Document ID: FDA-2010-N-0600-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Drug User Fee Cover Sheet, Form 3546
Posted Date: 2011-02-11T05:00Z

[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Notices]
[Pages 7866-7867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3167]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0600]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 March 
14, 2011.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0539. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 the Animal Drug User Fee 
Act (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.
    In the Federal Register of November 29, 2010 (75 FR 73103), 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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                           Annual
                 FD&C Act Section amended by ADUFA                        No. of       frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
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740(a)(1) FDA Form 3546 (Cover Sheet)..............................              76                1               76                1               76
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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

[[Page 7867]]

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: February 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3167 Filed 2-10-11; 8:45 am]
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