The Federal Register

National Institute on Aging; Notice of Closed Meetings

Fri, Nov 20 2009 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 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 [[Page 60278]]
would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institutes on Aging, Special Emphasis Panel Exceptional Aging.

Date: December 10, 2009.

Time: 9 a.m. to 12 p.m.

Agenda: To review and evaluate contract proposals.

Place: National Institutes of Health, Gateway Building, 7201 Wisconsin Avenue 2C212, Bethesda, MD 20982 (Telephone Conference Call).

Contact Person: Alicja L. Ma

Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning

Fri, Nov 20 2009 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 for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs, specifically on new data elements to be used in revised versions of Forms FDA 1932 and 1932a. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.

Request for Public Comment: 30-Day Notice; Proposed Information Collection: Indian Health Service Forms

Fri, Nov 20 2009 11:00:00 GMT

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the PRA95, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval.

The IHS received no comments in response to the 60day Federal Register notice (74 FR 30095) published on June 24, 2009. The purpose of this notice is to allow an addi

Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Changes to

Fri, Nov 20 2009 11:00:00 GMT

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2010.

In addition, this final rule with comment period updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we set forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these changes will apply, and other pertinent ratesetting information for the

National Institute on Drug Abuse; Notice of Closed Meeting

Fri, Nov 20 2009 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: National Institute on Drug Abuse Special Emphasis Panel; Conference Grant Application Review.

Date: December 3, 2009.

Time: 10 a.m. to 1 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6101 Executive Boulevard, Rockville, MD 20852, (Virtual Meeting).

Contact Person: Gerald L. McLaughlin, PhD, Scientific

Agency Information Collection Request; 60-Day Public Comment Request

Fri, Nov 20 2009 11:00:00 GMT

National Cancer Institute; Notice of Closed Meeting

Fri, Nov 20 2009 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: National Cancer Institute Initial Review Group; Subcommittee JPopulation and PatientOriented Training.

Date: February 10, 2010.

Time: 7:45 a.m. to 6 p.m.

Agenda: To review and evaluate grant applications.

Place: Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA 22314.

Contact Person: Ilda M. McKenna, PhD, Scientific Review Officer, Rese

Delegation of Authority

Fri, Nov 20 2009 11:00:00 GMT

Notice is hereby given that I have delegated to the Assistant Secretary for Aging the authorities vested in the Secretary of Health and Human Services under Section 1701(a)(3)(AB), Section 1701(a)(4), and Section 1703(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(3)(AB), 300u(a)(4), and 300u2(a), as amended), as they pertain to the exercise of the funds transferred by the Secretary to the Administration on Aging under the ``Prevention and Wellness Fund'' of the American Recovery and Reinvestment Act of 2009, Public Law 1115 (Feb. 17, 2009) to carry out evidencebased clinical and community based prevention and wellness strategies through chronic disease self management programs targeted to improving the health of seniors under the ``Communities Putting Prevention to Work'' initiative.

These authorities may be redelegated.

Exercise of these authorities is concurrent to and does not supplant existing delegations of authority from the Secretary. Exercise of these authorities sh

National Institute of General Medical Sciences; Notice of Closed Meeting

Fri, Nov 20 2009 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 Special Emphasis Panel; Minority Biomedical Research Support.

Date: December 3, 2009.

Time: 9:30 a.m. to 10:30 a.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Natcher Building, Room 3AN12, 45 Center Drive, Bethesda, MD 20892, (Telephone Conference Call).

Agency Forms Undergoing Paperwork Reduction Act Review

Thu, Nov 19 2009 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 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice. Proposed Project

Evaluation of the Action Plan for the National Public Health Initiative on Diabetes and Women's HealthNewNational Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Diabetes can have unique and profound effects on women's lives and health. For instance, diabetes is a more common cause of coronary hear

Administration on Children, Youth and Families; Notice To Award One Expansion Supplement Grant

Wed, Nov 18 2009 11:00:00 GMT

This notice announces the award of an expansion supplement grant to one grantee under the Family and Youth Services Bureau (FYSB)/ Family Violence Prevention and Services Program. The expansion supplement award is made to the Pennsylvania Coalition Against Domestic Violence, Harrisburg, PA, a technical assistance provider, to support their capacity to provide technical support and training to State and local domestic violence advocates and social service agencies. These efforts will allow FYSB to support collaborative work to enhance the capacity of Temporary Assistance to Needy Families (TANF) and other Federal programs to provide assistance to eligible victims of domestic violence.

Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of

Wed, Nov 18 2009 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 requirements relating to the reporting of biological product deviations (BPDs) and human cells, tissues, and cellular and tissuebased product (HCT/P) deviations, and Form FDA 3486 and Addendum 3486A.

Request for Public Comment: 60-Day Proposed Information Collection: Office of Urban Indian Health Programs Uniform

Wed, Nov 18 2009 11:00:00 GMT

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 day advance opportunity 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.

Proposed Collection: Title: Office of Urban Indian Health Programs (OUIHP) Uniform Data System (UDS). Type of Information Collection Request: Initial request and four year extension, for data collection to ensure compliance with legislative mandates and report to Congress and policymakers on program accomplishments. Form Number(s): New data collection. There are currently no form numbers. Reporting formats are contained in the UDS Instruction Manual. Need and Use of Information Collection: The Uniform Data System (UDS) contains the annual reporting requirements for the cluster of primary health care and case management/outreach and r

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Nov 18 2009 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.

Indian Health Service

Wed, Nov 18 2009 11:00:00 GMT

Loan Repayment Program for Repayment of Health Professions Educational Loans

Announcement Type: Initial.

CFDA Number: 93.164.

Key Dates: January 15, 2010 first award cycle deadline date, September 30, 2010 entry on duty deadline date.

I. Funding Opportunity Description

The Indian Health Service (IHS) estimated budget request for Fiscal Year (FY) 2010 includes $17,488,854 for the IHS Loan Repayment Program (LRP) for health professional educational loans (undergraduate and graduate) in return for fulltime clinical service 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 with other Government and private health management organizations to employ qualified health professionals.

This program is authorized by Section 108 of the Indian Health Care Improvement Act (IHCIA) as amended, 25 U.S.C. 1601 et seq. The IHS invites potential

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Nov 18 2009 11:00:00 GMT

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Wed, Nov 18 2009 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: Recovery Services for Adolescents and FamiliesNew

The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment will conduct a data collection on the helpfulness of recovery support services for young people and their families after leaving substance abuse treatment. Specifically, the Recovery Services for Adolescents and Families (RSAF) project is evaluating a pilot test of the following recovery support services for young people and their families find the following recovery support services helpful: (1) Telephone/text message support; (2) a recoveryoriented social networking site; and (3) a family program

Total Inward Leakage Requirements for Respirators

Wed, Nov 18 2009 11:00:00 GMT

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), will hold a public meeting concerning the proposed rule that was published in the Federal Register on Friday, October 30, 2009. The proposed rule proposes to establish total inward leakage (TIL) requirements for half mask airpurifying particulate respirators approved by NIOSH. The proposed new requirements specify TIL minimum performance requirements and testing to be conducted by NIOSH and respirator manufacturers to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome (SARS) coronavirus, and Mycobacterium tuberculosis).

Submission for OMB review; Comment Request; Parental Knowledge, Attitudes, and Behaviors Related to Pediatric

Wed, Nov 18 2009 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health 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 Wednesday, July 29, 2009, Volume 74, Number 144 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. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements:

Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30day Federal Register Notic

Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Facts

Wed, Nov 18 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; ``Real Time'' Surveys of Consumers'

Wed, Nov 18 2009 11:00:00 GMT

Memorandum of Understanding Between the Food and Drug Administration and Waterfront Media

Wed, Nov 18 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Waterfront Media. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls.

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Nov 17 2009 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

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Nov 17 2009 11:00:00 GMT

Proposed Revisions to Federal Drug Testing Custody and Control Form

Tue, Nov 17 2009 11:00:00 GMT

The Department of Health and Human Services (HHS) establishes the standards for Federal workplace drug testing programs under authority of Section 503 of Public Law 10071, 5 U.S.C. Section 7301 and Executive Order No. 12564. As required, HHS published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in the Federal Register on April 11, 1988 (53 FR 11979). The Substance Abuse and Mental Health Services Administration (SAMHSA) subsequently revised the Guidelines on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), on November 13, 1998 (63 FR 63483), on April 13, 2004 (69 FR 19644) and on November 25, 2008 (73 FR 71858) with an effective date of May 1, 2010 (correct effective date published on December 10, 2008; 73 FR 75122). The Guidelines establish comprehensive standards for all aspects of the Federal workplace drug testing program, including the requirement for all urine specimens to be collected using chain of custody procedures to document spec

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Nov 17 2009 11:00:00 GMT

Submission for OMB Review; Comment Request

Tue, Nov 17 2009 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 fu

Proposed Collection; Comment Request; The Atherosclerosis Risk in Communities Study (ARIC)

Mon, Nov 16 2009 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 Heart, Lung, and Blood Institute (NHLBI), 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: The Atherosclerosis Risk in Communities Study (ARIC). Type of Information Collection Request: Revision of a currently approved collection (OMB No. 09250281). Need and Use of Information Collection: This project involves annual followup by telephone of participants in the ARIC study, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence ra

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Nov 13 2009 11:00:00 GMT

Laboratory Medicine Best Practices Project (LMBP)NewNational Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), 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 systemic review of laboratory pr

Criteria for Vaccination Requirements for U.S. Immigration Purposes

Fri, Nov 13 2009 11:00:00 GMT

On April 8, 2009, the Centers for Disease Control and Prevention (CDC) published a notice in the Federal Register (74 FR 15986) seeking public comment on proposed criteria that CDC intends to use to determine which vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for the general U.S. population should be required for immigrants seeking admission into the United States or seeking adjustment of status to that of an alien lawfully admitted for permanent residence. This final notice describes the criteria that CDC has adopted.

At present, CDC requires all vaccinations against vaccine preventable diseases explicitly listed in section 212(a)(1)(A)(ii) of the Immigration and Nationality Act, as well as all vaccinations recommended by the ACIP for the general U.S. population. After the effective date of this notice, CDC will continue to require the vaccinations explicitly listed in section 212(a)(1)(A)(ii)mumps, measles, rubella, polio, tetanus and diphtheria toxoids,

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Nov 13 2009 11:00:00 GMT

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Nov 13 2009 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 4046395960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 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 collecte

Government-Owned Inventions; Availability for Licensing

Thu, Nov 12 2009 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.

Implementation of OMB Guidance on Drug-Free Workplace Requirements

Thu, Nov 12 2009 11:00:00 GMT

The Department of Health and Human Services (HHS or the Department) is removing its regulation implementing the Governmentwide common rule on drugfree workplace requirements for financial assistance, and issuing a new regulation to adopt Office of Management and Budget (OMB) guidance. This regulatory action implements the OMB's initiative to streamline and consolidate into one title of the CFR all Federal regulations on drugfree workplace requirements for financial assistance. These changes constitute an administrative simplification that would make no substantive change in HHS policy or procedures for drugfree workplace.

New Animal Drugs in Genetically Engineered Animals

Thu, Nov 12 2009 11:00:00 GMT

CFR Correction

In Title 21 of the Code of Federal Regulations, Parts 500599, revised as of April 1, 2009, on page 359, the heading for part 528 is corrected to read ``NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS''.
[FR Doc. E927305 Filed 111009; 8:45 am]
BILLING CODE 150501D

Government-Owned Inventions; Availability for Licensing

Thu, Nov 12 2009 11:00:00 GMT

Medicare Program; Home Health Prospective Payment System; Rate Update for Calendar Year 2010

Tue, Nov 10 2009 11:00:00 GMT

This final rule sets forth an update to the Home Health Prospective Payment System (HH PPS) rates; the national standardized 60day episode rates, the national pervisit rates, the nonroutine medical supply (NRS) conversion factors, and the low utilization payment amount (LUPA) addon payment amounts, under the Medicare prospective payment system for home health agencies effective January 1, 2010. This rule also updates the wage index used under the HH PPS. In addition, this rule changes the HH PPS outlier policy, requires the submission of OASIS data as a condition for payment under the HH PPS, implements a revised Outcome and Assessment Information Set (OASISC) for episodes beginning on or after January 1, 2010, and implements a Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home Health Care Survey (HHCAHPS) affecting payment to HHAs beginning in CY 2012. Also, this rule makes payment safeguards that will improve our enrollment process, improve the quality of care that Medicare

Current Good Manufacturing Practice Requirements for Combination Products; Extension of Comment Period

Tue, Nov 10 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is extending to February 5, 2010, the comment period for the proposed rule that appeared in the Federal Register of September 23, 2009. In the proposed rule, FDA requested comments on current good manufacturing practice (CGMP) requirements applicable to combination products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Grants for Research Projects

Tue, Nov 10 2009 11:00:00 GMT

The National Institutes of Health is amending the current regulations governing grants for research projects by revising the definition of Principal Investigator to mean one or more individuals designated by the grantee in the grant application and approved by the Secretary, who is or are responsible for the scientific and technical direction of the project, rather than limiting the role of Principal Investigator to one single individual; and the conditions for multiple or concurrent awards pursuant to one or more applications.

Notice of Interest Rate on Overdue Debts

Tue, Nov 10 2009 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.'' 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 \7/8\%, as fixed by the Secretary of the Treasury, is certified for the quarter ended September 30, 2009. This interest rate is effective until the Secretary of the Treasury notifies the Department of Health and Human Services of any change.

Proposed Information Collection Activity; Comment Request

Mon, Nov 9 2009 11:00:00 GMT

Proposed Projects

Title: Tax Refund Offset Program and Administrative Offset Program (TROP/ADOP).

OMB No.: 09700161.

