Document ID: FDA-2018-N-4206-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Small Business Qualification and Certification
Posted Date: 2021-12-23T05:00Z

[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72983-72985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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

[[Page 72984]]

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.

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, 
[email protected].

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 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-certification.
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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