[Federal Register: November 8, 2002 (Volume 67, Number 217)]

[Notices]               

[Page 68142]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr08no02-97]                         



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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: mmartine@cvm.fda.gov.



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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