[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Notices]
[Pages 12201-12202]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04688]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0222]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; User Fee Waivers, Reductions, and Refunds for Drug and 
Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on recommendations to applicants 
considering whether to request a waiver or reduction in user fees.

DATES: Submit either electronic or written comments on the collection 
of information by May 5, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: Under 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 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 concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    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.

User Fee Waivers, Reductions, and Refunds for Drug and Biological 
Products (OMB Control Number 0910-0693)--Extension

    The guidance provides recommendations for applicants planning to 
request waivers or

[[Page 12202]]

reductions in user fees assessed under sections 735 and 736 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g and 21 U.S.C. 
379h) (the FD&C Act). The 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. It 
also includes recommendations for submitting information for requests 
for reconsideration of denials of waiver or reduction requests, and for 
requests for appeals. The guidance also provides clarification on 
related issues such as user fee exemptions for orphan drugs.
    We estimate that the total annual number of waiver requests 
submitted for all of these categories will be 120, submitted by 100 
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 guidance. We estimate that we will 
receive 3 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 1 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. We have 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 the Center for Drug Evaluation and 
Research.
    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 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 under OMB control 
number 3245-0101.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Number of
    User fee waivers, reductions, and refunds for drug and          Number of       responses per     Total annual     Average  burden     Total hours
                      biological products                          respondents       respondent         responses       per response
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FD&C Act sections 735 and 736.................................              100               1.2               120                16             1,920
Reconsideration Requests......................................                3                 1                 3                24                72
Appeal Requests...............................................                1                 1                 1                12                12
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    Total.....................................................  ................  ................  ................  ................            2,004
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 26, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04688 Filed 3-3-14; 8:45 am]
BILLING CODE 4160-01-P