
[Federal Register: November 3, 2008 (Volume 73, Number 213)]
[Notices]               
[Page 65384-65385]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no08-49]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Emergency Processing Under Office of Management and Budget 
Review; 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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns the burden hours required for the Animal Generic 
Drug User Fee Cover Sheet, Form FDA 3728 and the timeframe requirement 
under the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (21 U.S.C. 
379j-21) for implementing the new user fee cover sheet Form FDA 3728.

DATES: Fax written comments on the collection of information by 
November 10, 2008.

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-NEW and 
``Implementation of the Animal Generic Drug User Fee Act of 2008 (21 
U.S.C. 379j-21(a)); User Fee Cover Sheet Form 3728; Emergency 
Request.'' 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: FDA is requesting emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). The Federal Food, Drug, and 
Cosmetic Act (the act), as amended by AGDUFA authorizes FDA to collect 
user fees: (1) For certain abbreviated applications for a generic new 
animal drug, (2) on certain generic new animal drug products, and (3) 
on certain sponsors of such abbreviated applications for generic new 
animal drugs and/or investigational submissions for generic new animal 
drugs.
    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); Emergency Request

    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\
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                         No. of        Annual Frequency     Total Annual        Hours per
 21 U.S.C. 379j-      Respondents        per Response        Responses           Response         Total Hours
-------21.------------------------------------------------------------------------------------------------------
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 new 
animal drug applicants. Based on FDA's data base system, there are an 
estimated 20 sponsors of new animal drugs potentially subject to 
AGDUFA. The

[[Page 65385]]

annual reporting burden estimates in table 1 of this document are based 
on FDA's previous experience.

    Dated: October 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26162 Filed 10-31-08; 8:45 am]

BILLING CODE 4160-01-S