Description: The Tax Refund Offset and Administration Offset Programs collect pastdue child 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 (FMS), the Federal Office of Child Support Enforcement (OCSE), and State Child Support Enforcement (CSE) agencies. The Passport Denial program reports noncustodial parents who owe arrears above a threshold to the Department of State (DOS), which will then deny passports to these individuals. On an ongoing basis, CSE agencies submit to OCSE the names, Social Security numbers (SSNs), and the amount(s) of pastdue child support of people who are delinquent in making child support payments.

Respondents: Sta

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Nov 9 2009 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 4046395960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Prospective Granting of an Exclusive License

Mon, Nov 9 2009 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 (DHHS), is contemplating the granting of an exclusive worldwide license to practice the invention embodied in the patent application referred to below to International Rollforms, Inc., having a place of business in Deptford, New Jersey. CDC intends to grant rights to practice this invention to no other licensees. The patent rights in this invention have been assigned to the government of the United States of America. The patent to be licensed is:

Title: Instrumented Rock Bolt, Data Logger and User Interface System, CDC Ref. : I01701.

Patent No.: 7,324,007.
[[Page 57688]]

Filing Date: 12/27/2002.

Issue Date: 01/29/2008.

The prospective exclusive license will be royaltybearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.

This inve

Proposed Collection; Comment Request; Clinical Trials Reporting Program (CTRP) Database (NCI)

Mon, Nov 9 2009 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 Cancer Institute (NCI), 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: Clinical Trials Reporting Program (CTRP) Database. Type of Information Collection Request: Revision of currently approved collection [OMB No. 09250600, expiration date 01/ 31/2010]. Need and Use of Information Collection: The NCI is developing an electronic resource, the NCI Clinical Trials Reporting Program (CTRP) Database, to serve as a single, definitive source of information about all NCIsupported clinical research, thereby enabling the NCI to execute its mission to reduce the burden of cancer and to ensure an optimal return on the nation's investment in cancer clini

Proposed Information Collection Activity; Comment Request

Mon, Nov 9 2009 11:00:00 GMT

Title: Evaluation of Adolescent Pregnancy Prevention Approaches Baseline Data Collection.

OMB No.: 09700360.

Description: The Administration for Children and Families (ACE), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the Evaluation of Adolescent Pregnancy Prevention Approaches (PPA). PPA is being undertaken to expand available evidence on effective ways to prevent teen pregnancy. The evaluation will document and test a range of pregnancy prevention approaches in up to eight program sites. Program impacts will be estimated using a random assignment design, involving random assignment at the school, individual, or other level, depending on the program setting. The findings of the evaluation will be of interest to the general public, to policymakers, and to organizations interested in teen pregnancy prevention.

This proposed information collection activity focuses on collecting baseline data from a selfadministered questionn

Submission for OMB Review; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

Title: Native Employment Works (NEW) Program Plan Guidance and Report Requirements.

OMB No.: 09700174.

Description: The Native Employment Works (NEW) program plan is the application for NEW program funding. As approved by the Department of Health and Human Services (HHS), it documents how the grantee will carry out its NEW program. The NEW program plan guidance provides instructions for preparing a NEW program plan and explains the process for plan submission every third year. The NEW program report provides information on the activities and accomplishments of grantees' NEW programs. The NEW program report and instructions specify the program data that NEW grantees report annually.

Respondents: Federally recognized Indian Tribes and Tribal organizations that are NEW program grantees.
Annual Burden Estimates Number of Average

Draft Guidance on Institutional Review Board Continuing Review of Research

Fri, Nov 6 2009 11:00:00 GMT

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``Guidance on IRB Continuing Review of Research,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, will represent OHRP's current thinking on this topic and will supersede OHRP's January 15, 2007 guidance document entitled ``Guidance on Continuing Review,'' available at http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm. The draft document, which is available on the OHRP Web site at http:// www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Departm

Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of

Fri, Nov 6 2009 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, 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 reporting requirements contained in the requirements for submission of labeling for human prescription drugs and biologics in electronic format.
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Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Nov 6 2009 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: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on September 2nd, 2009 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human

Fri, Nov 6 2009 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 bar code label requirements for human drug and biological products.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment will conduct a data collection on the helpfulness of recovery support services for whether young people and their families after leaving substance abuse treatment. Specifically, the Recovery Services for Adolescents and Families (RSAF) project is evaluating a pilot test of the following recovery support services for whether young people and their families find the following recovery support services helpful: (1) Telephone/ text message support; (2) a recoveryoriented social networking site; and (3)

Proposed Collection; Comment Request; Next Series of Tobacco Use Supplements to the Current Population Survey

Fri, Nov 6 2009 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 Cancer Institute (NCI), 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: Next Series of Tobacco Use Supplements to the Current Population Survey (TUSCPS). Type of information request: REINSTATEMENT WITH CHANGE of OMB 09250368, Expiration 4/30/2009. Need and Use of Information Collection: The 2010 2011 Tobacco Use Supplement to the Current Population Survey conducted by the Census Bureau will collect data from the U.S. civilian non institutionalized population on smoking, other tobacco use, and attempts at cessation; policy information such as home and workplace smoking policies; health professional advice to stop smoking; and changes in smoking no

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Nov 6 2009 11:00:00 GMT

Draft Guidance on Institutional Review Board Approval of Research With Conditions

Fri, Nov 6 2009 11:00:00 GMT

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled ``Guidance on IRB Approval of Research with Conditions,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at http://www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies

Fri, Nov 6 2009 11:00:00 GMT

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C 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), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines.

If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted fro

Submission for OMB Review; Comment Request

Thu, Nov 5 2009 11:00:00 GMT

Title: Emergency Contingency Fund for Temporary Assistance for Needy Families (TANF) Programs OFA100.

OMB No.: 09700366.

Description: On February 17, 2009, the President signed the American Recovery and Reinvestment Act of 2009 (Recovery Act), which establishes the Emergency Contingency Fund for State TANF Programs (Emergency Fund) as section 403(c) of the Social Security Act (the Act). This legislation provides up to $5 billion to help States, Territories, and Tribes in fiscal year (FY) 2009 and FY 2010 that have an increase in assistance caseloads and basic assistance expenditures, or in expenditures related to shortterm benefits or subsidized employment. The Recovery Act made additional changes to TANF extending supplemental grants through FY 2010, expanding flexibility in the use of TANF funds carried over from one fiscal year to the next, and adding a holdharmless provision to the caseload reduction credit for States and Territories serving more TANF families.

The Emergency

Food and Drug Administration's Safe Use Initiative; Availability of Information

Thu, Nov 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the launch of its Safe Use Initiative with the release of a report titled ``FDA's Safe Use InitiativeCollaborating to Reduce Preventable Harm from Medicines.'' FDA is opening a docket to enable the public to comment on the report and the initiative. In addition, a safe use Web site has been created to facilitate transparency as the initiative moves forward. The initiative proposes a series of next steps, including working with interested partnerspatients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, and other Federal agenciesto select specific candidate cases of preventable, drugrelated harm for analysis, intervention proposals, and evaluation metrics. The report identifies some specific areas of concern that could benefit from Safe Use Initiative partnerships.

Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Thu, Nov 5 2009 11:00:00 GMT

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at the Norton Company, Worcester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 29, 2009, 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 AWE employees who worked at the Norton Company in Worcester, Massachusetts, from January 1, 1945 through December 31, 1957, 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.
[[Page 57316]]
This designation became effective on October 29, 2009, as provided for under 42 U.S.C. 7384l(14)(C). Hence, beginning on October 29, 2009, members of this class of employees

Amendment to Memorandum of Understanding Between the Food and Drug Administration and WebMD, LLC

Thu, Nov 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of an amendment to a memorandum of understanding (MOU) between FDA's Office of External Relations and WebMD, LLC.

Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort

Thu, Nov 5 2009 11:00:00 GMT

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at the Lake Ontario Ordnance Works, Niagara, Falls, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 29, 2009, 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 DOE, its predecessor agencies, and their contractors and subcontractors who worked at Lake Ontario Ordnance Works in Niagara Falls, New York from January 1, 1944 through December 31, 1953, 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 SEC.
This designation became effective on October 29, 2009, as provided for under 42 U.S.C. 7384l(14)(C). Hence, begin

Medicare Programs; End-Stage Renal Disease Prospective Payment System; Extension of Comment Period

Wed, Nov 4 2009 11:00:00 GMT

This notice extends the comment period for a proposed rule published in the Federal Register on September 29, 2009, (74 FR 49922). The proposed rule would implement a casemix adjusted bundled prospective payment system (PPS) for Medicare outpatient endstage renal disease (ESRD) dialysis facilities. The proposed ESRD PPS would also replace the current basic casemix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD services. The comment period for the proposed rule, which would have ended on November 16, 2009, is extended for 30 days.

Privacy Act of 1974; Deletion of an Existing System of Records

Wed, Nov 4 2009 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, HRSA is deleting an existing system of records titled the ``Minority/Disadvantaged Health Professions Programs'' HRSA System No. 09150060, established at 63 Federal Register 14121 (March 24, 1998).

Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget

Wed, Nov 4 2009 11:00:00 GMT

Privacy Act of 1974; Deletion of a System of Records

Wed, Nov 4 2009 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is deleting an existing system of records titled ``Ricky Ray Hemophilia Relief Fund Act of 1998,'' HRSA System No. 09150061, established at Volume 64, Number 237 Federal Register pages 6927469277 on December 10, 1999.

Government-Owned Inventions; Availability for Licensing

Wed, Nov 4 2009 11:00:00 GMT

Privacy Act of 1974; Report of an Altered System of Records

Wed, Nov 4 2009 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for the Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Data System, HHS/HRSA/HSB/DoT, system of records number 09150055. The purpose of this alteration is to add a new routine use for this system of records. In addition, this notice clarifies system location, how the records are stored, retrieved, and disposed.

Agency Forms Undergoing Paperwork Reduction Act Review

Tue, Nov 3 2009 11:00:00 GMT

Field Evaluation of Prototype Kneelassist Devices in Lowseam MiningNewNational Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

NIOSH, under Public Law 91596, Sections 20 and 22 (Section 2022, Occupational Safety and Health Act of 1970) has the responsibility to conduct research relating to innovative methods, tech

Draft Guidance for Industry on Listing of Ingredients in Tobacco Products; Availability

Tue, Nov 3 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The draft guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by section 904 of the Federal Food, Drug, and Cosmetic Act (the act) as added by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

Proposed Data Collections Submitted for Public Comment and Recommendations

Tue, Nov 3 2009 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. Alternatively, to obtain a copy of the data collection plans and instrument, call 4046395960 and send comments to Maryam I. Daneshvar, CDC Reports Clearance Officer, 1600 Clifton Road NE., MSD74, Atlanta, Georgia 30333; comments may also be sent by 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 m

HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop 2009 and BARDA Industry

Tue, Nov 3 2009 11:00:00 GMT

The Department of Health and Human Services (HHS) is pleased to announce the upcoming HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop 2009 and BARDA Industry Day to be held December 24, 2009, at the Marriott Wardman Park Hotel in Washington, DC. This annual PHEMCE event will bring together private and publicsector stakeholders including: Federal Officials, International Governments, Industry, Healthcare Providers, First Responders, CommunityBased Organizations, and other interested audiences. Attendees will have opportunities to participate in forums on:

Best Practices for Dispensing Medical Countermeasures

Current and Future PHEMCE Initiatives

Maximizing Resources in a Public Health Emergency Response

Medical Countermeasure Development Initiatives

The Regulatory Pathway for Medical Countermeasures

BARDA Industry Day Presentations

This free Workshop will also address plans to enhance national res

Draft Guideline for the Prevention of Intravascular Catheter- Related Infections

Tue, Nov 3 2009 11:00:00 GMT

This notice is a request for review of and comment on the Draft Guideline for the Prevention of Intravascular CatheterRelated Infections, available on the following Web site: http://www.cdc.gov/ publiccomments/.

This document is for use by infection prevention staff, healthcare epidemiologists, healthcare administrators, nurses, other healthcare providers, and persons responsible for developing, implementing, and evaluating infection prevention and control programs for healthcare settings across the continuum of care. The guideline updates and expands the Guideline for the Prevention of Intravascular Device Related Infections published in 2002. These guidelines provide evidencebased recommendations for preventing intravascular catheter related infections.

Agency Information Collection Activities: Proposed Collection: Comment Request

Tue, Nov 3 2009 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, Public Law 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 on (301) 4431129.

Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (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 informa

Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information;

Mon, Nov 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for peramivir 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients. Peramivir is a drug that is not approved by FDA. FDA is issuing the Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of peramivir. The Authorization follows the determination by then Acting Secretary of the U.S. Department of Health and Human Services Charles E. Johnson (then Acting Secretary) that a public health emergency exists involving Swine Influenza A (now known as ``2009H1N1 Influenza'') that affects, or has the significant potential to affect, national security. The determination

Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug

Mon, Nov 2 2009 11:00:00 GMT

Proposed Information Collection Activity; Comment Request

Mon, Nov 2 2009 11:00:00 GMT

Proposed Projects

Title: OCSE75 Tribal Child Support Enforcement Program Annual Data Report.

OMB No.: 09700320.

Description: The data collected by form OCSE75 are used to prepare the OCSE preliminary and annual data reports. In addition, Tribes administering CSE programs under Title IVD of the Social Security Act are required to report program status and accomplishments and submit the OCSE75 report annually.

Respondents: Tribal Child Support Enforcement Organizations or the Department/Agency/Bureau responsible for Child Support Enforcement in each Tribe.
[[Page 56642]]
Annual Burden Estimates Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours OCSE75...............................

Determination and Declaration Regarding Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use

Mon, Nov 2 2009 11:00:00 GMT

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 360bbb3(b)(4). On April 26, 2009, the then Acting Secretary of HHS determined that a public health emergency exists nationwide involving Swine Influenza A (now known as 2009H1N1 Influenza A, or 2009H1N1 influenza) that affects or has significant potential to affect
[[Page 56641]]
national security. On July 24 and October 1, 2009 the Secretary renewed that determination of a public health emergency. On the basis of this determination, on October 20, 2009 the Secretary declared an emergency justifying the authorization of emergency use of the antiviral product peramivir accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs (Commissioner) under 21 U.S.C. 360bbb3(a). The Secretary also specified that this declaration is a declaration of emergency as defined in the De

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Nov 2 2009 11:00:00 GMT

Designation of a Class of Employees for Addition to the Special Exposure Cohort

Fri, Oct 30 2009 11:00:00 GMT

HHS gives notice of a decision to designate a class of employees at the Norton Company, Worcester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 29, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:

This designation will become effective on October 29, 2009, 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 the SEC or the resu

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Oct 30 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Oct 30 2009 11:00:00 GMT

Designation of a Class of Employees for Addition to the Special Exposure Cohort

Fri, Oct 30 2009 11:00:00 GMT

HHS gives notice of a decision to designate a class of employees at the Lake Ontario Ordnance Works, Niagara Falls, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 29, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:

This designation will become effective on October 29, 2009, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Fe

HIPAA Administrative Simplification: Enforcement

Fri, Oct 30 2009 11:00:00 GMT

The Secretary of the Department of Health and Human Services (HHS) adopts this interim final rule to conform the enforcement regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to the effective statutory revisions made pursuant to the Health Information Technology for Economic and Clinical Health Act (the HITECH Act), which was enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA). More specifically, this interim final rule amends HIPAA's enforcement regulations, as they relate to the imposition of civil money penalties, to incorporate the HITECH Act's categories of violations, tiered ranges of civil money penalty amounts, and revised limitations on the Secretary's authority to impose civil money penalties for established violations of HIPAA's Administrative Simplification rules (HIPAA rules). This interim final rule does not make amendments with respect to those enforcement provisions of the HITECH Act that are not yet e

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Oct 30 2009 11:00:00 GMT

Total Inward Leakage Requirements for Respirators

Fri, Oct 30 2009 11:00:00 GMT

The Centers for Disease Control and Prevention (``CDC'') proposes to establish total inward leakage (TIL) requirements for half mask airpurifying particulate respirators approved by the National Institute for Occupational Safety and Health (``NIOSH'') of CDC. The proposed new requirements specify TIL minimum performance requirements and testing to be conducted by NIOSH and respirator manufacturers to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome (SARS) coronavirus, and Mycobacterium tuberculosis).

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): CDC Grants for Public Health

Thu, Oct 29 2009 11:00:00 GMT

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 SEP:

Time and Date: 12 p.m.3 p.m., December 2, 2009 (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 ``CDC Grants for Public Health Research Dissertation, FOA PAR07231, Panel E.''

Contact Person for More Information: Sheree Marshall Williams, PhD, MSc, Scientific Review Administrator, CDC, 1600 Clifton Road, NE., Mailstop D73, Atlanta, GA 30333, Telephone 4046397742.

The Director, Management Analysis and Services Office, has been dele

Findings of Scientific Misconduct

Thu, Oct 29 2009 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Zhong Bin Deng, Medical College of Georgia: Based on the report of an investigation conducted by the Medical College of Georgia (MCG), the report of the MCG Adjudication Subcommittee, additional analysis conducted by ORI in its oversight review, and the Respondent's written and oral admissions and expressed remorse, ORI found that Dr. Zhong Bin Deng, former postdoctoral fellow at MCG in Augusta, GA, engaged in scientific misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grant 2 P01 AI42288.

ORI found that Dr. Deng engaged in scientific/research misconduct by falsifying research results reported in a paper published in Nature Medicine.\1\ Specifically:
\1\ Mi, Q.S., Deng, Z.B., Joshi, S.K., Wang, Z.Z., Zhou, L., Eckenrode, S., Joshi, R., Ly, D., Yi,

Investigational New Drug Applications; Technical Amendment

Thu, Oct 29 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the
[[Page 55771]]
Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.

Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License

Wed, Oct 28 2009 11:00:00 GMT

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Wed, Oct 28 2009 11:00:00 GMT

Agency Information Collection Request; 60-Day Public Comment Request

Wed, Oct 28 2009 11:00:00 GMT

Proposed Collection; Comment Request; A Generic Submission for Formative Research, Pretesting, and Customer

Wed, Oct 28 2009 11:00:00 GMT

Under the provisions 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 Cancer Institute (NCI), 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: A Generic Submission For Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources. Type of Information Collection Request: REVISION. Need and Use of Information Collection: In order to carry out NCI's legislative mandate to educate and disseminate information about cancer prevention, detection, diagnosis, and treatment to a wide variety of audiences and organizations (e.g., cancer patients, their families, the general public, health providers, the media, voluntary groups, scientific and medical organizations), it is beneficial for NCI, through its

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Oct 28 2009 11:00:00 GMT

Proposed Data Collections Submitted for Public Comment and Recommendations

Wed, Oct 28 2009 11:00:00 GMT

Agency Information Collection Request. 30-Day Public Comment Request

Wed, Oct 28 2009 11:00:00 GMT

Proposed Data Collections Submitted for Public Comment and Recommendations

Wed, Oct 28 2009 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
[[Page 55560]]
request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046395960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Prescription Drug User Fee Rates for Fiscal Year 2010; Correction

Tue, Oct 27 2009 11:00:00 GMT

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38451). The document announced the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. The document was published with errors. This document corrects those errors.

Proposed Information Collection Activity; Comment Request

Tue, Oct 27 2009 11:00:00 GMT

Proposed Projects

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

Submission for OMB Review; Comment Request

Tue, Oct 27 2009 11:00:00 GMT

Title: April 2010 Current Population Survey Supplement on Child Support.

OMB No.: 09920003.

Description: Collection of these data will assist legislators and policymakers in determining how effective their policymaking efforts have been over time in applying the various child support legislation to the overall child support enforcement picture. This information will help policymakers determine to what extent individuals on welfare would be removed from the welfare rolls as a result of more stringent child support enforcement efforts.

Respondents: Individuals and households.
Annual Burden Estimates Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours Child Support Survey............

Announcement of Final Priority Data Needs for Six Priority Hazardous Substances

Tue, Oct 27 2009 11:00:00 GMT

This notice announces the final priority data needs for six priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR SubstanceSpecific Applied Research Program (SSARP). This notice also serves as a continuous call for voluntary research proposals.

The exposure and toxicity priority data needs in this notice were distilled from the data needs identified in ATSDR's toxicological profiles by the logical scientific approach described in a decision guide published in the Federal Register on September 11, 1989 (54 FR 37618). The priority data needs represent information essential to improving the database for conducting public health assessments. Research to address these priority data needs will help to determine the types or levels of exposure that may present significant risks of adverse health effects in people exposed to the six hazardous substances.

The priority data needs announced in this notice reflect the opinion of ATSDR, in

Submission for OMB Review; Comment Request

Tue, Oct 27 2009 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. Annual Burden Estimates Number of Average burden Instrument Number

Privacy Act of 1974; Report of an Altered System of Records

Mon, Oct 26 2009 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is proposing to: change the security classification of the system from low to moderate; add an additional system location, to reflect the creation of a system contingency site; delete language from authorized users of the system; add information on physical safeguards pertaining to system security; delete the use of a receptionist controlled area from the physical safeguards for the system; change the room number for the system manager; change the legal authority cited for maintenance of system information; add a new routine use to Information Center (IC) Integrated Clearinghouse System (ICS), 09150067, last published at 72 Federal Register 4484644847 (August 9, 2007). The HRSA Office of Communications is responsible for the HRSA IC/ICS System of Records (SOR), which is an existing Agency SOR.

Submission for OMB Review; Comment Request

Mon, Oct 26 2009 11:00:00 GMT

Title: National Youth in Transition Database and Youth Outcome Survey.

OMB No.: 09700340.

Description: The Foster Care Independence Act of 1999 (42 U.S.C. 1305 et seq.) as amended by Public Law 106169 requires State child welfare agencies to collect and report to the Administration on Children and Families (ACF) data on the characteristics of youth receiving independent living services and information regarding their outcomes. The regulation implementing the National Youth in Transition Database, listed in 45 CFR 1356.80, contains standard data collection and reporting requirements for States to meet the law's requirements. ACF will use the information collected under the regulation to track independent living services, assess the collective outcomes of youth, and potentially to evaluate State performance with regard to those outcomes consistent with the law's mandate.

Respondents: State agencies that administer the John H. Chafee Foster Care Independence Program.

Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Standard for Flavored

Mon, Oct 26 2009 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 proposed extension of an existing collection of information pertaining to the tobacco product standard for flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Mon, Oct 26 2009 11:00:00 GMT

Since 2001, SAMHSA's Center for Substance Abuse Prevention has been operating a Fetal Alcohol Spectrum Disorder (FASD) Center of Excellence which addresses FASD mainly by providing trainings and technical assistance; and developing and supporting systems of care that respond to FASD using effective evidence based practices and interventions.

Currently the integration of evidencebased practices into service delivery organizations is being accomplished through subcontracts. One such intervention which integrates prevention strategies into service d

Submission for OMB Review; Comment Request

Mon, Oct 26 2009 11:00:00 GMT

Title: April 2010 Current Population Survey Supplement on Child Support.

OMB No.: 09920003.

Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug

Mon, Oct 26 2009 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 including each proposed extension of a collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for antimicrobial animal drug distribution as required by Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA).

Submission for OMB Review; Comment Request

Mon, Oct 26 2009 11:00:00 GMT

Title: CrossSite Evaluation of the Children's Bureau Grantee Cluster: Supporting EvidenceBased Home Visiting Programs to Prevent Child Maltreatment (EBHV).

OMB No.: New collection.

Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing this crosssite evaluation data collection activity to identify successful strategies for adopting, implementing, and sustaining highquality home visitation programs to prevent child maltreatment. An evaluation study will address four domains: (1) Systems change to develop
infrastructure, (2) fidelity to evidence
[[Page 55052]]
based models, (3) costs of home visiting programs, and (4) family and child outcomes (via a review of grantee analysis reports). A process study will focus on the broader grant initiative to understand how programs plan and develop the infrastructure needed to support home visitation services and how they ensure service quality.

Information will be coll

Agency Forms Undergoing Paperwork Reduction Act Review

Mon, Oct 26 2009 11:00:00 GMT

The Epidemiology and Impact of Workplace Violence in Pennsylvania Teachers and ParaprofessionalsNEWNational Institute for
Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Workplace violence (WPV) is a significant concern for employers and employees alike; every year in the U.S., WPV results in hundreds of deaths, nearly two mil

Proposed Information Collection Activity; Comment Request

Mon, Oct 26 2009 11:00:00 GMT

Proposed Projects:

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

OMB No.: New collection.

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

Agency Information Collection Activities; Proposed Collection;

Fri, Oct 23 2009 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 Investigational Device Exemptions Reports and Records.

New Animal Drug Applications

Fri, Oct 23 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend the regulations regarding new animal drug applications (NADAs). Specifically, this proposed rule is being issued to provide that NADAs shall be submitted in the form and containing the information described, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to address the development of all types of new animal drug products. This amendment will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Oct 23 2009 11:00:00 GMT

Program Effectiveness Evaluation of Workplace Intervention for Intimate Partner Violence (IPV)[OMB 09200789] [exp. 12/31/ 09]ExtensionNational Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Intimate partner violence (IPV) affects a substantial number of Americans, and there has recently been increasing recogni

Agency Information Collection Activities: Proposed Collection;

Fri, Oct 23 2009 11:00:00 GMT

Comment Request

Agency Information Collection Activities; Proposed Collection;

Fri, Oct 23 2009 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 requirements of FDA's regulations that require records on FDAregulated human food, including dietary supplements, and cosmetics that are manufactured from, processed with, or otherwise contain, material derived from cattle.

Agency Information Collection Activities: Proposed Collection;

Fri, Oct 23 2009 11:00:00 GMT

Comment Request

Agency Information Collection Activities; Proposed Collection;

Fri, Oct 23 2009 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 FDA Forms 3602 and FDA Form 3602A which will allow domestic and foreign applicants to certify that they qualify as a ``small business'' and pay certain medical device user fees at reduced rates.

Agency Information Collection Activities: Submission for OMB

Fri, Oct 23 2009 11:00:00 GMT

Review; Comment Request

New Animal Drug Applications

Fri, Oct 23 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to address the development of all types of new animal drug products. This amendment will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. FDA is amending the regulations in accordance with its direct final rule procedures.

Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedure for noticeand comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adve

Agency Information Collection Activities: Proposed Collection;

Fri, Oct 23 2009 11:00:00 GMT

Comment Request

Request for Comment: National Center for Complementary and Alternative Medicine Announcement of Strategic Planning

Thu, Oct 22 2009 11:00:00 GMT

The National Center for Complementary and Alternative Medicine (NCCAM) is developing its third strategic plan and invites the public to provide comments on three background papers which will support the development of this plan. The papers will cover three topics: Mission, priority setting, and communications and decisionmaking. They will be publicly available through the NCCAM Web site at from on or about October 19 through November 19, 2009. The public is invited to provide comments through the NCCAM Web site.

Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1998 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals.

To date, NCCAM's efforts to rigorously study CAM, to train CAM researchers, and to communicate with the public and professionals, have been guided by NCCAM's pr

Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons

Thu, Oct 22 2009 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 publication of the criteria FDA intends to use to accredit third parties to conduct inspections of eligible manufacturers of class II or class III medical devices.

Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit

Thu, Oct 22 2009 11:00:00 GMT

We are proposing revisions to the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) based on our continued experience in the administration of the Part C and D programs. The proposed revisions clarify various program participation requirements; specify changes to strengthen beneficiary protections; ensure that plan offerings to beneficiaries include meaningful differences; improve plan payment rules and processes; and implement new policy such as a Part D formulary policy.

