
[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40375-40376]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0108]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Revised Draft 
Guidance for Industry on User Fee Waivers, Reductions, and Refunds for 
Drug and Biological Products; Availability

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 (the PRA).

DATES: Fax written comments on the collection of information by August 
8, 2011.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Revised Draft Guidance for Industry on User Fee Waivers, 
Reductions, and Refunds for Drug and Biological Products; 
Availability.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

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.

Revised Draft Guidance for Industry on User Fee Waivers, Reductions, 
and Refunds for Drug and Biological Products; Availability--(OMB 
Control Number 0910--New)

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug 
and Biological Products.'' This revised draft guidance provides 
recommendations for applicants planning to request waivers or 
reductions in user fees assessed under sections 735 and 736 of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379g and 
379h). This revised draft guidance describes the types of waivers and 
reductions permitted under the user fee provisions of the FD&C Act, and 
the procedures for submitting requests for waivers or reductions and 
requests for reconsideration and appeal. The revised draft guidance 
also provides clarification on related issues such as user fee 
exemptions for orphan drugs. After comments are received and 
considered, FDA intends to promptly issue a final guidance.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on user 
fee waivers and reductions for drug products. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain 
approval from OMB for each collection of information that 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 for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, FDA invites comments on the following topics: (1) 
Whether the proposed information collected is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimated burden of 
the proposed information collected, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    The draft guidance describes how to submit requests for waivers, 
reductions, and refunds of certain user fees. It also includes 
recommendations for submitting information for requests for 
reconsideration of denials of waiver or reduction requests, and for 
requests for appeals. We estimate that the total annual number of 
waiver requests submitted for all of these categories will be 90, 
submitted by 75 different sponsors. We estimate that the average burden 
hours for preparation of a submission will total 16 hours. Because FDA 
may request additional information from the applicant during the review 
period, we have also included in this estimate time to prepare any 
additional information.

[[Page 40376]]

    The reconsideration and appeal requests are not addressed in the 
FD&C Act but are discussed in the draft guidance. We estimate that we 
will receive three requests for reconsideration annually, and that the 
total average burden hours for a reconsideration request will be 24 
hours. We estimate that we will receive one request annually for an 
appeal of a user fee waiver determination, and that the time needed to 
prepare an appeal would be approximately 12 hours. Reconsideration 
requests are sent to the Associate Director for Policy at the Center 
for Drug Evaluation and Research (CDER), and requests for appeals are 
sent to the User Fee Appeals Officer at FDA, with a copy to the 
Associate Director for Policy at CDER. We have also included in this 
estimate both the time needed to prepare the request for appeal and the 
time needed to create and send a copy of the request for an appeal to 
the Associate Director for Policy at CDER.
    The burden for filling out and submitting Form FDA 3397 
(Prescription Drug User Fee Coversheet) has not been included in the 
burden analysis because that information collection is already approved 
by OMB under OMB control number 0910-0297. The collections of 
information associated with a new drug application or biologics license 
application have been approved under OMB control numbers 0910-0001 and 
0910-0338, respectively.
    We have included in the burden estimate the preparation and 
submission of application fee waivers for small businesses because 
small businesses requesting a waiver must submit documentation to FDA 
on the number of their employees and must include the information that 
the application is the first human drug application, within the meaning 
of the FD&C Act, to be submitted to the Agency for approval. Because 
the Small Business Administration (SBA) makes the size determinations 
for FDA, small businesses must also submit information to the SBA. The 
submission of information to SBA is already approved by OMB under OMB 
control number 3245-0101.
    In the Federal Register of March 14, 2011 (76 FR 13629), 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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                                                                                      Average
                                    Number of       Number of      Total annual     burden per
                                   respondents    responses per      responses     response  (in    Total hours
                                                    respondent                        hours)
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Section 736 of the FD&C Act....              75              1.2              90              16           1,440
Reconsideration Requests.......               3              1                 3              24              72
Appeal Requests................               1              1                 1              12              12
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    Total......................  ..............  ...............  ..............  ..............           1,524
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17142 Filed 7-7-11; 8:45 am]
BILLING CODE 4160-01-P


