 2013 11:00:00 GMT

This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; 67 FR 46519, as last amended Wednesday, September 30, 2009; 74 FR 50227). This Order of Succession supersedes the Order of Succession for the Administrator, HRSA, published at 74 FR 50227, September 30, 2009.

This notice deletes the Senior Advisor to the Administrator from HRSA's hierarchy affecting the order of succession. This notice reflects the new Order of Succession for HRSA.

Section R30, Order of Succession

During the absence or disability of the Administrator, or in the event of a vacancy in the office, the officials designated below shall act as Administrator in the order in which they are listed:

1. Deputy Administrator;

2. Chief Operating Officer;

3. Associate Administrator, Bureau of Primary Health Care;

4. Associat

Fri, Feb 1 2013 11:00:00 GMT

Title: Head Start Program Performance StandardsFinal rule.

OMB No.: 09700148.

Description: Head Start Program Performance Standards require Head Start and Early Head Start Programs and Delegate Agencies to maintain program records. The Administration for Children and Families, Office of Head Start, is proposing to renew, without changes, the authority to require certain record keeping in all programs as provided for in 45 CFR part 1304 Head Start Program Performance Standards. These standards prescribe the services that Head Start and Early Head Start programs provide to enrolled children and their families.

Respondents: Head Start and Early Head Start grantees and delegate agencies.
[[Page 7436]]
Annual Burden Estimates Number of Average burden Instrument Number of responses per hours per Total burden

Patient Protection and Affordable Care Act; Exchange Functions:

Fri, Feb 1 2013 11:00:00 GMT

This proposed rule would implement certain functions of the Affordable Insurance Exchanges (``Exchanges''), consistent with title I of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. These specific statutory functions include determining eligibility for and granting certificates of exemption from the shared responsibility payment for not maintaining minimum essential coverage as described in section 5000A of the Internal Revenue Code. Additionally, this proposed rule implements the responsibility of the Secretary of Health and Human Services, in coordination with the Secretary of the Treasury, to designate other health benefits coverage as minimum essential coverage by providing that certain coverage be designated as minimum essential coverage. It also outlines substantive and procedural requirements that other types of individual coverage must fulfill in order to

Fri, Feb 1 2013 11:00:00 GMT

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Feb 1 2013 11:00:00 GMT

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. This proposed information collection project was previously published in the Federal Register (77 FR 69865) on November 21, 2012, and allowed 60 days for public comment, as required by 3506(c)(2)(A). No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB.

Proposed Collection: Title: 09170002, ``IHS Contract Health Service Report.'' Type of Information Collection Request: Extension, without change, of a currently approved information collection, 0917 0002, ``IHS Contract Health Service Report.'' While there were minor text changes (i.e., updating of statu

Medicare Program:

Fri, Feb 1 2013 11:00:00 GMT

This notice announces two new membership appointments to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). The two new appointments to the Panel will each serve a 4year period. The new members will have terms that begin on February 1, 2013 and continue through January 31, 2017. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their relative payment weights. The Panel also addresses and makes recommendations regarding supervision of outpatient services. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.

Exclusive Licenses:

Fri, Feb 1 2013 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions embodied in PCT Patent Application No. PCT/US2011/040750 and foreign equivalents thereof entitled ``Agonistic Human Monoclonal Antibodies Against DR4'' (HHS Ref. No. E1582010/0) to Customized Biosciences, Inc., which is located in Pasadena, CA. The patent rights in these inventions have been assigned to the United States of America.

The prospective startup exclusive commercial license territory may be worldwide and the field of use may be limited to ``use of the Licensed Patent Rights to develop therapeutic agents for the treatment of lymphomas, leukemias, hepatocellular cancer, colorectal cancer, ovarian cancer, lung cancer, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis, and Alzhe

Review Periods for Patent Extensions:

Thu, Jan 31 2013 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for XALKORI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

Determinations That Products Were Not Withdrawn From Sale for Reasons of Safety or

Thu, Jan 31 2013 11:00:00 GMT

The Food and Drug Administration (FDA) has determined that DIFFERIN (adapalene) solution, 0.1% (NDA 20338), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for adapalene solution, 0.1%, if all other legal and regulatory requirements are met.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human

Thu, Jan 31 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule) and for current good manufacturing practice and hazard analysis and riskbased preventive controls for human food (the preventive controls proposed rule), which are the first of several proposed rules that would establish the foundation of, and central framework for, the modern food safety system envisioned by Congress in the FDA Food Safety Modernization Act (FSMA). The purpose of the public meeting is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.
[[Page 6763]]

Public Hearings:

Thu, Jan 31 2013 11:00:00 GMT

The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on the Agency's regulation of drugs for the treatment and/or management of amyotrophic lateral sclerosis (ALS). FDA is holding this public hearing to allow patients, caregivers, advocates, health care providers, academia, industry, and other interested persons to give their perspectives on various aspects of the development of drugs for the treatment or management of ALS. The input from this public hearing will help inform the work of FDA offices that review applications for drugs for the treatment of ALS.

Patient Safety Organizations:

Thu, Jan 31 2013 11:00:00 GMT

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 10941, 42 U.S.C. 299b21b26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the BREF PSO of its status as a PSO, and has delisted the PSO accordingly.

Public Workshops:

Thu, Jan 31 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of January 7, 2013 (78 FR 951). The document announced a public workshop entitled ``Accessible Standardized Medical Device Labeling.'' The document was published with the incorrect date for submission of presentation materials. This document corrects that error.

Thu, Jan 31 2013 11:00:00 GMT

Title: Child Care and Development Fund Annual Financial Report (ACF696T) for Tribes.

OMB No.: 09700195.

Description: Tribes use the Financial Report Form ACF696T to report Child Care and Development Fund (CCDF) expenditures. Authority to collect and report this information is found in Section 658G of the Child Care and Development Block Grant Act of 1990, as revised. In addition to the Program Reporting Requirements set forth in 45 CFR part 98, subpart H, the regulations at 45 CFR 98.65(g) and 98.67(c)(1) authorize the Secretary to require financial reports as necessary.

Tribal grantees submit the ACF696T report on an annual basis on behalf of the Tribal Lead Agency administering the Child Care and Development Fund (CCDF).

The previous information collection requirements related to the American Recovery and Reinvestment Act (ARRA) of 2009 (Pub. L. 1115) have been deleted from this reporting form.

Respondents: Tribes and Tribal Organizations that are CCDF grantees.

Agency Information Collection Activities; Proposals, Submissions, and

Thu, Jan 31 2013 11:00:00 GMT

Wed, Jan 30 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 09900220, which expires on July 31, 2013. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Charter Renewals:

Wed, Jan 30 2013 11:00:00 GMT

This gives notice under the Federal Advisory Committee Act (Pub. L. 92463) of October 6, 1972, that the Healthcare Infection Control Practices Advisory Committee, Department of Health and Human Services, has been renewed for a 2year period through January 19, 2015.

For information, contact Jeffrey Hageman, M.H.S., Executive Secretary, Healthcare Infection Control Practices Advisory Committee, Department of Health and Human Services, 1600 Clifton Road NE., Mailstop A35, Atlanta, Georgia 30333, telephone 404/6394951 or fax 404/6392647.

The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
[FR Doc. 201301980 Filed 1291

Medicaid Programs:

Wed, Jan 30 2013 11:00:00 GMT

This document makes a technical correction to the proposed rule published in the January 22, 2013 Federal Register entitled ``Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing.'' The proposed rule provided for the close of the comment period to be February 13, 2013, whereas the close of the comment period was intended to be February 21, 2013. This document makes this technical correction.

