Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation), 106512-106513 [2024-31014]
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106512
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
Dated: December 17, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2024–31261 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
De Novo Classification Process
(Evaluation of Automatic Class III
Designation)—21 CFR Part 860, Subpart
D
Food and Drug Administration
[Docket No. FDA–2024–N–2149]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; De Novo
Classification Process (Evaluation of
Automatic Class III Designation)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 29,
2025.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0844. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
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
OMB Control Number 0910–0844—
Revision
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 Act (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 part
860, subpart D (21 CFR part 860, subpart
D) (§§ 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.
FDA’s guidance for industry and FDA
staff, ‘‘De Novo Classification Process
(Evaluation of Automatic Class III
Designation)’’, provides guidance on the
process for the submission and review
of a De Novo classification request
under section 513(f)(2) of the FD&C Act,
also known as the De Novo
classification process. This process
provides a pathway to class I or class II
classification for medical devices for
which general controls or general and
special controls provide a reasonable
assurance of safety and effectiveness,
but for which there is no legally
marketed predicate device.
In addition to regulatory requirements
set forth in part 860, subpart D, the
guidance document entitled
‘‘Acceptance Review for De Novo
Classification Requests’’ communicates
our thinking on criteria set out in
§ 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 guidance document ‘‘Electronic
Submission Template for Medical
Device De Novo Requests,’’ provides the
standards for the submission of De Novo
requests by electronic format, a
timetable for establishment of these
standards, and criteria for waivers of
and exemptions from the requirements
to meet a statutory requirement. This
guidance is also intended to represent
one of several steps in meeting FDA’s
commitment to the development of
electronic submission templates to serve
as guided submission preparation tools
for industry to improve submission
consistency and enhance efficiency in
the review process.
The collections of information
described by this notice are necessary to
satisfy the previously mentioned
statutory requirements for
administration of this voluntary
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 forprofit businesses.
In the Federal Register of May 29,
2024 (89 FR 46402), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR part 860, subpart D;
information collection activity
§§ 860.210, 860.220, 860.230; De
Novo requests—format, content,
and acceptance elements.
§ 860.230; FDA acceptance of request (GFI Acceptance Checklist;
Appendix A) 1.
VerDate Sep<11>2014
23:58 Dec 27, 2024
Number of
responses per
respondent
Number of
respondents
Jkt 265001
Total annual
responses
Average burden per response
Total hours
79
1
79
182 ...................................................
14,378
79
1
79
...........................................................
........................
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
E:\FR\FM\30DEN1.SGM
30DEN1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
106513
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued
21 CFR part 860, subpart D;
information collection activity
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden per response
Total hours
§ 860.250; withdrawal of request ......
5
1
5
0.17 (10 mins.) .................................
1
Total ...........................................
........................
........................
........................
...........................................................
14,379
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.
Since the publication of the 60-day
notice, we issued the guidance
document entitled ‘‘Electronic
Submission Template for Medical
Device De Novo Requests’’ (August 23,
2024, 89 FR 68166; https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
electronic-submission-templatemedical-device-de-novo-requests) and
are including it in this information
collection. Given that all submissions
were previously received electronically
and the ability to voluntarily submit De
Novo requests using eSTAR was
included in the previous information
collection request (ICR), inclusion of the
guidance in this ICR is not expected to
impact the estimated burden.
