[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52772-52773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20712]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0450]


Agency Information Collection Activities; Submission for Office 
of 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 
September 25, 2013.

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 emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0669 and 
title ``Abbreviated New Animal Drug Applications.'' Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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--Section 512(b)(2) and (n)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and 
(n)(1)) (OMB Control Number 0910-0669)--Extension

    On November 16, 1988, the President signed into law the Generic 
Animal Drug and Patent Restoration Act (GADPTRA) (Pub. L. 100-670). 
Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C 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 FD&C 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 April 30, 2013 (78 FR 25279), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received; however the 
comment was not responsive to any of the four topics solicited by the 
notice. Therefore, FDA does not address the comment here.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--ANADAs: Estimated Annual Reporting Burden
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                                                                                            Number of
              FD&C act section 512 (b)(2)                   FDA form        Number of     responses per   Total annual   Average  burden    Total hours
                                                                           respondents     respondent       responses     per  response
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ANADA..................................................            356v              18               1              18            159             2,862
Phased Review With Administrative ANADA................            356v               3               5              15             31.8             477
                                                        ------------------------------------------------------------------------------------------------
    Total..............................................  ..............  ..............  ..............  ..............  ...............           3,339
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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(b)(2) of the FD&C Act). Over 
the past 5 fiscal years, from October 2007 through September 2012, FDA 
has received an average of 21 ANADAs per year. FDA estimates that 
preparing the paperwork required under 21 U.S.C. 360b(n)(1) 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 five phased 
reviews per application. Therefore, assuming that three respondents 
will take advantage of the phased review option per year and an average 
of five phased reviews are submitted per application, times 31.8 hours 
per phased review, equals 477 total hours per year or 159 hours per 
application.)
    Although over the last 5 fiscal years all sponsors chose to submit 
traditional ANADAs, some sponsors did indicate an interest in using the 
phased review option in the future. FDA believes that, with time, more 
and more sponsors will take advantage of the phased review option as it 
provides greater flexibility and estimates that there will be three 
respondents for the phased review option. FDA also estimates that 
sponsors of ANADAs take approximately 25 percent less time to put 
together the information to support an ANADA than a new animal drug 
application (NADA) because they only need to provide evidence of 
bioequivalence and not the data required in a NADA to support a full 
demonstration of safety and effectiveness.

[[Page 52773]]

    Form FDA 356v. FDA requests that an applicant fills out and sends 
in a Form FDA 356v with an ANADA, and with requests for phased review 
of data to support ANADAs, to ensure efficient and accurate processing 
of information to support the approval of a generic new animal drug.
    Records and reports that are required post approval are described 
in 21 CFR 514.80, and that paperwork is already covered by that rule in 
OMB control number 0910-0284.

    Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20712 Filed 8-23-13; 8:45 am]
BILLING CODE 4160-01-P