Document ID: FDA-2008-N-0572-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-06-11T04:00Z

[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Page 27802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13716]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0572]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Implementation of the 
Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 
3728

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 (the PRA).

DATES: Fax written comments on the collection of information by July 
13, 2009.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0632. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

Implementation of the Animal Generic Drug User Fee Act of 2008; User 
Fee Cover Sheet Form FDA 3728--21 U.S.C. 379j-21 (OMB Control Number 
0910-0632)--Extension

    This collection of information is currently approved under the 
emergency processing provisions of the PRA for 180 days. FDA is now 
seeking a 3-year clearance.
    Section 741 of the 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. Because 
the submission of user fees concurrently with applications is required, 
the review of an application cannot begin until the fee is submitted. 
Form FDA 3728, the Animal Generic Drug User Fee Cover Sheet, is 
designed to provide the minimum necessary information in order to do 
the following: (1) Determine whether a fee is required for review of an 
application, (2) determine the amount of fee required, and (3) account 
for and track user fees.
    In the Federal Register of March 11, 2009 (74 FR 10596), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. 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 Frequency per
        21 U.S.C. 379j-21             No. of Respondents            Response          Total Annual Responses     Hours per Response       Total Hours
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Form FDA 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.

    Respondents to this collection of information are generic animal 
drug applicants. Based on FDA's database system, there are an estimated 
20 sponsors of new animal drugs potentially subject to the Animal 
Generic Drug User Fee Act of 2008.

    Dated: June 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13716 Filed 6-10-09; 8:45 am]
BILLING CODE 4160-01-S