Document ID: FDA-2011-D-0108-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry; Availability: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
Posted Date: 2011-03-14T04:00Z

[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13629-13631]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5737]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Revised Draft Guidance for Industry on User Fee Waivers, 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 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availability of a revised draft guidance for industry entitled ``User 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 This revised draft guidance provides recommendations to 
applicants considering whether to request a waiver or reduction in user 
fees. This guidance is a revision of the draft guidance entitled 
``Draft Interim Guidance Document for Waivers of and Reductions in User 
Fees,'' issued July 16, 1993.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by June 13, 2011.
    Submit written comments on the proposed collection of information 
by May 13, 2011.

ADDRESSES: Submit written requests for single copies of the revised 
draft guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring,

[[Page 13630]]

MD 20993-0002 or the Office of Communication, Outreach, and Development 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist that 
office in processing your requests.
    Submit electronic comments on the revised draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Michael Jones, Office of Regulatory 
Policy, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Avenue, Bldg. 51, rm. 6216, Silver 
Spring, MD 20993-0002, 301-796-3602, or Stephen Ripley, Center for 
Biologics Evaluation and Research, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

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). 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 Paperwork Reduction Act of 1995 (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 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.
    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. FDA estimates the burden of this collection 
of information as follows:

[[Page 13631]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                   Total number
                                     of waiver        Annual         Number of     Total average
                                     requests      frequency per     sponsors/     burden hours     Total hours
                                     annually        response       applicants
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Federal Food, Drug, and Cosmetic              90             1.2              75              16           1,440
 Act Section 736................
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 operating and maintenance costs associated with this collection of information.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
It is only necessary to send one set of comments. It is no longer 
necessary to send two copies of mailed comments. Identify comments with 
the docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov.BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/guidances/default.htm, or 
http://www.regulations.gov.

    Dated: March 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5737 Filed 3-11-11; 8:45 am]
BILLING CODE 4160-01-P