[Federal Register Volume 67, Number 217 (Friday, November 8, 2002)]
[Notices]
[Page 68142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-2912]


Final Guidance for Industry on the Development of Supplemental 
Applications for Approved New Animal Drugs; 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 ([numsign]82) entitled 
``Guidance for Industry: Development of Supplemental Applications for 
Approved New Animal Drugs.'' This guidance explains how and when drug 
sponsors may use data collected for original new animal drug 
applications (NADAs) to support the technical sections of a 
supplemental NADA. The guidance also explains when the Center may, 
under existing statutes or regulations, require the submission of new 
data. Finally, the guidance delineates the instances in which a sponsor 
will generally need to file a new NADA rather than a supplemental 
application.

DATES: Submit written or electronic comments on agency guidances 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, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests. Submit written comments on the final 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
final guidance document.

FOR FURTHER INFORMATION CONTACT: Marilyn N. Martinez, Office of New 
Animal Drug Evaluation (HFV-130), Center for Veterinary Medicine, Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
827-7577, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the Food and Drug Administration 
Modernization Act (FDAMA) (Public Law 105-115) was signed into law. 
Section 403 of FDAMA requires FDA to provide information regarding 
approval of supplemental applications for approved products.
    Section 403(b)(2) of FDAMA requires that FDA issue guidance on 
specific data requirements for supplemental NADAs in order to prevent 
duplication of previously submitted data. In the Federal Register of 
February 8, 2000 (65 FR 6214), FDA announced the availability of a 
draft guidance for industry entitled ``Guidance for Industry: 
Development of Supplemental Applications for Approved New Animal 
Drugs.'' The draft guidance illustrated the various types of 
supplemental applications and their dependence on new data. This draft 
guidance explained how and when drug sponsors could use data accepted 
in support of an original application to support supplemental 
applications. The draft guidance also explained when a sponsor should 
submit a new NADA rather than a supplemental NADA. The agency received 
no comments on the draft guidance. The content of the final guidance is 
the same as the draft.
    ``Guidance for Industry: Development of Supplemental Applications 
for Approved New Animal Drugs'' demonstrates the agency's dedication to 
assisting the sponsor in creating a project development strategy and to 
fostering a discussion between the sponsor and the agency. With this in 
mind, the guidance is organized in a user-friendly format with two 
distinctive sections. The first section separates supplemental 
applications into two categories: Category I includes applications that 
do not ordinarily require additional data and category II includes 
applications that may require additional data. The guidance then lists 
the 14 types of supplemental applications in each category as well as 
the instances in which a sponsor generally will need to file a new NADA 
rather than a supplemental NADA.
    The second section is dedicated to clarification of category II 
supplemental applications and the data to meet the technical section 
requirements. The data CVM would recommend be submitted for each 
category II supplement are provided in tables. The tables indicate if: 
(1) New data will generally be needed, (2) existing data included in a 
previously approved application will generally suffice, or (3) the 
nature of the supplemental application will dictate whether or not new 
data are generally needed. A comment section follows each table 
providing explanations and suggestions to the sponsor. The guidance 
also cross-references several FDA documents relating to the processing 
of supplemental applications, providing further assistance to the 
sponsor.
    This final level 1 guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The guidance 
represents the agency's current thinking on the development of 
supplemental applications for approved new animal drugs. 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 statutes and 
regulations.

II. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments pertinent to this guidance. FDA will 
periodically review the comments in the docket and, where appropriate, 
will amend the guidance. The agency will notify the public of any such 
amendments through a notice in the Federal Register.
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on this final guidance at any 
time. 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. The 
final 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cvm.

    Dated: October 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28472 Filed 11-7-02; 8:45 am]
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