Meetings:

Wed, Jan 30 2013 11:00:00 GMT

The meeting announced below concerns Birth Defects Study to Evaluate Pregnancy exposureS (BDSTEPS), FOA DD13003, initial review.

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date: 10:00 a.m.6:00 p.m., March 5, 2013 (Closed).

Place: Teleconference.

Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ``Birth Defects Study to Evaluate Pregnancy exposureS (BDSTEPS), FOA DD13003, initial review.''

Contact Person for More Information: M. Chris Langub, Ph.D., Scientific Review Officer, CDC, 4770 Buford Hi

Meetings:

Wed, Jan 30 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; VSL Fellowships.

Date: February 21, 2013.

Time: 12:00 p.m. to 3:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6120 Executive Blvd. Rockville, MD 20852 (Telephone Conference Call).

Contact Person: Sheo Singh,

Wed, Jan 30 2013 11:00:00 GMT

Meetings:

Wed, Jan 30 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Science Board to the Food and Drug Administration (Science Board).

General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex scientific and technical issues important to the FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science; and input into the Agency's research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agencysponsored intramural and extramural scientific research programs.

Date and Time: The meeting will be held o

Wed, Jan 30 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

The National Hospital Care Survey (NHCS) (OMB No. 09200212, expiration date: 04/30/2014)RevisionNational Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description

Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on the extent and nat

Wed, Jan 30 2013 11:00:00 GMT

Meetings:

Tue, Jan 29 2013 11:00:00 GMT

Name: President's Advisory Council on Faithbased and Neighborhood Partnerships Council Conference Calls

Time and Date: Wednesday, February 13th, 4:00 p.m.5:30 p.m. (e.s.t.); Wednesday, February 27th, 4:00 p.m.5:30 p.m. (e.s.t.); Wednesday, March 13th, 4:00 p.m.5:30 p.m. (e.s.t.)

Place: All meetings announced herein will be held by conference call The callin line is: 18668235144, Passcode: 1375705. Space is limited so please RSVP to partnerships@hhs.gov to participate.

Status: Open to the public, limited only by lines available.

Meetings:

Tue, Jan 29 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Renal Transport Program Projects.

Date: February 25, 2013.

Time: 2:00 p.m. to 5:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Confere

Tue, Jan 29 2013 11:00:00 GMT

This Request for Information (RFI) solicits ideas and information related to ways in which the U.S. Department of Health and Human Services (HHS) can work with interested partners to disseminate and apply a library of short, evidencebased messages known as TXT4Tots. This library of brief informational nutrition and physical activity focused messages was developed and tested by the American Academy of Pediatrics (AAP) under a cooperative agreement with the Health Resources and Services Administration (HRSA). The TXT4Tots library is targeted to parents and caregivers of children, ages 15 years, and is available in both English and Spanish. Content for the messages was derived from AAP's ``Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents,'' which uses a developmentally based approach to address children's health needs in the context of family and community. The name TXT4Tots describes the library of developed messages and does not necessarily imply the need

Tue, Jan 29 2013 11:00:00 GMT

The Food and Drug Administration (FDA), Office of Foods has modified its structure and reorganized to the Office of Foods and Veterinary Medicine (OFVM). This new organizational structure was approved by the Secretary of Health and Human Services on July 20, 2012, and implemented on October 1, 2012.

Single Source Cooperative Agreements; Funding Availability:

Tue, Jan 29 2013 11:00:00 GMT

Announcement Number: HHS2013IHSHPDP0001; Catalog of Federal Domestic Assistance Number: 93.443.
Key Dates

Application Deadline Date: February 25, 2013.

Review Date: March 4, 2013.

Earliest Anticipated Start Date: March 15, 2013.

Proof of NonProfit Status Due Date: February 25, 2013. I. Funding Opportunity Description

Statutory Authority

The Indian Health Service (IHS) Office of Clinical and Preventive Services (OCPS) is announcing a single source cooperative agreement application for support of the 5th International Meeting on Indigenous Child Health. This program is authorized under: the Snyder Act, 25 U.S.C. 13. This program is described in the Catalog of Federal Domestic Assistance under 93.443.

Background

The mission of the IHS is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives (AI/AN) to the highest level. The IHS, an agency within the Department of Health and Human Services (HHS), is responsible for providing Federa

Tue, Jan 29 2013 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 5, 2012 (77 FR 61008), and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Proposed Collection: Title: National Institutes of Health Information Collection Forms to Support Genomic Data Sharing for Research Purposes; Type of Information Collection Request: New; Need and Use of Information Collection: The

Smokeless Tobacco Product Warning Statements:

Tue, Jan 29 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is establishing a public docket to obtain comments, supported by scientific evidence, regarding what changes to the smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products.

Tue, Jan 29 2013 11:00:00 GMT

Mon, Jan 28 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Devices and Radiological Health (CDRH) radiation protection program. The goal of the 2013 Assuring Radiation Protection will be to coordinate Federal, State, and Tribal activities to achieve effective solutions to present and future radiation control problems. The recipient of this cooperative agreement award will be expected to obtain the States' cooperation and participation on committees and working groups established to deal with individual problems. The recipient will also plan and facilitate an annual meeting and develop and offer educational activities to demonstrate mutually beneficial techniques, procedures, and systems relevant to the mission of assuring radiation protection. The recipient will establish committees, in accordance with Federal statutes and regulations, to address, evaluate, and propose solutions for a wide range of radiation health and protection issue

Mon, Jan 28 2013 11:00:00 GMT

Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 6777276, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 77 FR 65390, dated October 26, 2012) is amended to reflect the reorganization of the Office of the Director, National Center for Environmental Health, Centers for Disease Control and Prevention.

Section CB, Organization and Functions, is hereby amended as follows: Delete in its entirety the title Office of Financial and Administrative Services (CUG14), Office of the Director (CUG1), National Center for Environmental Health (CUG) and insert the title Office of Financial, Administrative, and Information Services (CUG14), Office of the Director (CUG1), National Center for Environmental Health (CUG).

Revise the functional statement for the Office of Financial, Administrative, and Information Services (C

Mon, Jan 28 2013 11:00:00 GMT

Part J (Agency for Toxic Substances and Disease Registry) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (50 FR 2512925130, dated June 17, 1985, as amended most recently at 77 FR 68125, dated November 15, 2012) is amended to reflect the reorganization of the Office of [[Page 5812]]
Financial Administrative Services, Office of the Director, Agency for Toxic Substances and Disease Registry.

Section TB, Organization and Functions, is hereby amended as follows: Delete in its entirety the title for the Office of Financial and Administrative Services (JAA2), Office of the Director (JAA), Agency for Toxic Substances and Disease Registry (JA) and insert the title Office of Financial, Administrative, and Information Services (JAA2), Office of the Director (JAA), Agency for Toxic Substances and Disease Registry (JA).

Revise the functional statement for the Office of Financial, Administrative, and Information Services (JAA

Mon, Jan 28 2013 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluating the Knowledge and Educational Needs of Students of Health Professions on PatientCentered Outcomes Research.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 35013521, AHRQ invites the public to comment on this proposed information collection.

New Animal Drugs:

Mon, Jan 28 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug [[Page 5714]]
applications (NADAs) and abbreviated new animal drug applications (ANADAs) during December 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

Mon, Jan 28 2013 11:00:00 GMT

The Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) are announcing the end of support for the 3.1.1. version of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Implementation Guide (SDTM IG 3.1.1.). SDTM IG 3.1.2, which has been available since October 2009, is the newer standard supported by FDA. Support for SDTM IG 3.1.1 will end on January 28, 2015.

Mon, Jan 28 2013 11:00:00 GMT

Proposed Projects

Title: Federal Tax Offset, Administrative Offset, and Passport Denial.

OMB No.: 09700161.

