[Federal Register Volume 89, Number 104 (Wednesday, May 29, 2024)]
[Notices]
[Pages 46402-46404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2149]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; De Novo Classification Process (Evaluation of 
Automatic Class III Designation)

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 the information collection provisions 
related to the De Novo Classification Process.

DATES: Either electronic or written comments on the collection of 
information must be submitted by July 29, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 29, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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,

[[Page 46403]]

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-2024-N-2149 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; De Novo Classification Process 
(Evaluation of Automatic Class III Designation).'' 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 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: 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, 
[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.

De Novo Classification Process (Evaluation of Automatic Class III 
Designation)--21 CFR Part 860, Subpart D

OMB Control Number 0910-0844--Extension

    This information collection supports FDA regulations and 
information collection discussed in associated guidance. Sections 
201(h), 513(a) and (f), 701(a), and 704 of the Federal Food, Drug, and 
Cosmetic (FD&C Act) (21 U.S.C. 321(h), 360c(a) and (f), 371(a), and 
374) establish a comprehensive system for the regulation of medical 
devices intended for human use. Section 513(f)(2) of the FD&C Act 
provides for a ``De Novo'' classification process, most recently 
amended by section 3101 of the 21st Century Cures Act (Pub. L. 114-
255). The final rule ``Medical Device De Novo Classification Process'' 
(86 FR 54826), established 21 CFR part 860, subpart D (sections 860.200 
through 860.260) to implement provisions in section 513(f)(2) of the 
FD&C Act. These regulations govern format and content elements for De 
Novo device classification requests, as well as withdrawal of the 
requests, and explain FDA procedures for acceptance, review, and 
granting or denying a request.
    In addition to regulatory requirements set forth in 21 CFR part 
860, subpart D, the guidance document entitled ``Acceptance Review for 
De Novo Classification Requests'' communicates our thinking on criteria 
set out in 21 CFR part 860.230, in assessing whether a De Novo request 
should be accepted for substantive review. The guidance document 
includes an ``Acceptance Checklist'' to assist respondents in this 
regard.
    The collections of information described by this notice are 
necessary to satisfy the previously mentioned statutory requirements 
for administration of this voluntary

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submission program. FDA uses the information to evaluate whether a 
medical device may be reclassified from Class III into Class I or II, 
and if applicable, to determine the general and/or special controls 
necessary to sufficiently regulate the medical device. Respondents to 
this information collection are private sector or other for-profit 
businesses.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
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                                                                 Number of
   21 CFR part 860, subpart D; information       Number of     responses per   Total annual           Average burden per response           Total hours
             collection activity                respondents     respondent       responses
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Sec.  Sec.   860.210, 860.220, 860.230; De                79               1              79  182 hours.................................          14,378
 Novo requests--format, content, and
 acceptance elements.
Sec.   860.230; FDA acceptance of request                 79               1              79
 (GFI Acceptance Checklist; Appendix A) \1\.
Sec.   860.250; withdrawal of request.......               5               1               5  0.17 (10 mins.)...........................               1
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    Total...................................  ..............  ..............              84  ..........................................          14,379
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\1\ FDA assumes activities associated with review of the Acceptance Checklist are included in burden for submission of requests captured in row 1.

    Our estimated burden for the information collection reflects an 
overall increase of 2,002 hours and a corresponding increase of 11 
responses. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years.

    Dated: May 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11743 Filed 5-28-24; 8:45 am]
BILLING CODE 4164-01-P