The Federal Register

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Dec 16 2003 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) allow the proposed information collection project: ``National Children's Study Pilot: Primary Care PracticeBased Research Networks (PBRNs).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 100413 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Cooperative Agreement for

Tue, Dec 16 2003 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 following meeting:

Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Cooperative Agreement for Research on Prevention of Lyme Disease in Humans in the United States, Program Announcement 04008.

Times and Dates: 9 a.m.9:30 a.m., January 15, 2004 (Open); 9:30 a.m.4 p.m., January 15, 2004 (Closed).

Place: Atlanta Airport Marriott, 4711 Best Road, Atlanta, GA 30337, Telephone (404) 7667900.

Status: Portions of 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 review, discussion, and evaluation of applications received in response to Progra

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Data Coordinating Center for

Tue, Dec 16 2003 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 following meeting:

Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Data Coordinating Center for Autism and Other Developmental Disabilities Surveillance and

Epidemiological Research Program Announcement 04014.

Times and Dates: 8:45 a.m.9:35 a.m., January 11, 2004 (Open); 10 a.m.4:30 p.m., January 11, 2004 (Closed).

Place: Atlanta Airport Marriott, 4711 Best Road, College Park, GA 30337, Telephone (404) 7667900.

Status: Portions of 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 review, discussion, and evaluation of applications rec

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Cooperative Agreement for

Tue, Dec 16 2003 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 following meeting:

Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Cooperative Agreement for Research on the Laboratory Diagnosis, Immunology, and Pathogenesis of Lyme Disease in the United States, Program Announcement 04006.

Times and Dates: 8:30 a.m.9 a.m., January 14, 2004 (Open); 9 a.m.6 p.m., January 14, 2004 (Closed).

Place: Atlanta Airport Marriott, 4711 Best Road, Atlanta, GA 30337, Telephone (404) 7667900.

Matters to be Discussed: The meeting will include the review, discussion, and evaluation of applications

Guidance for Industry: Questions and Answers on the Interim Final Rule on Prior Notice of Imported Food; Availability

Tue, Dec 16 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Prior Notice of Imported Food, Questions and Answers.'' The guidance responds to various questions raised about the section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations that require, beginning on December 12, 2003, prior notice to FDA before food is imported or offered for import into the United States.

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

Tue, Dec 16 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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

Tue, Dec 16 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification Submissions

Tue, Dec 16 2003 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 premarket notification (510(k)) submissions.

Notice of Meeting of the Advisory Committee on Blood Safety and Availability

Tue, Dec 16 2003 11:00:00 GMT

The Advisory Committee on Blood Safety and Availability will meet to examine the role of the Federal Government in the distribution of the nation's blood supply. The meeting will be entirely open to the public.

Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin

Tue, Dec 16 2003 11:00:00 GMT

The Department of Health and Human Services (HHS) is extending the period for comments on revised Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons through January 6, 2004. This revised guidance was issued pursuant to Executive Order 13166.

Smallpox Vaccine Injury Compensation Program: Administrative Implementation

Tue, Dec 16 2003 11:00:00 GMT

The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), authorizes the Secretary of Health and Human Services (the Secretary), to establish the Smallpox Vaccine Injury Compensation Program (``the Program''). This program is designed to provide benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of these injuries.

On August 27, 2003, the Secretary published an interim final rule that set out a Smallpox (Vaccinia) Vaccine Injury Table (``the Table''). The table includes adverse effects (including injuries, disabilities, conditions, and deaths) within specific time periods that shall be presumed to result from the receipt of, or exposure to, the smallpox vaccine. The Secretary will use

National Cancer Institute; Notice of Closed Meeting

Tue, Dec 16 2003 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Cancer Institute Special Emphasis Panel; Preparation of Radiolabeled Materials.

Date: December 19, 2003.

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

Agenda: To review and evaluate contract proposals.

Place: National Institutes of Health, 6116 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

Contact Person: C. Michael Kerwin, Ph.D.,

National Cancer Institute; Notice of Closed Meeting

Tue, Dec 16 2003 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 property.

Name of Committee: National Cancer Institute Initial Review Group, Subcommittee GEducation.

Date: February 911, 2004.

