[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Pages 57161-57162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22351]



Meeting of the Secretary's Advisory Committee on Human Research 

AGENCY: Office of the Secretary, Office of the Assistant Secretary for 
Health, Department of Health and Human Services (HHS).

ACTION: Notice.


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 

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 
    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 
    Time will be allotted for public comment on both days. Note that 
public comment must be relevant to topics currently being addressed by 

    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]