Meeting of the Council on Graduate Medical Education, 67947-67948 [2024-18791]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 163 / Thursday, August 22, 2024 / Notices
Federal Food, Drug, and Cosmetic
(FD&C) Act (21 U.S.C. 360e–4). Section
515C of the FD&C Act has provisions
regarding PCCPs for devices requiring
premarket approval or premarket
notification. After the enactment of
FDORA, FDA issued a draft guidance
titled ‘‘Marketing Submission
Recommendations for a Predetermined
Change Control Plan for Artificial
Intelligence/Machine Learning (AI/ML)Enabled Device Software Functions,’’ 4
which incorporated stakeholder
feedback on the discussion paper and
reflected our initial thinking on the
statutory change and the types of
information we recommend be
submitted in a PCCP in a marketing
submission for AI/ML-enabled software
functions.
This draft guidance provides FDA’s
current thinking on a policy for PCCPs
and recommendations on the
information to include in a PCCP in a
marketing submission for a device. This
draft guidance recommends that a PCCP
for a device describe the planned device
modifications, the associated
methodology to develop, validate, and
implement those modifications, and an
assessment of the impact of those
modifications. FDA reviews the PCCP as
part of a marketing submission for a
device to ensure the continued safety
and effectiveness of the device without
necessitating additional marketing
submissions for implementing each
modification described in the PCCP.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Predetermined Change Control
Plans for Devices.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
radiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances. Persons unable to
download an electronic copy of
‘‘Predetermined Change Control Plans
for Devices’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number GUI00007026 and complete
title to identify the guidance you are
requesting.
II. Electronic Access
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in the following table have
been approved by OMB:
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-and-
OMB control
No.
Topic
807, subpart E ............................................................................
814, subparts A through E ..........................................................
860, subpart D ............................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
800, 801, 809, and 830 ..............................................................
Premarket notification ................................................................
Premarket approval ....................................................................
De Novo classification process ..................................................
Q-submissions and Early Payor Feedback Request Programs
for Medical Devices.
Medical Device Labeling Regulations; Unique Device Identification.
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.
Postmarket Surveillance of Medical Devices ............................
Good Laboratory Practice (GLP) Regulations for Nonclinical
Laboratory Studies.
820 ..............................................................................................
822 ..............................................................................................
58 ................................................................................................
[FR Doc. 2024–18828 Filed 8–21–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
BILLING CODE 4164–01–P
Meeting of the Council on Graduate
Medical Education
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
ddrumheller on DSK120RN23PROD with NOTICES1
III. Paperwork Reduction Act of 1995
21 CFR part or guidance
Dated: August 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
In accordance with the
Federal Advisory Committee Act, this
notice announces a change to the 2-day
Council on Graduate Medical Education
(COGME or Council) public meeting
SUMMARY:
4 Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/
VerDate Sep<11>2014
18:29 Aug 21, 2024
Jkt 262001
67947
Frm 00019
Fmt 4703
Sfmt 4703
0910–0485
0910–0073
0910–0449
0910–0119
scheduled for September 12, 2024, and
September 13, 2024. The meeting will
now be a 1-day meeting held on
September 12, 2024. Information about
COGME, agendas, and materials for this
meeting can be found on the COGME
website at https://www.hrsa.gov/
advisory-committees/graduate-medicaledu/meetings. This notice supersedes
information about COGME’s 2024
meetings found in the Federal Register
notice dated December 15, 2023,
Meeting of the Council on Graduate
Medical Education.
The COGME meeting will be
held on:
DATES:
marketing-submission-recommendationspredetermined-change-control-plan-artificial.
