82 FR 23581 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry-User Fee Waivers, Reductions, and Refunds for Drug and Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 98 (May 23, 2017)

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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.

[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23581-23583]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10534]


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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; Guidance for Industry--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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 July 24, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov/. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov/ 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov/. If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-0222 for ``User Fee Waivers, Reductions, and Refunds for 
Drug and Biological Products.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov/ or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint

[[Page 23582]]

North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794.

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.

Guidance for Industry--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 prescription drug 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 
prescription drug 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.
    Based on Agency records, we estimate that the total annual number 
of waiver requests submitted for all of these categories will be 150, 
submitted by 115 different applicants. 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. 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.
    Previously, after receipt of a small business waiver request, FDA 
would request a small business size determination from the Small 
Business Administration (SBA). Waiver applicants would submit their 
supporting documentation directly to SBA for evaluation and after 
completing their review, SBA provided FDA with a determination whether 
a waiver applicant qualified as a small business for purposes of 
evaluating user fee waivers. The burden for submission of this 
information to SBA is approved under OMB control number 3245-0101. 
Beginning fiscal year 2015, the SBA declined to conduct further size 
determinations for evaluation of small business user fee waivers and as 
a result, a processing change at FDA occurred. The new FDA process 
requires waiver applicants to submit documentation directly to FDA. In 
addition, fewer supporting documents than previously requested by SBA 
are required. As a result, we estimate that the 4 burden hours per 
small business waiver previously attributed to SBA and approved under 
OMB control number 3245-0101, should now be attributed to FDA because 
SBA is no longer conducting size determinations for FDA. Also, because 
FDA is asking that applicants submit fewer supporting documents, we 
estimate that these burden hours should be reduced to 2 hours instead 
of 4 hours. We understand that SBA plans to submit a revised burden 
estimate to OMB control number 3245-0101 to account for this 
redistribution.
    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 seven requests for reconsideration annually, and that the total 
average burden hours for a reconsideration request will be 24 hours. In 
addition, 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 We have included in 
this estimate both the time needed to prepare the request for appeal to 
the Chief Scientist, User Fee Appeals Officer, Office of the 
Commissioner, and the time needed to create and send a copy of the 
request for an appeal to the Director, Division of User Fee Management, 
Office of Management at the Center for Drug Evaluation and Research.
    The burden for completing and submitting Form FDA 3397 
(Prescription Drug User Fee Coversheet) is not included in this 
analysis as the burden is included under OMB control number 0910-0297. 
The collection of information associated with submission of a new drug 
application or biologics license application are approved under OMB 
control numbers 0910-0001 and 0910-0338, respectively.

                                 Table 1--Estimated Annual Reporting Burden \1\
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 User fee waivers, reductions, &                     Number of
 refunds for drug &  biological      Number of     responses per   Total annual   Average burden    Total hours
            products                respondents     respondent       responses     per response
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FD&C Act sections 735 and 736...             115             1.3             150              16           2,400
FD&C Act section 736(d)(1)(D)(4)              25               1              25               2              50
Reconsideration requests........               7               1               7              24             168
Appeal requests.................               1               1               1              12              12
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[[Page 23583]]

 
    Total.......................  ..............  ..............  ..............  ..............           2,630
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10534 Filed 5-22-17; 8:45 am]
BILLING CODE 4164-01-P