[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33316-33317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Secretary's Advisory Committee on Human Research 
Protections

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

ACTION: Notice.

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SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, U.S.C. Appendix 2, 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. 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.

DATES: The meeting will be held on Wednesday, July 21, from 11:00 a.m. 
until 4:30 p.m., and Thursday, July 22, 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 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.

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: <a href="/cdn-cgi/l/email-protection#8cdfcdcfc4dedccce4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="c39082808b919383ababb0eda4acb5">[email protected]</span></a>.

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 
Wednesday, July 21, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The 
meeting will begin with presentation of recommendations on justice as 
an ethical concept in 45

[[Page 33317]]

CFR 46, followed by an expert panel discussion on the impact of 
artificial intelligence algorithms on Institutional Review Board 
considerations for human subjects protections. The day will conclude 
with discussion of a new SACHRP charge addressing the current system of 
engagement and the interpretation of HHS support in 45 CFR 46. The 
second day, July 22, will include discussion of consideration of risks 
to third parties in research, 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.dhhs.gov/ohrp/sachrp-committee/meetings/index.html. The meeting will adjourn by 4:30 p.m. July 22.
    The public will have an opportunity to send comment to SACHRP 
during the meeting's public comment session or to submit written public 
comment in advance. Persons who wish to provide public comment should 
review instructions at https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html and respond by midnight July 16th, 2021, ET. 
Individuals submitting written statements as public comment should 
submit their comments to SACHRP at <a href="/cdn-cgi/l/email-protection#95c6d4d6ddc7c5d5fdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="095a484a415b594961617a276e667f">[email protected]</span></a>. 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 
SACHRP.

    Dated: June 14, 2021.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections, Office for Human Research Protections.
[FR Doc. 2021-13362 Filed 6-23-21; 8:45 am]
BILLING CODE 4150-36-P


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