[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Draft Guidance Document; Availability; Request for Comments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DATES: Submit written comments on the draft guidance document by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of the draft guidance document and the docket number found in brackets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Submit written requests for single copies of the draft guidance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FDA's draft guidance document entitled ``FDA Approval of Animal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]
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