Agency Information Collection Activities; Proposed Collections; Comment Request; Prescription Drug User Fee Program, 67958-67960 [2021-26079]
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67958
Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Notices
for PDUFA Products’’ have been
approved under OMB control number
0910–0429.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26006 Filed 11–29–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3233]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Technical Electronic
Product Radiation Safety Standards
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Technical Electronic
Product Radiation Safety Standards
Committee (TEPRSSC) in the Center for
Devices and Radiological Health.
Nominations will be accepted for
current and upcoming vacancies
effective January 1, 2022, with this
notice. FDA seeks to include the views
of women and men, members of all
racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before January 31, 2022, will be given
first consideration for membership on
TEPRSSC. Nominations received after
January 31, 2022, will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by accessing FDA’s
Advisory Committee Membership
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SUMMARY:
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Nomination Portal at https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Akinola Awojope, Office of
Management Services, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216,
Silver Spring, MD 20993–0002, 301–
636–0512, email: Akinola.Awojope@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on TEPRSSC that include five
general public representatives and five
government representatives.
I. General Description of the
Committee’s Duties
The committee provides advice and
consultation to the Commissioner of
Food and Drugs (Commissioner) on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products, and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
II. Criteria for Voting Members
The committee consists of a core of 15
voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of science or engineering,
applicable to electronic product
radiation safety. Members will be
invited to serve for overlapping terms of
up to 4 years. Terms of more than 2
years are contingent upon the renewal
of the committee by appropriate action
prior to its expiration.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the committee. Selfnominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available and a signed copy of the
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Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: November 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26002 Filed 11–29–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–N–0101]
Agency Information Collection
Activities; Proposed Collections;
Comment Request; Prescription Drug
User Fee Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collections 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 information
collection associated with FDA’s
Prescription Drug User Fee program.
DATES: Submit either electronic or
written comments on the collection of
information by January 31, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 31,
2022. The https://www.regulations.gov
electronic filing system will accept
SUMMARY:
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Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Notices
comments until 11:59 p.m. Eastern Time
at the end of January 31, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2005–N–0101 for ‘‘Agency Information
Collection Activities; Proposed
Collections; Comment Request;
Prescription Drug User Fee Program.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
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a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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 Dockets Management
Staff. 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.govinfo.gov/content/pkg/FR-201509-18/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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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.
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67959
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.
Prescription Drug User Fee Program
OMB Control Number 0910–0297—
Revision
This information collection supports
implementation of the Food and Drug
Administration Prescription Drug User
Fee (PDUFA) program. PDUFA was
enacted in 1992 and authorizes FDA to
collect fees from companies that
produce certain human drug and
biological products. Under the
prescription drug user fee provisions of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (sections 735 and
736 (21 U.S.C. 379g and 379h)), we have
the authority to assess and collect user
fees for certain new drug applications
(NDAs) and new biologics license
applications (BLAs). Under this
authority, pharmaceutical companies
pay a fee for certain new NDAs and
BLAs submitted to FDA for review. We
have established a PDUFA page on our
website at https://www.fda.gov/
forindustry/userfees/prescription
druguserfee/ that includes resources and
information regarding PDUFA topics at
FDA.
Because the submission of user fees
concurrently with applications is
required, review of an application by
FDA cannot begin until the fee is
submitted. To assist respondents in this
regard, we developed Form FDA 3397
entitled, ‘‘Prescription Drug User Fee
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Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Notices
Cover Sheet.’’ Associated instructions
may be found on our website at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm119184.htm. The cover sheet (Form
FDA 3397) need not be submitted for
certain FDA-regulated products, e.g.,
generic drugs, and Whole Blood and
Blood components for transfusion. The
list of exempted products is included
under the instructions to Form FDA
3397. Relatedly, sections 735 and 736 of
the FD&C Act also provide for waiver,
reduction, refund, and reconsideration
requests. We developed the guidance
document entitled ‘‘Guidance for
Industry—User Fee Waivers,
Reductions, and Refunds for Drug and
Biological Products,’’ and Form FDA
3971 (Small Business Waivers and
Refund Requests), which can be found
on our website at https://www.fda.gov/
media/131797/download.
