[Federal Register Volume 63, Number 209 (Thursday, October 29, 1998)]
[Notices]
[Pages 58056-58058]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-28903]


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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