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)

Page Range		23581-23583
FR Document		2017-10534

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 Issue 98 (Tuesday, May 23, 2017)

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------

[[Page 23583]]

Total....................... .............. .............. .............. .............. 2,630
----------------------------------------------------------------------------------------------------------------
\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

23582 Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices

North, 10A63, 11601 Landsdown St., the Federal Food, Drug, and Cosmetic result, a processing change at FDA
North Bethesda, MD 20852, 301–796– Act (21 U.S.C. 379g and 21 U.S.C. 379h) occurred. The new FDA process
3794. (the FD&C Act). The guidance describes requires waiver applicants to submit
SUPPLEMENTARY INFORMATION: Under the the types of waivers and reductions documentation directly to FDA. In
PRA (44 U.S.C. 3501–3520), Federal permitted under the prescription drug addition, fewer supporting documents
Agencies must obtain approval from the user fee provisions of the FD&C Act, and than previously requested by SBA are
Office of Management and Budget the procedures for submitting requests required. As a result, we estimate that
(OMB) for each collection of for waivers or reductions. It also the 4 burden hours per small business
information they conduct or sponsor. includes recommendations for waiver previously attributed to SBA and
‘‘Collection of information’’ is defined submitting information for requests for approved under OMB control number
in 44 U.S.C. 3502(3) and 5 CFR reconsideration of denials of waiver or 3245–0101, should now be attributed to
1320.3(c) and includes Agency requests reduction requests, and for requests for FDA because SBA is no longer
or requirements that members of the appeals. The guidance also provides conducting size determinations for FDA.
public submit reports, keep records, or clarification on related issues such as Also, because FDA is asking that
provide information to a third party. user fee exemptions for orphan drugs. applicants submit fewer supporting
Section 3506(c)(2)(A) of the PRA (44 Based on Agency records, we estimate documents, we estimate that these
U.S.C. 3506(c)(2)(A)) requires Federal that the total annual number of waiver burden hours should be reduced to 2
Agencies to provide a 60-day notice in requests submitted for all of these hours instead of 4 hours. We understand
the Federal Register concerning each categories will be 150, submitted by 115 that SBA plans to submit a revised
proposed collection of information, different applicants. We estimate that burden estimate to OMB control number
including each proposed extension of an the average burden hours for 3245–0101 to account for this
existing collection of information, preparation of a submission will total 16 redistribution.
before submitting the collection to OMB hours. Because FDA may request
additional information from the The reconsideration and appeal
for approval. To comply with this requests are not addressed in the FD&C
requirement, FDA is publishing notice applicant during the review period, we
have also included in this estimate time Act, but are discussed in the guidance.
of the proposed collection of We estimate that we will receive seven
information set forth in this document. to prepare any additional information.
We have included in the burden requests for reconsideration annually,
With respect to the following and that the total average burden hours
collection of information, FDA invites estimate the preparation and submission
of application fee waivers for small for a reconsideration request will be 24
comments on these topics: (1) Whether
businesses, because small businesses hours. In addition, we estimate that we
the proposed collection of information
requesting a waiver must submit will receive one request annually for an
is necessary for the proper performance
documentation to FDA on the number of appeal of a user fee waiver
of FDA’s functions, including whether
their employees and must include the determination, and that the time needed
the information will have practical
information that the application is the to prepare an appeal would be
utility; (2) the accuracy of FDA’s
first human drug application, within the approximately 12 hours We have
estimate of the burden of the proposed
meaning of the FD&C Act, to be included in this estimate both the time
collection of information, including the
submitted to the Agency for approval. needed to prepare the request for appeal
validity of the methodology and
Previously, after receipt of a small to the Chief Scientist, User Fee Appeals
assumptions used; (3) ways to enhance
business waiver request, FDA would Officer, Office of the Commissioner, and
the quality, utility, and clarity of the
request a small business size the time needed to create and send a
information to be collected; and (4)
determination from the Small Business copy of the request for an appeal to the
ways to minimize the burden of the
Administration (SBA). Waiver Director, Division of User Fee
collection of information on
applicants would submit their Management, Office of Management at
respondents, including through the use
supporting documentation directly to the Center for Drug Evaluation and
of automated collection techniques,
SBA for evaluation and after completing Research.
when appropriate, and other forms of
information technology. their review, SBA provided FDA with a The burden for completing and
determination whether a waiver submitting Form FDA 3397
Guidance for Industry—User Fee applicant qualified as a small business (Prescription Drug User Fee Coversheet)
Waivers, Reductions, and Refunds for for purposes of evaluating user fee is not included in this analysis as the
Drug and Biological Products—OMB waivers. The burden for submission of burden is included under OMB control
Control Number 0910–0693—Extension this information to SBA is approved number 0910–0297. The collection of
The guidance provides under OMB control number 3245–0101. information associated with submission
recommendations for applicants Beginning fiscal year 2015, the SBA of a new drug application or biologics
planning to request waivers or declined to conduct further size license application are approved under
reductions in prescription drug user fees determinations for evaluation of small OMB control numbers 0910–0001 and
assessed under sections 735 and 736 of business user fee waivers and as a 0910–0338, respectively.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
User fee waivers, reductions, & refunds for drug & Number of Total annual
sradovich on DSK3GMQ082PROD with NOTICES

responses per burden per Total hours
biological products respondents responses
respondent response

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

VerDate Sep<11>2014 21:15 May 22, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1

Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices 23583

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
User fee waivers, reductions, & refunds for drug & Number of Total annual
responses per burden per Total hours
biological products respondents responses
respondent response

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

Dated: May 18, 2017. SUPPLEMENTARY INFORMATION: In demonstrate active participation is also
Anna K. Abram, compliance with 44 U.S.C. 3507, we recommended.
Deputy Commissioner for Policy, Planning, have submitted the following proposed These documents are collected in
Legislation, and Analysis. collection of information to OMB for order to determine if the nominee has
[FR Doc. 2017–10534 Filed 5–22–17; 8:45 am] review and clearance. the expertise in the subject matter with
BILLING CODE 4164–01–P which the committee is concerned and
FDA Advisory Committee Membership
has diverse professional education,
Nominations—OMB Control Number
training, and experience so that the
0910–NEW
DEPARTMENT OF HEALTH AND committee will reflect a balanced
HUMAN SERVICES FDA chooses to select advisory composition of sufficient scientific
committee members through a expertise to handle the problems that
Food and Drug Administration nomination process. (Appendix A to come before it (21 CFR 14.80(b)(1)(i)). In
Subpart C of 41 CFR 102–3, the Federal the case of Industry and Consumer
[Docket No. FDA–2017–N–0366] Advisory Committee Management Final Representatives, information is
Rule notes that the Federal Advisory collected to assess the candidate’s
Agency Information Collection Committee Act (FACA, 5 U.S.C. App. 2) ability to represent all interested
Activities; Submission for Office of does not specify the manner in which persons within the class which the
Management and Budget Review; advisory committee members and staff member is selected to represent (21 CFR
Comment Request; Advisory must be appointed.) A person can self- 14.86).
Committee Nomination Applications nominate or be nominated by another Each nominee should be sure to
individual. In order to identify and review the Agency Web site for
AGENCY: Food and Drug Administration, select qualified individuals to serve on information on:
HHS. its advisory committees, FDA has • Vacancies, qualifications, and
ACTION: Notice. established an online portal, the FDA experience for more details concerning
Advisory Committee Membership vacancies on each committee and the
SUMMARY: The Food and Drug Application, to accept nominations of qualifications and experience common
Administration (FDA or we) is potential advisory committee members. for nominees. Vacancies are updated
announcing that a proposed collection The FDA Advisory Committee periodically; therefore, one or more
of information has been submitted to the Membership Application accepts vacancies listed may be in the
Office of Management and Budget nominations for Academician/ nomination process or a final
(OMB) for review and clearance under Practitioner, Consumer Representative, appointment may have been made.
the Paperwork Reduction Act of 1995 and Industry Representative • Potential conflicts of interest such
(the PRA). membership types. Nominees who are as financial holdings, employment, and
DATES: Fax written comments on the nominated as scientific members should research grants and/or contracts in order
collection of information by June 22, be technically qualified experts in the to permit evaluation of possible sources
2017. field (e.g., clinical medicine, of conflict of interest.
engineering, biological and physical Also, FDA asks that prospective
ADDRESSES: To ensure that comments on sciences, biostatistics, food sciences) nominees inform us of how they heard
the information collection are received, and have experience interpreting about the FDA Advisory Committees
OMB recommends that written complex data. Candidates must be able (e.g., attendance at a professional
comments be faxed to the Office of to analyze detailed scientific data and meeting, an article in a publication, our
Information and Regulatory Affairs, understand its public health Web site, while speaking with a friend
OMB, Attn: FDA Desk Officer, FAX: significance. The nomination process or colleague).
202–395–7285, or emailed to oira_ has recently been made electronic and To further the Agency’s goals of
submission@omb.eop.gov. All is available at http:// promoting transparency regarding the
comments should be identified with the accessdata.test.fda.gov/scripts/ advisory committee process, FDA will
OMB control number, 0910–NEW, and FACTRSPortal/FACTRS/index.cfm. To also require that nominees to serve on
title, ‘‘FDA Advisory Committee submit a nomination, nominators or advisory committees submit a consent
Membership Nominations.’’ Also prospective nominees should upload form authorizing FDA to publicly post
include the FDA docket number found the following documents in PDF format to FDA’s Web site the CV submitted as
in brackets in the heading of this (see 21 CFR 14.82(c)): (1) Curriculum part of their nomination materials if the
document. vitae (CV); (2) a written confirmation nominee is selected to serve on an
sradovich on DSK3GMQ082PROD with NOTICES

FOR FURTHER INFORMATION CONTACT: that the nominee(s) is (are) aware of the advisory committee. In the past, FDA
Jonnalynn Capezzuto, Office of nomination (unless self-nominated); and has generally posted the CVs of FDA
Operations, Food and Drug (3) letters of recommendation are also advisory committee members publicly
Administration, Three White Flint suggested. For Consumer Representative on http://www.fda.gov/
North, 10A63, 11601 Landsdown St., nominations, a cover letter that lists AdvisoryCommittees/ after reviewing
North Bethesda, MD 20852, 301–796– consumer or community organizations the CVs and redacting information that
3794, PRAStaff@fda.hhs.gov. for which the candidate can appeared to be confidential. However,

VerDate Sep<11>2014 21:15 May 22, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1

Document Created: 2017-05-23 02:14:28
Document Modified: 2017-05-23 02:14:28

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by July 24, 2017.
Contact		JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796- 3794.
FR Citation		82 FR 23581

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 SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration