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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health and Human Services Department

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health Resources and Services Administration

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.;

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Health Resources and Services Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : National Institutes of Health

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
[[Page 75412]]
is in response to a food additive petition filed by Nutrinova, Inc. It will simplify the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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
[[Page 75443]]
and Calendar Year 2004 Payment Rates; Final Rule.'' This notice is a supplement to the November 7, 2003 final rule

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Children and Families Administration

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreements to conduct methodologically sound research on how media violence affects youth violent behavior was published in the Federal Register on November 28, 2003, Volume 68, Number 229, pages 6682966834. The notice is amended as follows:

On page 66833,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

Announcement Type: New.

Funding Opportunity Number: 04072.

Catalog of Federal Domestic Assistance Number: 93.283.

Key Dates: Application Deadline: February 13, 2004. I. Funding Opportunity Description

Authority: This program is authorized under section 301(a) of the Public Health Service Act, (42 U.S.C. 241(a)).

Purpose: The

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreement to conduct a systematic examination of the impact of home visitor training and factors related to the implementation of an existing efficacious or effective home visiting program on family outcomes of child maltreatment and risk behaviors for youth

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

A notice announcing the availability of fiscal year (FY) 2004 funds for cooperative agreements for Capacity Building Assistance to Improve the Delivery and Effectiveness of HIV Prevention Services for Racial/ Ethnic Minority Populations was published in the Federal Register, Tuesday, December 2, 2003, Volume 68, Number 231, pages 6755867566.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Centers for Disease Control and Prevention

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (301) 4437978.

Protection

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Substance Abuse and Mental Health Services Administration