Performance Review Board Members

Wed, Oct 21 2009 11:00:00 GMT

Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95454, requires notice of appointment of individuals to serve as a member of the Performance Review Board shall be published in the Federal Register.

The following individuals are hereby appointed to serve on Performance Review Boards within the Department of Health and Human Services. These individuals supplement membership on existing Performance Review Boards.

Office of the Secretary

Moulds, Donald, Principal Deputy Assistant Secretary.

Monahan, John, Director, Office of Global Health Affairs. Centers for Disease Control and Prevention

Branche, Christine, Associate Director for NIOSH. Health Resources and Services Administration (HRSA)

Morford, Thomas G., Associate Administrator, Office of Operations. Indian Health Service (IHS)

Karol M.D., Susan, Chief Medical Officer.

Dated: October 16, 2009.
Antonia T. Harris,
Deputy Assistant Secretary for Human Resources, Department of Health

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent For In

Tue, Oct 20 2009 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 guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable.

Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and

Tue, Oct 20 2009 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 FDA's third party disclosure and recordkeeping requirements for reportable food.

Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2010 Proposed Guidance Development

Tue, Oct 20 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the Web location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Oct 20 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations for Clinical

Tue, Oct 20 2009 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 collections of information associated with the guidance issued January 30, 2008, and titled ``Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices''.

Solicitation for Members of the National Vaccine Advisory Committee

Mon, Oct 19 2009 11:00:00 GMT

The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, DHHS, is soliciting nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management support for the activities of this Committee is the responsibility of the NVPO.

Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assis

Agency Information Collection Request; 60-Day Public Comment Request

Mon, Oct 19 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Oct 16 2009 11:00:00 GMT

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
[[Page 53263]]
respondents, including through the use of automated coll

Government-Owned Inventions; Availability for Licensing

Fri, Oct 16 2009 11:00:00 GMT

Request for Nominations of Candidates To Serve on the Advisory Committee on Immunization Practices, (ACIP)

Fri, Oct 16 2009 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) is soliciting nominations for possible membership on the ACIP. This committee provides advice and guidance to the Secretary, Department of Health and Human Services (HHS), and the Director, CDC, regarding the most appropriate application of antigens and related agents for effective communicable disease control in the civilian population. The committee reviews and reports regularly on immunization practices and recommends improvements in the national immunization efforts.

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 the expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based upon expertise in the field of immunization practices; multidisciplinary expe

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Oct 16 2009 11:00:00 GMT

Proposed Project

Field Test of Communication and Marketing Variables for Health ProtectionNewNational Center for Health Marketing/Coordinating Center for Health Information Service (NCHM/CCHIS), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC does not have a mechanism to assess and monitor the health communication and marketing components of health protection. Whil

Government-Owned Inventions; Availability for Licensing

Fri, Oct 16 2009 11:00:00 GMT

Submission for OMB Review; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative

Fri, Oct 16 2009 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), 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 July 16, 2009, page 34580 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. The 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.

Proposed Collection: Title: Evaluation of the NIAID HIV Vaccine Research Education Initiative. Type of Information Collection Request: NEW

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Oct 16 2009 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 requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995. 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 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

National Health Interview Survey (NHIS), (OMB No. 09200214 exp. 12/31/09)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 N

Government-Owned Inventions; Availability for Licensing

Fri, Oct 16 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned

Fri, Oct 16 2009 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 information collection requirements for administrative detention and banned medical devices.

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Oct 16 2009 11:00:00 GMT

National Survey of Residential Care Facilities (NSRCF) (OMB No. 09200780)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 statistic

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet;

Thu, Oct 15 2009 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 Form FDA 3601 entitled ``Medical Device User Fee Cover Sheet,'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.
[[Page 52966]]

Office of Inspector General; Notice for Potential Monitors for Quality-of-Care Corporate Integrity Agreements

Thu, Oct 15 2009 11:00:00 GMT

The Office of Inspector General (OIG) is seeking to identify potential organizations to monitor health care entities under quality ofcare Corporate Integrity Agreements (CIA) with OIG. OIG is interested in receiving information from organizations that believe they have the capability to be monitors for qualityofcare CIAs. This is not a request for proposals and does not commit OIG to select or consider a particular organization to be a monitor. Any information provided to OIG in response to this notice is strictly voluntary. The Government will not pay for information submitted in response to this notice.

Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning

Thu, Oct 15 2009 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 requirements for recordkeeping and reports concerning experience with approved new animal drugs. The information contained in the reports required by the regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.

Agency Information Collection Activities: Proposed Collection: Comment Request

Wed, Oct 14 2009 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)
[[Page 52814]]
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 on (301) 4431129.

Statement of Organization, Functions, and Delegations of Authority

Wed, Oct 14 2009 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 73 FR 6250607, dated October 21, 2008) is amended to reflect the reorganization of the Division of Healthcare Quality Promotion within the National Center for Preparedness, Detection, and Control of Infectious Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention.

Section CB, Organization and Functions, is hereby amended as follows: After item (5) of the functional statement for the Division of Healthcare Quality Promotion (CVKD), insert the following and renumber the remaining items accordingly: (6) monitors vaccine safety and conducts scientific research to evaluate the safety of all currently available and new vaccines;

After item (13) of the functional

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of

Tue, Oct 13 2009 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 guidance on reagents for detection of specific novel influenza A viruses.

Agency Emergency Processing Under Office of Management and Budget Review; Tobacco Product Establishment Registration

Tue, Oct 13 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is reopening until October 26, 2009, the comment period for the notice published in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by The Family Smoking Prevention and Tobacco Control Act (FSPTCA). The agency is reopening the comment period because FDA has reevaluated the expected launch date of the electronic portal and to allow interested persons additional time to review the proposed collection of information and submit comments.

Agency Information Collection Request. 60-Day Public Comment Request

Tue, Oct 13 2009 11:00:00 GMT

Agency Forms Undergoing Paperwork Reduction Act Review

Tue, Oct 13 2009 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
[[Page 52495]]
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 or by fax to (202) 3955806. Written comments should be received within 30 days of this notice.

Proposed Project

National Program of Cancer Registries Cancer Surveillance System (OMB no. 09200469 exp. Date 1/31/2010)RevisionNational Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

In 1992, Congress passed the Cancer Registries Amendment Act, which established the National Program of Cancer Regis

Proposed Data Collections Submitted for Public Comment and Recommendations

Tue, Oct 13 2009 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 4046395960 and send comments to Maryam Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Agency Information Collection Request; 60-Day Public Comment Request

Fri, Oct 9 2009 11:00:00 GMT

Findings of Research Misconduct

Fri, Oct 9 2009 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Norma Couvertier, APT Foundation: Based on the report of an investigation conducted by the APT Foundation and additional analysis conducted by ORI in
[[Page 52236]]
its oversight review, ORI found that Norma Couvertier, former Research Assistant II, APT Foundation in New Haven, Connecticut, engaged in research misconduct in research supported by National Institute of Drug Abuse (NIDA), National Institutes of Health (NIH), award R37 DA015969.

Specifically, ORI found that Ms. Couvertier engaged in research misconduct by falsifying and fabricating data that were reported on Participant Urine Monitoring and Breathalyzer Result Forms (CRFs) completed by the Respondent for thirty two (32) of the enrolled study participants in the computer Based Training in Cognitive Behavioral Therapy (CBT4CBT) research study. A total of 253 alcohol breathalyze

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Oct 9 2009 11:00:00 GMT

Agency Information Collection Request. 60-Day Public Comment Request

Fri, Oct 9 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Oct 9 2009 11:00:00 GMT

Proposed Data Collections Submitted for Public Comment and Recommendations

Wed, Oct 7 2009 11:00:00 GMT

Regulation of Tobacco Products; Extension of Comment Period; Correction

Wed, Oct 7 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a notice; extension of comment period that appeared in the Federal Register of October 1, 2009 (74 FR 50810). The notice; extension of comment period announced that FDA is extending to December 28, 2009, the comment period for a notice that originally published in the Federal Register of July 1, 2009 (74 FR 31457). The notice; extension of comment period published with an inadvertent error in the DATES section. This document corrects that error.

Proposed Data Collections Submitted for Public Comment and Recommendations

Wed, Oct 7 2009 11:00:00 GMT

HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information

Wed, Oct 7 2009 11:00:00 GMT

The Department of Health and Human Services (HHS) proposes to modify certain provisions of the ``Standards for Privacy of Individually Identifiable Health Information'' (Privacy Rule), issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The purpose of these proposed modifications is to implement section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA) regarding the privacy and confidentiality of genetic information, as well as to make certain other changes to the HIPAA Privacy Rule.

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions

Tue, Oct 6 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Oct 6 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection: Comment Request

Tue, Oct 6 2009 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 on (301) 4431129.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Oct 6 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Oct 6 2009 11:00:00 GMT

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
[[Page 51281]]
information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated col

Notice of Establishment

Tue, Oct 6 2009 11:00:00 GMT

Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Director, National Institutes of Health (NIH), announces the establishment of the Interagency Breast Cancer and Environmental Research Coordinating Committee (Committee).

The Committee shall coordinate all efforts within the Department of Health and Human Services to share and coordinate information on existing research activities, and make recommendations to the Secretary DHHS, the National Institutes of Health and other Federal agencies regarding how to improve existing research programs.

The Committee's primary mission is to facilitate the efficient and effective exchange of information on breast cancer research activities among the member agencies, and to coordinate solicitation of proposals for collaborative, multidisciplinary research, including proposals to evaluate environmental and genomic factors that may be related to the etiology of breast cancer.

Duration of this committee is two yea

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Oct 6 2009 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) [[Page 51284]]
ways to minimize the burden of the collection of information on respondents, including through the use of automated coll

Agency Information Collection Activities: Proposed Collection: Comment Request

Tue, Oct 6 2009 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, call the HRSA Reports Clearance Officer on (301) 4431129.

Administration on Children, Youth and Families

Mon, Oct 5 2009 11:00:00 GMT

This notice announces the award of expansion supplement grants to five grantees under the Family and Youth Services Bureau (FYSB)/ Family Violence Prevention and Services Program. Expansion supplement awards are made to four technical assistance (TA) providers to support their capacity to enhance victim services by providing more extensive TA to local domestic violence programs and State domestic violence coalitions under the Open Doors to Safety: CapacityBuilding Grant (CapacityBuilding) project. The supplemental funds, coupled with the TA providers' expertise, will enable Open Doors Safety Capacity Building project grantees to receive more training and sitespecific consultation, so that they may build program capacity. The awards will also support Statelevel collaboration between domestic violence organizations and child welfare agencies. These combined efforts will strengthen the ability of domestic violence programs and their partners to better serve survivors who have diverse backgrounds, ex

Current Good Manufacturing Practice Requirements for Combination Products; Correction

Mon, Oct 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of September 23, 2009 (74 FR 48423). The document proposed to codify the current good manufacturing practice requirements applicable to combination products. The document published with an incorrect docket number. This document corrects that error.

Pandemic Influenza Vaccines--Amendment

Mon, Oct 5 2009 11:00:00 GMT

Amendment to declaration issued on June 15, 2009 (74 FR 30294) pursuant to section 319F3 of the Public Health Service Act (42 U.S.C. 247d6d) to provide targeted liability protections for pandemic countermeasures to add provisions consistent with other declarations issued under this authority that may facilitate vaccination campaigns, and republication of the declaration to reflect the declaration in its entirety, as amended.

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Oct 5 2009 11:00:00 GMT

National Institute of Child Health and Human Development Submission for OMB Review; Comment Request; NEXT Generation

Fri, Oct 2 2009 11:00:00 GMT

The National Institutes of Health is publishing this notice again to correct the errant data that appeared in Table 1 and Table 2 of the notice, as previously published in the Federal Register, September 24, 2009 (74 FR 4874748749). The data in Table 1 and Table 2 of this notice are correct.

[[Page 50972]]

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), 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 July 17, 2009, Volume 74, Number 136, pages 3476034761 and allowed 60days for public comment. Two public comments were received. One questioned the value of this study and suggested that the study could not possibly be completed within the stated cost estimates. We have alwa

Submission for OMB Review; Comment Request; Program Review of the Division of Acquired Immunodeficiency Syndrome

Fri, Oct 2 2009 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID) Office of Science Policy and Planning, the National Institute 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, July 16, 2009 (74 FR 34580), 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. The 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.

Proposed Collection: Title: Program Review of the DAIDS Policy Implementation Program Type of I

Privacy Act of 1974; Report of an Altered System of Records; Medical Staff Credentials and Privileges Records

Fri, Oct 2 2009 11:00:00 GMT

The Indian Health Service published a document in the Federal Register (FR) on September 9, 2009. The document contained three errors.

Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies

Fri, Oct 2 2009 11:00:00 GMT

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of subpart C 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), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted fro

Declaration Under the Public Readiness and Emergency Preparedness Act

Fri, Oct 2 2009 11:00:00 GMT

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d6d) to provide targeted liability protections for pandemic countermeasures based on the Secretary's finding under the Act that the 2009H1N1 virus strain and the resulting disease, 2009H1N1 influenza, constitutes a public health emergency.

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Oct 2 2009 11:00:00 GMT

Agency Forms Undergoing Paperwork Reduction Act Review

Thu, Oct 1 2009 11:00:00 GMT

Assessing Problem Areas in Referrals for Chronic Hematologic Malignancies and Developing Interventions to Address ThemNew Division of Cancer Prevention and Control (DCPC), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Despite the advent of new diagnostics and therapeutics for patients wi

Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting

Thu, Oct 1 2009 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
[[Page 50804]]
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: National Institute of Child Health and Human Development Special Emphasis Panel; NRSA Predoctoral Training Program in Systems Biology.

Date: October 28, 2009.