We are revising the collection to
include our current commitment goals,
as set forth in the document ‘‘PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2018 Through
2022,’’ also found on our website at
https://www.fda.gov/media/99140/
download. PDUFA is currently
authorized through September 30, 2022,
with reauthorization activities currently
underway. The commitment goals
represent the product of FDA’s
discussions with the regulated industry
and public stakeholders, as mandated
by Congress. FDA is committed to
meeting these goals and to continuous
operational improvements associated
with PDUFA implementation. The
commitment goals provide for the
development and issuance of topicspecific guidance. We maintain a
searchable guidance database on our
website at https://www.fda.gov/
regulatory-information/search-fdaguidance-document. In publishing the
respective notices of availability for
each guidance document, we include an
analysis under the PRA and invite
public comment on the associated
information collection
recommendations. In addition, all
Agency guidance documents are issued
in accordance with our Good Guidance
Practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Prescription drug user
fee activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total
hours
Sections 735 and 736 of the FD&C Act (PDUFA waivers,
not including small business waivers) ..............................
Section 736(d)(1)(C) of the FD&C Act and Form FDA
3971 (small business waivers) .........................................
Reconsideration Requests ...................................................
Appeal Requests ..................................................................
User Fee Cover Sheet Form FDA 3397 ..............................
112
1.68
189
17
3,213
37
6
1
174
1
1.67
1
1
37
10
1
174
2
24
12
0.5
(30 minutes)
74
240
12
87
Total ..............................................................................
........................
........................
411
........................
3,626
1 There
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Number of
respondents
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency records,
we estimate that the number of initial
waiver requests submitted annually
(excluding small business waiver
requests under section 736(d)(1)(C)) of
the FD&C Act) will be 189, submitted by
112 different applicants; and that 37
respondents annually will each submit
a small business waiver request. We
have included in the burden estimate
the time for preparation and submission
of application fee waivers for small
businesses, including completion of
Form FDA 3971. Small businesses
requesting a waiver must submit
documentation to FDA, including the
number of their employees, as well as
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.
We estimate receiving 10 requests for
reconsideration annually (including
small business waiver reconsiderations),
and assume the average burden for
preparing and submitting each request
is 24 hours. In addition, we estimate
receiving 1 request annually for appeal
of user fee waiver determination, and
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assume the time needed to prepare an
appeal is 12 hours. We have included in
this estimate both the time needed to
prepare the request for appeal to the
Chief Scientist and User Fee Appeals
Officer within the 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 within the Office
of Management at FDA’s Center for Drug
Evaluation and Research.
We assume 87 hours of burden for
completing and submitting Form FDA
3397 (Prescription Drug User Fee
Coversheet) for submission of a new
drug application or biologics license
application.
The information collection reflects an
overall increase since our last request
for OMB review and approval. We
attribute this to expected fluctuations in
submissions to the Agency.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–2224]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ZEPZELCA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: November 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ZEPZELCA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
[FR Doc. 2021–26079 Filed 11–29–21; 8:45 am]
DATES:
BILLING CODE 4164–01–P
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SUMMARY:
Anyone with knowledge that any
of the dates as published (see
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]]>Agencies
[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Notices]
[Pages 67958-67960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26079]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-N-0101]
Agency Information Collection Activities; Proposed Collections;
Comment Request; Prescription Drug User Fee Program
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 collections 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 information collection
associated with FDA's Prescription Drug User Fee program.
DATES: Submit either electronic or written comments on the collection
of information by January 31, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 31, 2022. The https://www.regulations.gov electronic filing system will accept
[[Page 67959]]
comments until 11:59 p.m. Eastern Time at the end of January 31, 2022.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2005-N-0101 for ``Agency Information Collection Activities;
Proposed Collections; Comment Request; Prescription Drug User Fee
Program.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
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 Dockets Management Staff. 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.govinfo.gov/content/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 Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Prescription Drug User Fee Program
OMB Control Number 0910-0297--Revision
This information collection supports implementation of the Food and
Drug Administration Prescription Drug User Fee (PDUFA) program. PDUFA
was enacted in 1992 and authorizes FDA to collect fees from companies
that produce certain human drug and biological products. Under the
prescription drug user fee provisions of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and
379h)), we have the authority to assess and collect user fees for
certain new drug applications (NDAs) and new biologics license
applications (BLAs). Under this authority, pharmaceutical companies pay
a fee for certain new NDAs and BLAs submitted to FDA for review. We
have established a PDUFA page on our website at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ that includes resources
and information regarding PDUFA topics at FDA.
