04-6287. International Cooperation on Harmonization of Technical Requirements for Approval of Veterinary Medicinal Products; Guidance for Industry on “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#148) entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing” (VICH GL32). This guidance has been developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This guidance document provides harmonized guidance on the core recommendation for a developmental toxicity study for the safety evaluation of veterinary drug residues in human food.

DATES:

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

ADDRESSES:

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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit written comments at any time 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 are to be identified with the full title of the guidance and the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Louis T. Mulligan, Center for Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6984, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important initiatives have been undertaken by regulatory authorities, industry associations, and individual sponsors to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and reduce the differences in technical requirements for drug development among regulatory agencies in different countries.

FDA has actively participated in the International Conference on Harmonization of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.

The VICH steering committee is composed of member representatives from the European Commission; European Medicines Evaluation Agency; European Federation of Animal Health; Committee on Veterinary Medicinal Products; the United States' FDA; the United States' Department of Agriculture; the Animal Health Institute; the Japanese Veterinary Pharmaceutical Association; the Japanese Association of Veterinary Biologics; and the Japanese Ministry of Agriculture, Forestry, and Fisheries.

Four observers are eligible to participate in the VICH steering committee: One representative from the Government of Australia/New Zealand, one representative from industry in Australia/New Zealand, one representative from the Government of Canada, and one representative from industry in Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the Confédération Mondiale de L'Industrie de la Santé Animale (COMISA). A COMISA representative also participates in the VICH steering committee meetings.

II. Guidance on Toxicity Testing

In the Federal Register of September 4, 2002 (67 FR 56572), FDA published the notice of availability of the VICH draft guidance, giving interested persons until October 4, 2002, to submit comments. After consideration of comments received, the final draft guidance was changed in response to the comments and submitted to the VICH Steering Committee. At a meeting held on October 10 and 11, 2002, the VICH Steering Committee endorsed the guidance for industry, VICH GL32.

This document provides guidance for developmental toxicity testing for those veterinary medicinal products used in food-producing animals. The objective of this guidance is to recommend that developmental toxicity assessment be performed according to an internationally harmonized guidance. This guidance describes recommended testing designed to provide information concerning the effects on the pregnant animal and on the developing organism following prenatal exposure.

III. Significance of Guidance

This document, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” Because guidance documents are not binding unless specifically supported by statute or regulation, mandatory words such as “must,” “shall,” and “will” in the original VICH documents have been substituted with “should” or “recommended.”

This guidance document represents the agency's current thinking on developmental toxicity testing for those veterinary medicinal products used in food-producing animals. This guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative method as long as it satisfies the requirements of the applicable statutes and regulations.

IV. Comments

As with all of FDA's guidances, the public is encouraged to submit written or electronic comments pertinent to this guidance. FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance. The agency will notify the public of any such amendments through a notice in the Federal Register.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this guidance document. Two paper copies of any comments are to be submitted, except individuals may submit one paper copy. Comments should be identified with the docket number found in the brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

Copies of the guidance document entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing” (VICH GL32) may be obtained on the Internet from FDA's Center for Veterinary Medicine home page at http://www.fda.gov/​cvm.

Dated: March 12, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.