
[Federal Register: March 26, 2009 (Volume 74, Number 57)]
[Notices]               
[Page 13213-13214]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr09-77]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0149]

 
Agency Emergency Processing Under Office of Management and Budget 
Review; Guidance for Industry: Animal Generic Drug User Fees and Fee 
Waivers and Reductions

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 to implement the new 
statutory requirements for the user fees and fee waivers reductions 
provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA) 
(Federal Food, Drug, and Cosmetic Act (the act)).

DATES: Fax written comments on the collection of information provisions 
by March 31, 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-NEW and 
title ``Guidance for Industry: Animal Generic Drug Fees and Fee Waivers 
Reduction; 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). Section 741(d) of the act 
(21 U.S.C. 379k(d)), as amended by AGDUFA, authorizes FDA to collect 
user fees for certain: (1) Abbreviated applications for generic new 
animal drugs, (2) new animal drug products, and (3) sponsors of such 
abbreviated applications for generic new animal drugs and/or 
investigational submissions of new animal drugs. However, AGDUFA also 
provides FDA with the authorization to grant a waiver from or a 
reduction of those fees in certain circumstances. To provide guidance, 
FDA has developed the guidance entitled ``Animal Generic Drug User Fees 
and Fee Waivers and Reductions,'' which is crucial to firms 
understanding whether they might qualify for the waiver or reduction, 
and if so, how to apply for it.
    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.

Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers 
and Reductions (Section 741(d) of the Federal Food, Drug, and Cosmetic 
Act); Emergency Request

    AGDUFA requires FDA to collect user fees for certain: (1) 
Abbreviated applications for a generic new animal drug, (2) generic new 
animal drug products, and (3) sponsors of such abbreviated applications 
for generic new animal drugs and/or investigational submissions for 
generic new animal drugs. AGDUFA also contains a specific provision 
under which a fee waiver or reduction may be requested for any or all 
of these fees. The type of fee waiver and reduction requests to be 
submitted is: Minor Use or Minor Species. FDA seeks OMB approval for 
this summary of information required for a fee waiver or reduction 
request.
    Respondents to the proposed collection of information will likely 
be private industry. Requests for a waiver or reduction may be 
submitted by a person paying any of the generic new animal drug user 
fees assessed--application fees, product fees, or sponsor fees.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 13214]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Section 741(d) of        No. of        Annual Frequency     Total Annual        Hours per
     the Act          Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
741(d)--Minor Use                  9                  1                  9                  2                 18
 or Minor Species
 Fee Waiver &
 Reduction
 Requests
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                  1                  1
 Reconsideration;
 CVM AGDUFA
 Waiver
 Officer\2\
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                  1                  1
 Review; CVM
 AGDUFA Appeals
 Officer
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                  1                  1
 Review; FDA User
 Fee Appeals
 Officer
----------------------------------------------------------------------------------------------------------------
Total                                                                                                         21
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ CVM means Center for Veterinary Medicine.

    Appeals for reconsideration or review of AGDUFA user fee waiver 
decisions will be very rare. Waivers are granted only for user fees 
involving minor use or minor species as defined by the Minor Use and 
Minor Species Act of 2008 (MUMS). Decisions on waivers of user fees 
based on minor species do not allow for agency discretion as ``minor 
species'' is defined specifically in the MUMS statute. As to minor use 
in a major species, FDA, under MUMS, determines that a new animal drug 
is for minor use in a major species at the time that the pioneer new 
animal drug application is submitted. This determination carries over 
to the abbreviated (generic) new animal drug application. Therefore, we 
do not anticipate that there will be more than one request for review 
or reconsideration for either the ``minor use'' or ``minor species'' 
waivers or reductions under AGDUFA per year.
    Fee Waiver or Reduction Requests: For those who, after reading the 
guidance, decide to apply for a waiver or reduction of one or more of 
the fees they were assessed, the time to complete the information 
required for their waiver application, based on the guidance provided, 
is estimated to be 2 hours or less.
    Based on FDA's database system, there are an estimated 50 sponsors 
of products subject to AGDUFA. However, not all sponsors will have 
submissions in a given year. CVM estimates nine waiver requests that 
include minor use or minor species. The estimated hours per response 
are based on past FDA experience with the various waiver requests in 
CVM. The hours per response listed in table 1 of this document are 
based on the average of these estimates.

    Dated: March 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6724 Filed 3-25-09; 8:45 am]

BILLING CODE 4160-01-S
