The Federal Register

Proposed Data Collections Submitted for Public Comment and Recommendations

Wed, Dec 31 2003 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 on (404) 4981210.

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 collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques

Proposed Data Collections Submitted for Public Comment and Recommendations

Wed, Dec 31 2003 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) 4981210. Send written comments to CDC, Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 3956974. Written comments should be received within 30 days of this notice.

Proposed Project: Housing and Health StudyNewNational Center for HIV, STD, and TB Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC). CDC is requesting OMB approval to conduct a study to examine the impact of providing housing for homeless or unstably housed people (people who are in temporary housing programs or doubled up with others) while living with HIV.

This project includes a unique collaboration with

Proposed Data Collections Submitted for Public Comment and Recommendations

Wed, Dec 31 2003 11:00:00 GMT

Medicare Program; Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year

Wed, Dec 31 2003 11:00:00 GMT

This document corrects errors in the final rule with comment period that appeared in the Federal Register on November 7, 2003, entitled ``Medicare Program; Changes to the Hospital Outpatient Prospective Payment System
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and Calendar Year 2004 Payment Rates; Final Rule.'' This notice is a supplement to the November 7, 2003 final rule and is completely separate from any notice that promulgates new policy that results from enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

Request for Public Comments on the Proposed Merger of Two Head Start Grantees in Rhode Island

Wed, Dec 31 2003 11:00:00 GMT

This notice is to solicit public comments and statements of interest from interested parties on the merger of two Rhode Island Head Start Programs.

Statement of Organization, Functions, and Delegations of Authority

Wed, Dec 31 2003 11:00:00 GMT

This notice amends Part K of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (DHHS), Administration for Children and Families (ACF) as follows: Chapter KB, the Children's Bureau, Administration on Children, Youth and Families (ACYF) (66 FR 3021518), as last amended June 5, 2001. This notice moves the Data Team from the Division of Data, Research and Innovation, Children's Bureau to the Office of the Associate Commissioner, Children's Bureau and renames the Division.

This Chapter is amended as follows:

1. Chapter KB, Administration on Children, Youth and Families.

A. Delete KB.10 Organization in its entirety and replace with the following:
KB.10 Organization. The Administration on Children, Youth and Families is headed by a Commissioner, who reports directly to the Assistant Secretary for Children and Families and consists of:
[sbull] Office of the Commissioner (KBA)
[sbull] Office of Management Services (K

Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium

Wed, Dec 31 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acesulfame potassium (ACK) as a generalpurpose sweetener and flavor enhancer in food, not including meat and poultry. This action
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is in response to a food additive petition filed by Nutrinova, Inc. It will simplify the existing regulations by replacing all of the currently listed uses of ACK with a singleuse category for food.

Pediculicide Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph

Wed, Dec 31 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for overthecounter (OTC) pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements. Pediculicide drug products are used for the treatment of head, pubic (crab), and body lice. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering public comment on its proposed regulation and all relevant data and information that have come to the agency's attention.

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

Wed, Dec 31 2003 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.

Advisory Committees; Tentative Schedule of Meetings for 2004

Wed, Dec 31 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2004. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of IOM's recommendations was for the agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements IOM's recommendation.

Biological Response Modifiers Advisory Committee; Notice of Meeting

Wed, Dec 31 2003 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: Biological Response Modifiers 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 March 18, 2004, from approximately 8:30 a.m. and 5 p.m.; and on March 19, 2004, from approximately 8:30 a.m. to 3 p.m.

Location: Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD.

Contact Person: Gail Dapolito or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 3018273014, email dapolito@cber.fda.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512389. Please call the Information Line for uptodate i

Memorandum of Understanding Between the Food and Drug Administration, Department of Health and Human Services of the

Wed, Dec 31 2003 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, Department of Health and Human Services of the United States of America and Swissmedic of the Swiss Confederation. The purpose of this MOU is to further enhance and strengthen communication and existing public health promotion and protection cooperative activities related to the regulation of human or animal pharmaceutical products and human medical devices in Switzerland and the United States of America.

