[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Notices]
[Page 40304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14431]



[[Page 40304]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

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

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. 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 Wednesday, July 22, 2020, from 11:00 
a.m. until 4:30 p.m., and Thursday, July 23, 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 [email protected]">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 
Wednesday, July 22, 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 NIH 
Draft Data Management and Sharing Policy. This will be followed by a 
review of the Deceased Organ Intervention Research recommendations, and 
edits discussed at the March SACHRP meeting. The remainder of the 
meeting will be devoted to a new topic, the interpretation of Public 
Health Surveillance, 45 CFR 46.102(l)(2) and 46.102(k). The second day, 
July 23rd, will again host discussion of Public Health Surveillance, 45 
CFR 46.102(l)(2) and 46.102(k), as well as consideration of a second 
new topic, Risks to Non-subjects in Human Subjects Research. 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, July 17, 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: June 30, 2020.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2020-14431 Filed 7-2-20; 8:45 am]
BILLING CODE 4150-36-P