02-22408. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products; Draft Guidance for Industry on “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#147) entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing” (VICH GL31). This draft guidance has been developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this draft guidance is to establish the minimum recommendations for an internationally harmonized 90-day repeat-dose testing strategy for identifying target organ toxicity and the no-observed adverse effect level (NOAEL) for toxicity of veterinary drug residues in human food based upon repeated dose 90-day toxicity studies for identifying target organ toxicity.

DATES:

Submit written or electronic comments on the draft guidance by October 4, 2002 to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance document to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments on the draft guidance document to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 Comments should be identified with the full title of the draft guidance and the docket number found in brackets in the heading of this document.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 and industry associations 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 then reduce differences in technical requirements for drug development among regulatory agencies in different countries.

FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical recommendations 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 recommendations 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 U.S. FDA, the U.S. 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.

Two observers are eligible to participate in the VICH Steering Committee: One representative from the Government of Australia/New Zealand and one representative from the industry in Australia/New Zealand. 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. Draft Guidance on Toxicity Testing

The VICH Steering Committee held a meeting in April 2002, and agreed that the draft guidance document entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing” (VICH GL31) should be made available for public comment.

A variety of toxicological evaluations are performed to establish the safety of veterinary drug residues in human food. The objective of this draft guidance is to establish the minimum recommendations for an internationally harmonized 90-day repeat-dose testing strategy for identifying target organ toxicity and the NOAEL for toxicity of veterinary drug residues in human food based upon repeated dose 90-day toxicity studies for identifying target organ toxicity.

FDA and the VICH will consider comments about the draft guidance document. Ultimately, FDA intends to adopt the VICH Steering Committee's final guidance and publish it as a final guidance.

III. Significance of Guidance

This draft 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.”

The draft guidance represents the agency's current thinking on establishing the safety of veterinary drug residues in human food in a variety of toxicological evaluations. This guidance does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative method may be used as long as it satisfies the requirements of applicable statutes and regulations.

IV. Comments

This draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit written or electronic comments regarding this draft guidance document. Written or electronic comments should be submitted to the Dockets Management Branch (address above). Submit written or electronic comments to ensure adequate consideration in preparation of the final guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

Electronic comments may be submitted on the Internet at http://www.fda.gov/​dockets/​ecomments. Once on this Internet site, select “[insert docket number] “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing” (VICH GL31) and follow the directions.

Copies of the draft guidance entitled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing” (VICH GL31) may be obtained on the Internet from the CVM home page at http://www.fda.gov/​cvm.

Dated: August 27, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.