Notice:  Guidance for Industry on Changes to Approved New Animal Drug 
Applications--New Animal Drug Applications Versus Category II 
Supplemental New Animal Drug Applications; Availability

Federal Register: November 20, 2009 (Volume 74, Number 223)              
                  Page 60277

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry 191 entitled ``Changes 
to Approved NADAs--New NADAs vs. Category II Supplemental NADAs.'' This 
guidance is intended to assist sponsors who wish to apply for approval 
of changes to approved new animal drugs that require FDA to reevaluate 
safety and/or effectiveness data. The goal of this guidance is to 
create greater consistency in how such applications are handled by 
sponsors and by FDA's Center for Veterinary Medicine (CVM).

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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 guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail: 
suzanne.sechen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
191 entitled ``Changes to Approved NADAs--New NADAs vs. 
Category II Supplemental NADAs.'' This guidance is intended to assist 
sponsors who wish to apply for approval of changes to approved new 
animal drugs that require FDA to reevaluate safety and/or effectiveness 
data. The guidance explains how the Office of New Animal Drug 
Evaluation (ONADE) categorizes possible changes to approved new animal 
drugs that require reevaluation of safety and/or effectiveness data and 
explains which administrative vehicle--a new original new animal drug 
application (NADA) (new NADA) or a Category II supplemental application 
to the original new animal drug application (Category II supplemental 
NADA)--a sponsor should use when applying for approval of these 
changes. The goal of this guidance is to create greater consistency in 
how such applications are handled by sponsors and by ONADE.
    In the Federal Register of December 16, 2008 (73 FR 76363), FDA 
published the notice of availability for a draft guidance entitled 
``Changes to Approved NADAs--New NADAs vs. Category II Supplemental 
NADAs,'' which gave interested persons until February 17, 2009, to 
comment on the draft guidance. FDA received a few comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. In addition to some of the changes based on the comments 
received, CVM made a few minor changes to the guidance to add clarity 
and accuracy. The guidance announced in this notice finalizes the draft 
guidance dated December 16, 2008.

II. Significance of Guidance

    This 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 topic. 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.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information have been approved under OMB control no. 
0910-0032 (expiration date April 30, 2010).

IV. Comments

    Submit written requests for single copies of the 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/AnimalVeterinary/default.htm or http://
www.regulations.gov.

    Dated: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27926 Filed 11-19-09; 8:45 am]

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