Notice2022-08726
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
April 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 87 Issue 79 (Monday, April 25, 2022)</title>
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[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24310-24311]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08726]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4206]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device User
Fee Small Business Qualification and Certification
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 25,
2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. All comments should be
identified with the OMB control number 0910-0508. Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-45, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#85d5d7c4d6f1e4e3e3c5e3e1e4abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="82d2d0c3d1f6e3e4e4c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device User Fee Small Business Qualification and Certification
OMB Control Number 0910-0508--Extension
This information collection helps support implementation of the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L.
107-250) and FDA's Medical Device User Fee program. Current
authorization for medical device user fees will be in place from
October 1, 2017, until September 30, 2022.
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
[[Page 24311]]
$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. 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.
Forms FDA 3602 (``MDUFA Small Business Certification Request for a
Business Headquartered in the United States'') and 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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In the Federal Register of December 23, 2021 (86 FR 72983), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received, however it did not
respond to the functional elements solicited in our 60-day notice or
suggest a revision to our burden estimate.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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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Total....................... .............. .............. .............. .............. 4,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our estimated burden is based on the number of applications
received in the last few years and includes the time we assume
necessary to prepare and submit required information. Based on our
experience with Forms FDA 3602 and 3602A, we assume it will take
respondents 1 hour to complete either form. We have adjusted our
estimated ``No. of Respondents'' to better reflect recent submission
volume. This adjustment results in a 2,500-hour decrease to the
information collection.
Dated: April 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08726 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P
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