[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73103-73104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29820]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0600]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Drug User Fee Cover Sheet, Form 3546
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 burden hours necessary to
complete FDA Form 3546, Animal Drug User Fee Act (ADUFA) Cover Sheet.
DATES: Submit either electronic or written comments on the collection
of information by January 28, 2011.
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: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, [email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
[[Page 73104]]
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.
Animal Drug User Fee Cover Sheet; FDA Form 3546 (OMB Control Number
0910-0539)--Extension
Under section 740 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 379j-12), as amended by ADUFA, FDA has the
authority to assess and collect for certain animal drug user fees.
Because the submission of user fees concurrently with applications and
supplements is required, review of an application cannot begin until
the fee is submitted. The types of fees that require a cover sheet are
certain animal drug application fees and certain supplemental animal
drug application fees. The cover sheet (FDA Form 3546) is designed to
provide the minimum necessary information to determine whether a fee is
required for the review of an application or supplement, to determine
the amount of the fee required, and to assure that each animal drug
user fee payment and each animal drug application for which payment is
made is appropriately linked to the payment that is made. The form,
when completed electronically, will result in the generation of a
unique payment identification number used in tracking the payment. FDA
will use the information collected to initiate administrative screening
of new animal drug applications and supplements to determine if payment
has been received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Annual
Section of the FD&C Act as Number of frequency per Total annual Hours per Total hours
amended by ADUFA respondents response responses response
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740(a)(1), FDA Form 3546 (Cover 76 1 76 1 76
Sheet).........................
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Total....................... .............. .............. .............. .............. 76
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Respondents to this collection of information are new animal drug
applicants or manufacturers. Based on FDA's database system, there are
an estimated 140 manufacturers of products or sponsors of new animal
drugs potentially subject to ADUFA. However, not all manufacturers or
sponsors will have any submissions in a given year and some may have
multiple submissions. The total number of annual responses is based on
the number of submissions received by FDA in fiscal year 2008. The
estimated hours per response are based on past FDA experience with the
various submissions. The hours per response are based on the average of
these estimates.
Dated: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29820 Filed 11-26-10; 8:45 am]
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