PO 00000
0910–0120
0910–0231
0910–0844
0910–0756
E:\FR\FM\22AUN1.SGM
22AUN1
ddrumheller on DSK120RN23PROD with NOTICES1
67948
Federal Register / Vol. 89, No. 163 / Thursday, August 22, 2024 / Notices
• September 12, 2024, 10:00 a.m.–5:30
p.m. Eastern Time
ADDRESSES: The meeting will be held by
teleconference and/or a video
conference platform. For updates on
how the meeting will be held, visit the
COGME website 20 calendar days before
the date of the meeting, where
instructions for joining meetings will be
posted. For meeting information
updates, go to the COGME website
meeting page at https://www.hrsa.gov/
advisory-committees/graduate-medicaledu/meetings.
FOR FURTHER INFORMATION CONTACT:
Shane Rogers, Designated Federal
Officer, Division of Medicine and
Dentistry, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Rockville,
Maryland 20857; 301–443–5260; or
SRogers@hrsa.gov.
SUPPLEMENTARY INFORMATION: COGME
provides advice and recommendations
to the Secretary of Health and Human
Services and Congress on policy,
program development, and other
matters of significance regarding the
issues listed in section 762(a)(1) of the
Public Health Service Act. Issues
addressed by COGME include the
supply and distribution of the physician
workforce in the United States,
including any projected shortages or
excesses; foreign medical school
graduates; the nature and financing of
undergraduate and graduate medical
education (GME); appropriation levels
for certain programs under Title VII of
the Public Health Service Act; and
deficiencies in databases concerning the
supply and distribution of the physician
workforce and postgraduate programs
for training physicians. COGME submits
reports to the Secretary of Health and
Human Services; the Senate Committee
on Health, Education, Labor and
Pensions; and the House of
Representatives Committee on Energy
and Commerce. COGME encourages
entities providing GME to conduct
activities to voluntarily achieve the
recommendations of the Council related
to appropriate efforts to be carried out
by hospitals, schools of medicine,
schools of osteopathic medicine, and
accrediting bodies with respect to the
supply and distribution of physicians in
the United States; current and future
shortages or excesses of physicians in
medical and surgical specialties and
subspecialties; and issues relating to
foreign medical school graduates,
including efforts for changes in
undergraduate and GME programs.
Since priorities dictate meeting times,
be advised that start times, end times,
and agenda items are subject to change.
For the September 12, 2024, meeting,
VerDate Sep<11>2014
17:28 Aug 21, 2024
Jkt 262001
agenda items may include, but are not
limited to, discussions on team-based
care, the Senate Finance Committee’s
Medicare GME draft policy document,
and the 2018 Government
Accountability Office’s Report on
Physician Workforce. Refer to the
COGME website listed above for all
current and updated information
concerning the September meeting,
including agendas and meeting
materials that will be posted 20 calendar
days before the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to COGME
should be sent to Shane Rogers using
the contact information above at least 5
business days before the meeting date.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–18791 Filed 8–21–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; The Maternal,
Infant, and Early Childhood Home
Visiting Program Quarterly
Performance Report
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than September 23,
2024.
ADDRESSES: Written comments and
recommendations for the proposed
SUMMARY:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
information collection should be sent
within 30 days of publication of this
notice to 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.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Quarterly Performance Report, OMB No.
0906–0016, Revision.
Abstract: This request is for continued
approval of the Maternal, Infant, and
Early Childhood Home Visiting
(MIECHV) Program Quarterly
Performance Report. The MIECHV
Program is administered by the
Maternal and Child Health Bureau
within HRSA in partnership with the
Administration for Children and
Families, and provides support to all 56
states and jurisdictions, as well as tribes
and tribal organizations. Through a
needs assessment, states, jurisdictions,
tribes, and tribal organizations identify
target populations and select the home
visiting service delivery model(s) that
best meet their needs. In response to
awardee feedback, HRSA is proposing
the following revisions to the data
collection forms to reduce
administrative burden related to this
performance report:
• Form 4, Table A.2: Remove Column
D: ZIP Codes
• Form 4, Definition of Key Terms:
Update definitions for Table A.2
• Form 4: Remove Section B
A 60-day notice published in the
Federal Register on May 2, 2024, vol.
89, No. 86; pp. 35841–42. HRSA
received one comment from an awardee.