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

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852 (Telephone

Draft Guidance for Industry on Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) giving FDA the authority to require REMS. The draft guidance describes the format and content of a proposed risk evaluation and mitigation strategy, including REMS supporting documentation, the content of assessments and proposed modifications of approved REMS, what identifiers to use on REMS documents, and how to communicate with FDA about a REMS.

Center for Scientific Review; Amended Notice of Meeting

Thu, Oct 1 2009 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Neurotransporters, Receptors, and Calcium Signaling Study Section, October 15, 2009, 8:30 a.m. to October 16, 2009, 6 p.m., Palomar Hotel, 2121 P Street, NW., Washington, DC, 20037 which was published in the Federal Register on September 22, 2009, 74 FR 4826948273.

The meeting will be one day only October 16, 2009, from 8 a.m. to 8 p.m. The meeting location remains the same. The meeting is closed to the public.

Dated: September 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E923600 Filed 93009; 8:45 am]
BILLING CODE 414001M

National Institute of Mental Health; Notice of Closed Meetings

Thu, Oct 1 2009 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.

Name of Committee: National Institute of Mental Health Special Emphasis Panel; Institutional Research TrainingClinical.

Date: November 12, 2009.

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

Agenda: To review and evaluate grant applications.

Place: St. Gregory Hotel, 2033 M Street, NW., Washington, DC 20036.

Contact Person: Aileen Schulte, PhD, Scientific Review Officer, Division of

Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2010;

Thu, Oct 1 2009 11:00:00 GMT

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 7, 2009 entitled ``Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2010'' (74 FR 39762).

Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting

Thu, Oct 1 2009 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; Reproduction, Andrology, and Gynecology Subcommittee.

Date: October 30, 2009.

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

Agenda: To review and evaluate grant applications.

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

Contact Person: Dennis Leszczynski, PhD,

National Mammography Quality Assurance Advisory Committee; Notice of Meeting

Thu, Oct 1 2009 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: National Mammography Quality Assurance 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 November 2, 2009, from 9 a.m. to 5 p.m.

Location: Holiday Inn, WalkerWhetstone Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.

Contact Person: Normica Facey, Center for Devices and Radiological Health (White Oak, Bldg. 66, rm. 4652), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 3017965914, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512397. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modifications tha

National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of

Thu, Oct 1 2009 11:00:00 GMT

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Hanford site in Richland, Washington, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

Facility: Hanford site.

Location: Richland, Washington.

Job Titles and/or Job Duties: All employees of the Department of Energy, its predecessor agencies, and its contractors and

subcontractors.

Period of Employment: October 1, 1943 through June 30, 1972.

Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting

Thu, Oct 1 2009 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 National Children's Study 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: National Children's Study Advisory Committee. [[Page 50803]]

Date: October 21, 2009.

Time: 9 a.m. to 5 p.m.

Agenda: The agenda will include a Report from the Director, NICHD, an update from the NCS Acting Director, discussions on recruitment strategies, the Vanguard Center protocol and interim outcome assessments. Additional information on the meeting logistics can be obtained on the conference Web site:

Postmarketing Safety Reporting for Combination Products

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product. The proposed rule is intended to promote and protect the public health by clarifying requirements for postmarketing safety reporting for combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.

National Institute on Drug Abuse; Notice of Closed Meeting

Thu, Oct 1 2009 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, NIDA.

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 Drug Abuse, 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 Committee: Board of Scientific Counselors, NIDA.

Date: November 1920, 2009.

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

Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators.

Place: Intramural Research Program, National Institute on Drug Abuse, NIH, John

Center for Scientific Review; Notice of Closed Meetings

Thu, Oct 1 2009 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 Conflicts: Visual System.

Date: October 1415, 2009.

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

Agenda: To review and evaluate grant applications.

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

Contact Person: Christine L. Melchior, PhD, Scientific Review O

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Thu, Oct 1 2009 11:00:00 GMT

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting

Thu, Oct 1 2009 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; Function, Integration, and Rehabilitation Sciences Subcommittee.

Date: October 29, 2009.

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

Agenda: To review and evaluate grant applications.

Place: The Legacy, 1775 Rockville Pike, Rockville, MD 20852.

Contact Person: Anne Krey, Scientific Review Of

National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of

Thu, Oct 1 2009 11:00:00 GMT

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees of Hangar 481, at Kirtland Air Force Base, Albuquerque, New Mexico, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

Facility: Hangar 481 at Kirtland Air Force Base.

Location: Albuquerque, New Mexico.

Job Titles and/or Job Duties: All employees who worked at Hangar 481, at Kirtland Air Force Base.

Period of Employment: March 1, 1989 through June 30, 1996.

Pilot Program To Evaluate Proposed Proprietary Name Submissions; Procedures To Register for Participation and Submit

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the opportunity for pharmaceutical firms (applicants) to participate in a voluntary 2year pilot program for the evaluation of proposed proprietary names to be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The pilot program will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to FDA for review, as outlined in the FDA concept paper entitled ``PDUFA Pilot Project Proprietary Name Review.'' This document describes procedures to register and submit data for applicants who wish to have their proposed proprietary names evaluated under the pilot program.

Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting

Thu, Oct 1 2009 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; Population Sciences Subcommittee.

Date: November 56, 2009.

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

Agenda: To review and evaluate grant applications.

Place: The Madison Hotel, 1177 15th St., NW., Washington, DC 20005.

Contact Person: Carla T. Walls, PhD, Scientific Review Officer, Divis

Determination of Regulatory Review Period for Purposes of Patent Extension; CLEVIPREX

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for CLEVIPREX 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.

Center for Scientific Review; Amended Notice of Meeting

Thu, Oct 1 2009 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, October 12, 2009, 8 a.m. to October 13, 2009, 12 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on September 22, 2009, 74 FR 4826948273.

The meeting will be held October 13, 2009 to October 14, 2009. The meeting time and location remain the same.

The meeting is closed to the public.

Dated: September 24, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E923597 Filed 93009; 8:45 am]
BILLING CODE 414001M

Office of Community Services, Program Expansion Supplement Grant Award

Thu, Oct 1 2009 11:00:00 GMT

CFDA Number: 93.710.

Legislative Authority: The legislative authority is provided in the American Recovery and Reinvestment Act of 2009 (ARRA) [Pub. L. 1115]. Additional legislative authority and requirements are provided in Section 674(b)(2)(B) of the Community Services Block Grant Act (CSBG), as amended, by the Community Opportunity Accountability, and Training and Educational Services (Coats Human Services Reauthorization Act of 1998) [Pub. L. 105285].

Amount of Award: $500,000.

Project Period: July 1, 2009June 30, 2010.

Summary: The Office of Community Services (OCS) announces the award of a $500,000 single source program
[[Page 50810]]
expansion supplement to the National Association for State Community Services Programs (NASCSP), located in Washington, DC, to support performance training and technical assistance on data collection, analysis and dissemination issues faced by state community services programs within the Community Services Block Grant (CSBG) Network; develo

Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting

Thu, Oct 1 2009 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; Instruments and Devices for the Neonatal Intensive Care Units.

Date: November 2, 2009.

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

Agenda: To review and evaluate grant applications.

Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015.

Contac

Regulation of Tobacco Products; Extension of Comment Period

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is extending to December 28, 2009, the comment period for the notice that appeared in the Federal Register of July 1, 2009 (74 FR 31457). In the notice, FDA requested comments on the implementation of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Act). The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Statement of Organization, Functions and Delegations of Authority

Wed, Sep 30 2009 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, June 11, 2008; 73 FR 33099). This Order of Succession supersedes the Order of Succession for the Administrator, HRSA, published at FR 73 33099, June 11, 2008.

This notice deletes the Chief Financial Officer from the order of succession and adds the Chief Operating Officer to HRSA's hierarchy affecting the order of succession; this notice also changes the name of the Office of Performance Review to the Office of Regional Operations. 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. Senior Advisor to t

Privacy Act of 1974; Report of Modified or Altered System; Indian Health Service Scholarship and Loan Repayment

Wed, Sep 30 2009 11:00:00 GMT

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a SOR, ``Indian Health Service Scholarship and Loan Repayment Programs,'' System No. 09170002. We propose to modify the SOR to reflect current program changes, statutory and
implementation changes. Under the system name, we propose to clarify language under the ``Categories of individuals covered by the system'' section; to include statutory authorities for the grants program under the ``Authority for maintenance of the system'' section; to include the IHS Grants Program (Indians Into Nursing, Indians Into Medicine, and Indians Into Psychology) and the IHS Health Professions Support Branch in the ``Purposes'' section; various minor language edits to routine use number 4 for litigation as these records are not Health Insurance Portability and Accountability Act (HIPAA) protected records; add a new routine use number 20 to comply with Office of M

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Sep 30 2009 11:00:00 GMT

National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods

Wed, Sep 30 2009 11:00:00 GMT

NICEATM announces availability of the ICCVAM Test Method Evaluation Report: The Reduced Murine Local Lymph Node Assay: An Alternative Test Method Using Fewer Animals to Assess the Allergic Contact Dermatitis Potential of Chemicals and Products (NIH Publication 096439). The TMER provides ICCVAM's evaluation and recommendations for the reduced Murine Local Lymph Node Assay (rLLNA) test method as a reduction alternative that uses fewer animals compared to the traditional Murine Local Lymph Node Assay (LLNA) for assessing the potential of test substances to cause allergic contact dermatitis (ACD). The report includes ICCVAM's recommendations on (a) the usefulness and limitations of the rLLNA, (b) an updated ICCVAM LLNA test method protocol, which includes the procedures for conducting the rLLNA, (c) future studies to further characterize the usefulness and limitations of the rLLNA, and (d) rLLNA test method performance standards. The TMER includes the report of an international independent scienti

Government-Owned Inventions; Availability for Licensing

Wed, Sep 30 2009 11:00:00 GMT

Submission for OMB Review; Comment Request

Tue, Sep 29 2009 11:00:00 GMT

The Impact of Continuing Medical Education on Physician Practice

Summary: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center, 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 May 14, 2009, page 22749 and allowed 60days for public comment. One comment was received: `These meetings should be on computer software and the general population of this nation should be able to attend. This is a very cheap way to distribute information, the general public can have some understanding of what you are telling doctors to do and the open ness of the project will help all americans. It is time to stop secret meetings. They cost more for taxpayers, they don't get the message through when videotapes can be made of the information transmi

National Institute of Environmental Health Sciences; Submission for OMB Review; Comment Request; The Sister Study

Tue, Sep 29 2009 11:00:00 GMT

Summary: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), 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 10 July 2009 on page 33259 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. The 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 [[Page 49878]]
October 1, 1995, unless it displays a currently valid OMB control number.

5 CFR 1320.5: Reporting and Recordkeeping Requirements: Final Rule: Respondents to this collection of infor

Medicare Programs; End-Stage Renal Disease Prospective Payment System

Tue, Sep 29 2009 11:00:00 GMT

This proposed rule would implement a case-mix adjusted bundled prospective payment system (PPS) for Medicare outpatient endstage renal disease (ESRD) dialysis facilities beginning January 1, 2011, in compliance with the statutory requirement of the Medicare Improvements for Patients and Providers Act (MIPPA), enacted July 15, 2008. The proposed ESRD PPS would replace the current basic casemix adjusted composite payment system and the methodologies for the reimbursement of separately billable outpatient ESRD services.

Medicare Program; Town Hall Meeting on End-Stage Renal Disease Prospective Payment System

Tue, Sep 29 2009 11:00:00 GMT

This notice announces the date, time, and location of the town hall meeting to discuss the Medicare EndStage Renal Disease (ESRD) Prospective Payment System (PPS) proposed rule. This meeting provides a forum for interested parties including, but not limited to beneficiaries, caregivers, providers, and other industry
representatives to make oral statements in response to the ESRD PPS proposed rule. The meeting is open to the public, but registration is required and attendance is limited to space available.

Submission for OMB Review; Comment Request

Mon, Sep 28 2009 11:00:00 GMT

Proposed Projects:

Title: Project LAUNCH CrossSite Evaluation.

OMB No.: New Collection.

Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is planning to collect data as part of a crosssite evaluation of a new initiative called Project LAUNCH (Linking Actions for Unmet Needs in Children's Health): Project LAUNCH is intended to promote the healthy development and wellness of children ages birth to eight years. A total of 18 Project LAUNCH grantees will be funded to improve coordination among child serving systems, build infrastructure, and improve methods for providing services. Grantees will also implement a range of public health strategies to support young child wellness in a designated locality.

Data for the crosssite evaluation of Project LAUNCH will be collected through: (1) Interviews conducted during annual site visits to Project LAUNCH grantees, and (2) semiannual reports that will be submitted electronically on a

Statement of Organization, Functions, and Delegations of Authority

Mon, Sep 28 2009 11:00:00 GMT

Notice is hereby given that I have delegated to the Director, Program Operations Division, Office of Head Start, Administration for Children and Families the following authority vested in me by the Assistant Secretary for Children and Families in the memorandum dated February 16, 2007.

(a) Authority Delegated

Authority to approve or disapprove requests for nonFederal share waivers under 42 USC 9835(b) for expenditures funded by the American Recovery & Reinvestment Act of 2009, Public Law 1115 (February 17, 2009)

(b) Limitations

1. This delegation shall be exercised under financial and administrative requirements applicable to all Administration for Children and Families authorities.

2. Any delegation requires the concurrence of the Deputy Assistant Secretary, Office of Administration and the Director, Office of Head Start.

