The Federal Register

Food Labeling: Health Claims; Dietary Guidance

Tue, Nov 25 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to request comments on alternatives for regulating qualified health claims in the labeling of conventional human foods and dietary supplements. FDA also is soliciting comments on various other issues related to health claims and on the appropriateness and nature of dietary guidance statements on conventional food and dietary supplement labels. Comments on the regulatory alternatives and the additional topics will inform FDA's rulemaking to establish regulations for qualified health claims, as well as any policy initiative(s) that FDA may undertake to provide information to consumers to help them make wise food choices.

Determination of Regulatory Review Period for Purposes of Patent Extension; XIGRIS

Tue, Nov 25 2003 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for XIGRIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of three applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of three patents which claim that human biological product.

Joint Meeting of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health

Tue, Nov 25 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 Committees: Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs.

General Function of the Committees: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on December 16, 2003, from 8 a.m. to 5 p.m.

Addresses: Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Select ``01P0075Switch Status of
Emergency Contraceptives from Rx to OTC'' and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852