[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Page 60476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21232]


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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.

ACTION: Notice.

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SUMMARY: Pursuant to 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. 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, October 20th, 2020, from 
11:00 a.m. until 4:30 p.m., and Wednesday, October 21, 2020, 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.

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 20, 2020, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair. The 
meeting will begin with presentation of recommendations on the 
interpretation of the public health surveillance exclusion, 45 CFR 
46.102(l)(2) and 46.102(k). This will be followed by a panel review of 
ethical considerations regarding ``justice'' within 45 CFR 46, and how 
this concept may affect the actions of IRBs. The following day 
continues with a discussion of recommendations on risks to bystanders 
posed by the research setting. 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 comment to the SACHRP during 
the meeting's public comment session or by submitting written public 
comment. 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 Wednesday, October 14, 2020, ET. 
Individuals submitting written statements as public comment should 
submit their comments to SACHRP at [email protected]. Verbal comments will 
be 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 18, 2020.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2020-21232 Filed 9-24-20; 8:45 am]
BILLING CODE 4150-28-P