Animal & Veterinary
Draft Guidance on Dispute Resolution Procedures Available
May 20, 2003
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM).'' This draft guidance document (Guidance Document #79) describes dispute resolution procedures by which sponsors, applicants, or manufacturers of FDA regulated products for animals may request review of science-based decisions. This draft guidance does not address procedures for handling issues associated with FDA's new initiative to enhance pharmaceutical good manufacturing practices.
Draft guidance #79 is posted on the FDA/Center for Veterinary Medicine Home Page. Single copies of the draft guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.
This Level 1 draft guidance is being issued consistent with FDA's Good Guidance Practices regulation. The draft guidance, when finalized, will represent the Agency's current thinking on dispute resolution and the procedures regarding requests for review of scientific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.
Written comments on the draft guidance may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted. Comments should be identified with the full title of the draft guidance and Docket Number 03D-0167. Written comments on the draft guidance may be submitted at any time; however, comments should be submitted by August 4, 2003, to ensure their adequate consideration in preparation of the final document. Written comments on the information collection requirements must be received by July 18, 2003.
Additional information about this draft guidance may be found in the May 19, 2003, Federal Register and from Dr. Marcia Larkins, Center for Veterinary Medicine (HFV-7), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 301-827-4535, e-mail: firstname.lastname@example.org.
CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM(PDF - 139KB) Dockets Management Notice: Draft Guidance for Industry on Dispute Resolution Procedures for Science-based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability