[Federal Register Volume 89, Number 131 (Tuesday, July 9, 2024)]
[Notices]
[Pages 56390-56391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2844]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reclassification Petitions for Medical Devices

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 information collection associated with 
reclassification of medical devices.

DATES: Either electronic or written comments on the collection of 
information must be submitted by September 9, 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 September 9, 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, 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-2844 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reclassification Petitions for 
Medical Devices.'' 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 56391]]

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.

Reclassification Petitions for Medical Devices--21 CFR Part 860, 
Subpart C

OMB Control Number 0910-0138--Extension

    This information collection helps support implementation of 
statutory provisions found in sections 513(e) and (f), 514(b), 515(b), 
and 520(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 360c(e) and (f), 21 U.S.C. 360d(b), 21 U.S.C. 360e((b), and 21 
U.S.C. 360j(l)) pertaining to the reclassification of medical devices. 
Specifically, the FD&C Act establishes three tiers of regulatory 
control for medical devices, by establishing three classes of medical 
devices, and requiring that all devices be classified into one of these 
three classes. The classification of a device depends upon the degree 
of regulatory control necessary to provide a reasonable assurance of 
the safety and effectiveness of the device. The three tiers of 
regulatory control are: (1) Class I--general controls, subject to 
sections 501 adulteration, 502 misbranding, 510 registration, 516 
banned devices, 518 notification and other remedies, 519 records and 
reports, and 520 general provisions of the FD&C Act; (2) Class II--
performance standards; and (3) Class III--premarket approval.
    Implementing regulations in 21 CFR part 860, subpart C (parts 
860.120 through 860.136) provide that any person may petition for 
reclassification of a device from any class to any other class, and 
prescribe requisite format and content elements for reclassification 
petitions submitted to the Agency. We also provide information on our 
website at https://www.fda.gov/about-fda/cdrh-transparency/reclassification regarding medical device reclassification, which may 
serve as a helpful resource to respondents.
    FDA is responsible for reviewing petitions for reclassification and 
determining whether the subject device will be reclassified. In some 
instances, FDA also submits such petitions to one of its medical device 
advisory panels for review and recommendations. FDA's decision 
regarding the reclassification of a device is based primarily upon the 
information contained in the petition. Respondents to the information 
collection are private sector, for-profit businesses. We have not 
identified reclassification petitions as a type of submission we are 
currently prepared to accept electronically. Submission instructions, 
including addresses, are provided in Sec.  860.123(b).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                       21 CFR part; activity                            Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Sec.   860.123; supporting data for reclassification petitions.....              12                1               12              497            5,964
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Reclassification petitions must be submitted as set forth in the 
applicable regulations, which provide for the submission of an original 
and two copies (Sec.  860.123(b)(4)). Each petition must include 
supporting data to show why reclassification of the device type will 
provide reasonable assurance of the safety and effectiveness of the 
device type. The principal data in such a petition will typically be 
reports of clinical trials.
    Our estimated burden for the information collection reflects an 
increase of 6 responses and a corresponding increase of 2,982 hours. We 
attribute this adjustment to an increase in the number of submissions 
we received over the last few years.

    Dated: July 3, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-14995 Filed 7-8-24; 8:45 am]
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