Notice2021-27889
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 244 (Thursday, December 23, 2021)</title>
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[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72983-72985]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27889]
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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.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management
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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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#99c9cbd8caedf8ffffd9fffdf8b7f1f1eab7fef6ef"><span class="__cf_email__" data-cfemail="dc8c8e9d8fa8bdbaba9cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a>.
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.
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\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
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification</a>.
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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
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