Document ID: FDA-2011-N-0708-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet
Posted Date: 2011-10-05T04:00Z

[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61709-61710]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25708]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; FDA Form 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 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 a 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 the information collection 
burden of the Animal Generic Drug User Fee Cover Sheet Form FDA 3728 
that further implements certain provisions of the Animal Generic Drug 
User Fee Act of 2008 (AGDUFA).

DATES: Submit either electronic or written comments on the collection 
of information by December 5, 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: Juanmanuel 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 
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.

FDA Form 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. FDA Form 3728 is the 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. FDA estimates 
the burden of this collection of information as follows:

[[Page 61710]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                            FDA Form No.                                Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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FDA Form 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 data base system, there are an 
estimated 20 sponsors of new animal drugs potentially subject to 
AGDUFA.

    Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25708 Filed 10-4-11; 8:45 am]
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