[Federal Register: October 29, 1998 (Volume 63, Number 209)]
[Notices]
[Page 58056-58058]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc98-91]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0217]


Proposals to Increase the Legal Availability of Animal Drugs for
Minor Species and Minor Uses; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a report entitled ``Proposals to Increase the Legal
Availability of Animal Drugs for Minor

[[Page 58057]]

Species and Minor Uses.'' The report contains proposals for
legislative, regulatory, and policy changes to the approval process for
new animal drugs intended for use in minor species and for minor uses
in major species (minor use drugs). This report is the agency's
response to the requirement of the Animal Drug Availability Act of 1996
(the ADAA ) that the Secretary of Health and Human Services (the
Secretary) consider and announce proposals to facilitate approvals for
minor use drugs. Implementation of these proposals should result in an
increase in the number of approved new animal drugs for use in minor
species and for minor uses.

DATES: Written comments may be provided at any time.

ADDRESSES: Submit written comments on the report to Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.

    FDA will also accept e-mail comments. They should be labeled as
comments, be identified with the docket number found in brackets in the
heading of this document, and be addressed to
``jbutlerl@bangate.fda.gov''. The agency will make paper copies of the
comments and will place them in the public docket along with the
comments submitted in writing.
    Submit written requests for single copies of ``Proposals to
Increase the Legal Availability of Animal Drugs for Minor Species and
Minor Uses'' to the Communications Staff (HFV-12), Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855. Enclose one self-addressed adhesive label to
assist that office in processing your requests. Copies of this report
are also posted on the Center for Veterinary Medicine (CVM) Internet
home page at ``http://www.fda.gov/cvm''.
FOR FURTHER INFORMATION CONTACT:
    For questions about section 2(f) of the ADAA: George A. (Bert)
Mitchell, Center for Veterinary Medicine (HFV-6), Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5587,
FAX 301-594-1807, e-mail ``gmitchel@bangate.fda.gov'', or
    For further information about the changes proposed in the report to
the approval process: Linda Wilmot, Center for Veterinary Medicine
(HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 301-594-0614, FAX 301-594-2297, e-mail
``lwilmot@bangate.fda.gov''.

SUPPLEMENTARY INFORMATION:

I. Background.

    On October 9, 1996, the President signed the ADAA (Pub. L. 104-250)
into law. Enactment of the ADAA reflected Congress' concerns about the
lack of availability of approved new animal drugs. Among other things,
the legislation recognized particular problems relating to the
availability of approved new animal drugs for minor uses in major
species and for use in minor species (minor use drugs).
    Section 2(f) of the ADAA directs the Secretary to consider
legislative and regulatory options for facilitating approval under
section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 360b) of new animal drugs intended for use in minor species or
for minor uses. The ADAA statute further requires the Secretary to
announce within 18 months after the date of enactment proposals for
legislative or regulatory change to the approval process for new animal
drugs intended for use in minor species or for minor uses. Publication
of the notice announcing the availability of ``Proposals to Increase
the Legal Availability of Animal Drugs for Minor Species and Minor
Uses, ADAA Minor Use/Minor Species Working Group'' fulfills that
statutory obligation.
    The authority of the Secretary regarding new animal drug approvals
is delegated to the Commissioner of Food and Drugs by 21 CFR 5.10, and
that authority is redelegated to the Director and Deputy Director of
CVM in 21 CFR 5.83. In order to respond to the ADAA mandate, CVM
established a working group of scientific, legal, and policy experts in
animal drug approval and minor species issues to explore possible
solutions to the problem and to draft a report with proposals. The
working group, recognizing that public input was critical to the
development of proposals that would most broadly and effectively
facilitate approvals, solicited comments from the public through a
Federal Register document entitled ``Request for Comments on
Development of Options to Encourage Animal Drug Approvals for Minor
Species and Minor Uses'' (62 FR 33781, June 23, 1997).
    In addition, on December 19, 1997, CVM posted on its Internet home
page a discussion draft entitled ``Proposals to Increase the Legal
Availability of Animal Drugs for Minor Species and Minor Uses.'' The
discussion draft, which was identified as a ``working document,''
included discussions of several options for possible change. CVM
encouraged the public to comment on the concepts in the working
document and to express any related concerns, and asked for comments on
a number of specific questions that focused on particular issues.
    CVM received 110 comments in response to the two documents. Among
those commenting were minor-species producer groups, exotic-animal
(e.g., guinea pigs, ornamental fish) breeders, pharmaceutical
companies, veterinarians, zoological organizations, the American
Veterinary Medical Association, trade associations, pet shop owners,
university faculty, and members of other Federal and State regulatory
agencies. The comments were extensive, indicating a high level of
interest in the draft proposals. All the comments were reviewed and
many have been incorporated into the recommendations. The comments are
on file in Docket No. 97N-0217 and may be viewed in the Dockets
Management Branch (address above) and on FDA's home page at ``http://
www.fda.gov''.

II. The Report

    While the proposals in this report represent FDA's best thinking
for facilitating the approval of animal drugs for minor uses and for
use in minor species, the report is not intended to represent formal
administration position in support of any of the proposals. FDA hopes
that the announcement of these proposals will engender further debate
on these issues and stimulate the interest of drug sponsors,
manufacturers, and individuals who care for and raise animals.
    The report describes a range of legislative and regulatory
proposals intended to facilitate minor use and minor species drug
approvals and to otherwise increase the legal availability of drugs for
minor uses and minor species. The proposals are as follows:
    1. Creation by Statute of a ``Minor Use Animal Drug'' Program
    2. Enhancement of Existing Programs for Data Development
    3. Conditional Drug Approval for Minor Uses With No Human Food
Safety Concern
    4. An Alternate Process to Provide for Legal Marketing of New
Animal Drugs for Minor Species With No Human Food Safety Concern
    5. Other Legislative Options
    6. Other Changes in Regulation or Policy
    FDA has presented a broad array of options in response to the
congressional charge to propose changes that would facilitate the
approval of new animal drugs for minor species or minor uses. It is the
agency's perception that neither the current animal drug approval
process nor any other single approval process can adequately address
the

[[Page 58058]]

enormous diversity of minor species for which animal drugs are needed.
Each proposal has merit with respect to certain minor species or minor
uses.
    Many of the proposals require legislative change. Congress
recognized the possibility that statutory changes might be needed in
its charge at Section 2(f) of the ADAA. On close examination, the
existing statutes simply fail to provide adequate options for FDA and
sponsors to fully serve the minor species and minor use needs of the
literally hundreds of animal species that people care for. To achieve
the goal of increasing the availability of safe and effective drugs for
minor species and minor uses, FDA concludes that Federal statutes must
be amended.
    FDA is willing to work with Congress and other concerned parties to
further characterize any proposed statutory changes and to assist as
requested and as appropriate in their enactment. If the act is amended
as a result of these proposals, the agency will focus its efforts on
issuing any necessary regulations through notice and comment rulemaking
or otherwise implementing the statutory changes as directed. Increasing
the availability of drugs for minor species and minor uses increases
protection of public and animal health and is a significant issue for
FDA.

III. Comments

    Interested persons, may at any time, submit written comments to the
Dockets Management Branch (address above) regarding this report. Two
copies of any comments are to be submitted, except individuals may
submit one copy. Comments should be identified with the docket number
found in brackets in the heading of this document. A copy of the
document and received comments are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.

    Dated: September 16, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-28903 Filed 10-28-98; 8:45 am]
BILLING CODE 4160-01-F