(c) Effective Date

This delegation is effective on the date of signature. (d) Effect on Existing Delegations

This delegation of authority supplements the

Agency Forms Undergoing Paperwork Reduction Act Review

Mon, Sep 28 2009 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 Maryam I. Daneshvar, the CDC Reports Clearance Officer, at (404) 639 5960 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

Evaluating the Quality of Interview Data Collected by Teratology Information Services About Pregnancy Outcomes, Maternal and Infant Health, Following Medication Use During Pregnancy and LactationNew National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description

This data collection is ba

Agency Forms Undergoing Paperwork Reduction Act Review

Mon, Sep 28 2009 11:00:00 GMT

CDC American Recovery and Reinvestment Act of 2009 (ARRA) Performance Progress ReportNewOffice of the Chief Operating Officer (OCOO), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The American Recovery and Reinvestment Act of 2009 was signed into law on February 17, 2009, Public Law 1115 (``Recovery Act''). The purpose of this proposed data collection is to collect

Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2009 Performance Review

Fri, Sep 25 2009 11:00:00 GMT

The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2009 Performance Review Board. This action is being taken in accordance with Title 5, U.S.C., Section 4314(c)(4), which requires that members of performance review boards be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals and requires that notice of the appointment of an individual to serve as a member be published in the Federal Register.

The following persons will serve on the NIH Performance Review Board, which oversees the evaluation of performance appraisals of NIH Senior Executive Service (SES) members: Ms. Colleen Barros (Chair); Dr. Michael Gottesman; Ms. Lenora Johnson; Ms. Robin Kawazoe; Dr. Raynard Kington; Ms. Janis Mullaney; Dr. Sally Rockey.

For further information about the NIH Performance Review Board, contact the Office of Human Resources, Workforce Relations Division, National I

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--April through June 2009

Fri, Sep 25 2009 11:00:00 GMT

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2009 through June 2009, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coveragerelated guidance documents, and special onetime notices regarding national coverage provision

Enforcement of General Tobacco Standard Special Rule for Cigarettes

Fri, Sep 25 2009 11:00:00 GMT

The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that as of the effective date identified in the FSPTCA, cigarettes that contain certain characterizing flavors are considered adulterated under the act. FDA is also providing in this notice contact information to which individuals

Proposed Collection: Comment Request; 0MB No. 0925-0601/exp. 2/ 28/2010, ``Request for Human Embryonic Stem Cell Line

Fri, Sep 25 2009 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, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (0MB) for review and approval.

Proposed Collection: Title: Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research. Type of Information Collection Request: Extension, 0MB 09250601, Expiration Date 2/28/ 2010. Form Number: 2890. The form is used by applicants to request that human embryonic stem cell lines be approved for use in NIH funded research. Applicants may submit applications at any time; this request is a onetime submission. Affected Public: Business or other for profit; Notforprofit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: Adult scientific profession

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Sep 25 2009 11:00:00 GMT

National Institute of Child Health and Human Development; Submission for OMB Review; Comment Request; NEXT Generation

Thu, Sep 24 2009 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), 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 July 17, 2009, Volume 74, Number 136, pages 3476034761 and allowed 60 days for public comment. Two public comments were received. One questioned the value of
[[Page 48748]]
this study and suggested that the study could not possibly be completed within the stated cost estimates. We have always conducted extremely efficient studies within stated cost estimates. The value of this research is demonstrated by the involvement of multiple government agencies. The second email simply expressed interest in more information. The purpose of this notice is to allow an additional 30 days for p

Findings of Scientific Misconduct

Thu, Sep 24 2009 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Nagendra S. Ningaraj, PhD, Vanderbilt University School of Medicine: Based on the reports of an investigation conducted by Vanderbilt University School of Medicine (VUSM) and additional analysis by the Division of Investigative Oversight (DIO), ORI, in its oversight review, found that Nagendra S. Ningaraj, PhD, former Associate Professor of Neurological Surgery and Cancer Biology, VUSM, engaged in scientific misconduct by falsifying MALDIMS images and mass spectral tracings and associated text in Figure 21 reported in National Cancer Institute (NCI), National Institutes of Health (NIH), grant application 1 U54 CA11942101 and by falsifying MALDIMS images in a presentation during the American Association for Cancer Research (AACR) meeting held on April 1620, 2005, which cited support from NCI, NIH, grants R25 CA92943 and P50 CA098131.

Spe

Notice of Non-Competitive Award of Funding to the Communities Advocating Emergency AIDS Relief (CAEAR) Coalition

Thu, Sep 24 2009 11:00:00 GMT

This Federal Register Notice announces the non-competitive extension of Grant Number U69HA07626, Supporting Networks of HIV Care by Enhancing Primary Medical Care (SNHC by EPMC), to the CAEAR Coalition Foundation, Inc., the awardee of record, for one additional year, through August 31, 2010, at a funding level of approximately $1,451,445. The purpose of the award extension is to allow for the completion of ongoing work and an external evaluation assessment of the project's activities undertaken during the project period of September 1, 2006, through August 31, 2009, before a new competitive cycle is started. Evaluation findings will help HRSA frame a new competitive opportunity in fiscal year (FY) 2010. The authority for this funding is the Public Health Service Act, section 2692, 42 U.S.C. Sec. 300ff111, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Pub. L. 109415); it can be viewed under the Catalog for Federal Domestic Assistance (CFDA) Number 93.145.

Agency Forms Undergoing Paperwork Reduction Act Review

Thu, Sep 24 2009 11:00:00 GMT

Occupational Injuries and Illnesses Among Emergency Medical Services (EMS) Workers: A NEISSWork Telephone Interview SurveyNew National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Studies have reported that EMS workers have higher rates of non fatal injuries and illnesses as compared to the general worker popula

Proposed Data Collections Submitted for Public Comment and Recommendations

Thu, Sep 24 2009 11:00:00 GMT

Government-Owned Inventions; Availability for Licensing

Wed, Sep 23 2009 11:00:00 GMT

Proposed Comment Request for Review of ACF Disaster Case Management Implementation Guide; Office of Human Services

Wed, Sep 23 2009 11:00:00 GMT

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 10413, May 22, 1995), this notice announces that the Administration for Children and Families (ACF), Office of Human Services Emergency Preparedness and Response (OHSEPR) intends to submit to notice in the Federal Register for comments on the ACF Disaster Case Management Implementation Guide, dated December 10, 2008.

Disaster case management is the process of organizing and providing a timely, coordinated approach to assess disasterrelated needs as well as existing healthcare, mental health and human services needs that may adversely impact an individual's recovery if not addressed. Disaster case management facilitates the delivery of appropriate resources and services, works with a client to implement a recovery plan and advocates for the client's needs to assist him/her in returning to a predisaster status while respecting human dignity. If necessary, disaster case management helps transition the client with preexisting needs

Government-Owned Inventions; Availability for Licensing

Wed, Sep 23 2009 11:00:00 GMT

Current Good Manufacturing Practice Requirements for Combination Products

Wed, Sep 23 2009 11:00:00 GMT

The Food and Drug Administration (FDA or agency) proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed 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.

Proposed Information Collection Activity; Comment Request

Wed, Sep 23 2009 11:00:00 GMT

Proposed Projects:

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

OMB No.: New Collection.

Description: The CrossSite Evaluation of the Child Welfare Implementation Centers (IC) and National Resource Centers (NRC) 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 fiveyear, crosssite evaluation that examines the effectiveness of the ICs' and NRCs' activities and service provision 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 will examine the degree to which networking, collaboration, information sharing, adherence to common principles, and common messaging occurs across all members of the Children's Bureau Training and Technical Assistance (T/ TA) Network, which is design

Agency Information Collection Activities: Proposed Collection: Comment Request

Tue, Sep 22 2009 11:00:00 GMT

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency; (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 c

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Tue, Sep 22 2009 11:00:00 GMT

Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 4431129.

The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:
Proposed Project: HRSA National Environmental Policy Act (NEPA) Environmental Information and Documentation (EID) (OMB No. 09150324) Extension

HRSA is requesting 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 Act of 1969 (NEPA). NEPA establ

Public Health Service Act, Section 330A(f)

Tue, Sep 22 2009 11:00:00 GMT

HRSA has issued a non-competitive replacement award under the Rural Health Network Development Program to White River Rural Health Center, Inc. (WRRHC). The original grantee, Siloam Springs Memorial Hospital, is no longer eligible to serve as the lead entity for this network of rural health care providers serving a five county area in Arkansas and Oklahoma. This replacement award will ensure that the medically underserved residents of western Benton and Washington counties in Arkansas and Adair, Cherokee, and Delaware counties in Oklahoma continue receiving necessary medical care and services without disruption.

Agency Forms Undergoing Paperwork Reduction Act Review

Mon, Sep 21 2009 11:00:00 GMT

Minimum Data Elements (MDEs) for the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) (OMB 09200571 exp. 1/31/2010)ExtensionNational Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Congress established the National Breast and Cervical Cancer Early Detection Program (NB

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Sep 21 2009 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 project or to obtain a copy of data collection plans and instruments, call the CDC Reports Clearance Officer on 4046395960 or send comments to CDC/ATSDR Assistant Reports Clearance Officer, 1600 Clifton Road, MS D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Statement of Organization, Functions and Delegations of Authority

Mon, Sep 21 2009 11:00:00 GMT

This notice reflects organizational changes in the Health Resources and Services Administration. This notice renames the Office of Performance Review (RE) to the Office of Regional Operations (ORO) (RE), and changes the mission and functions of the office.
Chapter REOffice of Regional Operations (RE)

Section RE00, Mission

Delete in its entirety and replace with the following:

The mission of ORO is to improve health care systems and America's health care safety net, increase access to quality care, reduce disparities, and advance public health by providing leadership in support of the HHS and HRSA missions, goals and strategic priorities in each region.
Section RE10, Organization

Agency Forms Undergoing Paperwork Reduction Act Review

Mon, Sep 21 2009 11:00:00 GMT

Management Information System for Comprehensive Cancer Control ProgramsNewNational Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC currently funds the National Comprehensive Cancer Control Program (NCCCP), which provides funding and technical support to all 50 states, the District of Columbia,

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Sep 21 2009 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 4046395960 or send comments to CDC Acting Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Patient Safety Organizations: A Compliance Self-Assessment Guide

Mon, Sep 21 2009 11:00:00 GMT

AHRQ is announcing the availability of a document entitled: ``Patient Safety Organizations: A Compliance SelfAssessment Guide.'' The Patient Safety and Quality Improvement Act of 2005, Public Law 109 41, 42 U.S.C. 299b21b26 (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 healthcare 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; and request additional information and conduct reviews (including announced or unannounced site visits) to assess PSO compliance. To assist PSOs in making the required attestations and preparing for a compliance review, AHRQ developed the sample questions in this guide to encourage each PSO to take a thorough and systemati

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Sep 21 2009 11:00:00 GMT

Agency Information Collection Request. 30-Day Public Comment Request

Fri, Sep 18 2009 11:00:00 GMT

Statement of Organization, Functions, and Delegations of Authority

Fri, Sep 18 2009 11:00:00 GMT

Notice is hereby given that I have delegated to the Regional Program Managers, American Indian Alaska Native Program Branch Chief, and Migrant and Seasonal Program Branch Chief the following authority vested in me by the Director, Office of Head Start in the memorandum dated August 27, 2009.

(a) Authority Delegated:

Authority to approve or disapprove requests for nonFederal share waivers under 42 U.S.C. 9835(b) for expenditures funded by the American Recovery & Reinvestment Act of 2009, Public Law 1115 (Feb. 17, 2009). (b) Limitations:

1. This delegation shall be exercised under financial and administrative requirements applicable to all Administration for Children and Families authorities.

2. These authorities may not be redelegated.

(c) Effective Date:

This redelegation is effective on the date of signature. (d) Effect on Existing Delegations:

This redelegation of authority supplements the previous delegations from the Director, Division of Program Operation

Agency Information Collection Request: 30-Day Public Comment Request

Fri, Sep 18 2009 11:00:00 GMT

National Institute of Environmental Health Sciences; Division of Extramural Research and Training; Submission for OMB

Fri, Sep 18 2009 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), 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 April 14, 2009, pages 1719517196, 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. The 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.

Proposed Collection: Title: Hazardous Waste Worker Training42 CFR Part 65. Type of Information Collection Request: Revision of OMB No.

Notice of Availability of Draft Policy Documents for Comment

Fri, Sep 18 2009 11:00:00 GMT

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments.

Background: HRSA administers the Health Center Program, which supports more than 7,500 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve medically underserved communities, delivering preventive and primary care services to patients regardless of their ability to pay. The purpose of the recently published draft PIN is (a) To convey and clarify HRSA's policy regarding Health Center Program statutory and regulatory governance requirements for all Health Cent

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Sep 18 2009 11:00:00 GMT

Draft Guidance for Industry on Microbiological Data for Systemic Antibacterial Drug Products--Development, Analysis, and

Thu, Sep 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled
``Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation.'' The draft guidance informs industry of FDA's current thinking regarding the types of
microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product. Recommendations in this guidance cover microbiological considerations in the three major areas of conducting general nonclinical studies; conducting animal and human studies and clinical trials; and establishing and updating in vitro susceptibility test methods, quality control (QC) parameters, and interpretive criteria. This guidance also recommends the content and format for presentation of microbiological data for antibacterial drug products in the Microbiology subsection of labeling.

Agency Forms Undergoing Paperwork Reduction Act Review

Thu, Sep 17 2009 11:00:00 GMT

Assessing the Safety Culture of Underground Coal MiningNew National Institute for Occupational Safety and Health, (NIOSH), Centers for Disease Control and Prevention, (CDC).

Background and Brief Description

NIOSH, under Public Law 91596, (Section 2022, Occupational Safety and Health Act of 1970) has the responsibility to conduct research relating to innovative methods, techniques, and approaches dealing with occ

Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Contract Health Services

Thu, Sep 17 2009 11:00:00 GMT

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires a 60day advance opportunity for public comment on the proposed information collection project, 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.