The Federal Tax Offset, Administrative Offset, and Passport Denial programs collect pastdue child
[[Page 5813]]
support by intercepting certain federal payments, including federal tax refunds, of parents who have been ordered to pay child support and who are behind in paying the debt. The program is a cooperative effort among the Department of the Treasury's Financial Management Service, the federal Office of Child Support Enforcement (OCSE), and state child support enforcement (CSE) agencies. The Passport Denial program reports noncustodial parents who owe child support above a threshold to the Department of State, which will then deny passports to these individuals. On an ongoing basis, CSE agencies submit to OCSE the names, Social Security numbers, and the amount(s) of pastdue child support of people who are delinquent in making child support payments.

Respondents: State

Mon, Jan 28 2013 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Applying Novel Methods To Better
[[Page 5808]]
Understand the Relationship Between Health IT and Ambulatory Care Workflow Redesign.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 35013521, AHRQ invites the public to comment on this proposed information collection.

Mon, Jan 28 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 40400001, which expires on March 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Prior to submitting that ICR to OMB, EGOV seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Guidance for Industry; Availability:

Mon, Jan 28 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clinical Pharmacogenomics: Premarket Evaluation in EarlyPhase Clinical Studies and Recommendations for Labeling.'' This guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect a drug's
pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The guidance provides recommendations on when and how genomic principles should be considered and applied in earlyphase clinical studies to address questions arising during drug development and regulatory review.

Meetings:

Mon, Jan 28 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; TimeSensitive Obesity Applications.

Date: February 15, 2013.

Time: 10:00 p.m. to 11:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Confe

Request for Nominations:

Mon, Jan 28 2013 11:00:00 GMT

The Agency for Healthcare Research and Quality (AHRQ) is seeking nominations for both a timelimited work group and a standing work group to be convened by an AHRQ contractor. The work groups shall be comprised of individuals with knowledge of the AHRQ Quality Indicators (QIs), their technical specifications, and associated methodological issues. The overarching goals of each group are to provide feedback to AHRQ regarding refinements to the Qls. The time limited workgroup is more restricted to specific clinical or methodological issues, while the standing workgroup addresses broader issues related to the measurement cycle.

Mon, Jan 28 2013 11:00:00 GMT

Meetings:

Mon, Jan 28 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public conference entitled ``Detecting and Evaluating DrugInduced Liver Injury; What's Normal, What's Not, and What Should We Do About It?'' This conference will be cosponsored with the Critical Path Institute (CPath) and the Pharmaceutical Research and Manufacturers of America. Its purpose is to discuss, debate, and build consensus among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose.

Fri, Jan 25 2013 11:00:00 GMT

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Jan 25 2013 11:00:00 GMT

Medicare Program:

Fri, Jan 25 2013 11:00:00 GMT

This document is a request for information regarding patient and family member or close friend experiences with hospice care.

Fri, Jan 25 2013 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

Rao M. Adibhatla, Ph.D., University of Wisconsin: Based on the report of an investigation conducted by the University of Wisconsin (UW) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Rao M. Adibhatla, Assistant Professor, Department of Neurological Surgery, UW, engaged in research misconduct by falsifying results in two publications supported by National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS042008 and in three unfunded applications that Dr. Adibhatla submitted to NINDS, NIH, as R01 NS04200805, 05A1, and 05A2. The questioned papers are:
1. Adibhatla, R.M., Hatcher, J.F., Larsen E.C. et al. ``CDPcholine Significantly Restores Phoshatidylcholine Levels by Differentially Affecting Phospholipase A2 and CTP:Phosphocholine Cytidylyltransferase after Stroke.'' J. Biol. Chem.

Meetings:

Fri, Jan 25 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Population Sciences and Epidemiology Integrated Review Group, Behavioral Genetics and Epidemiology Study Section.

Date: February 20, 2013.

Time: 8:00 a.m. to 7:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Sir Francis Drake Hotel, 450 Powell Street at Sutter, San Francisco, CA 94102.

Contact Person: George Vogler, Ph.D., Scie

Meetings:

Fri, Jan 25 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Vaccines and Related Biological Products Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on February 27, 2013 between approximately 8:30 a.m. and 2:45 p.m.

Location: National Institutes of Health (NIH) Fishers Lane Conference Center, Terrace Level, Rooms 508510, 5635 Fishers Lane, Rockville, MD, 20852. Please enter the building through the main front entrance on Fishers Lane and take the elevators down to the T Terrace Level. For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at http://videocast.nih.gov.

Contact Person: Donald W. Jehn or Denise Royster, Center for Biologics Evalu

Meetings:

Fri, Jan 25 2013 11:00:00 GMT

Pursuant to Public Law 92463, notice is hereby given that the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB) will meet on February 11, 2013, from 10:30 a.m. to 4:30 p.m. and February 12, 2013, from 9:00 a.m. to 2:00 p.m. E.S.T. The DTAB will convene in both open and closed sessions over these two days.

On February 11, 2013, from 10:30 a.m. to 4:30 p.m., the meeting will be open to the public and will include updates on the proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs, the custody and control form, and the medical review officer certification. The meeting also will include federal drug testing updates from the Department of Transportation, the Department of Defense, the Nuclear Regulatory Commission, and the Federal Drug Free Workplace Programs.

The public is invited to attend the open session in person or to listen via teleconference. Due

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Jan 25 2013 11:00:00 GMT

Proposed Projects

Title: Guidance for Tribal TANF.

OMB No.: 09700157.

Description

42 U.S.C. 612 (Section 412 of the Social Security Act) requires each Indian Tribe that elects to administer and operate a TANF program to submit a TANF Tribal Plan. The TANF Tribal Plan is a mandatory statement submitted to the Secretary by the Indian Tribe, which consists of an outline of how the Indian Tribes TANF program will be administered and operated. It is used by the Secretary to determine whether the plan is approvable and to determine that the Indian Tribe is eligible to receive a TANF assistance grant. It is also made available to the public.

Respondents

Indian Tribes applying to operate a TANF program. Annual Burden Estimates Number of Average burden Instrument Number of responses per hours per Total Burden

Fri, Jan 25 2013 11:00:00 GMT

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) DEBUT Challenge is open to teams of undergraduate students working on projects that develop innovative solutions to unmet health and clinical problems. NIBIB's mission is to improve health by leading the development and accelerating the application of biomedical technologies. The goals of the challenge are (1) to provide undergraduate students valuable experiences such as working in teams, identifying unmet clinical needs, and designing, building, and debugging solutions for such openended problems; (2) to generate novel, innovative tools to improve health care, consistent with NIBIB's purpose to support research, training, the dissemination of health information, and other programs with respect to biomedical imaging and engineering and associated technologies and modalities with biomedical applications; and (3) to highlight and acknowledge the contributions and accomplishments of undergraduate students.

Fri, Jan 25 2013 11:00:00 GMT

Management Information System for Comprehensive Cancer Control ProgramsRevision (OMB No. 09200841, exp. 1/31/2013)National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Through the National Comprehensive Cancer Control Program (NCCCP), CDC currently provides cooperative agreement funding and tech

Medical Devices:

Fri, Jan 25 2013 11:00:00 GMT

The Food and Drug Administration (FDA or Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to exempt the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket notification (510(k)) and to continue to require premarket notification (510(k)) for all other scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The scleral plug is a prescription device used to provide temporary closure of a scleral incision during an ophthalmic surgical procedure.

Fri, Jan 25 2013 11:00:00 GMT

The Department of Health and Human Services (HHS or ``the Department'') is issuing this final rule to: Modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Enforcement Rules to implement statutory amendments under the Health Information Technology for Economic and Clinical Health Act (``the HITECH Act'' or ``the Act'') to strengthen the privacy and security protection for individuals' health information; modify the rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule) under the HITECH Act to address public comment received on the interim final rule; modify the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and make certain other modifications to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the HIPAA Rules) to improve their workability and effecti

Thu, Jan 24 2013 11:00:00 GMT

This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.

