[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]
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