Proposed Collection: Title: 09170002, ``Indian Health Service Contract Health Services Report.'' Type of Information Collection Request: Three year renewal, with change of currently approved information collection, 09170002, ``Indian Health Service Contract Health Services Report'' Form Number(s): IHS8431A. Reporting formats are contained in an IHS Contract Health Services Manual Exhibit and IHS Web site. Need and Use of Information Collection: The IHS Contract Health Services Program needs this information to certify that the health care services requested and authorized by the IHS have been performed by the Contract Health Services provider(

Agency Forms Undergoing Paperwork Reduction Act Review

Thu, Sep 17 2009 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) 6394766 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 State Nutrition and Physical Activity Programs to Prevent Obesity and Other Chronic Diseases [OMB 09200669 exp. 6/30/2011]RevisionNational Center for Chronic Disease Prevention and Health Promotion (NCCDHP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

In order to prevent and control obesity and other chronic diseases, CDC established statebased nutriti

National Fisheries Institute; Filing of Food Additive Petition; Amendment

Wed, Sep 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the [[Page 47593]]
filing notice for a food additive petition filed by the National Fisheries Institute, to provide for the safe use of ionizing radiation for control of foodborne pathogens in crustaceans and processed crustaceans.

Findings of Research Misconduct

Tue, Sep 15 2009 11:00:00 GMT

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

Jennifer N. Arriaga, Universidad Central Del Caribe: Based on the findings of an investigation report by the Universidad Central Del Caribe (UCC) and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review, ORI found that Jennifer N. Arriaga, former Research Assistant in a clinical trial project entitled Brief Strategic Family Therapy for Adolescent Drug Abusers (BSFT) at UCC, engaged in research misconduct in research funded by National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), cooperative agreement U10 DA13720.

Specifically, ORI found that Ms. Arriaga knowingly and intentionally engaged in research misconduct by fabricating 17 interviews and falsifying 10 subject incentive receipts in the BSFT. The interview record consisted of Timeline Follow Back information, confidentiality selfreport fo

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Sep 15 2009 11:00:00 GMT

Office of the National Coordinator for Health Information Technology; HIT Standards Committee; Notice and Publication

Tue, Sep 15 2009 11:00:00 GMT

This notice publishes recommendations made by the HIT Standards Committee (Committee) at its public meeting on August 20, 2009, and invites public input on the recommendations at the Committee's next meeting on September 15, 2009. The Committee is a Federal advisory committee to the Office of the National Coordinator for Health Information Technology (ONC).

Name of Committee: HIT Standards Committee.

General Function of the Committee: To provide recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee. Sections 3003(b)(4) and (e) of the Health Information Technology for Economic and Clinical Health (HITECH) Act requires ONC to publish the Committee's recommendations to the National Coordinator in the Fed

Agency Emergency Processing Under the Office of Management and Budget Review; Tobacco Product Establishment

Tue, Sep 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by the Family Smoking Prevention and Tobacco Control Act. The document was published with an incorrect date for submitting written or electronic comments on the proposed collection. This document corrects that error.

Statement of Delegation of Authority

Tue, Sep 15 2009 11:00:00 GMT

Notice is hereby given that I have delegated to the Administrator, Health Resources and Services Administration (HRSA), authorities vested in the Secretary under Title III, Part B, Section 313 of the Public Health Service Act (42 U.S.C. 245), as amended, as they pertain to the functions assigned to HRSA.

These authorities may be redelegated.

This delegation excludes the authority to issue regulations, to establish advisory councils and committees, and appoint their members, and to submit reports to Congress, and shall be exercised in accordance with the Department's applicable policies, procedures and guidelines.

In addition, I have affirmed and ratified any actions taken by the Administrator, or other HRSA officials, which involved the exercise of these authorities prior to the effective date of this delegation.

This delegation is effective upon date of signature.

Dated: September 8, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E922203 Filed 91409; 8:45 am]
BILLING CODE 4165

Acquisition Regulations

Tue, Sep 15 2009 11:00:00 GMT

CFR Correction

In Title 48 of the Code of Federal Regulations, Chapters 3 to 5, revised as of October 1, 2008, on page 81, in 352.2701, in the clause, reinstate paragraph (c)(4) to read as follows:
352.2701 Accessibility of meetings, conferences, and seminars to persons with disabilities.
* * * * *
(c) * * *
(4) The Contractor is responsible for making a reasonable effort to ascertain the number of individuals with sensory impairments who plan to attend the meeting, conference, or seminar. However, if it can be determined that there will be no person with sensory impairment in attendance, the provision of those services under paragraph (c) of this clause for the nonrepresented group, or groups, is not required.
* * * * *
[FR Doc. E922255 Filed 91409; 8:45 am]
BILLING CODE 150501D

Government-Owned Inventions; Availability for Licensing

Tue, Sep 15 2009 11:00:00 GMT

Agency Forms Undergoing Paperwork Reduction Act Review

Tue, Sep 15 2009 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 or by fax to (202) 3956974. Written comments should be received within 30 days of this notice. Proposed Project

The National Violent Death Reporting System (NVDRS)[OMB 09200607, exp.01/31/2010]RevisionNational Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Violence is an important public health problem. In the United States, homicide and suicide are the second and third leading causes of death, respectively, in the 13

Memorandum of Understanding With Duke University

Mon, Sep 14 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and Duke University. The purpose of this MOU is to establish a framework for collaboration between the Parties and for pursuing specific collaborative projects. This collaboration between the Parties shall be known as the Cardiac Safety Research Consortium.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Sep 11 2009 11:00:00 GMT

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Sep 11 2009 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 project or to obtain a copy of data collection plans and instruments, call the CDC Reports Clearance Officer on 4046395960 or send comments to CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Sep 11 2009 11:00:00 GMT

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Sep 11 2009 11:00:00 GMT

Submission for OMB Review; Comment Request

Fri, Sep 11 2009 11:00:00 GMT

Title: Title IVE Foster Care Eligibility Review and Child and Family Service Reviews; Final Rule.

OMB No.: 09700214.

Description: The following five separate activities are associated with this information collection: Foster Care Eligibility Review (FCER) Program Improvement Plan; Child and Family Services Reviews (CFSR) State agency Statewide Assessment; CFSR Onsite Review; CFSR Program Improvement Plan; and AntiDiscrimination Enforcement Corrective Action Plan. The collection of information for review of Federal payments to States for foster care maintenance payments (45 CFR 1356.71(i)) is authorized by title IVE of the Social Security Act (the Act), section 474 [42 U.S.C. 674]. The Foster Care Eligibility Reviews (FCER) ensure that States claim title IVE funds only on behalf of title IVE eligible children. The collection of information for review of State child and family services programs (45 CFR 1355.33(b), 1355.33(c) and 1355.35(a)) is to determine whether such programs are in

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Sep 11 2009 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 the CDC Reports Clearance Officer at 4046395960 or send comments to CDC/ATSDR Assistant Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Sep 11 2009 11:00:00 GMT

The Agency for Toxic Substances and Disease Registry (ATSDR) 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/ATSDR Reports Clearance Officer at (404) 639 5960 or send an email to omb@cdc.gov. Send written comments to the 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

Tremolite Asbestos Registry (TAR)ExtensionAgency for Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

The Agency for Toxic Substances and Disease Registry (ATSDR) requests an extension of data collection and procedures for the previously approved Tremolite Asbestos Registry (TAR) project for an additional three years. ATSDR is mandated pursuant to the 1

Government-Owned Inventions; Availability for Licensing

Thu, Sep 10 2009 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.

Government-Owned Inventions; Availability for Licensing

Thu, Sep 10 2009 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.

Submission for OMB Review; Comment Request

Thu, Sep 10 2009 11:00:00 GMT

Title: Head Start Program Administrative Practice and Procedure; Appeal Procedures, 45 CFR Part 1303.

OMB No.: 09800242.

Description: Section 646 of the Head Start Act requires the Secretary of Health and Human Services to prescribe a timeline for conducting administrative hearings when adverse actions are taken or proposed against Head Start and Early Head Start grantees and delegate agencies. The Office of Head Start is proposing to renew, without changes, this rule, which implements these requirements and which prescribes when a grantee must submit certain information and what that information shall include.

Respondents: Head Start and Early Head Start grantees and Delegate Agencies.
Annual Burden Estimates Number of Average burden Instrument Number of responses per hours per Total burden

Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations

Wed, Sep 9 2009 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 regulations entitled ``Environmental Impact Considerations.''

Privacy Act of 1974; Report of an Altered System of Records Medical Staff Credentials and Privileges Records

Wed, Sep 9 2009 11:00:00 GMT

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09170003, ``Medical Staff Credentials and Privileges Records.'' The amended and altered system of records makes several administrative revisions which includes the deletion of the Social Security Numbers (SSNs) language to comply with the Office of Management and Budget (OMB) Memorandum (M)07 16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information (May 22, 2007); and the HHS Directive Memorandum of October 6, 2008 to all Operating Division Heads to develop and execute a plan to eliminate the unnecessary collection and use of SSNs; and the inclusion of a new routine use to comply with OMB (M)0716 and the HHS Memorandum dated September 19, 2007 to incorporate Notification of Breach Routine Use language; and the update of the Appendix 1 of the SOR.

Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and

Wed, Sep 9 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH).

FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget

Wed, Sep 9 2009 11:00:00 GMT

Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Customer Satisfaction

Tue, Sep 8 2009 11:00:00 GMT

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60day advance opportunity 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.

Proposed Collection: Title: 0917NEW, ``Indian Health Service Customer Satisfaction Survey.'' Type of Information Collection Request: Threeyear approval of this new information collection, 0917NEW, ``Indian Health Service Customer Satisfaction Survey.'' Form(s): Tribal Homeowner Survey, Tribal Partner Survey, Annual Operator Operation and Maintenance (O&M)
[[Page 46202]]
Survey, and Post Construction O&M Survey. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native people to the highest possible level by providing comprehensive health care and preventive health servic

Agency Forms Undergoing Paperwork Reduction Act Review

Tue, Sep 8 2009 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) 6394766 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) 3955809. Written comments should be received within 30 days of this notice. Proposed Project

Formative Research and Tool DevelopmentNewNational Center for HIV, viral hepatitis, STD, and TB Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC previously published a clearance mechanism to support behavioral projects for HIV/AIDS prevention and control (Federal Register, volume 73, number 33, page 492, January 3, 2008). This project has bee

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Tue, Sep 8 2009 11:00:00 GMT

SAMHSA's Center for Substance Abuse Treatment (CSAT) is responsible for collecting data from 20 recently funded Adult Treatment Drug Court grantees and clients being served by expansion and/or enhancement grants. The main evaluation question is whether the addition of substance abuse treatment resources increases the positive results of drug courts. SAMHSA's CSATfunded grantees are required to participate in a crosssite evaluation as a contingency of their award. Data on each drug court and their processes will be collected during t

Proposed Data Collections Submitted for Public Comment and Recommendations

Tue, Sep 8 2009 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 4046395960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 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
[[Page 46201]]
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

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Sep 4 2009 11:00:00 GMT

Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments;

Fri, Sep 4 2009 11:00:00 GMT

Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon, by holders of approved drug and biological products. This is the agency's report on the status of the studies and clinical trials that applicants have agreed to or are required to conduct.

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Sep 4 2009 11:00:00 GMT

Proposed Collection; Comment Request; NCCAM Customer Service Data Collection

Fri, Sep 4 2009 11:00:00 GMT

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Complementary and Alternative Medicine (NCCAM), the National Institutes of Health (NIH), will submit to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. A notice of this proposed information collection was previously published in the Federal Register on June 26, 2009 (Volume 74, Number 122, page 30577). To date, no public comments have been received. The purpose of this notice is to announce a final 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: NCCAM Customer Service Data Collection.

Type of Information Collection Request: Revision.

Need and Use of Information

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Sep 4 2009 11:00:00 GMT

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Sep 4 2009 11:00:00 GMT

Postural Analysis in LowSeam MinesExisting collection without an OMB control numberNational Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description

NIOSH, under Public Law 91596, sections 20 and 22 (section 2022, Occupational Safety and Health Act of 1970) has the responsibility to conduct research relating to innovative

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Sep 4 2009 11:00:00 GMT

Submission for OMB Review; Comment Request

Fri, Sep 4 2009 11:00:00 GMT

Title: Child Care and Development Fund Annual Aggregate Report ACF800.

OMB No.: 09700150.

