The Federal Register

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Nov 23 2007 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
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comments should be received within 30 days of this notice.

Proposed Project

Followup Survey of Chronic Fatigue Syndrome in GeorgiaNew Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is planning a followup study of chronic fatigue syndrome (CFS) in metropolitan, urban and rural communities in Georgia. This is in response to Congressional recommendations that the Centers for

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Nov 23 2007 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

Use of a Reader Response Postcard for Workers Notified of Results of Epidemiologic Studies Conducted by the National Institute for Occupational Safety and Health (NIOSH)ReinstatementThe National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

NIOSH, under Section 20(a)(1), (a)(4), (a)(7)(c), and Section 22 (d), (

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Nov 23 2007 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

Medicaid Integrity Program; Eligible Entity and Contracting Requirements for the Medicaid Integrity Audit Program

Fri, Nov 23 2007 11:00:00 GMT

Section 1936 of the Social Security Act (the Act) (as added by section 6034 of the Deficit Reduction Act of 2005 (DRA)) established the Medicaid Integrity Program to promote the integrity of the Medicaid program by requiring CMS to enter into contracts with eligible entities to: Review the actions of individuals or entities furnishing items or services (whether on a feeforservice, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of such plan approved under section 1115 of the Act; audit claims for payment of items or services furnished, or administrative services rendered, under a State plan; identify overpayments to individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care.

This proposed rule would provide requirements for an eligible entity to enter into a contract under the Medicaid integrity audit pr

Medicare and Medicaid Programs; Waiver of Disapproval of Nurse Aide Training Program in Certain Cases and Nurse Aide

Fri, Nov 23 2007 11:00:00 GMT

This proposed rule would permit a waiver of nurse aide training disapproval as it applies to skilled nursing facilities, in the Medicare program, and nursing facilities, in the Medicaid program, that are assessed a civil money penalty of at least $5,000 for noncompliance that is not related to quality of care. This is a statutory provision enacted by section 932 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108 173, enacted December 8, 2003.)

In addition, this proposed rule would codify an additional statutory provision enacted by section 4755 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 10533, enacted on August 5, 1997) that requires the State to establish a procedure to permit a nurse aide to petition the State to have a single finding of neglect removed from the nurse aide registry if the State determines that the employment and personal history of the nurse aide does not reflect a pattern of abusive behavior or neglect and the neglect i

Medicare and Medicaid Programs; Approval of the American Osteopathic Association's Deeming Authority for Critical

Fri, Nov 23 2007 11:00:00 GMT

This notice announces our decision to approve the American Osteopathic Association (AOA) for recognition as a national accreditation program for critical access hospitals (CAHs) seeking to participate in the Medicare or Medicaid programs.

Medicare Program; Listening Session on Hospital-Acquired Conditions and Present on Admission Indicator Reporting,

Fri, Nov 23 2007 11:00:00 GMT

This notice announces a listening session being conducted as part of the selection of HospitalAcquired Conditions (HAC) and implementation of Present on Admission (POA) Indicator Reporting, as authorized by section 5001(c) of the Deficit Reduction Act of 2005 (DRA). The purpose of this listening session is to solicit informal comments in preparation for the fiscal year 2009 inpatient prospective payment system (IPPS) rulemaking process. Hospitals, hospital associations, representatives of consumer purchasers, payors of health care services, and all interested parties are invited to attend and make comments in person or in writing. It will also be possible to listen to the session by teleconference. However, because of time constraints, telephone participants will not be able to make verbal comments. Informal written comments will be accepted. This meeting is open to the public, but registration is required due to limited space and security requirements to enter the meeting location. This Listen

Privacy Act of 1974; Report of a Modified or Altered System of Records

Fri, Nov 23 2007 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an SOR, ``Employee Building Pass File (EBP) System, System No. 09703002,'' last published at 67 FR 40937 (June 14, 2002). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09700529.

We propose to modify existing routine use number 2 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separately from CMS contractors and/or consultants. The modified routine use will remain as routine use num

Submission for OMB Review; Comment Request

Fri, Nov 23 2007 11:00:00 GMT

Title: Notice of Lien.

OMB No.: 09700153.

Description: Section 452(a)(11) of the Social Security Act requires the Secretary of Health and Human Services to promulgate a form for imposition of liens to be used by the State child support enforcement (Title IVD) agencies in interstate cases. Section 454(9)(E) of the Social Security Act requires each State to cooperate with any other State in using the Federal form for imposition of liens in interstate child support cases. Tribal IVD agencies are not required to use this form but may choose to do so. OMB approval of this form is expiring in January 2008 and the Administration for Children and Families is requesting an extension of this form.

