Document ID: FDA-2014-N-0222-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; User Fee Waivers,
Reductions, and Refunds for Drug and Biological Products
Posted Date: 2014-07-16T04:00Z

[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Notices]
[Pages 41579-41580]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16709]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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.

DATES: Fax written comments on the collection of information by August 
15, 2014.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0693. 
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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.

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 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,

[[Page 41580]]

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.
    In the Federal Register of March 4, 2014 (79 FR 12201), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two comments. However, these 
comments did not address the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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 User fee waivers, reductions,                      Number of
    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: July 11, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16709 Filed 7-15-14; 8:45 am]
BILLING CODE 4164-01-P