Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification, 72983-72985 [2021-27889]
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Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information under 21 CFR part 807,
subpart E, have been approved under
OMB control number 0910–0120; the
collections of information under 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; the collections of
information under 21 CFR part 814,
subpart H, have been approved under
OMB control number 0910–0332; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information for the De
Novo Classification Process (Evaluation
of Automatic Class III Designation) have
been approved under OMB control
number 0910–0844; and the collections
of information in the guidance
document entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program’’ have been approved under
OMB control number 0910–0756. The
collections of information in 21 CFR
part 314 (Applications for FDA
Approval to Market a New Drug) and 21
CFR part 601 (General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension) have been approved under
OMB control numbers 0910–0001 and
0910–0338, respectively. The
collections of information in 21 CFR
parts 50 and 56 (Protection of Human
Subjects: Informed Consent;
Institutional Review Boards) have been
approved under OMB control number
0910–0130.
jspears on DSK121TN23PROD with NOTICES1
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may obtain the draft guidance at https://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/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
Dated: December 20, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27894 Filed 12–22–21; 8:45 am]
BILLING CODE 4164–01–P
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20:50 Dec 22, 2021
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4206]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Small Business Qualification
and Certification
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 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 Form FDA 3602
and Form FDA 3602A, on which
domestic and foreign applicants certify
that they qualify as a small business and
pay certain medical device user fees at
reduced rates.
DATES: Submit either electronic or
written comments on the collection of
information by February 22, 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 February 22,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 22, 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.
SUMMARY:
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
PO 00000
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72983
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–
2018–N–4206 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device User Fee Small Business
Qualification and Certification.’’
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
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Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
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:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
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.
Medical Device User Fee Small
Business Qualification and Certification
OMB Control Number 0910–0508—
Extension
Medical device user fees were first
established in 2002 by the Medical
Device User Fee and Modernization Act
(MDUFMA) (Pub. L. 107–250). User fees
were renewed in 2007, with the Medical
Device User Fee Amendments to the
FDA Amendments Act (MDUFA II), in
2012 with the Medical Device User Fee
Amendments to the FDA Safety and
Innovation Act (MDUFA III), and in
2017 with the Medical Device User Fee
Amendments to the FDA
Reauthorization Act (MDUFA IV).
MDUFA IV will be in place from
October 1, 2017, until September 30,
2022.
A ‘‘small business’’ is eligible for
reduced or waived fees. If an applicant
does not provide information to FDA
demonstrating to FDA’s satisfaction that
the applicant is a small business, the
applicant must pay the standard (full)
fee for any application it submits.
Section 738(d)(2)(A) and (e)(2)(A) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j(d)(2)(A) and
(e)(2)(A)) define a ‘‘small business’’ as
an entity that reported $100 million or
less of gross receipts or sales in its most
recent Federal income tax return,
including such returns of its affiliates,
partners, and parent firms. If a firm’s
gross receipts or sales are no more than
$30 million (including all affiliates,
partners, and parent firms), they will
also qualify for a waiver of the fee for
their first (ever) premarket application,
product development protocol,
biological licensing application, or
premarket report.
Forms FDA 3602 (‘‘MDUFA Small
Business Certification Request for a
Business Headquartered in the United
States’’) and FDA 3602A (‘‘MDUFA
Foreign Small Business Certification
Request for a Business Headquartered
Outside the United States’’) are
submitted to FDA to demonstrate that
an applicant qualifies as a MDUFA
small business. The guidance ‘‘Medical
Device User Fee Small Business
Qualification and Certification;
Guidance for Industry, Food and Drug
Administration Staff and Foreign
Governments’’ 1 describes the process by
which a business may request
certification as a small business and the
criteria FDA will use to decide whether
an entity qualifies as a MDUFA small
business and is eligible for a reduction
in user fees.
This estimated burden is based on the
number of applications received in the
last few years and includes time
required to collect the required
information. Based on our experience
with Forms FDA 3602 and FDA 3602A,
FDA believes it will take respondents 1
hour to complete either form.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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FDA form No.
FDA 3602—MDUFA Small Business Certification Request
For a Business Headquartered in the United States .......
FDA 3602A—MDUFA Foreign Small Business Certification
Request For a Business Headquartered Outside the
United States ....................................................................
1 The guidance ‘‘Medical Device User Fee Small
Business Qualification and Certification Guidance
for Industry, Food and Drug Administration Staff
VerDate Sep<11>2014
20:50 Dec 22, 2021
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Number of
responses per
respondent
Frm 00068
Average
burden per
response
Total hours
2,500
1
2,500
1
2,500
2,000
1
2,000
1
2,000
and Foreign Governments’’ is available at https://
www.fda.gov/regulatory-information/search-fda-
PO 00000
Total annual
responses
Fmt 4703
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guidance-documents/medical-device-user-feesmall-business-qualification-and-certification.
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Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
FDA form No.
Total ..............................................................................
1 There
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
4,500
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated ‘‘No. of Respondents’’
has been updated to better reflect the
recent submission volume. This
adjustment has resulted in a 2,500-hour
decrease in the estimated ‘‘Total Hours’’
burden.
Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27889 Filed 12–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990–0479]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, Health
and Human Service, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
SUMMARY:
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before January 24, 2022.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When requesting
information, please include the
document identifier 0990–0479–30D
and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
Number of
respondents
Type of respondent
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Family
Planning Annual Report 2.0.
Type of Collection: Revision.
OMB No. 0990–0479.
Abstract: The Office of Population
Affairs (OPA), within the Office of the
Assistant Secretary for Health, seeks
approval for a revision of the 3-year
encounter level data collection for the
Family Planning Annual Report (FPAR).