Respondents: State, local or Tribal agencies administering a child support enforcement program under title IVD of the Social Security Act.
Annual Burden Estimates Number of Average bu

Submission for OMB Review; Comment Request

Fri, Nov 23 2007 11:00:00 GMT

Title: Child Care and Development Fund Tribal Annual Report (ACF 700 Report).

OMB No.: 09800241.

Description: The Child Care and Development Fund (CCDF) report requests annual Tribal aggregate information on services provided through the CCDF, which is required by the CCDF Final Rule (45 FR parts 98 and 99). Tribal Lead Agencies (TLAs) are required to submit annual aggregate data appropriate to Tribal programs on children and families receiving CCDFfunded child care services. The CCDF statute and regulations also require TLAs to submit a supplemental narrative as part of the ACF700 report. This narrative describes general child care activities and actions in the TLA's service area and is not restricted to CCDFfunded child care activities. Instead, this description is intended to address all child care available in the TLA's service area. The ACF700 and supplemental narrative report will be included in the Secretary's report to Congress, as appropriate, and will be shared with all TLA

New Animal Drugs For Use in Animal Feeds; Ractopamine

Fri, Nov 23 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in twoway combination Type B and Type C medicated feeds containing ractopamine hydrochloride and monensin for cattle fed in confinement for slaughter.

Memorandum of Understanding Between the Food and Drug Administration and Duke University

Fri, Nov 23 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Duke University. The purpose of this MOU is to establish the terms of collaboration between FDA and Duke, beginning with an initiative to strengthen Human Subjects Protection by reexamining and modernizing the conduct of clinical trials to ensure that design, execution, and analysis are of optimal quality. To this end, Duke will be the convener of a Public Private Partnership, to which FDA will be a founding partner, to systematically modernize the clinical trial process.

Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to

Fri, Nov 23 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is extending the expiration date of the compliance policy guide (CPG) entitled ``Sec. 400.210Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2008.

Draft Guidance for Industry on Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention;

Fri, Nov 23 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention.'' In this draft guidance, FDA provides recommendations on the development of drugs to be used to treat or prevent smallpox (variola) infection. This guidance is intended to help sponsors plan and design appropriate studies during the development of these drugs.

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal

Fri, Nov 23 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (73) entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision) VICH GL3(R).'' This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised document is intended to provide guidance regarding the development of stability testing data for new animal drug applications (referred to as registration applications in the guidance) submitted to the European Union (EU), Japan, and United States.

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal

Fri, Nov 23 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (93) entitled ``Impurities in New Veterinary Medicinal Products (Revision)'' VICH GL11(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products.

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal

Fri, Nov 23 2007 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry (92) entitled ``Impurities in New Veterinary Drug Substances (Revision)'' VICH GL10(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The revised document is intended to provide guidance for registration applicants on the content and qualification of impurities in new veterinary drug substances produced by chemical syntheses and not previously registered in a country, region, or member state.

Government-Owned Inventions; Availability for Licensing

Fri, Nov 23 2007 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.

Public Teleconference Regarding Licensing and Collaborative Research Opportunities for: ``Brother of the Regulator of

Fri, Nov 23 2007 11:00:00 GMT

Technology Summary

The technology describes the discovery of a novel gene encoding the DNAbinding factor, ``Brother of the Regulator of Imprinted Sites'', BORIS, related to the unique, evolutionarily conserved, CTCF factor involved in regulation of genomic imprinting and cancer. Furthermore, it describes several splice variants of BORIS that translate into different proteins and antibodies of BORIS that can be used for diagnosis and treatment of cancer.

Technology Description

A very recent finding is that protein CTCF (expressed in all somatic tissues) binds, in a methylationdependent manner, to the imprinting control regions thus allowing somatic cells to distinguish functionally maternal from paternal alleles. The new factor, BORIS, shares with CTCF the same spectrum of DNA sequence specificity and it is normally expressed only in germ cells of human gonads (when patterns of gene imprinting are reestablished), but not in CTCFexpressing somatic cells.

Additionally, since cellgrowth

National Institute of Environmental Health Sciences; Notice of Closed Meeting

Fri, Nov 23 2007 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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 of Environmental Health Sciences Special Emphasis Panel, Genetic Environmental Training.

Date: November 27, 2007.

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

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Agenda: To review and evaluate grant applications.

Place: Sheraton Imperial Hotel RTP, Sheraton Imperial Hotel, 4700 Emperor Blvd, Durham, NC 27703.

Contact Person: Leroy

Center for Scientific Review; Notice of Closed Meeting

Fri, Nov 23 2007 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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 of commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Center for Scientific Review Special Emphasis Panel, Endocrinology and Metabolism.

Date: December 5, 2007.

Time: 10 a.m. to 12 p.m.

Agenda: To review and evaluate grant applications.

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

Contact Person: Ann A. Jerkins, PhD, Scientific Revi