Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry
| Citation | 86 FR 71508 |
| Record Number | 2021-27262 |
| Published date | 16 December 2021 |
| Section | Notices |
| Court | Health Resources And Services Administration |
71508
Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / Notices
single hard copy of the draft guidance
document entitled ‘‘Referencing the
Definition of ‘Device’ in the Federal
Food, Drug, and Cosmetic Act in
Guidance, Regulatory Documents,
Communications, and Other Public
Documents’’ to the Office of Policy,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT
: Eli
Tomar, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5462, Silver Spring,
MD 20993–0002, 240–893–1926, or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION
:
I. Background
For many years, the definition of
‘‘device’’ has been codified at section
201(h) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act). As a result of
the enactment of the Safeguarding
Therapeutics Act (Pub. L. 116–304), the
definition of ‘‘device’’ was redesignated
as paragraph (h)(1) and a new definition
of ‘‘counterfeit device’’ was codified at
paragraph (h)(2) of section 201 of the
FD&C Act.
FDA is issuing this draft guidance to
clarify how the Agency intends to
interpret existing references to section
201(h) of the FD&C Act and how we
intend to reference the definitions of
‘‘device’’ and ‘‘counterfeit device’’ going
forward. This guidance, when finalized,
is intended to provide clarity on
references to the terms ‘‘device’’ and
‘‘counterfeit device’’—as well as
references to section 201(h) of the FD&C
Act—in guidance, regulatory
documents, and other communications
and documents for FDA staff, industry,
and other stakeholders.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Referencing the Definition of
‘Device’ in the Federal Food, Drug, and
Cosmetic Act in Guidance, Regulatory
Documents, Communications, and
Other Public Documents.’’ 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.
II. Electronic Access
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-comprehensive-
regulatory-assistance/guidance-
documents-medical-devices-and-
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-blood-
biologics/guidance-compliance-
regulatory-information-biologics.
Persons unable to download an
electronic copy of ‘‘Referencing the
Definition of ‘Device’ in the Federal
Food, Drug, and Cosmetic Act in
Guidance, Regulatory Documents,
Communications, and Other Public
Documents’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number 21008 and complete title to
identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27266 Filed 12–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Training and Primary Care Medicine
and Dentistry
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 that the Advisory
Committee on Training and Primary
Care Medicine and Dentistry
(ACTPCMD) will hold public meetings
for the 2022 calendar year (CY).
Information about ACTPCMD, agendas,
and materials for these meetings can be
found on the ACTPCMD website at
https://www.hrsa.gov/advisory-
committees/primarycare-dentist/
index.html.
DATES
: ACTPCMD meetings will be held
on:
•February 17, 2022, 10:00 a.m.–5:00
p.m. Eastern Time (ET) and February 18,
2022, 10:00 a.m.–2:00 p.m. ET; and
•August 2, 2022, 10:00 a.m.–5:00
p.m. ET.
ADDRESSES
: Meetings will be held
virtually and by teleconference. No in-
person meetings will be conducted in
2022. For updates on how the meetings
will be held, visit the ACTPCMD
website 30 business days before the date
of the meeting, where instructions for
joining meetings will be posted. For
meeting information updates, go to the
ACTPCMD website meeting page at
https://www.hrsa.gov/advisory-
committees/primarycare-dentist/
meetings.html.
FOR FURTHER INFORMATION CONTACT
:
Shane Rogers, Designated Federal
Official, Division of Medicine and
Dentistry, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Room
15N142, Rockville, Maryland 20857;
301–443–5260; or SRogers@hrsa.gov.
SUPPLEMENTARY INFORMATION
: The
ACTPCMD provides advice and
recommendations to the Secretary of
Health and Human Services (Secretary)
on policy, program development, and
other matters of significance concerning
the activities under Section 747 of Title
VII of the Public Health Service (PHS)
Act, as it existed upon the enactment of
Section 749 of the PHS Act in 1998.
ACTPCMD prepares an annual report
describing the activities of the
committee, including findings and
recommendations made by the
committee concerning the activities
under Section 747, as well as training
programs in oral health and dentistry.
