[Federal Register Volume 86, Number 39 (Tuesday, March 2, 2021)]
[Notices]
[Page 12194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04244]


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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 http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

DATES: The meeting will be held on Tuesday, March 23rd, 2021, from 
11:00 a.m. until 4:30 p.m., and Wednesday, March 24, 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#4c1f0d0f041e1c0c24243f622b233a"><span class="__cf_email__" data-cfemail="80d3c1c3c8d2d0c0e8e8f3aee7eff6">[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 or guidelines for human subjects research 
adopted by various agencies or offices within HHS would benefit from 
harmonization, consistency, clarity, simplification or coordination.
    The SACHRP meeting will open to the public at 11:00 a.m., on 
Tuesday, March 23, 2021, 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 CFR 46, followed by an expert panel discussion 
of draft recommendations on Mandatory Exploratory Biopsies in Research. 
The day will conclude with discussion of a new SACHRP topic, IRB 
Authority to Restrict Use of Data in Research. March 24th will include 
presentation of Interactions between Sponsors, Clinical Trial Sites, 
and Research Subjects, and lastly, Consideration of Risks to Bystanders 
in Research. Other topics may be added; for the full and updated 
meeting agenda, see http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.
    The public will have an opportunity to send comments to SACHRP 
during the meeting's public comment session or to submit written public 
comments in advance. Persons who wish to provide public comments should 
review instructions at https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html and respond by midnight Wednesday, March 18th, 
2021, ET. Individuals submitting written statements as public comment 
should submit their comments to SACHRP at <a href="/cdn-cgi/l/email-protection#fcafbdbfb4aeacbc94948fd29b938a"><span class="__cf_email__" data-cfemail="97c4d6d4dfc5c7d7ffffe4b9f0f8e1">[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: February 22, 2021.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2021-04244 Filed 3-1-21; 8:45 am]
BILLING CODE 4150-36-P


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