The Federal Register

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.