Document ID: FDA-2011-N-0708-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Generic Drug User Fee Act Cover Sheet
Posted Date: 2012-07-17T04:00Z

[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Notices]
[Pages 41984-41985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17369]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0708]

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

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 August 
16, 2012.

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,

[[Page 41985]]

OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed 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 II, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 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.

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

    Section 741 of the Federal Food, Drug, and Cosmetic Act (FD&C 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 (21 U.S.C. 379j-21(a)). 
Because the submission of user fees concurrent with applications is 
required, the review of an application cannot begin until the fee is 
submitted. Form FDA 3728 is the Animal Generic Drug User Fee Act 
(AGDUFA) Cover Sheet, which is designed to provide the minimum 
necessary information to determine whether a fee is required for review 
of an application, to determine the amount of the fee required, and to 
account for and track user fees.
    In the Federal Register of October 5, 2011 (76 FR 61709), 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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                                                                                  Number of
                     FDA Form Number                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
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3728.....................................................                20                  2                 40       .08 (5 min.)                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 AGDUFA.

    Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17369 Filed 7-16-12; 8:45 am]
BILLING CODE 4160-01-P