Notice2024-11743
Agency Information Collection Activities; Proposed Collection; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 104 (Wednesday, May 29, 2024)</title>
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[Federal Register Volume 89, Number 104 (Wednesday, May 29, 2024)]
[Notices]
[Pages 46402-46404]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically,
[[Page 46403]]
including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#e3b3b1a2b097828585a3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="a3f3f1e2f0d7c2c5c5e3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>.
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
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