Meetings:

Thu, Jan 24 2013 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``Patient Centered Outcomes Research (PCOR) Pathway to Independence Award (K99/R00)''.

Guidances for Industry and Staff; Availability:

Thu, Jan 24 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for the industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. Devices that receive HUD designations may be eligible for marketing approval under the Humanitarian Device Exemption (HDE) marketing pathway. This guidance document is intended to assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests. This guidance finalizes the draft guidance of the same title dated December 2011.

Environmental Assessments; Availability, etc.:

Thu, Jan 24 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is issuing this notice to advise the public that HHS/CDC has prepared, and signed on January 3, 2013, a Finding of No Significant Impact (FONSI) based on the Final Environmental Assessment (FINAL EA) for Metropolitan Sewer District of Greater Cincinnati Easement on the HHS/CDC/NIOSH Taft North Campus, Cincinnati, Ohio. HHS/CDC prepared the final EA, dated November 2012, in accordance with the National Environmental Policy Act (NEPA).

Workshops:

Thu, Jan 24 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Clinical Flow Cytometry in Hematologic Malignancies.'' The purpose of this public workshop is to seek public input from academia, Government, laboratorians, industry, clinicians, patients and other stakeholders on the role of clinical flow cytometry in hematologic malignancies, in order to develop a specific regulatory policy for this class of in vitro diagnostic devices.

Date and Time: The workshop will be held on February 25 and 26, 2013 from 8 a.m. to 5 p.m.

Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Rm. 1503 (Section A of the Great Room) in Bldg. 31, Silver Spring, MD 209930002. All visiting public workshop participants (non FDA employees) must enter through Building 1 for routine security check procedures. For parking and security information, please visit the following Web site:

Meetings:

Thu, Jan 24 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute on Aging Special Emphasis Panel; Circadian Clocks and Aging: Molecular Mechanisms.

Date: February 19, 2013.

Time: 8:30 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Embassy SuitesChevy Chase Pavilion, 4300 Military Rd. NW., Washington, DC 20015.

Contact Person: Elaine Lewis, Ph.D., Scientific Revie

Meetings:

Wed, Jan 23 2013 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Recombinant DNA Advisory Committee, January 24, 2013, 09:00 a.m. to January 24, 2013, 04:00 p.m., National Institutes of Health, Building 45, 45 Center Drive, Lower Level, Conference Room C1C2, Rockville, MD, 20892 which was published in the Federal Register on January 08, 2013, 78FRN1216.

The time of the meeting has been changed from 9:00 a.m.4:00 p.m. to 8:30 a.m.4:30 p.m. Additionally, this meeting will not be webcast and there will be no opportunity to submit comments during the meeting. The meeting is open to the public.

Dated: January 16, 2013.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 201301231 Filed 12213; 8:45 am]
BILLING CODE 414001P

Meetings:

Tue, Jan 22 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Cardiovascular Sciences.

Date: February 78, 2013.

Time: 9:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: Bradley Nuss, Ph.D., Scientific R

Draft Guidances for Industry and Staff; Availability:

Tue, Jan 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.'' This draft guidance intends to provide the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a combination product that is approved under one marketing application, i.e., a biologics license application (BLA), a new drug application (NDA), or a device premarket approval application (PMA).

Medicaid, Children's Health Insurance Programs, and Exchanges:

Tue, Jan 22 2013 11:00:00 GMT

This proposed rule would implement provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act), and the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA). This proposed rule reflects new statutory eligibility provisions; proposes changes to provide states more flexibility to coordinate Medicaid and the Children's Health Insurance Program (CHIP) eligibility notices, appeals, and other related administrative procedures with similar procedures used by other health coverage programs authorized under the Affordable Care Act; modernizes and streamlines existing rules, eliminates obsolete rules, and updates provisions to reflect Medicaid eligibility pathways; revises the rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; implements other CHIPRA eligibilityrelated provisions, including eligibility

Tue, Jan 22 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Assessment of the Psychosocial Impact of Newborn Screening for Congenital Cytomegalovirus (CMV) InfectionNewNational Center for Immunization and Respiratory Diseases (NCIRD) and National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).
[[Page 4412]]

Background and Brief Description

Each year in the United States, more than 30,000 children are born with congenital CM

Electronic Submission Process for Requesting Export Certificates:

Tue, Jan 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of an electronic submission process for requesting export certificates for products regulated by FDA's Center for Devices and Radiological Health (CDRH). The electronic process will help fulfill both the legislative and application time processing requirements set out by the FDA Export Reform and Enhancement Act of 1996 and the terms of clearance of the Office of Management and Budget approval (OMB control number 09100498) of the Form FDA 3613 series. The new eSubmitter process will complement the current paperbased process.

Tue, Jan 22 2013 11:00:00 GMT

Title: Procedures for Requests from Tribal Lead Agencies to use Child Care and Development Fund (CCDF) Funds for Construction or Major Renovation of Child Care Facilities.

OMB No.: 09700160.

Description: The Child Care and Development Block Grant Act, as amended, allows Indian Tribes to use Child Care and Development Fund (CCDF) grant awards for construction and renovation of child care facilities. A tribal grantee must first request and receive approval from the Administration for Children and Families (ACF) before using CCDF funds for construction or major renovation. This information collection contains the statutorilymandated uniform procedures for the solicitation and consideration of requests, including instructions for preparation of environmental assessments in conjunction with the National Environmental Policy Act. The proposed draft procedures update the procedures that were originally issued in August 1997 and last updated in April 2010. Respondents will be CCDF tribal gra

Tue, Jan 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for ``singleentity'' and ``copackaged'' combination products.

Agency Information Collection Activities; Proposals, Submissions, and

Tue, Jan 22 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.

Tue, Jan 22 2013 11:00:00 GMT

This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS10453] entitled ``The Medicare Advantage and Prescription Drug Program: Part C Explanation of Benefits CFR 422.111(b)(12)'' that was published in the November 26, 2012 (77 FR 70445) Federal Register. The comment period for the information collection request, which would have ended on January 25, 2013, is extended to February 1, 2013.

Meetings:

Fri, Jan 18 2013 11:00:00 GMT

This document corrects a notice that was published in the Federal Register on January 7, 2013 (78 FR 949950). The 10th Biannual Tribal Consultation session has been postponed to coincide with the summer 2013 meetings; the dates will be announced once they are determined. The Tribal Advisory Committee Meeting will be extended and held February 5, 6, and 7, 2013, from 8:00 a.m.4:30 p.m.

Fri, Jan 18 2013 11:00:00 GMT

This notice announces the development of Set 26 Toxicological Profiles, which will consist of three updated profiles and two new profiles. Draft for Public Comment versions of these profiles will be available to the public on or about October 17, 2013. Electronic access to these documents will be available at the ATSDR Web site: http://www.atsdr.cdc.gov/toxprofiles/index.asp. Set 26 Toxicological Profiles

The following toxicological profiles are now being developed: [[Page 4148]]
Name CAS 1. Trichloroethylene (UPDATE)............. 79016
2. Tetrachloroethylene (UPDATE)........... 127184
3. Hydrogen sulfide/Carbonyl sulfide 7783064
(UPDATE). 463581
4. Glutaraldehyde (NEW)................... 111308
5. Parathion (NEW)........................ 56382

Requests for Information:

Fri, Jan 18 2013 11:00:00 GMT

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) seeks comment on the types of hazard identification and risk management research that should be considered for updating the NIOSH FY2013FY2016 nanotechnology strategic plan. This draft strategic plan (Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan 20132016) can be found in Docket CDC20130001 at http://www.regulations.gov.