Because the submission of user fees concurrently with applications
is required, review of an application by FDA cannot begin until the fee
is submitted. To assist respondents in this regard, we developed Form
FDA 3397 entitled, ``Prescription Drug User Fee
[[Page 67960]]
Cover Sheet.'' Associated instructions may be found on our website at
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm. The cover sheet (Form FDA 3397) need not be submitted
for certain FDA-regulated products, e.g., generic drugs, and Whole
Blood and Blood components for transfusion. The list of exempted
products is included under the instructions to Form FDA 3397.
Relatedly, sections 735 and 736 of the FD&C Act also provide for
waiver, reduction, refund, and reconsideration requests. We developed
the guidance document entitled ``Guidance for Industry--User Fee
Waivers, Reductions, and Refunds for Drug and Biological Products,''
and Form FDA 3971 (Small Business Waivers and Refund Requests), which
can be found on our website at https://www.fda.gov/media/131797/download.
We are revising the collection to include our current commitment
goals, as set forth in the document ``PDUFA Reauthorization Performance
Goals and Procedures Fiscal Years 2018 Through 2022,'' also found on
our website at https://www.fda.gov/media/99140/download. PDUFA is
currently authorized through September 30, 2022, with reauthorization
activities currently underway. The commitment goals represent the
product of FDA's discussions with the regulated industry and public
stakeholders, as mandated by Congress. FDA is committed to meeting
these goals and to continuous operational improvements associated with
PDUFA implementation. The commitment goals provide for the development
and issuance of topic-specific guidance. We maintain a searchable
guidance database on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-document. In publishing the respective
notices of availability for each guidance document, we include an
analysis under the PRA and invite public comment on the associated
information collection recommendations. In addition, all Agency
guidance documents are issued in accordance with our Good Guidance
Practice regulations in 21 CFR 10.115, which provide for public comment
at any time.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Prescription drug user fee Number of responses per Total annual Average burden Total hours
activity respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sections 735 and 736 of the FD&C 112 1.68 189 17 3,213
Act (PDUFA waivers, not
including small business
waivers).......................
Section 736(d)(1)(C) of the FD&C 37 1 37 2 74
Act and Form FDA 3971 (small
business waivers)..............
Reconsideration Requests........ 6 1.67 10 24 240
Appeal Requests................. 1 1 1 12 12
User Fee Cover Sheet Form FDA 174 1 174 0.5 87
3397........................... (30 minutes)
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Total....................... .............. .............. 411 .............. 3,626
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of Agency records, we estimate that the number of
initial waiver requests submitted annually (excluding small business
waiver requests under section 736(d)(1)(C)) of the FD&C Act) will be
189, submitted by 112 different applicants; and that 37 respondents
annually will each submit a small business waiver request. We have
included in the burden estimate the time for preparation and submission
of application fee waivers for small businesses, including completion
of Form FDA 3971. Small businesses requesting a waiver must submit
documentation to FDA, including the number of their employees, as well
as 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.
We estimate receiving 10 requests for reconsideration annually
(including small business waiver reconsiderations), and assume the
average burden for preparing and submitting each request is 24 hours.
In addition, we estimate receiving 1 request annually for appeal of
user fee waiver determination, and assume the time needed to prepare an
appeal is 12 hours. We have included in this estimate both the time
needed to prepare the request for appeal to the Chief Scientist and
User Fee Appeals Officer within the 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 within the Office of
Management at FDA's Center for Drug Evaluation and Research.
We assume 87 hours of burden for completing and submitting Form FDA
3397 (Prescription Drug User Fee Coversheet) for submission of a new
drug application or biologics license application.
The information collection reflects an overall increase since our
last request for OMB review and approval. We attribute this to expected
fluctuations in submissions to the Agency.
Dated: November 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26079 Filed 11-29-21; 8:45 am]
BILLING CODE 4164-01-P
