Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546, 65341-65342 [E7-22649]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 223 (Tuesday, November 20, 2007)]
[Notices]
[Pages 65341-65342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0220]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Animal Drug User Fee 
Cover Sheet, FDA 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 
December 20, 2007.

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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0539. Also

[[Page 65342]]

include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Denver Presley Jr. Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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; 21 U.S.C. 379j-12; 
(OMB Control Number: 0910-0539)--Extension

    Under Section 740 of the act, as amended by ADUFA (21 U.S.C. 379j-
12), 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 that payment. The 
form, when completed electronically, will result in the generation of a 
unique payment identification number used for 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 a Federal Register of June 15, 2007 (72 FR 33231), FDA published 
a 60-day notice soliciting public comment on the proposed collection of 
information provisions. In response to that notice, no comments were 
received.
    Respondents to this collection of information are new animal drug 
sponsors applicants or manufacturers.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                       Number of       Annual Frequency     Total annual        Hours per
21 U.S.C. 379j-12     Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
740(a)(1)                         69    1 time for each                 69                  1                 69
FDA Form 3546                               application
 (Cover Sheet)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22649 Filed 11-19-07; 8:45 am]
BILLING CODE 4160-01-S