Meeting of the Secretary's Advisory Committee on Human Research Protections, 18657 [2017-08017]
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Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices
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[FR Doc. 2017–07989 Filed 4–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
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
and the full meeting agenda will be
posted on the SACHRP Web site at:
https://www.dhhs.gov/ohrp/sachrpcommittee/meetings/.
DATES: The meeting will be held on
Thursday, May 25, from 8:30 a.m. until
5:00 p.m., and Friday, May 26 from 8:30
a.m. until 4:30 p.m. Please note: this
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:27 Apr 19, 2017
Jkt 241001
meeting was originally scheduled to be
held March 15–16, but was postponed
due to a predicted snow storm.
ADDRESSES: Fishers Lane Conference
Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
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:
SACHRP@hhs.gov.
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 be open to
the public at 8:30 a.m., on Thursday,
May 25, 2017, followed by opening
remarks from Dr. Jerry Menikoff,
Director of OHRP and Executive
Secretary of SACHRP, and Dr. Stephen
Rosenfeld, SACHRP Chair. Dr. Menikoff
will then lead a discussion focusing on
selected sections of the new Common
Rule, which was published January 19,
2017, with an effective date of January
19, 2018 (see https://www.gpo.gov/
fdsys/pkg/FR-2017-01-19/html/201701058.htm).
The SOH will present their
recommendations for consideration of
the new Common Rule’s compliance
dates and transition provisions, as well
as for the interpretation and
implementation of the new broad
consent provision.
The SAS will discuss their report on
the interpretation of the new exemption
involving benign behavioral
interventions.
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18657
The Thursday meeting will adjourn at
approximately 5:00 p.m.
The Friday, May 26, meeting will
begin at 8:30 a.m. with
recommendations from the SOH on the
FDA Draft Guidance ‘‘Use of Real-World
Evidence to Support Regulatory
Decision-Making for Medical Devices,’’
issued July 27, 2016. SOH will also
present recommendations on the return
of incidental findings to research
subjects. The SAS will present
recommendations surrounding the new
Common Rule’s expedited review
requirements.
The meeting will adjourn at 4:30 p.m.
May 26, 2017. Time for public comment
sessions will be allotted both days. Note
that public comment must be relevant to
issues being addressed by the SACHRP.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated SACHRP point of contact at
the address/phone number listed above
at least one week prior to the meeting.
On-site registration is required for
participation in the live public comment
session. Individuals who would like to
submit written statements as public
comment should email or fax their
comments to SACHRP at SACHRP@
hhs.gov at least five business days prior
to the meeting.
Dated: April 17, 2017.
Julia G. Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections.
[FR Doc. 2017–08017 Filed 4–19–17; 8:45 am]
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HUMAN SERVICES
National Preparedness and Response
Science Board; Call for Nominees
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Office of the Secretary
seeks application submissions from
qualified individuals for consideration
for membership on the National
Preparedness and Response Science
Board (NPRSB). Terms of eight members
expire December 31, 2017; therefore, the
Secretary must appoint eight new voting
members. Nominees shall represent the
following categories: Industry,
academia, health care consumer
organizations, and organizations
representing other appropriate
SUMMARY:
E:\FR\FM\20APN1.SGM
20APN1
Agencies
[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Page 18657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08017]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 and the full meeting
agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp-committee/meetings/.
DATES: The meeting will be held on Thursday, May 25, from 8:30 a.m.
until 5:00 p.m., and Friday, May 26 from 8:30 a.m. until 4:30 p.m.
Please note: this meeting was originally scheduled to be held March 15-
16, but was postponed due to a predicted snow storm.
ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers
Lane, Rockville, Maryland 20852.
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: SACHRP@hhs.gov.
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 be open to the public at 8:30 a.m., on
Thursday, May 25, 2017, followed by opening remarks from Dr. Jerry
Menikoff, Director of OHRP and Executive Secretary of SACHRP, and Dr.
Stephen Rosenfeld, SACHRP Chair. Dr. Menikoff will then lead a
discussion focusing on selected sections of the new Common Rule, which
was published January 19, 2017, with an effective date of January 19,
2018 (see https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm).
The SOH will present their recommendations for consideration of the
new Common Rule's compliance dates and transition provisions, as well
as for the interpretation and implementation of the new broad consent
provision.
The SAS will discuss their report on the interpretation of the new
exemption involving benign behavioral interventions.
The Thursday meeting will adjourn at approximately 5:00 p.m.
The Friday, May 26, meeting will begin at 8:30 a.m. with
recommendations from the SOH on the FDA Draft Guidance ``Use of Real-
World Evidence to Support Regulatory Decision-Making for Medical
Devices,'' issued July 27, 2016. SOH will also present recommendations
on the return of incidental findings to research subjects. The SAS will
present recommendations surrounding the new Common Rule's expedited
review requirements.
The meeting will adjourn at 4:30 p.m. May 26, 2017. Time for public
comment sessions will be allotted both days. Note that public comment
must be relevant to issues being addressed by the SACHRP.
Public attendance at the meeting is limited to space available.
Individuals who plan to attend and need special assistance, such as
sign language interpretation or other reasonable accommodations, should
notify the designated SACHRP point of contact at the address/phone
number listed above at least one week prior to the meeting. On-site
registration is required for participation in the live public comment
session. Individuals who would like to submit written statements as
public comment should email or fax their comments to SACHRP at
SACHRP@hhs.gov at least five business days prior to the meeting.
Dated: April 17, 2017.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research
Protections.
[FR Doc. 2017-08017 Filed 4-19-17; 8:45 am]
BILLING CODE 4150-36-P