[Federal Register: September 29, 1997 (Volume 62, Number 188)] [Notices] [Page 50952-50953] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr29se97-61] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D-0389] FDA Approval of Animal Drugs for Minor Uses and Minor Species; Draft Guidance Document; Availability; Request for Comments AGENCY: Food and Drug Administration, HHS. [[Page 50953]] ACTION: Notice of availability; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability for comment on a draft Level 1 guidance document entitled ``FDA Approval of Animal Drugs for Minor Uses and for Minor Species.'' The guidance document defines minor species and minor uses and sets forth suggestions for generating safety and effectiveness data to support the approval of minor use and minor species drugs. The draft Level 1 guidance document sets forth substantive changes in policy that warrant input from affected parties. DATES: Submit written comments on the draft guidance document by December 29, 1997. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm 1-23, Rockville, MD 20857. Comments should be identified with the full title of the draft guidance document and the docket number found in brackets in the heading of this document. Submit written requests for single copies of the draft guidance document to the Communications and Education Team (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send two self-addressed adhesive labels to assist that office in processing your requests. FOR FURTHER INFORMATION CONTACT: Margaret R. Oeller, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1650. E-mail: moeller@bangate.fda.gov. SUPPLEMENTARY INFORMATION: I. Background FDA's draft guidance document entitled ``FDA Approval of Animal Drugs for Minor Uses and for Minor Species,'' is a Level 1 guidance document by definition in the Good Guidance Practices (62 FR 8961, February 27, 1997). This notice of availability for comment should not be confused with the Federal Register document of June 23, l997 (62 FR 33781), entitled ``Request for Comments on Development of Options to Encourage Animal Drug Approvals for Minor Species and for Minor Uses,'' which dealt with the same subject matter but was issued to seek comment and suggestions on legislative and regulatory options which could be utilized if adopted in the future to facilitate approval of new animal drugs for minor uses and minor species. This draft, when finalized, will replace the previous guidance entitled ``Guidelines for the Preparation of Data to Satisfy the Requirements of Section 512 of the Act Regarding Minor Use of Animal Drugs,'' (guidelines) dated April 1986. In the Federal Register of May 30, l986 (51 FR 19612), FDA issued a notice of availability of the guidelines. No comments were received on the guidelines. A previous version of the draft guidance document was made available in November 1996 to interested parties who requested a copy. The draft guidance document suggests procedures that could be used to demonstrate the safety and efficacy of a minor use animal drug. Minor use animal drugs are defined as: (1) New animal drugs used in minor animal species or (2) new animal drugs used in any animal species for the control of a disease that occurs infrequently or in limited geographic areas. ``Minor species'' are defined by regulation as animals other than cattle, horses, swine, chickens, turkeys, dogs, and cats. According to current regulations, sheep are a minor species except with respect to human food safety data collection requirements, for which sheep are considered a major species. FDA intends to issue a proposed regulation in which sheep would be considered a minor species for all requirements of the drug approval process. The procedures set forth in the draft guidance document for demonstrating the safety and efficacy of a minor use animal drug apply to production drugs as well as therapeutic drugs. The draft guidance document has been organized in two parts. Part 1 includes general information on the document, an overview of the approval process, data extrapolation, advice on working with the Center for Veterinary Medicine (CVM), and definitions. Part 2 presents specific options for satisfying data requirements for minor uses in major species, minor avian species (gamebirds, semi-domestic waterfowl, and ratites), minor ruminants (goats, bison, semi-domestic deer), rabbits, and aquatic species (finfish, aquatic invertebrates, alligators, etc.). Each section in part 2 contains information on efficacy, target animal safety, human food safety, and environmental data requirements. The major data components, excluding manufacturing chemistry, of the animal drug approval process are represented in part 2. When finalized, the draft guidance document will represent the agency's current thinking on the means of generating efficacy and safety data to support approval of new animal drug applications for minor use of new animal drugs. This draft guidance document will 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 statute, regulations, or both. II. Request for Comments Interested persons may, on or before December 29, 1997, submit to the Dockets Management Branch (address above) written comments on the draft guidance document. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document, and with the full title of the guidance document. The comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. After review of these comments, FDA will implement the guidance document with any appropriate changes. Thereafter, interested persons may submit written comment on the guidance document directly to the CVM Communications and Education Team (address above). III. Electronic Access A copy of the draft guidance document may be obtained from the CVM Home Page on the Internet. Dated: September 17, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-25667 Filed 9-26-97; 8:45 am] BILLING CODE 4160-01-F