The Federal Register

Privacy Act of 1974; Report of a New System of Records

Wed, Nov 23 2005 11:00:00 GMT

In accordance with the requirements of the Privacy Act of 1974, we are proposing a new SOR titled, ``National Disaster Medical System (NDMS) Claims Processing System (CPS), No. 09700572.'' CMS is responsible for establishing and administering a payment mechanism for definitive medical care provided under the National Disaster Medical System (NDMS) in accordance with section 2811 of the Public Health Service Act, 42 United States Code (U.S.C.) 300hh11, a Memorandum of Agreement (MOA) entered into by the NDMS Partnersthe Departments of Homeland Security, Health and Human Services, Defense, and Veteran's Affairs, and an InterAgency Agreement between CMS and the Federal Emergency Management Agency (FEMA). Reimbursement to NDMSparticipating hospitals (and practitioners furnishing medical services to NDMS authorized patients during inpatient stays in those hospitals) for definitive medical care will be administered through the NDMSCPS. The new system will collect data relating to individuals who recei

Investigational New Drugs: Export Requirements for Unapproved New Drug Products

Wed, Nov 23 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs.

Organ Procurement and Transplantation Network

Wed, Nov 23 2005 11:00:00 GMT

This notice sets forth the Secretary's proposal to include intestines within the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network. The Secretary further proposes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act, as amended.

Office of the Director, National Institutes of Health; Notice of Meeting

Wed, Nov 23 2005 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 meeting of the Advisory Committee to the Director, National Institutes of Health (NIH).

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

A portion of the meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(6) and 552b(c)(9)(B), title 5 U.S.C., as amended, because the disclosure of which would constitute a clearly unwarranted invasion of personal privacy and the premature disclosure of information and the discussions would likely significantly frustrate implementation of the program.

Name of Committee: Advisory Committee to the Director, NIH.

Date:

National Cancer Institute; Notice of Closed Meeting

Wed, Nov 23 2005 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 Cancer Institute Initial Review Group, Subcommittee DClinical Studies.

Date: December 1314, 2005.

Time: 9 a.m. to 6 p.m.

Agenda: To review and evaluate grant applications.

Place: Marriott Bethesda North Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852.

Contact Person: William D. Merritt, PhD, Scientific Review

National Cancer Institute; Notice of Closed Meeting

Wed, Nov 23 2005 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 percent 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 CBasic & Preclinical.

Date: December 1314, 2005.

Time: 8 a.m. to 2 p.m.

Agenda: To review and evaluate grant applications.

Place: Marriott Bethesda North Hotel and Conference Ctr., 5701 Marinelli Road, North Bethesda, MD 28052.

Contact Person: Michael B. Small, PhD, Scientific Review

National Cancer Institute; Notice of Closed Meeting

Wed, Nov 23 2005 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 applicants 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 ECancer Epidemiology, Prevention & Control.

Date: December 1314, 2005.

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

Agenda: To review and evaluate grant applications.

Place: Bethesda North Marriott, 5701 Marinelli Road, North Bethesda, MD 20852.

Contact Person: Hasnaa Shafik, PhD, MD, Scientific Review Ad

National Eye Institute; Notice of Closed Meeting

Wed, Nov 23 2005 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: National Eye Institute Special Emphasis Panel, NEI Review Panel.

Date: December 1, 2005.

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

Agenda: To review and evaluate grant applications.

Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814.

Contact Person: Houmam H. Araj, PhD, Scientific Review Administrator, Division of Extramural Research, National

National Institutes of Allergy and Infectious Diseases; Notice of Closed Meeting

Wed, Nov 23 2005 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.

Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel International Epidemiological Databases to Evaluate AIDS (IEDEA).

Date: December 57, 2005.

Time: 7 p.m. to 12 p.m.

Agenda: To review and evaluate grant applications.

Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852.

Contact Person: John A. Bogd

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

Wed, Nov 23 2005 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.

Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel, Communication of People With Mental Retardation.

Date: December 2, 2005.

Time: 10:30 a.m. to 12:30 p.m.

Agenda: To review and evaluate grant applications.

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

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

Wed, Nov 23 2005 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.

Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel, Specialized Centers in Reproduction Research.

Dates: December 56, 2005.

Time: 8:30 a.m. to 4 p.m.

Agenda: To review and evaluate grant applications.

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

Contact Pers

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

Wed, Nov 23 2005 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 552(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, Estrogen and Neural Pathways in Female Pain Syndromes.

Date: November 30, 2005.

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

Agenda: To review and evaluate grant applications.

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

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

Wed, Nov 23 2005 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.

Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel, Reproductive Health in Developing Countries P01 Review.

Date: December 5, 2005.

Time: 8:30 a.m. to 4 p.m.

Agenda: To review and evaluate grant applications.

Place: Renaissance Mayflower Hotel, 1127 Connecticut Avenue, NW., Washington, DC 20036.

Contact Person: C

National Institute of Dental & Craniofacial Research; Notice of Closed Meetings

Wed, Nov 23 2005 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 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 Dental and Craniofacial Research Special Emphasis Panel 0632, Review R03.

Date: December 2, 2005.

Time: 10 a.m. to 11 a.m.

Agenda: To review and evaluate grant applications.

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

Contact Person: Soheyla

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

Wed, Nov 23 2005 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 meetings.

Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, DietInduced Obesity.

Date: December 2, 2005.

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

Agenda: To review and evaluate grant applications.

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

National Institute of Mental Health; Notice of Closed Meetings

Wed, Nov 23 2005 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 meetings.

Name of Committee: National Institute of Mental Health Special Emphasis Panel, Individual Fellowships.

Date: November 29, 2005.

Time: 11 a.m. to 12:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

Contact Person: Ai

National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings

Wed, Nov 23 2005 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 meetings.

Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel, ZAA1 DD53 (RFAAA06001SBIR).

Date: December 5, 2005.

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

Agenda: To review and evaluate grant applications. [[Page 70859]]

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

Contact Person: Sathas

Center for Scientific Review; Notice of Closed Meetings

Wed, Nov 23 2005 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 meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel, Eukaryotic Pathogens and Vectors.

Date: November 21, 2005.

Time: 8 a.m. to 4 p.m.

Agenda: To review and evaluate grant applications and/or proposals.

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

Contact Person: Fouad A. ElZaatari, PhD, Scientific Revie

Center for Substance Abuse Prevention; Notice of Meeting

Wed, Nov 23 2005 11:00:00 GMT

Pursuant to Pub. L. 92463, notice is hereby given of the meeting of the Substance Abuse and Mental Health Services Administration (SAMHSA) Drug Testing Advisory Board on December 1314, 2005.

A portion of the meeting will be open and will include a roll call, general announcements, a Department of Health and Human Services drug testing program update, a Department of Transportation drug testing program update, and a Nuclear Regulatory Commission drug testing program update.

Attendance by the public will be limited to space available. Public comments are welcome. Please communicate with the individual listed below as contact to make arrangements to comment or to request special accommodations for persons with disabilities.

The Board will also meet to develop the final revisions to the proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs that were published in the Federal Register on April 13, 2004 (69 FR 19673) and to discuss Federal agency specimen results, med