Fri, Jan 18 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal semi constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semiconstrained, with an uncemented acetabular component, prosthesis. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements.

Meetings:

Fri, Jan 18 2013 11:00:00 GMT

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Preregistration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at http://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 2026905566 and provide name, organization, and email address.

Medicare Program:

Fri, Jan 18 2013 11:00:00 GMT

This notice extends the comment period for a request for information (RFI) which was published in the January 3, 2013 Federal Register (78 FR 308). The RFI requests that hospitals, electronic health record (EHR) vendors, and other interested parties respond to questions regarding their readiness to conduct electronic reporting of certain patientlevel data under the Hospital Inpatient Quality Reporting (IQR) Program using the Quality Reporting Document Architecture (QRDA) Category I. The comment period for the RFI, which would have ended on January 22, 2013, is extended to February 1, 2013.

Fri, Jan 18 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

Restriction on Interstate Travel of Persons (OMB Control No. 0920 0488, Exp. 3/31/2013)RevisionNational Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention is requesting OMB approval for a revision of the information collection, ``Restriction on Interstate Travel of Persons'' (OMB Control No.

Fri, Jan 18 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OASH seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Jan 18 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.

Meetings:

Thu, Jan 17 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Program Project Meeting II.

Date: February 45, 2013.

Time: 8:00 a.m. to 6:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852.

Contact Person: Majed M. Hamawy, Ph.D., Scientific Review Off

Thu, Jan 17 2013 11:00:00 GMT

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Mound Plant, in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Mound Plant in Miamisburg, Ohio, from September 1, 1972, through December 31, 1972, or from January 1, 1975, through December 31, 1976, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on January 6, 2013, as prov

Thu, Jan 17 2013 11:00:00 GMT

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Oak Ridge National Laboratory (X10), in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked in any area at the Oak Ridge National Laboratory (X10) in Oak Ridge, Tennessee, from June 17, 1943, through July 31, 1955, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on January 6, 2013, as

Prospective Grants of Co-Exclusive Licenses:

Thu, Jan 17 2013 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide coexclusive license, to practice the inventions embodied in US patent 6,013,638 (HHS Reference E1291991/0 US03), issued January 11, 2000 and entitled ``Adenovirus Comprising Deletions on the E1A, E1B And E3 Regions for Transfer of Genes to the Lung'', and US patent 6,136,594 (HHS Reference E1291991/1 US03), issued October 24, 2000, and entitled ``Replication Deficient Recombinant Adenovirus Vector'' to Life Technologies Corporation (LTC) of Carlsbad, California. The United States of America is an assignee of the rights of the above inventions.

The field of use may be limited to the ``use of adenovirusbased recombinant constructs as controls and calibrators for molecular diagnostics for infectious disease agents.''

Thu, Jan 17 2013 11:00:00 GMT

Generic Drug User Fees:

Thu, Jan 17 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), enacted the Food and Drug Administration Safety and Innovation Act, as further amended by the FDA User Fee Corrections Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on Type II API drug master files (DMF) to be made available for reference. GDUFA directs FDA to establish each year the generic drug user fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices

Thu, Jan 17 2013 11:00:00 GMT

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Nuclear Metals, Inc. facility in West Concord, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

All Atomic Weapons Employees who worked at the facility owned by Nuclear Metals, Inc. (or a subsequent owner) in West Concord, Massachusetts, during the period from October 29, 1958, through December 31, 1979, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.
This designation became effective on January 6, 2013, as provided for under

Thu, Jan 17 2013 11:00:00 GMT

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Los Alamos National Laboratory (LANL), in Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at the Los Alamos National Laboratory (LANL) in Los Alamos, New Mexico from January 1, 1976, through December 31, 1995, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.
This designation became effective on January 6, 2013

Thu, Jan 17 2013 11:00:00 GMT

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Jan 16 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Ron Otten, at 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Wed, Jan 16 2013 11:00:00 GMT

To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) is proposing to establish sciencebased minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is proposing these standards as part of our implementation of the FDA Food Safety Modernization Act (FSMA). These standards would not apply to produce that is rarely consumed raw, produce for personal or onfarm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance would be eligible for exemption from the requirements of this rule. The proposed rule would set forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to pr

Wed, Jan 16 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In
Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science, and riskbased preventive controls the norm across all sectors of the

Agency Information Collection Activities; Proposals, Submissions, and

Wed, Jan 16 2013 11:00:00 GMT

Title: School Readiness Goals and Head Start Program Functioning.

OMB No.: New Collection.

Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing a data collection as part of the ``School Readiness Goals and Head Start Program Functioning'' research project. The purpose of this study is to improve understanding of how local Head Start and Early Head Start programs define, measure, and communicate school readiness goals, and how they use these goals in program planning to improve program functioning. ACF is proposing to use a semistructured telephone interview protocol to collect information from program directors and other key staff from approximately 60 local grantees and site visit protocols to collect further qualitative information through interviews and/or focus groups with program staff, oversight boards, key stakeholders, and parents in a subset of 12 of these grantees. ACF has contracted with the Urban

Wed, Jan 16 2013 11:00:00 GMT

Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations:

Wed, Jan 16 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of, and requesting comment on, a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co Located on a Farm'' (the draft RA). The purpose of the draft RA is to provide a sciencebased risk analysis of those activity/food combinations that would be considered low risk. FDA conducted this draft RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a sciencebased risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA. Elsewhere in this issue of the Federal Register, FDA is using the results of the draft RA to propose to exempt food facilities that are small or very small businesses that are engaged only in specific types of onfarm manufacturing, processing, packing, or holding activities identified in the draft RA as lowrisk activity/food combinations

Tue, Jan 15 2013 11:00:00 GMT

The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing the direct final rule that August 28, 2012. HHS/FDA published the direct final rule to exempt scientific research misconduct proceedings records from certain requirements of the Privacy Act of 1974 in order to protect records compiled in the course of misconduct inquiries and investigations, and to safeguard the identity of confidential sources. The comment period closed on November 13, 2012. HHS/FDA is withdrawing the direct final rule because the Agency received significant adverse comment.

Tue, Jan 15 2013 11:00:00 GMT

The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) published in the Federal Register of August 28, 2012, a direct final rule to exempt a new system of records from certain provisions of the Privacy Act of 1974 in order to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. The comment period for this direct final rule closed November 13, 2012. HHS is withdrawing the direct final rule because the agency has received significant adverse comment.

Food and Drug Administration Modernization Act of 1997:

Tue, Jan 15 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 030'' (Recognition List Number: 030), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

Meetings:

Tue, Jan 15 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel.

Date: January 31, 2013.

Time: 10:30 a.m. to 1:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892.

Contact Person: Victor Henriquez, Ph.D., Scientific Review O

Tue, Jan 15 2013 11:00:00 GMT

Meetings:

Tue, Jan 15 2013 11:00:00 GMT

Public Hearings:

Tue, Jan 15 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or lifethreatening conditions that would address an unmet medical need. The drug's safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, welldefined subpopulations in which the drug's benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages.

Tue, Jan 15 2013 11:00:00 GMT

The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice collects comments on the information collection requirements relating to the continuation of an existing collection for University Centers for Excellence in Developmental Disabilities Education, Research, and Service.

Tue, Jan 15 2013 11:00:00 GMT

Dental Devices:

Mon, Jan 14 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to reclassify the blade form endosseous dental implant, a preamendments class III device, into class II (special controls). On its own initiative, based on new information, FDA is proposing to revise the classification of bladeform endosseous dental implants.