The commentor discussed the
usefulness of collecting ZIP codes of
families served by MIECHV-funded
sites, suggested considering collection
of data on Tables A.2, A.3, and A.4 on
an annual basis, and supported the
burden estimate. While HRSA
recognizes the value of collecting
participant ZIP code data, after
weighing the significant burden
awardees have reported on collecting
and reporting this data, and considering
that its continued collection of
participant county data supports its data
needs, HRSA has decided to make no
changes to the proposed information
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 89, Number 163 (Thursday, August 22, 2024)]
[Notices]
[Pages 67947-67948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Meeting of the Council on Graduate Medical Education
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, this
notice announces a change to the 2-day Council on Graduate Medical
Education (COGME or Council) public meeting scheduled for September 12,
2024, and September 13, 2024. The meeting will now be a 1-day meeting
held on September 12, 2024. Information about COGME, agendas, and
materials for this meeting can be found on the COGME website at https://www.hrsa.gov/advisory-committees/graduate-medical-edu/meetings. This
notice supersedes information about COGME's 2024 meetings found in the
Federal Register notice dated December 15, 2023, Meeting of the Council
on Graduate Medical Education.
DATES: The COGME meeting will be held on:
[[Page 67948]]
September 12, 2024, 10:00 a.m.-5:30 p.m. Eastern Time
ADDRESSES: The meeting will be held by teleconference and/or a video
conference platform. For updates on how the meeting will be held, visit
the COGME website 20 calendar days before the date of the meeting,
where instructions for joining meetings will be posted. For meeting
information updates, go to the COGME website meeting page at https://www.hrsa.gov/advisory-committees/graduate-medical-edu/meetings.
FOR FURTHER INFORMATION CONTACT: Shane Rogers, Designated Federal
Officer, Division of Medicine and Dentistry, Bureau of Health
Workforce, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301-443-
5260; or [email protected].
SUPPLEMENTARY INFORMATION: COGME provides advice and recommendations to
the Secretary of Health and Human Services and Congress on policy,
program development, and other matters of significance regarding the
issues listed in section 762(a)(1) of the Public Health Service Act.
Issues addressed by COGME include the supply and distribution of the
physician workforce in the United States, including any projected
shortages or excesses; foreign medical school graduates; the nature and
financing of undergraduate and graduate medical education (GME);
appropriation levels for certain programs under Title VII of the Public
Health Service Act; and deficiencies in databases concerning the supply
and distribution of the physician workforce and postgraduate programs
for training physicians. COGME submits reports to the Secretary of
Health and Human Services; the Senate Committee on Health, Education,
Labor and Pensions; and the House of Representatives Committee on
Energy and Commerce. COGME encourages entities providing GME to conduct
activities to voluntarily achieve the recommendations of the Council
related to appropriate efforts to be carried out by hospitals, schools
of medicine, schools of osteopathic medicine, and accrediting bodies
with respect to the supply and distribution of physicians in the United
States; current and future shortages or excesses of physicians in
medical and surgical specialties and subspecialties; and issues
relating to foreign medical school graduates, including efforts for
changes in undergraduate and GME programs.
Since priorities dictate meeting times, be advised that start
times, end times, and agenda items are subject to change. For the
September 12, 2024, meeting, agenda items may include, but are not
limited to, discussions on team-based care, the Senate Finance
Committee's Medicare GME draft policy document, and the 2018 Government
Accountability Office's Report on Physician Workforce. Refer to the
COGME website listed above for all current and updated information
concerning the September meeting, including agendas and meeting
materials that will be posted 20 calendar days before the meeting.
Members of the public will have the opportunity to provide
comments. Public participants may submit written statements in advance
of the scheduled meeting. Oral comments will be honored in the order
they are requested and may be limited as time allows. Requests to
submit a written statement or make oral comments to COGME should be
sent to Shane Rogers using the contact information above at least 5
business days before the meeting date.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-18791 Filed 8-21-24; 8:45 am]
BILLING CODE 4165-15-P
