[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Pages 25279-25280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-10088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the paperwork associated with 
abbreviated new animal drug applications submitted to the Center for 
Veterinary Medicine, FDA.

DATES: Submit either electronic or written comments on the collection 
of information by July 1, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Information Management, Food and Drug Administration, 1350 Piccard 
Drive, PI50-400B, Rockville, MD 20850, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 25280]]

Abbreviated New Animal Drug Applications--Sections 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.
    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 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. 
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: April 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10088 Filed 4-29-13; 8:45 am]
BILLING CODE 4160-01-P