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

Agenda: To review and evaluate grant applications.

Place: Wyndham Washington, DC, 1400 M Street, NW., Washington, DC 20005.

Contact Person: Ilda M. McKenna, Scientific Review Administrator, Research Training Review Branch,

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

Tue, Dec 16 2003 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, Biodefense Proteomics Research Programs: Identifying Targets for Therapeutic Interventions Using Proteomic Technology.

Date: January 79, 2004.

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

Agenda: To review and evaluate contract proposals.

Place: Bethesda Marriott, 5151 Pooks Hill Road, Beth

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

Tue, Dec 16 2003 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; Innate Immune Receptors and Adjuvant Discovery.

Date: January 23, 2004.

Time: 8 a.m. to 3 p.m.

Agenda: To review and evaluate contract proposals.

Place: Holiday Inn Chevy Chase, 5520 Wisconsin Avenue, Chevy Chase, MD 20815.

Contact Person: Paul A. Amstad, Ph.D., Sc

National Institute of Environmental Health Sciences; Notice of Closed Meeting

Tue, Dec 16 2003 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 [[Page 70022]]
would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel, Research Program Projects.

Date: February 34, 2004.

Time: 7 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: Doubletree Guest Suites, 2515 Meridian Parkway, Research Triangle Park, NC 27713.

Contact Person:Sally EckertTilotta, Ph.

Center for Scientific Review; Amended Notice of Meeting

Tue, Dec 16 2003 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, December 19, 2003, 1 p.m. to December 19, 2003, 3 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on November 26, 2003, 68 FR 6647166472.

The meeting will be held December 18, 2003. The time and location remain the same. The meeting is closed to the public.

Dated: December 10, 2003.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 0330974 Filed 121503; 8:45 am]
BILLING CODE 414001M

Center for Scientific Review; Notice of Closed Meetings

Tue, Dec 16 2003 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: Center for Scientific Review Special Emphasis Panel, Geriatrics.
[[Page 70023]]

Date: December 12, 2003.

Time: 12:00 pm to 1:30 pm.

Agenda: To review and evaluate grant applications.

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

Contact Person: Charles G. Hollingsworth, DRPH, Sci

Center for Scientific Review; Amended Notice of Meeting

Tue, Dec 16 2003 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, December 11, 2003, 2 p.m. to December 11, 2003, 3 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on December 3, 2003, 68 FR 6769067691.

The meeting will be held December 17, 2003, from 1 p.m. to 2 p.m. The location remains the same. The meeting is closed to the public.

Dated: December 10, 2003.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 0330977 Filed 121503; 8:45 am]
BILLING CODE 414001M

Center for Scientific Review; Amended Notice of Meeting

Tue, Dec 16 2003 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, December 10, 2003, 2 p.m. to December 10, 2003, 3 p.m., National Institute of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on December 3, 2003, 68 FR 6769067691.

The meeting will be held December 17, 2003. The time and location remains the same. The meeting is closed to the public.

Dated: December 10, 2003.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 0330978 Filed 121503; 8:45 am]
BILLING CODE 414001M

Center for Scientific Review; Amended Notice of Meeting

Tue, Dec 16 2003 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, December 9, 2003, 12 p.m., to December 9, 2003, 1 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on December 8, 2003, 68 FR 6840468405.

The meeting will be held December 12, 2003, from 10 a.m. to 11 a.m. The location remains the same. The meeting is closed to the public.

Dated: December 10, 2003.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 0330979 Filed 121503; 8:45 am]
BILLING CODE 414001M

Center for Scientific Review; Amended Notice of Meeting

Tue, Dec 16 2003 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Review Special Emphasis Panel, December 19, 2003, 3 p.m. to December 19, 2003, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on November 26, 2003, 68 FR 6647166472.

The meeting will be held December 16, 2003, from 1 p.m. to 3 p.m. The location remains the same. The meeting is closed to the public.

Dated: December 10, 2003.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 0330980 Filed 121503; 8:45 am]
BILLING CODE 414001M

Agency Information Collection Activities: Proposed Collection; Comment Request

Tue, Dec 16 2003 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 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 (301) 4437978.

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 techniques or ot