Mon, Jan 14 2013 11:00:00 GMT

On June 25, 2012, the Department of Health and Human Services (HHS) published a notice of proposed rulemaking proposing to update respirator approval standards in response to a petition to amend our regulations, current requirements for selfcontained breathing apparatus (SCBA) remaining servicelife indicators or warning devices. These indicators are built into a respirator to alert the user that the breathing air provided by the respirator is close to depletion. In this final rule, HHS responds to public comment on the proposed rule and revises the current standard, employed by the National Institute for Occupational Safety and Health (NIOSH) located within the Centers for Disease Control and Prevention (CDC), to allow greater flexibility in the setting of the indicator alarm to ensure that the alarm more effectively meets the different worker protection needs of different work operations. This final rule sets a minimum alarm point at 25 percent of the rated service time and allows the manufact

Mon, Jan 14 2013 11:00:00 GMT

The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs.

Subpart MMedical Review Officer (MRO), Section 13.1(b), ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug testing results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall publish a list in the Federal Register of those entities and boards that have been approved.''

HHS has completed its review of entities that train and certify MROs, in accordance with requests submitted by such entities to HHS.

Draft Guidances for Industry:

Mon, Jan 14 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Abuse Deterrent OpioidsEvaluation and Labeling.'' The draft guidance describes how abusedeterrent properties of opioid analgesic products should be studied and evaluated, and what claims regarding such properties may be suitable for inclusion in labeling. In addition to general input on this draft guidance, FDA is seeking input on the research topics outlined in the final section of the draft guidance. FDA also intends to hold a public meeting to solicit additional input from affected stakeholders on the draft guidance.

Meetings:

Mon, Jan 14 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Vector Biology Study Section

Date: February 6, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Sheraton DFW Airport, 4440 W. John Carpenter Frwy., Irving, TX 75063.

Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center f

Mon, Jan 14 2013 11:00:00 GMT

Meetings:

Mon, Jan 14 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Blood Products Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Fri, Jan 11 2013 11:00:00 GMT

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Jan 11 2013 11:00:00 GMT

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (0MB) for review. This proposed information collection project was previously published in the Federal Register (77 FR 60219) on October 2, 2012, and allowed 60 days for public comment, as required by 3506(c)(2)(A). No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB.

Proposed Collection: Title: 09170030, ``IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164).'' Type of Information Collection Request: Extension, without revisions, of currently approved information collection, 09170030, ``IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164).'' F

Fri, Jan 11 2013 11:00:00 GMT

Meetings:

Fri, Jan 11 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel, Translational SEP.

Date: January 24, 2013.

Time: 9:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

Contact Pe

Fri, Jan 11 2013 11:00:00 GMT

Meetings:

Fri, Jan 11 2013 11:00:00 GMT

The purpose of this Notice is to announce an Indian Health Service (IHS) Listening Session on the draft Policy on Conferring with Urban Indian Organizations (UIOs). IHS will provide an opportunity for interested parties to provide oral comments on the draft Policy on Conferring with UIOs that was published in the Federal Register on July 26, 2012.

Name of Listening Session: IHS Urban Listening Session.

Type of Meeting: Open Listening Session.

Agency Information Collection Activities; Proposals, Submissions, and

Fri, Jan 11 2013 11:00:00 GMT

Proposed Projects:

Title: Child Support Noncustodial Parent Employment Demonstration (CSPED).

OMB No.: 0970NEW.

Description:

The Office of Child Support Enforcement (OCSE) within the Administration for Children and Families (ACF) is proposing data collection activity as part of the Child Support Noncustodial Parent Employment Demonstration (CSPED). In October 2012, OCSE issued grants to eight state child support agencies to provide employment, parenting, and child support services to noncustodial parents who are having difficulty meeting their child support obligation. The overall objective of the CSPED evaluation is to document and evaluate the effectiveness of the approaches taken by these eight CSPED grantees. This evaluation will yield information about effective strategies for improving child support payments by providing noncustodial parents employment and other services through child support programs. It will generate extensive information on how these programs operate

Thu, Jan 10 2013 11:00:00 GMT

Information Collection Request Title: Telehealth Resource Center Performance Measurement Tool (OMB No. 0915xxxx)NEW.

Abstract: In order to ensure the best use of public funds and to meet GPRA requirements, the Office for the Advancement of Telehealth (OAT) in collaboration with Telehealth Resource Centers (TRCs) has developed a set of performance metrics to evaluate the

Meetings:

Thu, Jan 10 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel Member Conflict: Learning and Memory.

Date: January 31, 2013.

Time: 9:00 a.m. to 6:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: Kirk Thompson, Ph.D., Scientific Review

Meetings:

Thu, Jan 10 2013 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), notice is hereby given of the following meeting:

Name: National Advisory Council on Nurse Education and Practice (NACNEP).

Dates and Times: January 31, 2013, 9:30 a.m.12:30 p.m. Eastern Standard Time.

Place: Conference Call Format.

Canned Tuna Deviating from Identity Standard:

Thu, Jan 10 2013 11:00:00 GMT

The Food and Drug Administration (FDA or we) received an application for a temporary permit from Chicken of the Sea International (the applicant). We are announcing that we have issued a temporary permit to the applicant to market test products (designated as ``no drain canned tuna'' products) that deviate from the U.S. standard of identity for canned tuna. The purpose of the temporary permit is to market test the product throughout the United States. The permit will allow the applicant to measure consumer acceptance of the new product and assess the new product's commercial feasibility.

Thu, Jan 10 2013 11:00:00 GMT

The Department of Health and Human Services (HHS) is proposing to amend its Federal Acquisition Regulation (FAR) Supplementthe HHS Acquisition Regulation (HHSAR)to add two clauses, ``Patent Rights Exceptional Circumstances'' and ``Rights in DataExceptional Circumstances,'' and their prescriptions.

Meetings:

Wed, Jan 9 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel, Chemosensory Fellowships Review Meeting.

Date: February 22, 2013.

Time: 11:00 a.m. to 2:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call).

Tue, Jan 8 2013 11:00:00 GMT

Title: Head Start Grant Application and Budget Instruments.

OMB No.: 09700207.

Description: The Office of Head Start is proposing to renew, without changes, the Head Start Grant Application and Budget Instrument, which standardizes the grant application information that is requested from all Head Start and Early Head Start grantees applying for continuation grants. The application and budget forms are available in a passwordprotected, webbased system. Completed applications can be transmitted electronically to Regional and Central Offices. The Administration for Children and Families believes that this application form makes the process of applying for Head Start program grants more efficient for applicants.

Respondents: Head Start and Early Head Start grantees. Respondents
Annual Burden Estimates Number of Average burden Instrument

Tue, Jan 8 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to reclassify the external cardiac compressor, including cardiopulmonary resuscitation (CPR) aids, from class III devices into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended.

Tue, Jan 8 2013 11:00:00 GMT

The meeting announced below concerns Natural History and Prevention of Viral Hepatitis Among Alaska Natives, Funding Opportunity Announcement (FOA) PS13001, initial review.

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date: 1:00 p.m.3:00 p.m., February 11, 2013 (Closed).

Place: Teleconference.

Matters To Be Discussed: The meeting will include the initial review, discussion, and evaluation of applications received in response to ``Natural History and Prevention of Viral Hepatitis Among Alaska Natives, FOA PS13001.''

Contact Person for More Information: Gregory Anderson, M.S., M.P.H

Tue, Jan 8 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel Chemosensory P50 Review.

Date: January 31, 2013.

Time: 12:00 p.m. to 3:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call).

Contact Person: She

Tue, Jan 8 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Emerging Technologies and Training Neurosciences Integrated Review Group Bioengineering of
Neuroscience, Vision and Low Vision Technologies Study Section.

