[Federal Register Volume 65, Number 76 (Wednesday, April 19, 2000)]
[Notices]
[Pages 20997-20998]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-9713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0790]


Draft Guidance for Industry: The Use of Published Literature in 
Support of New Animal Drug Approval; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of a draft guidance for industry entitled 
``The Use of Published Literature in Support of New Animal Drug 
Approval.'' The draft guidance is intended to fulfill the section of 
the FDA Modernization Act of 1997 (FDAMA) that requires the agency to 
issue guidance to clarify the circumstances in which published matter 
may be the basis for approval of a supplemental application. The draft 
guidance also clarifies the circumstances in which published

[[Page 20998]]

literature may be the basis for approval of an original application. 
The draft guidance is intended to provide specific advice on when FDA 
may be able to rely on published literature, with or without the 
submission of underlying data, to support new animal drug approval.

DATES: Submit written comments on the draft guidance for industry by 
July 18, 2000.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests. Submit written comments on this draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Copies of the draft guidance may be obtained on the Internet at http://
www.fda.gov/cvm/fda/TOCs/guideline.html.

FOR FURTHER INFORMATION CONTACT: Gail L. Schmerfeld, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20850, 301-594-1620, e-mail: 
gschmer1@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 403(b) of FDAMA (Public Law 105-115) requires FDA to issue 
guidances to clarify the requirements for, and facilitate the 
submission of data to support, the approval of supplemental 
applications for articles approved under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public 
Health Service Act (42 U.S.C. 262). This provision includes a 
requirement that FDA publish guidance to clarify circumstances in which 
published matter may be the basis for approval of a supplemental 
application.
    This draft guidance for industry clarifies the circumstances in 
which published literature may be the basis for approval of both 
original and supplemental new animal drug applications. Specifically, 
the draft guidance describes the circumstances under which FDA could 
rely on published literature without access to the underlying data and 
the circumstances under which the applicant should provide additional 
information about a published study.

II. Significance of Guidance

    This draft guidance represents the agency's current thinking with 
regard to the use of published literature in support of new animal drug 
approval. It does not create or confer any rights for or on any person 
and does 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. The agency has developed this 
draft guidance in accordance with the agency's good guidance practices 
(62 FR 8961, February 27, 1997), which set forth the policies and 
procedures for the development, issuance, and use of guidance 
documents.

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance by July 18, 
2000. Two copies of any comments are to be submitted, except 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the draft guidance 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: April 10, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-9713 Filed 4-18-00; 8:45 am]
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