Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)-RFA-OH-22-001, Panel B, Occupational Safety and Health Education and Research Centers (ERC); Amended Notice of Closed Meeting, 3415 [2023-00901]
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Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP)—RFA–OH–22–
001, Panel B, Occupational Safety and
Health Education and Research
Centers (ERC); Amended Notice of
Closed Meeting
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Protection of
Human Subjects and Institutional
Review Boards
Notice is hereby given of a change in
the meeting of the Disease, Disability,
and Injury Prevention and Control
Special Emphasis Panel (SEP)—RFA–
OH–22–001, Panel B, Occupational
Safety and Health Education and
Research Centers (ERC); February 23–
24, 2023, 12 p.m.–5 p.m., EST, in the
original FRN. The meeting was
published in the Federal Register on
December 9, 2022, Volume 87, Number
236, page 75632. The meeting is being
amended to change the Notice of
Funding Opportunity (NOFO) number
and should read as follows:
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
RFA–OH–23–003, Panel B,
Occupational Safety and Health
Education and Research Centers (ERC).
The meeting is closed to the public.
HHS.
[Docket No. FDA–2013–N–0403]
FOR FURTHER INFORMATION CONTACT:
khammond on DSKJM1Z7X2PROD with NOTICES
Michael Goldcamp, Ph.D., Scientific
Review Officer, Office of Extramural
Programs, National Institute for
Occupational Safety and Health, CDC,
1095 Willowdale Road, Morgantown,
West Virginia 26505; Telephone: (304)
285–5951; Email: MGoldcamp@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2023–00901 Filed 1–18–23; 8:45 am]
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AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA or we) is
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(OMB) for review and clearance under
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DATES: Submit written comments
(including recommendations) on the
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21, 2023.
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the information collection are received,
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comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
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by using the search function. The OMB
control number for this information
collection is 0910–0130. Also include
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brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Protection of Human Subjects; Informed
Consent; and Institutional Review
Boards—21 CFR Parts 50 and 56
OMB Control Number 0910–0130—
Extension
This information collection supports
Agency regulations pertaining to the
protection of human subjects, informed
consent, and responsibilities of
institutional review boards (IRBs) as set
forth in parts 50 and 56 (21 CFR parts
50 and 56). Parts 50 and 56 apply to all
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clinical investigations regulated by FDA
under sections 505(i) and 520(g) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(i) and 360j(g),
respectively), as well as clinical
investigations that support applications
for research or marketing permits for
products regulated by FDA. The
regulations in parts 50 and 56 are
intended to protect the rights and safety
of subjects involved in such
investigations. The regulations also
contain the standards for composition,
operation, and responsibilities of IRBs
that review clinical investigations
regulated by FDA.
21 CFR Part 50—Protection of Human
Subjects
Provisions in part 50 provide for the
protection of human subjects involved
in FDA-regulated clinical investigations.
With few exceptions, no investigator
may involve a human being as a subject
in FDA-regulated research unless the
investigator has obtained the legally
effective informed consent of the subject
or the subject’s legally authorized
representative. Basic elements of
informed consent are set forth in § 50.25
(21 CFR 50.25) and include, among
other things: (1) a statement of the
purpose and duration of a subject’s
participation in the research; (2) a
description of the procedures to be
followed; (3) identification of any
experimental procedures; (4) a
description of risks, benefits, and
appropriate alternative procedures or
treatments; (5) a description of extent to
which confidentiality of records
identifying the subject will be
maintained; (6) certain contact
information; and (7) a statement that
participation is voluntary and may be
discontinued at any time. Additional
elements set forth in § 50.25 are
required in the informed consent as
appropriate. Exceptions to these
requirements are governed by 21 CFR
50.23, which requires both investigator
and physician to certify in writing that
necessary elements for exception from
general requirements have been
satisfied; and § 50.24 (21 CFR 50.24),
which covers exception from informed
consent requirements for emergency
research. In accordance with § 50.27 (21
CFR 50.27) informed consent must be
documented, except as provided in
§ 56.109(c) (21 CFR 56.109(c)), which
provides for an IRB to waive
documentation of informed consent in
certain circumstances.
Informed consent must be
documented using a written consent
form approved by the IRB and signed
and dated by the subject or the subject’s
legally authorized representative at the
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]]>Agencies
[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Page 3415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00901]
[[Page 3415]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP)--RFA-OH-22-001, Panel B, Occupational Safety and
Health Education and Research Centers (ERC); Amended Notice of Closed
Meeting
Notice is hereby given of a change in the meeting of the Disease,
Disability, and Injury Prevention and Control Special Emphasis Panel
(SEP)--RFA-OH-22-001, Panel B, Occupational Safety and Health Education
and Research Centers (ERC); February 23-24, 2023, 12 p.m.-5 p.m., EST,
in the original FRN. The meeting was published in the Federal Register
on December 9, 2022, Volume 87, Number 236, page 75632. The meeting is
being amended to change the Notice of Funding Opportunity (NOFO) number
and should read as follows:
Name of Committee: Disease, Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)--RFA-OH-23-003, Panel B,
Occupational Safety and Health Education and Research Centers (ERC).
The meeting is closed to the public.
FOR FURTHER INFORMATION CONTACT: Michael Goldcamp, Ph.D., Scientific
Review Officer, Office of Extramural Programs, National Institute for
Occupational Safety and Health, CDC, 1095 Willowdale Road, Morgantown,
West Virginia 26505; Telephone: (304) 285-5951; Email:
[email protected].
The Director, Strategic Business Initiatives Unit, Office of the
Chief Operating Officer, Centers for Disease Control and Prevention,
has been delegated the authority to sign Federal Register notices
pertaining to announcements of meetings and other committee management
activities, for both the Centers for Disease Control and Prevention and
the Agency for Toxic Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2023-00901 Filed 1-18-23; 8:45 am]
BILLING CODE 4163-18-P
