[Federal Register Volume 76, Number 49 (Monday, March 14, 2011)]
[Notices]
[Pages 13629-13631]
From the Federal Register Online via the Government Publishing 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Revised Draft Guidance for Industry on User Fee Waivers,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availability of a revised draft guidance for industry entitled ``User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 This revised draft guidance provides recommendations to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 This guidance is a revision of the draft guidance entitled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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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draft guidance to the Division of Drug Information, Center for Drug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Submit electronic comments on the revised draft guidance to http://www.regulations.gov.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section for electronic access to the draft guidance document.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