[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
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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