Dated: December 13, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31014 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Request for Nominations of Individuals
and Industry Organizations for the
Patient Engagement Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
requesting that any industry
organizations interested in participating
in the selection of a pool of nonvoting
industry representatives to serve as
temporary nonvoting members on the
Patient Engagement Advisory
SUMMARY:
VerDate Sep<11>2014
23:58 Dec 27, 2024
Jkt 265001
Committee (the Committee) in the
Center for Devices and Radiological
Health notify FDA in writing. FDA is
also requesting nominations for
temporary nonvoting industry
representatives to be included in a pool
of individuals to serve on the
Committee. Nominees recommended to
serve as a temporary nonvoting industry
representative may either be selfnominated or nominated by an industry
organization. This position may be filled
by representatives from different
medical device areas based on expertise
relevant to the topics being considered
by the Committee. Nominations will be
accepted for upcoming vacancies
effective with this notice. FDA seeks to
include the views of women and men,
members of all racial and ethnic groups,
and individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interest
must send a letter stating that interest to
the FDA by January 29, 2025, (see
sections I and II of this document for
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by January 29,
2025.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of a pool of nonvoting industry
representatives should be sent
electronically to Margaret Ames (see FOR
FURTHER INFORMATION CONTACT). All
nominations for nonvoting industry
representatives should be submitted
electronically by accessing the FDA
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
PO 00000
Frm 00108
Fmt 4703
Sfmt 4703
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring,
MD 20993–0002, 301–796–5960, email:
margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for a pool of
nonvoting industry representatives for
the Committee. The list of needed
expertise on May 1, 2025, is identified
below:
• Cybersecurity
• Communication of Benefit & Risk
Information to Patients; Medical
Device Labeling
• Digital Health Technology/Artificial
Intelligence
• Health Equity
• Patient Engagement
• Patient Preference Elicitation
• Patient-Reported Outcomes
Development, Validation, and Use in
Regulatory Studies or Clinical
Practice
• Postmarket Studies, Including
Observational and Registry-Based
Studies
• Human Factors
FDA is publishing separate
documents regarding:
1. Request for Nominations for Voting
Members for the Patient Engagement
Advisory Committee
2. Request for Nominations for
Consumer Representative for the
Patient Engagement Advisory
Committee
I. General Description of the
Committee’s Duties
The Committee provides advice on
complex issues relating to medical
devices, the regulation of devices, and
their use by patients. Agency guidance
and policies, clinical trial or registry
design, patient preference study design,
benefit-risk determinations, device
labeling, unmet clinical needs, available
alternatives, patient reported outcomes
and device-related quality of life or
E:\FR\FM\30DEN1.SGM
30DEN1
Agencies
[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106512-106513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31014]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2149]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; De Novo
Classification Process (Evaluation of Automatic Class III Designation)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 29, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0844. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
De Novo Classification Process (Evaluation of Automatic Class III
Designation)--21 CFR Part 860, Subpart D
OMB Control Number 0910-0844--Revision
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 Act (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 part 860, subpart D (21 CFR part 860,
subpart D) (Sec. Sec. 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.
FDA's guidance for industry and FDA staff, ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'', provides
guidance on the process for the submission and review of a De Novo
classification request under section 513(f)(2) of the FD&C Act, also
known as the De Novo classification process. This process provides a
pathway to class I or class II classification for medical devices for
which general controls or general and special controls provide a
reasonable assurance of safety and effectiveness, but for which there
is no legally marketed predicate device.
In addition to regulatory requirements set forth in part 860,
subpart D, the guidance document entitled ``Acceptance Review for De
Novo Classification Requests'' communicates our thinking on criteria
set out in Sec. 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 guidance document ``Electronic Submission Template for Medical
Device De Novo Requests,'' provides the standards for the submission of
De Novo requests by electronic format, a timetable for establishment of
these standards, and criteria for waivers of and exemptions from the
requirements to meet a statutory requirement. This guidance is also
intended to represent one of several steps in meeting FDA's commitment
to the development of electronic submission templates to serve as
guided submission preparation tools for industry to improve submission
consistency and enhance efficiency in the review process.
The collections of information described by this notice are
necessary to satisfy the previously mentioned statutory requirements
for administration of this voluntary 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.
In the Federal Register of May 29, 2024 (89 FR 46402), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
21 CFR part 860, subpart D; Number of
information collection Number of responses per Total annual Average burden Total hours
activity respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 860.210, 860.220, 79 1 79 182............. 14,378
860.230; De Novo requests--
format, content, and
acceptance elements.
Sec. 860.230; FDA acceptance 79 1 79 ................ ..............
of request (GFI Acceptance
Checklist; Appendix A) \1\.
[[Page 106513]]
Sec. 860.250; withdrawal of 5 1 5 0.17 (10 mins.). 1
request.
---------------
Total..................... .............. .............. .............. ................ 14,379
----------------------------------------------------------------------------------------------------------------
\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. Since the publication
of the 60-day notice, we issued the guidance document entitled
``Electronic Submission Template for Medical Device De Novo Requests''
(August 23, 2024, 89 FR 68166; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests) and are including it in this
information collection. Given that all submissions were previously
received electronically and the ability to voluntarily submit De Novo
requests using eSTAR was included in the previous information
collection request (ICR), inclusion of the guidance in this ICR is not
expected to impact the estimated burden.
Dated: December 13, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31014 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P