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Department: DEPARTMENT OF HEALTH AND HUMAN SERVICES

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The Federal Register
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1. Government-Owned Inventions; Availability for Licensing

NOTICES: Government-Owned Inventions; Availability for Licensing,

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 federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

2. Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting

NOTICES: American Health Information Community,

This notice announces the meeting date for the 24th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

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

NOTICES: National Institute of Child Health and Human Development,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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

NOTICES: National Institute of Child Health and Human Development,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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

NOTICES: National Institute of Child Health and Human Development,

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 contract proposals and the discussions

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

6. National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

NOTICES: National Institute on Deafness and Other Communication Disorders,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

7. Prospective Grant of Exclusive License: Live, Attenuated Virus Vaccines Against RSV, PIV, and hMPV

NOTICES: Live, Attenuated Virus Vaccines Against RSV, PIV, and hMPV,

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 worldwide exclusive license to practice the invention embodied in: RSV Technologies
(1) U.S. Patents 5,993,824 (issued November 30, 1999) and
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

8. National Toxicology Program (NTP); Report on Carcinogens (RoC); Request for Public Comments on the RoC Expert Panel's

NOTICES: RoC Expert Panels Recommendation on Listing Status for Styrene in the 12th RoC and the Scientific Justification for the Recommendation,

The RoC Office invites public comment on the recommendation from an expert panel on the listing status for styrene in the 12th RoC and the scientific justification for the recommendation. The recommendation and scientific justification for styrene is available electronically in Part B of the Expert Panel Report (

9. Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals

RULES: Amendments to Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals,

The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

10. Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals

RULES: Restrictions on African Rodents, Pairie Dogs, and Certain Other Animals,

The Food and Drug Administration (FDA) is removing its regulation that established restrictions on the capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals. We are removing the restrictions because we believe they are no longer needed to prevent the further introduction,
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

11. FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference; Public Workshop

NOTICES: FDA Clinical Trial Requirements Regulations, Compliance, and Good Clinical Practice Conference; Public Workshop,

The Food and Drug Administration (FDA) Dallas District, in cooperation with the Society of Clinical Research Associates(SoCRA), is announcing a workshop on FDA Clinical Trial statutory and regulatory requirements. This 2day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards,
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

12. Proposed Collection; Comment Request; the National Diabetes Education Program Comprehensive Evaluation Plan

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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 Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

13. Proposed Collection; Comment Request; Simulations for Drug Related Science Education

NOTICES: Simulations for Drug Related Science Education,

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

15. Agency Information Collection Activities: Proposed Collection; Comment Request

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Medicare & Medicaid Services

16. National Center for Complementary & Alternative Medicine; Notice of Closed Meetings

NOTICES: National Center for Complementary & Alternative Medicine,

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 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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

NOTICES: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

18. International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs;

NOTICES: Gamma-hydroxybutyric acid; Ketamine; Dextromethorphan; N-benzylpiperazine; 1-(3-trifluoromethylphenyl)piperazine; etc.,

The Food and Drug Administration (FDA) is requesting comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. These comments will be considered in preparing the United States' response to the World Health Organization (WHO) regarding
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

19. Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

NOTICES: Peripheral and Central Nervous System Drugs Advisory Committee,

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: Peripheral and Central Nervous System Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

20. Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

NOTICES: Product-Specific Bioequivalence Recommendations; Publication of Guidances for Industry,

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft productspecific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

21. Science Board to the Food and Drug Administration; Request for NominationsSUBJECT>

NOTICES: Science Board to the Food and Drug Administration; Request for Nominations,

The Food and Drug Administration (FDA) is requesting nominations to serve on the Science Board to the FDA (Science Board).

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

22. National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

NOTICES: National Institute of Dental and Craniofacial Research,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

23. National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

NOTICES: National Institute on Alcohol Abuse and Alcoholism,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

24. Center for Scientific Review; Amended Notice of Meeting

NOTICES: Center for Scientific Review,

Notice is hereby given of a change in the meeting of the Social Psychology, Personality and Interpersonal Processes Study Section, October 6, 2008, 8 a.m. to October 6, 2008, 5 p.m., Admiral Fell Inn, 888 South Broadway, Baltimore, MD, 21231 which was published in the Federal Register on August 21, 2008, 73 FR 4946549467.

The meeting will

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

25. Center for Scientific Review; Amended Notice of Meeting

NOTICES: Center for Scientific Review,

Notice is hereby given of a change in the meeting of the Macromolecular Structure and Function B Study Section, October 6, 2008, 8 a.m. to October 7, 2008, 6 p.m., Melrose Hotel, 2430 Pennsylvania Avenue, NW., Washington, DC, 20037 which was published in the Federal Register on August 21, 2008, 73 FR 4946549467.

The meeting will be held one

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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