04-8075. Guidance for Industry: Use of Unapproved Hormone Implants in Veal Calves; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#172) entitled “Use of Unapproved Hormone Implants in Veal Calves.” This guidance outlines special measures to ensure the safety of veal in response to the identified illegal use of unapproved hormone implants in veal calves.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for electronic access to the document.

Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

Gloria J. Dunnavan, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-1168, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good guidance practices (GGPs) regulation in § 10.115 (21 CFR 10.115). It is being implemented immediately without prior public comment, under § 10.115(g)(2), because of the agency's urgent need to provide guidance concerning veal that has been implanted with unapproved hormones. However, under GGPs, FDA requests comments on the guidance and will revise the document, if appropriate. Comments will be considered by the agency in the development of future policy.

This guidance represents the agency's current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Copies of this guidance document may be obtained from the CVM home page (http://www.fda.gov/​cvm) and from the Division of Dockets Management Web site (http://www.fda.gov/​ohrms/​dockets/​default.htm).

Dated: April 5, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.