This annual reporting requirement is for
competitively awarded grants
authorized and funded by the Title X
Family Planning Program. Currently
approved under 0990–0479, this
revision is adding the collection of two
new data elements, sexual orientation
and gender identity. OPA does not
expect the addition of these elements to
substantially change the burden.
Number
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Grantees ..........................................................................................................
70
1
102
7140
Total ..........................................................................................................
70
1
102
7140
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2021–27829 Filed 12–22–21; 8:45 am]
BILLING CODE 4150–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
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Total hours
Substance Abuse and Suicide
Prevention Program: Suicide
Prevention, Intervention, and
Postvention; Correction
Indian Health Service,
Department of Health and Human
Services.
AGENCY:
ACTION:
Notice; correction.
VerDate Sep<11>2014
20:50 Dec 22, 2021
The Indian Health Service
published a Notice of Funding
Opportunity in the Federal Register of
November 4, 2021, for the Suicide
Prevention, Intervention, and
Postvention grant program. The notice
was missing a section in the description
of the required Project Narrative that
applicants must submit with their
application. The Project Narrative will
have a fourth section added, Statement
of Need, and the page limit for the
Project Narrative will increase from 15
to 17 pages.
SUMMARY:
Paul
Gettys, Acting Director, Division of
Grants Management, 5600 Fishers Lane,
Rockville, MD 20857, Phone: (301) 443–
2114.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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Corrections
1. In the Federal Register of
November 4, 2021, in FR Doc 2021–
24022, on page 60861, in the second
column, under IV. Application and
Submission Information, under 3. SF–
424B, Assurances—Non-Construction
Programs, correct ‘‘Project Narrative’’ to
read: Project Narrative (not to exceed 17
pages).
2. In the Federal Register of
November 4, 2021, in FR Doc 2021–
24022, starting on page 60861, in the
third column and continuing to page
60862, in the first column, correct ‘‘A.
Project Narrative,’’ to read:
A. Project Narrative: This narrative
should be a separate document that is
no more than 17 pages and must: (1)
Have consecutively numbered pages; (2)
use black font 12 points or larger; (3) be
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]]>Agencies
[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72983-72985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27889]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4206]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device User Fee Small Business Qualification
and Certification
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 Form FDA 3602 and Form FDA 3602A, on which
domestic and foreign applicants certify that they qualify as a small
business and pay certain medical device user fees at reduced rates.
DATES: Submit either electronic or written comments on the collection
of information by February 22, 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 February 22, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 22, 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-2018-N-4206 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device User Fee Small
Business Qualification and Certification.'' 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
[[Page 72984]]
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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Medical Device User Fee Small Business Qualification and Certification
OMB Control Number 0910-0508--Extension
Medical device user fees were first established in 2002 by the
Medical Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107-
250). User fees were renewed in 2007, with the Medical Device User Fee
Amendments to the FDA Amendments Act (MDUFA II), in 2012 with the
Medical Device User Fee Amendments to the FDA Safety and Innovation Act
(MDUFA III), and in 2017 with the Medical Device User Fee Amendments to
the FDA Reauthorization Act (MDUFA IV). MDUFA IV will be in place from
October 1, 2017, until September 30, 2022.
A ``small business'' is eligible for reduced or waived fees. If an
applicant does not provide information to FDA demonstrating to FDA's
satisfaction that the applicant is a small business, the applicant must
pay the standard (full) fee for any application it submits.
Section 738(d)(2)(A) and (e)(2)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(d)(2)(A) and (e)(2)(A)) define a ``small
business'' as an entity that reported $100 million or less of gross
receipts or sales in its most recent Federal income tax return,
including such returns of its affiliates, partners, and parent firms.
If a firm's gross receipts or sales are no more than $30 million
(including all affiliates, partners, and parent firms), they will also
qualify for a waiver of the fee for their first (ever) premarket
application, product development protocol, biological licensing
application, or premarket report.
Forms FDA 3602 (``MDUFA Small Business Certification Request for a
Business Headquartered in the United States'') and FDA 3602A (``MDUFA
Foreign Small Business Certification Request for a Business
Headquartered Outside the United States'') are submitted to FDA to
demonstrate that an applicant qualifies as a MDUFA small business. The
guidance ``Medical Device User Fee Small Business Qualification and
Certification; Guidance for Industry, Food and Drug Administration
Staff and Foreign Governments'' \1\ describes the process by which a
business may request certification as a small business and the criteria
FDA will use to decide whether an entity qualifies as a MDUFA small
business and is eligible for a reduction in user fees.
---------------------------------------------------------------------------
\1\ The guidance ``Medical Device User Fee Small Business
Qualification and Certification Guidance for Industry, Food and Drug
Administration Staff and Foreign Governments'' is available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification.
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This estimated burden is based on the number of applications
received in the last few years and includes time required to collect
the required information. Based on our experience with Forms FDA 3602
and FDA 3602A, FDA believes it will take respondents 1 hour to complete
either form.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
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FDA 3602--MDUFA Small Business 2,500 1 2,500 1 2,500
Certification Request For a
Business Headquartered in the
United States..................
FDA 3602A--MDUFA Foreign Small 2,000 1 2,000 1 2,000
Business Certification Request
For a Business Headquartered
Outside the United States......
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[[Page 72985]]
Total....................... .............. .............. .............. .............. 4,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimated ``No. of Respondents'' has been updated to better
reflect the recent submission volume. This adjustment has resulted in a
2,500-hour decrease in the estimated ``Total Hours'' burden.
Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27889 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P
