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Guidance for Industry on Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#79) entitled “Guidance for Industry: Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM).” This guidance document describes dispute resolution procedures by which sponsors, applicants, or manufacturers of FDA-regulated products for animals may request review of science-based decisions. This guidance does not address procedures for handling issues associated with FDA's new initiative to enhance pharmaceutical good manufacturing practices (GMPs).

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.

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.

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FOR FURTHER INFORMATION CONTACT:

Marcia Larkins, Center for Veterinary Medicine (HFV-7), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4535, e-mail: mlarkins@cvm.fda.gov.

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SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 19, 2003 (68 FR 27094), FDA published a notice of availability for a draft guidance for industry entitled “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM)” giving interested persons until August 4, 2003, to submit comments on the draft guidance and until July 18, 2003, to comment on the information collection. FDA considered all comments received and, where appropriate, made changes in the guidance.

II. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good guidance Start Printed Page 41407practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on dispute resolution and the procedures regarding requests for review of scientific controversies relating to decisions affecting animal drugs or other products regulated by CVM. The document does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations. If an applicant wants to discuss an alternative approach, the applicant should contact FDA staff responsible for implementing the guidance. If the applicant cannot identify appropriate FDA staff, the applicant should call the CVM Ombudsman at 301-827-4535.

III. Paperwork Reduction Act of 1995

FDA is announcing that a collection of information entitled “Final Guidance for Industry on Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. In the Federal Register of May 19, 2003 (68 FR 27094), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0566. The approval expires on June 30, 2008. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/​ohrms/​dockets.

IV. Comments

As with all 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 periodically will 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 document in the Federal Register.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. 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 the brackets in the heading of this document. A copy of the documents and received comments may be seen 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 “Guidance for Industry: Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM)” may be obtained on the Internet from the CVM home page at http://www.fda.gov/​cvm.

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Dated: July 12, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 05-14137 Filed 7-18-05; 8:45 am]

BILLING CODE 4160-01-S