Date: February 7, 2013.

Time: 8:00 a.m. to 6:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA 94102.

Contact Per

Tue, Jan 8 2013 11:00:00 GMT

Title: Descriptive Study of County versus State Administered Temporary Assistance for Needy Families (TANF) Programs.

OMB No.: New Collection.

Description: The Administration for Children and Families (ACF) is proposing an information collection activity as part of the Descriptive Study of County and State Administered TANF Programs. The proposed information collection consists of semistructured interviews with key County and State staff on questions of county TANF administration, policies, service delivery, and program context. Through this information collection, ACF seeks to gain an indepth, systematic understanding of the differences in program implementation, operations, outputs and outcomes between state and county administered TANF programs, and identify special technical assistance needs of state supervised, county administered programs.

Respondents: Semistructured interviews will be held with state and county TANF administrators and staff.

Tue, Jan 8 2013 11:00:00 GMT

On its own initiative, based on new information, the Food and Drug Administration (FDA) is proposing to reclassify membrane lung devices for longterm pulmonary support, a preamendments class III device, into class II (special controls) for conditions where imminent death is threatened by cardiopulmonary failure in neonates and infants or where cardiopulmonary failure results in the inability to separate from cardiopulmonary bypass following cardiac surgery. A membrane lung for longterm pulmonary support refers to the oxygenator component of an extracorporeal circuit used during longterm procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because circuit components used with the oxygenator are to be subject to the same regulatory controls, all of the device components used in an ECMO procedure are being considered in the scope of this proposed order, and the title and identification of the regulation will be revised accordingly to include extracorporeal circuit and ac

Tue, Jan 8 2013 11:00:00 GMT

The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda.

Tue, Jan 8 2013 11:00:00 GMT

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Recombinant DNA Advisory Committee.

The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

Name of Committee: Recombinant DNA Advisory Committee.

Date: January 24, 2013.

Time: 9:00 a.m. to 4:00 p.m.

Agenda: The NIH Recombinant DNA Advisory Committee (RAC) will discuss Biosafety measures for research with highly pathogenic avian influenza H5N1 strains that have the potential to be transmissible through respiratory droplets and related data management activities. Please check the meeting agenda at OBA Meetings Page (available at the following URL: http:/

Agency Information Collection Activities; Proposals, Submissions, and

Mon, Jan 7 2013 11:00:00 GMT

This document withdraws a Food and Drug Administration (FDA) notice that published in the Federal Register of December 11, 2012 (77 FR 73662).

National Vaccine Injury Compensation Program:

Mon, Jan 7 2013 11:00:00 GMT

The Health Resources and Services Administration (HRSA) is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).

Section 100.2 of the VICP's implementing regulation (42 CFR Part 100) states that the revised amounts of an average cost of a health insurance policy, as determined by the Secretary, are to be published periodically in a notice in the Federal Register and filed with the United States Court of Federal Claims (the Court). This figure is calculated using the most recent Medical Expenditure Panel Survey Insurance Component (MEPSIC) data available as the baseline for the average monthly cost of a health insurance policy. This baseline is adjusted by the annual percentage increase/decrease obtained from the most recent annual Kaiser Family Foundation and Health Research and Educational Trust (KFF/HRET) Employer Health Benefits survey or other authoritative source that may be mo

Mon, Jan 7 2013 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Pilot Test of the Proposed Value and Efficiency Surveys and Communicating About Value Checklist.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 35013521, AHRQ invites the public to comment on this proposed information collection.

Mon, Jan 7 2013 11:00:00 GMT

Summary: In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 4431984.

Medical Devices:

Mon, Jan 7 2013 11:00:00 GMT

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 4431984.
[[Page 955]]
Information Collection Request Title: HRSA Environmental Information and Documentation (EID) (OMB No. 09150324)Revision

Abstract: HRSA is requesting an extension of the approval for the Environmental Information and Documentation (EID) checklist, which consists of information that the agency is required to obtain to comply with the National Environmental Policy

Public Workshops:

Mon, Jan 7 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Accessible Standardized Medical Device Labeling.'' The purpose of this public workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling.

Meetings:

Mon, Jan 7 2013 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92463, codified at 5 U.S.C. App. 2), notice is hereby given of the following meeting:

Name: Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC).

Dates and Times: January 31, 2013, 9:30 a.m. to 5:00 p.m., February 1, 2013, 9:30 a.m. to 1:15 p.m.

Place: Virtual via Webinar.

Status: The meeting is open to the public. For more information on registration and webinar details, please visit the SACHDNC Web site: http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders.

Mon, Jan 7 2013 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

Paul J. Muchowski, Ph.D., The J. David Gladstone Institutes: Based on the report of an investigation conducted by The J. David Gladstone Institutes (Gladstone) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Paul J. Muchowski, former Senior Investigator, Gladstone Institute of Neurological Disease, Gladstone, engaged in research misconduct in research supported by National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS05475306A1.

ORI found that the Respondent engaged in research misconduct by falsifying and fabricating data that was included in one (1) funded NIH grant R01 NS05475306A1 and two (2) submitted NIH grant applications R01 NS05475306 and R01 NS04723706.

Specifically, ORI finds that the Respondent knowingly and intentionally:

Falsely reported research experi

Mon, Jan 7 2013 11:00:00 GMT

This notice reflects organizational changes to the Health Resources and Services Administration. This notice updates the functional statements for the Office of Management (RB4) and Office of Information Technology (RB5). Specifically, this notice: (1) Transfers the records management function from the Office of Management (RB4) to the Office of Information Technology (RB5); (2) updates the functional statement for the Office of Management (RB4) and the Office of the Director and Chief Information Officer, Office of Information Technology; and (3) establishes the Division of Information Technology (IT) Security and Records Management (RBR) within the Office of Information Technology

Mon, Jan 7 2013 11:00:00 GMT

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Using Health Information Technology in Practice Redesign: Impact of Health Information Technology on Workflow.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 35013521, AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on October 31st, 2012 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

Mon, Jan 7 2013 11:00:00 GMT

Meetings:

Mon, Jan 7 2013 11:00:00 GMT

Dated: December 21, 2012.
James Scanlon,
Deputy Assistant Secretary for Planning and Evaluation, Office of the Assistant Secretary for Planning and Evaluation.
[FR Doc. 201300011 Filed 1413; 8:45 am]
BILLING CODE 415105P

Meetings:

Fri, Jan 4 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel U.S.China Program for Biomedical Collaborative Research (R01)2.

Date: January 2425, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6700B Rockledge Drive, Room 3139, Bethesda, MD 20892, (Telephone Con

Prospective Grants of Exclusive Licenses:

Fri, Jan 4 2013 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Empire Genomics LLC of an exclusive patent license to practice the inventions embodied in US Provisional Patent Application 61/558,402 entitled, ``Gene Expression Signatures of Neoplasm Responsiveness to Therapy'' [HHS Ref. E0132012/0US01], and all continuing applications and foreign counterparts. The patent rights in this invention have been assigned to the Government of the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to:
the use of the licensed patent rights limited to an FDAcleared or an FDAapproved in vitro diagnostic test kit for human use and predictive of the therapeutic benefit of combination therapy comprising an HDAC inhibitor and an mTOR inhibitor in the treatment of multiple myeloma, breast cancer, melanoma, lym

Meetings:

Fri, Jan 4 2013 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Medical Imaging Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time: The meeting will be held on February 14, 2013, from 8 a.m. to 3 p.m.

Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 209930002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading ``Resources for You,'' click on ``Public Meetings at the FDA White Oak Campus.'' Please note that visitors to the White Oak Campus must enter through Building 1.

