[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9224-9225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03352]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0079]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Generic Drug User Fee Act Cover Sheet
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 burden of animal
drug sponsors to fill out the Animal Generic Drug User Fee Act (AGDUFA)
cover sheet.
DATES: Submit either electronic or written comments on the collection
of information by April 21, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [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.
Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet--21 U.S.C.
379j-21 (OMB Control Number 0910-0632)--Revision
Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 379j-21) establishes three different kinds of user
fees: (1) Fees for certain types of abbreviated applications for
generic new animal drugs; (2) annual fees for certain generic new
animal drug products; and (3) annual fees for certain sponsors of
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). Because concurrent submission of user fees with
applications is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3728 is the AGDUFA cover sheet,
which is designed to provide the minimum necessary information to
determine whether a fee is required for review of an application, to
determine the amount of the fee required, and to account for and track
user fees.
The Animal Generic Drug User Fee Amendments of 2013, signed by the
President on June 13, 2013 (AGDUFA II) (Title II of Pub. L. 113-14),
amended the FD&C Act authorizing FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, for certain
generic new animal drug products, and for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. To implement
changes under the reauthorization by their effective date of October 1,
2013, FDA sought and received OMB approval to update its Form FDA 3728
as described here:
On page 1 of the electronic questions under ``Select an Application
Type'' users must select ``Original'' and then choose either,
``Abbreviated New Animal Drug Application (ANADA)--under provisions of
512(b)(2) of the FD&C Act (21 U.S.C. 360b(b)(2))''; or ``Abbreviated
New Animal Drug Application--for certain combination pioneer products
approved under provisions of 512(d)(4) of the FD&C Act (21 U.S.C.
360b(d)(4)).'' If they select the first ANADA type, they will be
charged 100 percent of the application fee. If they select the second
ANADA type, then they will be charged at rate of 50 percent of the
original application fee. To facilitate the application process in this
regard, on Form FDA 3728 we have added a line in Section 3 that allows
applicants to select the option, ``3.2 Original Abbreviated New Animal
Drug Application--for certain combination pioneer products approved
under provisions of 512(d)(4) of the FD&C Act.''
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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3728 20 2 40 .08 3.2
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 9225]]
Respondents to this collection of information are generic animal
drug applicants. Based on data for the past 3 years, FDA estimates
there are approximately 20 submissions annually and a total of 3.2
burden hours.
Dated: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03352 Filed 2-14-14; 8:45 am]
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