82 FR 18657 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 75 (April 20, 2017)

Page Range		18657-18657
FR Document		2017-08017

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

Federal Register, Volume 82 Issue 75 (Thursday, April 20, 2017)

[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Page 18657]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08017]


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

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: [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 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.thefederalregister.org/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 
[email protected] 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

Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices 18657

121. Dustin Mobley, Washington, meeting was originally scheduled to be The Thursday meeting will adjourn at
District of Columbia, Court of held March 15–16, but was postponed approximately 5:00 p.m.
Federal Claims No: 17–0454V. due to a predicted snow storm. The Friday, May 26, meeting will
122. Gary Schneider, Dana Point, ADDRESSES: Fishers Lane Conference begin at 8:30 a.m. with
California, Court of Federal Claims Center, Terrace Level, 5635 Fishers recommendations from the SOH on the
No: 17–0456V. Lane, Rockville, Maryland 20852. FDA Draft Guidance ‘‘Use of Real-World
123. Jackie Mills on behalf of L. M., Evidence to Support Regulatory
Portage, Michigan, Court of Federal FOR FURTHER INFORMATION CONTACT: Julia Decision-Making for Medical Devices,’’
Claims No: 17–0457V. Gorey, J.D., Executive Director, issued July 27, 2016. SOH will also
124. Joseph Charneco, Boca Raton, SACHRP; U.S. Department of Health present recommendations on the return
Florida, Court of Federal Claims No: and Human Services, 1101 Wootton of incidental findings to research
17–0458V. Parkway, Suite 200, Rockville, subjects. The SAS will present
125. Anita Schmitter, Ann Arbor, Maryland 20852; telephone: 240–453– recommendations surrounding the new
Michigan, Court of Federal Claims 8141; fax: 240–453–6909; email address: Common Rule’s expedited review
No: 17–0459V. SACHRP@hhs.gov. requirements.
126. Mariah Corbett on behalf of N. C., SUPPLEMENTARY INFORMATION: Under the The meeting will adjourn at 4:30 p.m.
Deceased, Longs, South Carolina authority of 42 U.S.C. 217a, Section 222 May 26, 2017. Time for public comment
Court of Federal Claims No: 17– of the Public Health Service Act, as sessions will be allotted both days. Note
0460V. amended, SACHRP was established to that public comment must be relevant to
127. Hugh Gose, Seymour, Tennessee, provide expert advice and issues being addressed by the SACHRP.
Court of Federal Claims No: 17– recommendations to the Secretary of Public attendance at the meeting is
0461V. Health and Human Services, through limited to space available. Individuals
128. Jane Elise Delzer, Waukesha, the Assistant Secretary for Health, on who plan to attend and need special
Wisconsin, Court of Federal Claims issues and topics pertaining to or assistance, such as sign language
No: 17–0462V. associated with the protection of human interpretation or other reasonable
129. Sharyn Lynn Lobell, Ponchatoula, research subjects. accommodations, should notify the
Louisiana, Court of Federal Claims The Subpart A Subcommittee (SAS) designated SACHRP point of contact at
No: 17–0463V. was established by SACHRP in October the address/phone number listed above
130. Sharon Kabelitz, Washington, 2006 and is charged with developing at least one week prior to the meeting.
District of Columbia, Court of recommendations for consideration by On-site registration is required for
Federal Claims No: 17–0466V. SACHRP regarding the application of participation in the live public comment
131. Charles Huggins, Watkinsville, subpart A of 45 CFR part 46 in the session. Individuals who would like to
Georgia, Court of Federal Claims current research environment. submit written statements as public
No: 17–0467V. The Subcommittee on Harmonization comment should email or fax their
132. Barbara Jayne, Washington, District (SOH) was established by SACHRP at its comments to SACHRP at SACHRP@
of Columbia, Court of Federal July 2009 meeting and charged with hhs.gov at least five business days prior
Claims No: 17–0469V. identifying and prioritizing areas in to the meeting.
[FR Doc. 2017–07989 Filed 4–19–17; 8:45 am] which regulations and/or guidelines for Dated: April 17, 2017.
BILLING CODE 4165–15–P human subjects research adopted by Julia G. Gorey,
various agencies or offices within HHS Executive Director, Secretary’s Advisory
would benefit from harmonization, Committee on Human Research Protections.
DEPARTMENT OF HEALTH AND consistency, clarity, simplification and/ [FR Doc. 2017–08017 Filed 4–19–17; 8:45 am]
HUMAN SERVICES or coordination. BILLING CODE 4150–36–P
The SACHRP meeting will be open to
Meeting of the Secretary’s Advisory
the public at 8:30 a.m., on Thursday,
Committee on Human Research
May 25, 2017, followed by opening DEPARTMENT OF HEALTH AND
Protections
remarks from Dr. Jerry Menikoff, HUMAN SERVICES
AGENCY: Department of Health and Director of OHRP and Executive
Human Services, Office of the Secretary, Secretary of SACHRP, and Dr. Stephen National Preparedness and Response
Office of the Assistant Secretary for Rosenfeld, SACHRP Chair. Dr. Menikoff Science Board; Call for Nominees
Health. will then lead a discussion focusing on AGENCY: Office of the Secretary,
ACTION: Notice. selected sections of the new Common Department of Health and Human
Rule, which was published January 19, Services.
SUMMARY: Pursuant to Section 10(a) of 2017, with an effective date of January
ACTION: Notice.
the Federal Advisory Committee Act,, 19, 2018 (see https://www.gpo.gov/
notice is hereby given that the fdsys/pkg/FR-2017-01-19/html/2017- SUMMARY: The Office of the Secretary
Secretary’s Advisory Committee on 01058.htm). seeks application submissions from
Human Research Protections (SACHRP) The SOH will present their qualified individuals for consideration
will hold a meeting that will be open to recommendations for consideration of for membership on the National
the public. Information about SACHRP the new Common Rule’s compliance Preparedness and Response Science
asabaliauskas on DSK3SPTVN1PROD with NOTICES

and the full meeting agenda will be dates and transition provisions, as well Board (NPRSB). Terms of eight members
posted on the SACHRP Web site at: as for the interpretation and expire December 31, 2017; therefore, the
http://www.dhhs.gov/ohrp/sachrp- implementation of the new broad Secretary must appoint eight new voting
committee/meetings/index.html. consent provision. members. Nominees shall represent the
DATES: The meeting will be held on The SAS will discuss their report on following categories: Industry,
Thursday, May 25, from 8:30 a.m. until the interpretation of the new exemption academia, health care consumer
5:00 p.m., and Friday, May 26 from 8:30 involving benign behavioral organizations, and organizations
a.m. until 4:30 p.m. Please note: this interventions. representing other appropriate

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Document Created: 2017-04-20 01:42:08
Document Modified: 2017-04-20 01:42:08

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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;
FR Citation		82 FR 18657