Contact P

Thu, Jan 3 2013 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 6397570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

National HIV Prevention Program Monitoring and Evaluation (NHM&E) (OMB 09200696, Expiration 08/31/2013)RevisionNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is requesting a 3year approval for revision to the previously approved project.

The purpose of this revision is to continue collecting standardized HIV

Thu, Jan 3 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 or send comments to Ron Otten, 1600 Clifton Road, MS D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Meetings:

Thu, Jan 3 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Cancer Institute Special Emphasis Panel, U.S.China Program for Biomedical Collaborative Research (R01).

Date: January 28, 2013.

Time: 8:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, MD 20852.

Contact Person: Zhiqiang Zou, MD, Ph.D., Scientific

Guidance for Industry on Providing Regulatory Submissions in Electronic

Thu, Jan 3 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.'' The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA) which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 2 years after publication of the final version of the draft guidance. The draft guidance describes how FDA plans to implement the requirements for the electronic submission of applications for certain human pharmaceutical products and is being issued for public comment. In its final form, this document will also supersede the guidance titled ``Guidance for Indu

Nicotine Replacement Therapies and Smoking-Cessation Products:

Thu, Jan 3 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is extending the comment period for the notice of public hearing that appeared in the Federal Register of November 28, 2012 (77 FR 70955). In the public hearing notice, FDA requested comments on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence. The Agency is taking this action to allow interested persons additional time to submit comments.

Thu, Jan 3 2013 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046397570 and send comments to Ron Otten, 1600 Clifton Road MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have a practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the co

Medicare Program:

Thu, Jan 3 2013 11:00:00 GMT

This document is a request for information from hospitals, electronic health record (EHR) vendors, and other interested parties regarding hospital readiness beginning calendar year 2014 discharges to electronically report certain patientlevel data under the Hospital Inpatient Quality Reporting (IQR) Program using the Quality Reporting Document Architecture (QRDA) Category I.

Center for Scientific Review; Notice of Closed Meetings

Wed, Jan 2 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel Member Conflict: Molecular and Cellular Hematology.

Date: January 2223, 2013.

Time: 10:00 a.m. to 7:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

Contact Person: AiPing Zou, MD, Ph.D.,

New Animal Drugs:

Wed, Jan 2 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect
[[Page 23]]
approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

National Human Genome Research Institute; Notice of Closed Meeting

Wed, Jan 2 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Center for Inherited Disease Research Access Committee CIDR Access Conflict.

Date: January 16, 2013.

Time: 11:00 a.m. to 1:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Human Genome Research Institute, 3rd Floor Conference Room, 5635 Fishers Lane, Rockville, MD 20851 (Telephone Conference Call).

Contact Person: Ken D.

Meetings:

Wed, Jan 2 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel Biophysics and Biochemistry of Membranes.

Date: January 23, 2013.

Time: 1:00 p.m. to 1:30 p.m.

Agenda: To review and evaluate grant applications.

Place: Renaissance Mayflower Hotel, 1127 Connecticut Avenue NW., Washington, DC 20036.

Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review Off

National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

Wed, Jan 2 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Science Education Awards (R25).

Date: January 22, 2013.

Time: 11:00 a.m. to 2:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Rockledge 6700, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conference Call).

Guidance for Industry and Food and Drug Administration Staff;

Wed, Jan 2 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete, which determines whether it should be accepted for substantive review and clearance. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

Center for Scientific Review; Notice of Closed Meetings

Wed, Jan 2 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

Name of Committee: Bioengineering Sciences & Technologies Integrated Review Group Nanotechnology Study Section.

Date: January 31February 1, 2013.

Time: 7:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: Hotel Nikko San Francisco, 222 Mason Street, San Francisco, CA 94102.

Contact Person: James J Li, Ph.D., Scientific Review Officer, C

Test Tools and Test Procedures Approved by National Coordinator;

Wed, Jan 2 2013 11:00:00 GMT

This notice announces the availability of test tools and test procedures approved by the National Coordinator for Health Information Technology (the National Coordinator) for the testing of EHR technology to the 2014 Edition EHR certification criteria under the ONC HIT Certification Program. The approved test tools and test procedures are identified on the ONC Web site at: http://www.healthit.gov/policyresearchersimplementers/2014editionfinaltestmethod.

National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting

Wed, Jan 2 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as [[Page 108]]
amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel, 201305 ZEB1 OSRD(M1)S/Low Dose CT Imaging (U01).

Date: February 22, 2013.

Time: 9:00 a.m. to 5:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, Suite 920, 6707 Democracy Boulevard, Bethesda

Calls for Committee Membership Nominations:

Wed, Jan 2 2013 11:00:00 GMT

The Department of Health and Human Services (Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee. As specified in Public Law 111 148 (``Patient Protection and Affordable Care Act'') the Committee will: (a) Develop a summary of advances in pain care research supported or conducted by the Federal agencies relevant to the diagnosis, prevention, and treatment of pain and diseases and disorders associated with pain; (b) identify critical gaps in basic and clinical research on the symptoms and causes of pain; (c) make recommendations to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort; (d) make recommendations on how best to disseminate information on pain care; and (e) make recommendations on how to expand partnerships between public entities and private entities to expand collaborative, crosscutting research.

Membership on the committe

Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions;

Wed, Jan 2 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``eCopy Program for Medical Device Submissions.'' The purpose of the guidance is to explain the new electronic copy (eCopy) Program for medical device submissions, which is intended to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version. The guidance describes how FDA has implemented the eCopy Program under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance also provides the standards for a valid eCopy under the FD&C Act and identifies the submission types that must include an eCopy in accordance with these standards for the submission to be processed and accepted for review by FDA. This final guidance will be considered in effect on January 1, 2013, or at the time of publication, whichever is later.

Determinations Concerning Petitions:

Wed, Jan 2 2013 11:00:00 GMT

HHS gives notice of a determination concerning a petition to add a class of employees from the United Nuclear Corporation in Hematite, Missouri, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On December 7, 2012, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

All site employees who worked in any area of the United Nuclear CorporationHematite, Missouri, site from January 1, 1958, through December 31, 1973, and the residual period January 1, 1974, through July 31, 2006.

Center for Scientific Review; Notice of Closed Meeting

Wed, Jan 2 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Center for Scientific Review Special Emphasis Panel; Program Project: Conus Peptides.

Date: January 1011, 2013.

Time: 8:00 a.m. to 8:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

Contact Person: Peter B Guthrie, Ph.D., Scientific Review

Meetings:

Wed, Jan 2 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2013. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the Agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.

Supplemental Records of Decisions:

Wed, Jan 2 2013 11:00:00 GMT

The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Supplementary Risk Assessment and a thorough consideration of public comments on the Draft and Final Supplementary Risk Assessment, to implement the Proposed Action, which is identified as the Preferred Alternative in the Final Environmental Impact Statement (EIS). This action reaffirms the NIH's previous decision to partially fund the construction of a stateoftheart National Biocontainment Laboratory (NBL), the National Emerging Infectious Diseases Laboratories (NEIDL), at the Boston University Medical Campus (BUMC) in Boston,
Massachusetts.

Center for Scientific Review; Notice of Closed Meeting

Wed, Jan 2 2013 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

Name of Committee: Center for Scientific Review Special Emphasis Panel Member Conflict: Dementia, Cognitive Dysfunction, and Stroke.

Date: January 8, 2013.

Time: 5:00 p.m. to 7:00 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call).

Contact Person: Samuel C

Medicare and Medicaid Programs:

Wed, Jan 2 2013 11:00:00 GMT

Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval

Wed, Jan 2 2013 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).'' The purpose of the acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete. This guidance document is intended to clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA paneltrack supplements reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).