[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57161-57162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22351]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Office of the Secretary, Office of the Assistant Secretary for
Health, Department of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee
Act, notice is hereby given that the Secretary's Advisory Committee on
Human Research Protections (SACHRP) will hold a meeting that will be
open to the public.
[[Page 57162]]
DATES: The meeting will be held on Tuesday, October 26, from 11:00 a.m.
until 4:30 p.m., and Wednesday, October 27, 2021, from 11:00 a.m. until
4:30 p.m. (times are tentative and subject to change). The confirmed
times and agenda will be posted at on the SACHRP website when this
information becomes available.
ADDRESSES: This meeting will be held via webcast. Members of the public
may also attend the meeting via webcast. Instructions for attending via
webcast will be posted one week prior to the meeting at https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html.
Information about SACHRP, the full meeting agenda, and instructions
for linking to public access will be posted on the SACHRP website at
https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html.
FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-453-8141;
fax: 240-453-6909; email address: [email protected].
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service Act, as amended, SACHRP was
established to provide expert advice and recommendations to the
Secretary of Health and Human Services, through the Assistant Secretary
for Health, on issues and topics pertaining to or associated with the
protection of human research subjects.
The Subpart A Subcommittee (SAS) was established by SACHRP in
October 2006 and is charged with developing recommendations for
consideration by SACHRP regarding the application of subpart A of 45
CFR part 46 in the current research environment.
The Subcommittee on Harmonization (SOH) was established by SACHRP
at its July 2009 meeting and charged with identifying and prioritizing
areas in which regulations and/or guidelines for human subjects
research adopted by various agencies or offices within HHS would
benefit from harmonization, consistency, clarity, simplification and/or
coordination.
The SACHRP meeting will open to the public at 11:00 a.m., on
Tuesday, October 26, followed by opening remarks from Dr. Jerry
Menikoff, Director of the Office for Human Research Protections (OHRP),
and Dr. Douglas Diekema, SACHRP Chair. The meeting will begin with
discussion of draft recommendations on ethical and regulatory
considerations for the use of artificial intelligence in human subjects
research, followed by a presentation of draft recommendations on the
status of third parties in research. The second day, October 27, will
include consideration of the current HHS policy of engagement and the
interpretation of HHS support in 45 CFR part 46, and continue
discussion of topics from the first day's agenda. Other topics may be
added; for the full and updated meeting agenda, see https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html. The meeting will
adjourn by 4:30 p.m. October 27.
The public will have an opportunity to send comment to the SACHRP
during the meeting's public comment session or to submit written public
comment in advance. Individuals submitting written statements as public
comment should submit their comments to SACHRP at [email protected] by
midnight October 22, 2021, ET. Comments are limited to three minutes
each.
Time will be allotted for public comment on both days. Note that
public comment must be relevant to topics currently being addressed by
the SACHRP.
Dated: September 28, 2021.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2021-22351 Filed 10-13-21; 8:45 am]
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