Agency Information Collection Activities; Proposed Collection; Comment Request; Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728, 10596 [E9-5107]

Agencies

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

[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Notices]
[Page 10596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5107]



[[Page 10596]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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.

-----------------------------------------------------------------------

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 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 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 written or electronic comments on the collection of 
information by May 11, 2009.

ADDRESSES:  Submit electronic comments on the collection of information 
to https://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:  Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

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 of 1995 for 90 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: (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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Annual Frequency      Total Annual
                21 U.S.C. 379j-21                  No. of Respondents      per Response          Responses        Hours per Response      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3728                                                       20                  2                    40                   .08                3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: March 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5107 Filed 3-10-09; 8:45 am]
BILLING CODE 4160-01-S