[Federal Register Volume 73, Number 242 (Tuesday, December 16, 2008)]
[Notices]
[Pages 76363-76364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29691]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0614]


Draft Guidance for Industry on Changes to Approved New Animal 
Drug Applications--New Animal Drug Applications Versus Category II 
Supplemental New Animal Drug Applications; 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availability of a draft guidance for industry 191 entitled 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

[[Page 76364]]

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:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by February 17, 2009.

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    Submit written comments on the draft guidance to the Division of 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section for electronic access to the draft guidance document.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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
191 entitled ``Changes to Approved NADAs--New NADAs vs. 
Category II Supplemental NADAs''. In the past, applications for changes 
to approved new animal drugs may have been handled inconsistently by 
sponsors and the agency. Inconsistency in handling such applications 
has been confusing for sponsors and for CVM, particularly when 
reviewing and referencing the history of specific new animal drug 
applications (NADAs). This guidance is intended to improve consistency 
in the way applications for changes are handled. We believe that 
consistent handling of these types of applications also will help 
maintain clarity in the administrative record, which is an important 
part of protecting the public health.
    When proposing a change to an approved new animal drug that may 
affect the safety and/or effectiveness of the drug, such changes 
generally must be submitted to FDA either as a new NADA or a 
supplemental application to the original NADA. Category II supplemental 
NADAs are the type of supplement that is used to propose changes that 
may require a reevaluation of certain safety or effectiveness data in 
the parent application. Specific changes meeting the requirements for a 
Category II supplemental NADA are described in 21 CFR 514.106(b)(2). 
This guidance provides examples and makes specific recommendations 
about when a change to an approved NADA that requires FDA to review 
safety and/or effectiveness data should be submitted as a new NADA and 
when such a change should be submitted as a Category II supplemental 
NADA. In addition, the guidance addresses how to handle submissions 
relating to certain types of proposed changes at the investigational 
stage.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the agency's current thinking on this 
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 draft 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.

IV. Comments

    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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

V. Electronic Access

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

    Dated: Decmeber 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29691 Filed 12-15-08; 8:45 am]
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