[Federal Register Volume 75, Number 51 (Wednesday, March 17, 2010)]
[Notices]
[Pages 12759-12760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5747]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0497]


Agency Information Collection Activities; Submission for Office 
and Management and Budget Review; Comment Request; Abbreviated New 
Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
16, 2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Abbreviated New Animal Drug Application.'' Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
P150-400B, Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Abbreviated New Animal Drug Applications--FD&C Act/Section 512(n)(1)--
(OMB Control Number 0910-NEW)

    On November 16, 1988, the President signed into law the Generic 
Animal Drug and Patent Restoration Act (GADPTRA) (Public Law 100-670). 
Under Section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(the act), as amended by GADPTRA, any person may file an abbreviated 
new animal drug application (ANADA) seeking approval of a generic copy 
of an approved new animal drug. The information required to be 
submitted as part of an abbreviated application is described in section 
512(n)(1) of the act. Among other things, an abbreviated application is 
required to contain information to show that the proposed generic drug 
is bioequivalent to, and has the same labeling as, the approved drug 
referenced in the abbreviated application. FDA allows applicants to 
submit a complete ANADA or to submit information in support of an ANADA 
for phased review followed by the submission of an administrative ANADA 
when FDA finds that all the applicable technical sections for an ANADA 
are complete. FDA requests that an applicant accompany ANADAs and 
requests for phased review of data to support ANADAs with the Form FDA 
356v to ensure efficient and accurate processing of information to 
support approval of the generic new animal drug.
    In the Federal Register of November 2, 2009 (74 FR 56643), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 12760]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                           Annual
          Section 512(n)(1) of the FD&C Act              FDA Form         No. of        Frequency per    Total Annual       Hours per       Total Hours
                                                                        Respondents       Response         Responses        Response
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ANADA                                                           356v              17                 1              17             159              2703
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Phased Review With Administrative ANADA                         356v               5                 5              25              31.8             795
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Total                                                                                                                                               3498
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    ANADA Paperwork Burden (Section 512(n)(1) of the Act) (21 U.S.C. 
360b(b)(2)): Over the past 5 fiscal years, from October 2003 through 
September 2008, FDA has received an average of 22 ANADAs per year. FDA 
estimates that preparing the paperwork required under section 512(n)(1) 
of the act to be contained in an ANADA, whether all of the information 
is submitted with the ANADA or the applicant submits information for 
phased review followed by an Administrative ANADA that references that 
information, will take approximately 159 hours. FDA is estimating that 
each ANADA that uses the phased review process will have approximately 
5 phased reviews per application. Therefore, assuming that 5 
respondents will take advantage of the phased review option per year 
and an average of 5 phased reviews are submitted per application, times 
31.8 hours per phased review, equals 795 total hours per year or 159 
hours per application.
    FDA believes that with time, more sponsors will take advantage of 
the phased review option, as it provides greater flexibility. 
Eventually, phased review will increase to the point of being the 
majority of ANADAs submitted during the course of the year. FDA also 
estimates that it takes sponsors of ANADAs approximately 25 percent 
less time to put together the information to support an ANADA than an 
NADA because they only need to provide evidence of bioequivalence and 
not the data required in an NADA to support a full demonstration of 
safety and effectiveness.
    Form FDA 356v: FDA requests that an applicant fill out and send in 
with an ANADA and requests for phased review of data to support an 
ANADAs, a Form FDA 356v to ensure efficient and accurate processing of 
information to support the approval of a generic new animal drug.
    This document also refers to previously approved collections of 
information found in FDA regulations. The collections of information 
under 21 CFR 514.80, which describes records and reports that are 
required post approval, have been approved under OMB control no. 0910-
0284.

    Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5747 Filed 3-16-10; 8:45 am]
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