[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24310-24311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification.
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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......
                                 -------------------------------------------------------------------------------
    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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