[Federal Register Volume 89, Number 36 (Thursday, February 22, 2024)]
[Notices]
[Pages 13349-13351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03619]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1873]


Select Updates for the Medical Device User Fee Small Business 
Qualification and Certification Guidance; Draft Guidance for Industry; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Select Updates 
for the Medical Device User Fee Small Business Qualification and 
Certification Guidance.'' The guidance includes select updates to the 
guidance ``Medical Device User Fee Small Business Qualification and 
Certification'' which describe how FDA plans to determine if a small 
business is experiencing ``financial hardship'' which makes them 
eligible for a waiver of their registration fee. The guidance will 
detail what information FDA will review and consider in making this 
determination. This draft guidance is not final nor is it for 
implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by April 22, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit electronic or written comments on the 
proposed collection of information in the draft guidance by April 22, 
2024.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-D-1873 for ``Select Updates for the Medical Device User Fee 
Small Business Qualification and Certification Guidance.'' Received 
comments 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 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this draft guidance 
document entitled ``Select Updates for the Medical Device User Fee 
Small Business Qualification and Certification Guidance'' to Office of 
Policy, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a Fax number to which 
the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the draft guidance: Jason Brookbank, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5234, Silver Spring, MD 20993-0002, 
301-796-5498, [email protected] or James Myers, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911.
    With regard to the proposed collection of information: 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:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Select Updates for the Medical Device User Fee Small 
Business Qualification and Certification Guidance.'' On December 29, 
2022, the Food and Drug

[[Page 13350]]

Omnibus Reform Act of 2022 was signed into law as part of the 
Consolidated Appropriations Act, 2023, Public Law 117-328. section 3309 
of the Omnibus--``Small Business Fee Waiver''--amended section 
738(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by 
adding clause (ii) ``Small business fee waiver.'' The amended language 
gave FDA the discretion, beginning in fiscal year 2025, to waive the 
annual registration fee for device establishments that are small 
businesses if FDA determines that paying such fee represents a 
financial hardship. Additionally, the amended statute acknowledges that 
device establishments may be located in countries without a national 
taxing authority (NTA). As a result of this amended statutory language, 
FDA is issuing this draft guidance to propose select updates to the 
guidance ``Medical Device User Fee Small Business Qualification and 
Certification'' which will describe how FDA plans to determine if a 
small business is experiencing ``financial hardship'' which makes them 
eligible for a waiver of their registration fee. The guidance details 
what information FDA will review and consider in making this 
determination.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on Select Updates 
for the Medical Device User Fee Small Business Qualification and 
Certification guidance. It does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Select Updates for the Medical Device 
User Fee Small Business Qualification and Certification Guidance'' may 
send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 
GUI00018007 and complete title to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    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 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.

MDUFMA Small Business Qualification 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.
    The proposed updates to the Small Business Guidance describe how 
small businesses can show ``financial hardship'' to qualify for a small 
business waiver of the registration fee. Manufacturers 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 how firms based in jurisdictions 
without an NTA need not submit a 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 form to be completed by foreign 
as well as U.S. businesses/applicants.
    We propose the following revisions to the information collection:
     Consolidation of forms FDA 3602 and FDA 3602A into a 
single form, FDA 3602, to be completed by foreign as well as domestic 
businesses; and
     Addition of a ``Registration & Listing Fee Waiver'' 
section in the revised form, which asks if the business/applicant will 
apply for a registration and listing fee waiver and whether they have 
registered in the past. FDA recommends that applicants seeking this 
waiver include documentation supporting eligibility, including evidence 
that applicants have filed a petition for bankruptcy in United States 
Bankruptcy Court and that the bankruptcy is currently active (debts 
have yet to be discharged or a reorganization plan has not been 
confirmed) as well as evidence of prior registration as applicable.
    FDA estimates the burden of this collection of information as 
follows:

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                                 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
                                         respondents       respondent       responses       response      hours
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FDA 3602 MDUFA Small Business                   4,500                1            4,500             1     4,500
 Certification Request...............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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. Based on a review of the 
information collection since our last request for OMB approval, we have 
made no adjustments to our total burden estimate.

    Dated: February 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03619 Filed 2-21-24; 8:45 am]
BILLING CODE 4164-01-P