[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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