Document ID: FDA-2010-N-0600-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Drug User Fee Cover Sheet
Posted Date: 2010-11-29T05:00Z

[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]               
[Page 73103-73104]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no10-101]                         

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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, juanmanuel.vilela@fda.hhs.gov.

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]
BILLING CODE 4160-01-P