[Federal Register Volume 65, Number 216 (Tuesday, November 7, 2000)]
[Notices]
[Page 66758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28448]



[[Page 66758]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0790]


Final 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 of a final guidance for industry (#106) entitled ``The Use 
of Published Literature in Support of New Animal Drug Approval.'' The 
final 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 final 
guidance also clarifies the circumstances in which published literature 
may be the basis for approval of an original application. The final 
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 approvals.

DATES: Submit written comments at any time.

ADDRESSES: Submit written requests for single copies of the final 
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 final 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Copies of the final 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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 19, 2000 (65 FR 20997), FDA 
published the draft guidance entitled ``The Use of Published Literature 
in Support of New Animal Drug Approval'' giving interested persons 
until July 18, 2000, to submit comments. No comments were received.
    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 final 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 final 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 final 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 method 
may be used as long as it satisfies the requirements of the applicable 
statutes and regulations. The agency has developed this final guidance 
in accordance with the agency's good guidance practices published in 
the Federal Register of September 19, 2000 (65 FR 56468), which set 
forth the policies and procedures for the development, issuance, and 
use of guidance documents.

III. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
this guidance. FDA will periodically review the comments in the docket 
and, where appropriate, will amend the guidance. The public will be 
notified of any such amendments through a notice in the Federal 
Register.

    Dated: October 30, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-28448 Filed 11-6-00; 8:45 am]
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