Notice2025-10387
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
June 9, 2025
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 90 Issue 109 (Monday, June 9, 2025)</title>
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[Federal Register Volume 90, Number 109 (Monday, June 9, 2025)]
[Notices]
[Pages 24280-24281]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10387]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1873]
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, 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: Submit written comments (including recommendations) on the
collection of information by July 9, 2025.
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. The OMB control number for
this information collection is 0910-0508. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#1b4b495a486f7a7d7d5b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="a8f8fae9fbdcc9cecee8ceccc986c0c0db86cfc7de">[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--Revision
This information collection helps support implementation of the
Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L.
107-250), most recently reauthorized in 2022 from October 1, 2022,
until September 30, 2027. To qualify as a ``small business,'' and
therefore be eligible for reduced or waived fees, respondents submit
information to FDA so we can determine whether the applicant is a small
business. Sections 738(d)(2)(A) and (e)(2)(A) of the FD&C 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 (PMA), product
development protocol (PDP), biological licensing application (BLA), or
premarket report.
In the Federal Register of February 22, 2024 (89 FR 13349), FDA
announced the availability of the draft guidance for industry entitled
``Select Updates for the Medical Device User Fee Small Business
Qualification and Certification Guidance'' (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-medical-device-user-fee-small-business-qualification-and-certification-guidance">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-medical-device-user-fee-small-business-qualification-and-certification-guidance</a>). The guidance includes select updates to
the guidance ``Medical Device User Fee Small Business Qualification and
Certification'' (August 2018), 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>) which describe
how FDA plans to determine if a small business is experiencing
``financial hardship'' that makes them eligible for a waiver of their
registration fee. A manufacturer seeking the small business fee waiver
may provide evidence of a reported $1 million or less of gross receipts
or sales in its most recent Federal income tax return, as well as
evidence that they have filed a petition for bankruptcy and that the
bankruptcy is currently active. The proposed updates also reflect that
firms based in jurisdictions without a National Taxing Authority (NTA)
need not submit a
[[Page 24281]]
certification from their NTA to be eligible for fee waivers or
reductions.
Additionally, FDA intends to consolidate the forms previously known
as FDA 3602 and FDA 3602A into a single webform, the ``MDUFA Small
Business Request'' (MDUFA SBR, FDA 3602N) to be completed by foreign as
well as U.S. businesses/applicants via FDA's Center for Devices and
Radiological Health Customer Collaboration Portal (CDRH Portal). We
have also added to the MDUFA SBR a ``Registration & Listing Waiver''
section which asks if the business/applicant will apply for a
registration and listing fee waiver and whether they have applied in
the past. Applicants seeking this waiver will be asked to include proof
of bankruptcy documentation in the supporting documentation section.
In the Federal Register of February 22, 2024 (89 FR 13349), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Three comments were received, but they were
not related to the information collection.
FDA estimates 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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MDUFA Small Business Request webform--FDA 3602N.................... 4,500 1 4,500 1 4,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
As discussed previously in this document, we have proposed updates
to the guidance document, ``Medical Device User Fee Small Business
Qualification and Certification Guidance for Industry, Food and Drug
Administration Staff and Foreign Governments,'' (August 2018)
consistent with amendments to section 738(a)(3)(B) of the FD&C Act.
Because we assume that current bankruptcy documentation is readily
available to applicants, we assume no change to the Average Burden per
Response for this information collection.
Aside from the changes already discussed, the total burden estimate
remains unchanged from the last OMB approval.
Dated: June 3, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10387 Filed 6-6-25; 8:45 am]
BILLING CODE 4164-01-P
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