Description: Section 658K of the Child Care and Development Block Grant Act of 1990 (Pub. L. 101508, 42 U.S.C. 9858) requires that States and Territories submit annual aggregate data on the children and families receiving direct services under the Child Care and Development Fund. The implementing regulations for the statutorily required reporting are at 45 CFR 98.70. Annual aggregate reports include data elements represented in the ACF800 reflecting the scope, type, and methods of child care delivery. This provides ACF with the information necessary to make reports to Congress, address national child care needs, offer technical assistance to grantees, meet performance measures, and conduct research. Consistent with the statute and [[Page 45858]]
regulations, ACF requests extension of the ACF800. With this extension, ACF is proposing several changes and clarifications to the reporting requirements

Proposed Data Collections Submitted for Public Comment and Recommendations

Thu, Sep 3 2009 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 4046395960 or send comments to Maryam Daneshvar, CDC Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Agency Forms Undergoing Paperwork Reduction Act Review

Thu, Sep 3 2009 11:00:00 GMT

STD Surveillance Network (SSuN)NEW National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis Elimination Programs (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The purpose of the proposed study is to improve the capacity of national, State, and local STD programs to detect, monitor, and respond rapidly to trends in S

Agency Information Collection Activities: Proposed Collection; Comment Request

Wed, Sep 2 2009 11:00:00 GMT

Common Formats for Patient Safety Data Collection and Event Reporting

Wed, Sep 2 2009 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 healthcare 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. As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. The initial release of the formats, Version 0.1 Beta, was announced in the Federal Register on August 29, 2008: 73 FR 5097450976. The purpose of th

Agency Emergency Processing Under Office of Management and Budget Review; Tobacco Product Establishment Registration

Tue, Sep 1 2009 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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by The Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Agency Forms Undergoing Paperwork Reduction Act Review

Tue, Sep 1 2009 11:00:00 GMT

National Adult Tobacco Survey (NATS)NewOffice on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description

Tobacco use remains the leading preventable cause of disease and death in the United States. Although the prevalence of current smoking among adults decreased significantly

Agency Forms Undergoing Paperwork Reduction Act Review

Tue, Sep 1 2009 11:00:00 GMT

Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PharmHIV)NewNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

HIV continues to be one of the leading causes of illness and death in the US, among injection drug users who are at high risk

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Sep 1 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Sep 1 2009 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: ``Health IT Community Tracking Study 2009.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on June 30th, 2009 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Importer's Entry

Tue, Sep 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Importer's Entry Notice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Forms Undergoing Paperwork; Reduction Act Review

Tue, Sep 1 2009 11:00:00 GMT

Evaluation of the Effectiveness of the Smoke Alarm Installation and Fire Safety Education (SAIFE) Program [OMB No. 09200730 Exp. 9/30/ 2009]ExtensionNational Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).
[[Page 45215]]

Background and Brief Description

This project seeks a one year extension of its OMB PRA clearance for data collection. Due to early

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for

Mon, Aug 31 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Prospective Grant of Exclusive License: Development of Anti- Angiogenesis Cancer Therapeutics Targeting Adrenomedullin

Mon, Aug 31 2009 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 an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/002,514, filed on August 18, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E206 1995/0US01); U.S. Patent Application No. 60/002,936, filed on August 30, 1995, entitled ``Functional Role of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E2061995/1US01); U.S. Patent Application No. 60/ 013,172, filed on March 12, 1996, entitled ``Functional Role of Adrenomedullin (AM) and the GeneRelated Product (PAMP) in Human Pathology and Physiology'' (HHS Reference No. E2061995/2US01); PCT Application No. PCT/US96/13286, filed on August 16, 1996, entitled ``F

Proposed Data Collections Submitted for Public Comment and Recommendations

Mon, Aug 31 2009 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 4046395960 or send comments to Maryam Daneshvar, CDC Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Mon, Aug 31 2009 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. [[Page 44851]]
Project: Jail Diversion and Trauma RecoveryPriority to Veterans Program Evaluation(OMB NO. 09300277)Revision

The Substance Abuse and Mental Health Services Administration's (SAMHSA), Center for Mental Health Services (CMHS) has implemented the Targeted Capacity Expansion Grants for Jail Diversion Programs, and the Jail Diversion and Trauma Recovery Program represents the newest cohort of grantees. The Program currently collects client outcome measures from program participants who agree to participate in the evaluation. Data collection consists of interviews conducted at baseline, 6 and 12month intervals.

The current proposal requests:

1. Sub

National Toxicology Program (NTP): Report on Carcinogens (RoC); Availability of the Draft Background Document for

Mon, Aug 31 2009 11:00:00 GMT

The NTP announces the availability of the draft background document for formaldehyde by September 3, 2009, on the RoC Web site (http://ntp.niehs.nih.gov/go/29679) or in printed text from the RoC (see ADDRESSES below). The NTP invites the submission of public comments on the draft background document for formaldehyde. The expert panel will meet on November 24, 2009, at the Hilton RaleighDurham Airport at Research Triangle Park, 4810 Page Creek Lane, Durham, NC 27703 to peer review the draft background document for formaldehyde and, once completed, make a recommendation regarding the listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for formaldehyde in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance i

Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies

Mon, Aug 31 2009 11:00:00 GMT

If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted fro

Egg Safety; Final Rule for Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and

Mon, Aug 31 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing two public meetings to discuss the final rule concerning the prevention of Salmonella Enteritidis (SE) in shell eggs during production, storage, and transportation. The purpose of the public meetings is to explain the requirements of the rule and how to comply with it, and to provide the public an opportunity to ask questions.
Dates, Times, and Locations: See ``How to Participate in the Meetings'' in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the meetings, closing dates for advance registration, requesting special accommodations due to disability, and other information regarding meeting participation.
Contact Person: For general questions about the meetings or for special accommodations due to a disability, contact Juanita Yates, Center for Food Safety and Applied Nutrition (HFS009), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301 4361731, email:

Proposed Collection; Comment Request; Evaluation of the NIAID HIV Vaccine Research Education Initiative

Mon, Aug 31 2009 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 Allergy and Infectious Diseases (NIAID), 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: Evaluation of the NIAID HIV Vaccine Research Education Initiative, Highly Impacted Population Survey. Type of Information Collection Request: NEW. Need and Use of Information Collection: Developing measures that protect against HIV infection is one of NIAID's highest priorities. Methods in development for the prevention of HIV infection include: HIV vaccines, microbicides, and preexposure prophylaxis (PrEP). Given the daunting complexity of the HIV virus, developing these methods will ultimately require tens of thousands of volunteers to participate in

Office of Research Integrity; Privacy Act of 1974; Report of an Altered System of Records

Mon, Aug 31 2009 11:00:00 GMT

HHS proposes to revise the Privacy Act exempt system of records 09370021, entitled ``Public Health Service Records Related to Inquiries and Investigations of Scientific Misconduct, HHS/OASH/ORI.'' This system became effective on August 29, 1994 (59 FR 36717, July 19, 1994). Changes were made in response to comments received, and the revised systems notice was published on January 6, 1995 (60 FR 2140). The proposed revisions include changing the routine uses and changing the title of the system to ``HHS Records Related to Research Misconduct Proceedings, HHS/OS/ORI.'' The revisions are necessary to reflect the changes made by the Public Health Service Policies on Research Misconduct (``PHS Policies on Research Misconduct''), 42 CFR Part 93 (``Part 93''), and to update the system to reflect current practices and procedures under that regulation.

Request for Nominations to the SAMHSA National Advisory Council

Mon, Aug 31 2009 11:00:00 GMT

The Substance Abuse and Mental Health Services Administration (SAMHSA) is accepting nominations through October 7, 2009, to fill vacancies for its five advisory committees (the SAMHSA National Advisory Council, the Center for Substance abuse Prevention, Center for Substance Abuse Treatment and Center for Mental Health Services National Advisory Councils and the Advisory Committee for Women's Services). Under section 502 of the Public Health Service Act, the National Advisory Councils (NAC) provide advice to the Secretary of the U.S. Department of Health and Human Services (HHS), SAMHSA Administrator, and/or Center Directors on a broad range of polices and services related to substance use and mental health.

Legislation requires that each NAC be composed of 12 members: nine members must be leading representatives of the health disciplines (including public health, behavioral health, and social sciences) relevant to the mission of SAMHSA and its Centers and three members must be from the

Agency Emergency Information Collection Clearance Request for Public Comment

Fri, Aug 28 2009 11:00:00 GMT

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Aug 28 2009 11:00:00 GMT

Agency Information Collection Request, 30-Day Public Comment Request

Fri, Aug 28 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Aug 28 2009 11:00:00 GMT

Notice of Availability of Draft Policy Document for Comment

Fri, Aug 28 2009 11:00:00 GMT

Background: HRSA administers the Health Center Program, which supports more than 1,100 organizations operating more than 7,500 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve medically underserved communities delivering preventive and primary care services to patients regardless of their ability to pay. The Health Center Program's authorizing statute and implementing regulations (Section 330 of the PHS Act and 42 CFR Part 51c) state that any public or n

Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal

Thu, Aug 27 2009 11:00:00 GMT

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capitalrelated costs of acute care hospitals to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the TMA, Abstinence Education, and QI Program Extension Act of 2007, the Medicare Improvements for Patients and Providers Act of 2008, and the American Recovery and Reinvestment Act of 2009. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capitalrelated costs. These changes are applicable to discharges occurring on or after October 1, 2009. We also are setting forth the update to the rateofincrease limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The updated rateof increase limits are effective for cost report

Memorandum of Understanding Between the Food and Drug Administration, National Center for Toxicological Research, and

Thu, Aug 27 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Air Force Research Laboratory. This Memorandum of Understanding (MOU) between the Food and Drug Administration, National Center for Toxicological Research (NCTR), and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, Applied Biotechnology Branch (711 HPW/RHPB) (hereinafter referred to as ``the Parties''), sets forth the agreement of the Parties to facilitate information sharing in the area of toxicogenomic and computational toxicology research. Through the exchange of information, the Parties intend to coordinate research efforts so as to identify and expedite research and development of new tools and technologies that can be implemented that promote new understanding of the mechanisms of biological responses to environmental stressors, including toxic injury, and to identify biomarkers of exposu

Electronic Public Comment Transmission Error for Two Medicare Program Rules

Wed, Aug 26 2009 11:00:00 GMT

This document requests that the public resubmit their comments on the CY 2010 Physician Fee Schedule or CY 2010 Hospital Outpatient Prospective Payment System/Ambulatory Surgical Center Payment System proposed rule before the close of the comment period for these rules (that is, August 31, 2009) if their comments were originally submitted via www.regulations.gov during the period from July 26, 2009 through July 30, 2009.

Privacy Act of 1974; Report of an Altered System of Records; Sanitation Facilities Construction Individual Applicant

Wed, Aug 26 2009 11:00:00 GMT

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a SOR, System No. 09170004, ``Sanitation Facilities Construction Individual Applicant (SFCIA) Records.'' Under the provisions of the Indian Sanitation Facilities Act, Public Law 86 121 (42 U.S.C. 2004a), IHS is charged with carrying out the [[Page 43144]]
functions to determine basic individual and home eligibility for sanitation services. The primary change to this SOR notice is to delete the reference to the Social Security Numbers (SSNs) under the Categories of Records; Retrievability; Notification; Record Access; and Contesting Record Procedures to comply with the Office of Management and Budget (OMB) Memorandum (M)0716, Safeguarding Against and Responding to the Breach of Personally Identifiable Information (May 22, 2007); and the HHS Directive Memorandum of October 6, 2008 to all Operating Division Heads to develop and execute a plan to eli

Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment

Wed, Aug 26 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. These actions are needed to implement the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents requesting nominations for voting and nonvoting membership on this committee. This document also amends the agency's regulations to add the Tobacco Products Scientific Advisory Committee (the committee) to the agency's list of standing advisory committees.

Office of Health Information Technology, Office for the Advancement of Telehealth

Wed, Aug 26 2009 11:00:00 GMT

The Health Resources and Services Administration (HRSA) is issuing noncompetitive supplemental funding under the Office of Health Information Technology, Office for the Advancement of Telehealth, Telehealth Resource Center Grant Program to ensure that the Center for Telehealth & EHealth Law, the National Telehealth Resource Center (NTRC) in Washington, DC, can continue to provide much needed technical assistance services to the Regional Telehealth Resource Centers (RTRCs), HRSA grantees and new and existing telehealth organizations in order to address legal and regulatory barriers to the effective implementation of telehealth technologies at the State and national level.

Submission for OMB Review; Comment Request

Wed, Aug 26 2009 11:00:00 GMT

Title: Summary Data Component, National Child Abuse and Neglect Data System (NCANDS).

OMB No.: 09800229.

Description: The Child Abuse and Neglect Treatment Act (42 U.S.C. 5101 et seq.) as amended requires States to annually work with the Secretary to provide to the maximum extent practical, a report that includes 12 data items listed in the statute. The National Child Abuse and Neglect Data System (NCANDS), administered by the Children's Bureau, meets this reporting requirement. In addition, the amendments of 1988 require that the data system shall be universal and case specific and integrated with other casebased foster care and adoption data collected by the Secretary. There are two data components, the Detailed Case Data Component (DCDC), which includes the caselevel data submitted through the Child File and some aggregated data submitted through the Agency File, and the Summary Data component (SC), which is used by States that cannot submit caselevel data. No changes are being r

Acrylamide in Food; Request for Comments and for Scientific Data and Information

Wed, Aug 26 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting comments and scientific data and information on acrylamide in food. Acrylamide is a chemical that can form in some foods during certain types of high temperature cooking. FDA is seeking information on practices that manufacturers have used to reduce acrylamide in food and the reductions they have been able to achieve in acrylamide levels. FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.

Submission for OMB Review; Comment Request

Wed, Aug 26 2009 11:00:00 GMT

Title: Grant Application Data Summary (GADS) Form.

OMB No.: 09700328.

Description: The Grant Application Data Summary (GADS) form collects information from applicants seeking grants from the Administration for Native Americans (ANA). Applicants complete the GADS form as part of their funding package. This standardized format allows ANA to evaluate applications for financial assistance and to determine the relative focus of the projects for which such assistance is requested. The data collected focuses on the specific ANA program area for which the applicant is applying. ANA awards annual grants in the following nine competitive areas: (1) Social & Economic Develop Strategies (SEDS); (2) Alaska SEDS; (3) Special Initiative: Family Preservation: Improving the WellBeing of Children Planning; (4) Special Initiative: Family Preservation: Improving the WellBeing of Children Implementation; (5) Native Language Preservation & Maintenance Assessment; (6) Native Language Preservation & Mainten

Solicitation of Nominations for Membership on the Presidential Advisory Council on HIV/AIDS

Wed, Aug 26 2009 11:00:00 GMT

The Office of HIV/AIDS Policy (OHAP), a program office within the Office of Public Health and Science, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as members to the Presidential Advisory Council on HIV/AIDS (PACHA). The activities of this council are governed by the Federal Advisory Committee Act (FACA). Management support for the activities of this Council is the responsibility of the OHAP.

The Council provides advice, information, and recommendations to the Secretary of Health and Human Services regarding programs and policies to promote effective prevention and cure of HIV disease and AIDS. The functions of the Council shall be solely advisory in nature.

Proposed Data Collections Submitted for Public Comment and Recommendations

Wed, Aug 26 2009 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 4046395960 or send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 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)
[[Page 43139]]
ways to enhance the quality, utility, and clarity of the information t