The Federal Register

Implantation or Injectable Dosage Form New Animal Drugs; Flunixin Meglumine Solution

Fri, Dec 19 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the veterinary prescription use of flunixin meglumine injectable solution for the control of inflammation in horses, beef cattle, and nonlactating dairy cattle.

Agency Information Collection Activities; Comment Request; Guidance for Industry--Changes to an Approved New Drug

Fri, Dec 19 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 the collection of information contained in a guidance for industry entitled ``Changes to an Approved NDA or ANDA.''

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs

Fri, Dec 19 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: Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs 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 February 26 and 27, 2004, from 8 a.m. to 5 p.m.

Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Shalini Jain, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 3018277001, email: jains@cder.fda.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), codes 3014512535 or 3014512534. Please call the

Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and

Fri, Dec 19 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: Advisory Committee on Special Studies Relating to the Possible LongTerm Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee).

General Function of the Committee: To advise the Secretary and the Assistant Secretary for Health concerning its oversight of the conduct of the Ranch Hand Study by the U.S. Air Force and provide scientific oversight of the Department of Veterans Affairs Army Chemical Corps Vietnam Veterans Health Study, and other studies in which the Secretary or the Assistant Secretary for Health believes involvement by the committee is desirable.

Date and Time: The meeting will be held on January 21, 2004, 8 a.m. to 3:30 p.m.

Location: Food and Drug Administration, 5630 Fishers Lane, rm. 1066, Rockville, MD 20857.

Contact Person: Leonard Schechtman, Nationa

Guidance for Industry and FDA Staff; Premarket Notification Submissions for Chemical Indicators; Availability

Fri, Dec 19 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Premarket Notification [510(k)] Submissions for Chemical Indicators.'' The document provides guidance for industry and other interested parties regarding the submission of chemical indicators such as process indicators, chemical integrators, and air removal indicators used in test packs.

Compliance Policy Guide Sec.110.300--``Registration of Food Facilities Under the Public Health Security and

Fri, Dec 19 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) Sec. 110.300 entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA's staff on enforcement of section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which require, beginning on December 12, 2003, registration with FDA for all domestic and foreign facilities that manufacture/ process, pack, or hold food for human or animal consumption in the United States.