October 30, 2006
FDA/CVM Draft Guidance on “Blue Bird” Medicated Feed Labels Available for Comment
In the October 30, 2006, Federal Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-18148.htm ), the Food and Drug Administration (FDA) announced the availability of draft guidance for industry #181 entitled, “Draft Guidance for Industry: Blue Bird Medicated Feed Labels.” This draft guidance is intended to provide new animal drug application (NADA) sponsors with FDA/Center for Veterinary Medicine’s (CVM’s) current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds. This draft guidance provides recommendations on the content and format of representative labeling, also known as “Blue Bird” labeling, for type B and Type C medicated feeds only.
Under the regulations, a sponsor of a Type A medicated article is required to include in its NADA, among other things, a representative labeling proposed to be used for Type B and Type C medicated feeds containing the new animal drug. A Type A medicated article is defined in the regulations as “intended solely for the manufacture of other Type A medicated articles or medicated feeds (Type B or Type C).” A Type B medicated feed is defined in the regulations as intended solely for the manufacture of other medicated feeds (Type B or C). And, Type C medicated feed is defined in the regulations as “intended as the complete feed for the animal or may be fed “top dressed” (added on top of the usual ration) on or offered ‘free-choice’ … in conjunction with other animal feed.”
This draft guidance is posted on the CVM home page at: http://www.fda.gov/cvm/Guidance/guide181.htm . Single copies of the draft guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855. 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This Level 1 draft guidance is being issued consistent with FDA's good guidance practices regulations (GGPs). The draft guidance, when finalized, will represent the Agency's current thinking on this topic. It does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Written comments on the guidance document may be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.fda.gov/dockets/ecomments. Comments should be submitted by January 16, 2007, to ensure their adequate consideration in preparation of the final document. General comments on Agency guidance documents are welcome at any time. All comments should be identified with the full title of the guidance document and Docket number 2006D-0413.
Additional information is available from Dr. Dragan Momcilovic, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6856, e-mail: Dragan.Momcilovic@FDA.HHS.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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