July 19, 2005
CVM Dispute Resolution Final Guidance Available
The Food and Drug Administration (FDA) is announcing the availability of a Guidance For Industry (#79) entitled “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).
Guidance for Industry #79 is posted on the CVM Home Page. Single paper copies of the guidance document may be obtained from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request.
Written comments on the guidance may be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA. Comments may be submitted at any time, and they should be identified with the full title of the guidance and Docket No. 03D-0167.
This Level 1 guidance is being issued consistent with FDA’s Good Guidance Practices regulation. 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, they should contact the FDA staff responsible for implementing the guidance. If the applicant cannot identify the appropriate FDA staff, they should call the CVM Ombudsman on 40-276-9015.
Additional information about the guidance document may be found in the July 19, 2005, Federal Register and from Dr. Marcia Larkins, Center for Veterinary Medicine (HFV-7), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9015, e-mail: mlarkins@cvm.fda.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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