Memorandum of Understanding Between the Food and Drug Administration and the Health Products and Food Branch, Health

Wed, Dec 31 2003 11:00:00 GMT

The Food and Drug Administration is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration (FDA), Department of Health and Human Services of the United States of America and the Health Products and Food Branch, Health Canada of Canada. The purpose of this MOU is to enhance and strengthen the exchange of information and existing public health protection cooperative activities related to the regulation of the specified therapeutic products.

Over-the-Counter Drug Products; Safety and Efficacy Review

Wed, Dec 31 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a call for data for certain categories of ingredients in overthecounter (OTC) drug products that are eligible for the original OTC drug review but have not been reviewed by FDA to date. FDA will review the submitted data and information as part of its ongoing review of OTC drug products to determine whether these ingredients and products are generally recognized as safe and effective (GRAS/E) for their labeled uses. This document also requests the
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identification of other categories of OTC drug products that were in the marketplace when the OTC drug review began on May 11, 1972, or that were marketed before December 4, 1975, and describes FDA's general regulatory policy governing the marketing of these OTC drug products during the pendency of this review.

Exchange of Letters Between the Food and Drug Administration and the European Commission and the European Agency for

Wed, Dec 31 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of an exchange of letters between FDA and the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA). The participants concluded this exchange of letters on September 12, 2003. These letters express the intentions of FDA, the European Commission, and EMEA to continue cooperative activities to further enhance and strengthen communication between the respective organizations and further enhance public health promotion and protection in the European Union and the United States of America.

Secretary's Council on Public Health Preparedness; Notice of Meeting

Wed, Dec 31 2003 11:00:00 GMT

Pursuant to Section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is given of a meeting of the Secretary's Council on Public Health Preparedness.

The purpose of this public meeting is to convene the Council to discuss issues related to preparing the nation to respond to public health emergencies in general and bioterrorism in particular. The Council may consider the following major issues: BioShield; Modeling Initiatives: Transport of Possibly Infected Exotic Animals; Global IT Monitoring; Public Health Preparedness Effort; State and Local Programs; R&D Initiatives.

Name of Committee: Secretary's Council on Public Health Preparedness.

Date: January 2223, 2004.

Time: January 229 a.m.6 p.m.; January 239 a.m.3 p.m.

Place: Holiday Inn Capitol, 550 C Street, SW., Washington, DC 20024, Telephone: (202) 4794006.

Contact Person: Dr. Judy Blumenthal, Executive Director, Secretary's Council on Public Health Preparedness, Office of the Assi

Agency Information Collection Activities: Proposed Collection: Comment Request

Wed, Dec 31 2003 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 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.

National Advisory Committee on Rural Health and Human Services; Notice of Meeting

Wed, Dec 31 2003 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92463), notice is hereby given that the following committee will convene its fortysixth meeting.

Name: National Advisory Committee on Rural Health and Human Services

Date and Time: February 22, 2004; 2 p.m.5 p.m.; February 23, 2004; 8:30 a.m.5 p.m.; February 24, 2004; 8:30 a.m.10:30 a.m.

Place: Grand Hyatt Washington, 1000 H Street NW., Washington, DC 20001, Phone: 18002331234.

Status: The meeting will be open to the public.

Purpose: The National Advisory Committee on Rural Health and Human Services provides advice and recommendations to the Secretary with respect to the delivery, research, development and
administration of health and human services in rural areas.

Agenda: Sunday afternoon, February 22, 2004 at 2 p.m., the Chairperson, the Honorable David Beasley, will open the meeting and welcome the Committee. The first session will open with a discussion of the Committee business an

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

Wed, Dec 31 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Botulinum Toxin Biophysics P01.

Date: January 16, 2004.

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

Agenda: To review and evaluate grant applications.

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

Contact Person; Tracy A. Shahan, PhD, Scientific Review Admini

National Institute of Mental Health; Notice of Closed Meetings

Wed, Dec 31 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 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 Institute of Mental Health Special Emphasis Panel, SBIR Phase I, Topic 46.

Date: January 8, 2004.

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

Agenda: To review and evaluate contract proposals.

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

Contact Person: Marth