The annual report is submitted to the
Secretary as well as the Chairman and
ranking members of the Senate
Committee on Health, Education, Labor
and Pensions and the House of
Representatives Committee on Energy
and Commerce. The ACTPCMD
develops, publishes and implements
performance measures and guidelines
for longitudinal evaluations of programs
authorized under Title VII, Part C of the
PHS Act, and recommends
appropriation levels for programs under
this Part. Since priorities dictate
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71509
Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / Notices
meeting times, be advised that start
times, end times, and agenda items are
subject to change. For CY 2022
meetings, agenda items may include,
but are not limited to, inter-professional
team-based education, practice, and
retention in underserved rural
communities, as well as matters
pertaining to policy, program
development, and other matters of
significance concerning medicine and
dentistry activities authorized under the
relevant sections of the PHS Act. Refer
to the ACTPCMD website listed above
for all current and updated information
concerning the CY 2022 ACTPCMD
meetings, including draft agendas and
meeting materials that will be posted 30
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(s). 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 the
ACTPCMD should be sent to Shane
Rogers using the contact information
above at least 5 business days before the
meeting date(s). Individuals who need
special assistance or another reasonable
accommodation should notify Shane
Rogers using the contact information
listed above at least 10 business days
before the meeting(s) they wish to
attend.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–27262 Filed 12–15–21; 8:45 am]
BILLING CODE 4165–15–P
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 (HHS).
ACTION
: Notice.
SUMMARY
: In accordance with the
Federal Advisory Committee Act, this
notice announces that the Council on
Graduate Medical Education (COGME or
Council) will hold public meetings for
the 2022 calendar year (CY).
Information about COGME, agendas,
and materials for these meetings can be
found on the COGME website at https://
www.hrsa.gov/advisory-committees/
graduate-medical-edu/index.html.
DATES
: COGME meetings will be held
on:
•March 24, 2022, 10:00 a.m.–5:00
p.m. Eastern Time (ET) and March 25,
2022, 10:00 a.m.–2:00 p.m. ET; and
•September 12, 2022, 10:00 a.m.–
5:00 p.m. ET.
ADDRESSES
: Meetings will be held
virtually and by teleconference. No in-
person meetings will be conducted in
2022. For updates on how the meetings
will be held, visit the COGME website
30 business 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/
index.html.
FOR FURTHER INFORMATION CONTACT
:
Shane Rogers, Designated Federal
Official, Division of Medicine and
Dentistry, Bureau of Health Workforce,
HRSA, 5600 Fishers Lane, Room
15N142, Rockville, Maryland 20857;
301–443–5260; or SRogers@hrsa.gov.
SUPPLEMENTARY INFORMATION
: The
COGME provides advice and
recommendations to the Secretary of
HHS on policy, program development,
and other matters of significance
concerning the activities listed in
section 762(a) of Title VII of the Public
Health Service (PHS) 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; appropriation levels for
certain programs under Title VII of the
PHS Act; and deficiencies in databases
of the supply and distribution of the
physician workforce and postgraduate
programs for training physicians.
COGME submits reports to the Secretary
of HHS; the Senate Committee on
Health, Education, Labor and Pensions;
and the House of Representatives
Committee on Energy and Commerce.
Additionally, COGME encourages
entities providing graduate medical
education to conduct activities to
voluntarily achieve the
recommendations of the Council.
Since priorities dictate meeting times,
be advised that start times, end times,
and agenda items are subject to change.
For CY 2022 meetings, agenda items
may include, but are not limited to,
discussions on advancing health equity,
addressing disparities in rural areas,
enhancing the delivery of behavioral
health and mental health care, and
expanding the role of telehealth. Refer
to the COGME website listed above for
all current and updated information
concerning the CY 2022 COGME
meetings, including draft agendas and
meeting materials that will be posted 30
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(s). 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 the COGME
should be sent to Shane Rogers using
the contact information above at least 5
business days before the meeting
date(s).
Individuals who need special
assistance or another reasonable
accommodation should notify Shane
Rogers using the contact information
listed above at least 10 business days
before the meeting(s) they wish to
attend.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–27263 Filed 12–15–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Extended Clinical Trial (R01); NIAID Clinical
Trial Planning Grants (R34 Clinical Trial Not
Allowed).
Date: January 12, 2022.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
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