[Federal Register Volume 62, Number 188 (Monday, September 29, 1997)]
[Notices]
[Pages 50952-50953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25667]


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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Draft Guidance Document; Availability; Request for Comments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.

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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DATES: Submit written comments on the draft guidance document by 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of the draft guidance document and the docket number found in brackets 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    Submit written requests for single copies of the draft guidance 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: 
[email protected].

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    FDA's draft guidance document entitled ``FDA Approval of Animal 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 (http://www.cvm.fda.gov) 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