04-3557. Guidance for Industry: Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora; 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 (#52) entitled “Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora.” This guidance is a revision of the guidance document #52 entitled “Microbiological Testing of Antimicrobial Drug Residues in Food,” which was implemented in 1996. In this guidance, the agency recommends a pathway approach for assessing the microbiological safety of antimicrobial drug residues in food, rather than the approach described in the 1996 version of the guidance. The agency's decision to revise this guidance is based on new information available to the agency.

DATES:

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

ADDRESSES:

Submit written comments on this 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 guidance document.

Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

Haydee Fernandez, Center for Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6981, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 27, 2001 (66 FR 66910), FDA published a notice of availability for a draft guidance document entitled “Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora.” The agency gave interested persons until March 27, 2002, to comment on the draft guidance. FDA received several comments that were considered in the preparation of this guidance document. This guidance replaces former guidance #52 entitled “Microbiological Testing of Antimicrobial Drug Residues in Food.” A document entitled “History and Scientific Issues Related to Guidance #52” provides the scientific rationale for the revisions made (Docket No. 93D-0398).

CVM is aware that the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is currently drafting a related guideline and that this guidance may be superceded at a future date by the guideline published by VICH.

II. Paperwork Reduction Act of 1995

FDA is announcing that a collection of information entitled “Guidance for Industry: Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. In the Federal Register of March 4, 2003 (68 FR 10253), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. According to the Paperwork Reduction Act of 1995, a collection of information should display a valid OMB control number. The valid OMB control number for this information collection is 0910-0521. It expires on January 31, 2007. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/​ohrms/​dockets.

III. Significance of Guidance

This level 1 guidance document is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance document 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 as long as it satisfies the requirements of applicable statutes and regulations.

IV. Comments

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

V. Electronic Access

Persons with access to the Internet may obtain a copy of the guidance document entitled “Guidance for Industry: Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora” from FDA's CVM home page at http://www.fda.gov/​cvm.

Dated: October 6, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.