82 FR 45033 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 186 (September 27, 2017)

Page Range		45033-45034
FR Document		2017-20651

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 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 186 (Wednesday, September 27, 2017)

[Federal Register Volume 82, Number 186 (Wednesday, September 27, 2017)]
[Notices]
[Pages 45033-45034]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20651]


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

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 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 Tuesday, October 17, 2017, from 8:30 
a.m. until 5:00 p.m., and Wednesday, October 18, 2017, from 8:30 a.m. 
until 4:00 p.m.

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.

[[Page 45034]]

    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 8:30 a.m., on 
Tuesday, October 17, 2017, followed by opening remarks from Dr. Jerry 
Menikoff, Director, Office for Human Research Protections (OHRP) and 
Dr. Stephen Rosenfeld, SACHRP Chair.
    The SAS will present their recommendations regarding the revised 
Common Rule's (https://www.thefederalregister.org/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm) expedited review requirements, followed by a discussion of 
the meaning of ``context'' when considering requirement for single IRB 
review. This will be followed by a discussion of SOH recommendations on 
the revised Common Rule's HIPAA exemption, section 104(d)(4)(iii), and 
a panel discussion with a representative of the Office for Civil 
Rights. The day will conclude with a presentation by OHRP staff on a 
new public outreach Web site, About Participation. The Tuesday meeting 
will adjourn at approximately 5:00 p.m.
    The Wednesday, October 18, meeting will begin at 8:30 a.m. with a 
presentation and discussion led by FDA staff on a recent FDA experience 
with IRB review under 21 CFR 50.54, and the lessons learned. Time is 
allotted for review of the previous day's recommendations. The meeting 
will adjourn at approximately 4:00 p.m., October 18, 2017.
    Time for public comment sessions will be allotted both days. On-
site registration is required for participation in the live public 
comment session. Note that public comment must be relevant to issues 
currently being addressed by the SACHRP. Individuals submitting 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.
    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 one of the designated SACHRP points of contact at the address/
phone number listed above at least one week prior to the meeting.

    Dated: September 21, 2017.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2017-20651 Filed 9-26-17; 8:45 am]
 BILLING CODE 4150-36-P

Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Notices 45033

Dated: September 20, 2017. for Americans, including those at risk accessible online and upon request at
John R. Graham, for chronic disease. the Office of Disease Prevention and
Acting Assistant Secretary for Planning and Description of the Committee’s Health Promotion, OASH/HHS; 1101
Evaluation. Mission and Composition: The 2018 Wootton Parkway, Suite LL100 Tower
[FR Doc. 2017–20613 Filed 9–26–17; 8:45 am] PAGAC was established to perform a Building; Rockville, MD 20852;
BILLING CODE 4151–05–P single, time-limited task. The work of Telephone: (240) 453–8280; Fax: (240)
the Committee is solely advisory in 453–8281.
nature. The Committee is charged to Dated: September 21, 2017.
DEPARTMENT OF HEALTH AND examine the current PAG, take into
Don Wright,
HUMAN SERVICES consideration new scientific evidence
and current resource documents, and Deputy Assistant Secretary for Health (Deputy
Meeting of the 2018 Physical Activity Prevention and Health Promotion).
develop a scientific report to the
Guidelines Advisory Committee Secretary of HHS that outlines its [FR Doc. 2017–20607 Filed 9–26–17; 8:45 am]

AGENCY: Office of Disease Prevention science-based advice and BILLING CODE 4150–32–P

and Health Promotion, Office of the recommendations for development of
Assistant Secretary for Health, Office of the second edition of the PAG. The
Committee consists of 17 members, who DEPARTMENT OF HEALTH AND
the Secretary, Department of Health and HUMAN SERVICES
Human Services. were appointed by the Secretary in June
2016. Information on the Committee
ACTION: Notice. Meeting of the Secretary’s Advisory
membership is available at
Committee on Human Research
SUMMARY: As stipulated by the Federal www.health.gov/paguidelines/second-
Protections
Advisory Committee Act (FACA), the edition/committee/.
U.S. Department of Health and Human It has been planned for the Committee AGENCY: Office of the Assistant
Services (HHS) is hereby giving notice to hold five meetings to accomplish its Secretary for Health, Office of the
that the fifth and final meeting of the mission. The first meeting was held in Secretary, Department of Health and
2018 Physical Activity Guidelines July 2016, the second meeting was held Human Services.
Advisory Committee (2018 PAGAC or in October 2016, the third meeting was
held in March 2017, the fourth meeting ACTION: Notice.
Committee) will be held. This meeting
will be open to the public via videocast. was held in July 2017, and the fifth
SUMMARY: Pursuant to Section 10(a) of
DATES: The meeting will be held on
meeting will be held in October 2017. It
the Federal Advisory Committee Act,
October 17, 2017, from 1:00 p.m. E.D.T. is stipulated in the charter that the
U.S.C. Appendix 2, notice is hereby
to 4:30 p.m. E.D.T., on October 18, 2017, Committee will be terminated after
given that the Secretary’s Advisory
from 8:00 a.m. to 11:15 a.m. E.D.T., on delivery of its report to the Secretary of
Committee on Human Research
October 19, 2017, from 8:00 a.m. to HHS or two years from the date the
Protections (SACHRP) will hold a
11:15 a.m. E.D.T., and on October 20, charter was filed, whichever comes first.
Purpose of the Meeting: In accordance meeting that will be open to the public.
2017, from 8:00 a.m. E.D.T. to 11:15 a.m. Information about SACHRP and the full
with FACA and to promote
E.D.T. meeting agenda will be posted on the
transparency of the process,
ADDRESSES: The meeting will be SACHRP Web site at: http://
deliberations of the Committee will
accessible by videocast on the Internet. occur in a public forum. At this www.dhhs.gov/ohrp/sachrp-committee/
FOR FURTHER INFORMATION CONTACT: meeting, the Committee will conclude meetings/index.html.
Designated Federal Officer, 2018 its deliberations. DATES: The meeting will be held on
Physical Activity Guidelines Advisory Meeting Agenda: The meeting will Tuesday, October 17, 2017, from 8:30
Committee, Richard D. Olson, M.D., include subcommittee reports on the a.m. until 5:00 p.m., and Wednesday,
M.P.H. and/or Alternate Designated remainder of their literature review October 18, 2017, from 8:30 a.m. until
Federal Officer, Katrina L. Piercy, Ph.D., questions, discussion of overarching 4:00 p.m.
R.D., Office of Disease Prevention and issues, and discussion of plans for ADDRESSES: Fishers Lane Conference
Health Promotion (ODPHP), Office of finalizing the Committee’s report to the Center, Terrace Level, 5635 Fishers
the Assistant Secretary for Health Secretary. Lane, Rockville, Maryland 20852.
(OASH), HHS; 1101 Wootton Parkway, Meeting Registration: The meeting is
Suite LL–100; Rockville, MD 20852; open to the public via videocast; pre- FOR FURTHER INFORMATION CONTACT: Julia
Telephone: (240) 453–8280. Additional registration is required. To register, Gorey, J.D., Executive Director,
information is available at please visit www.health.gov/ SACHRP; U.S. Department of Health
www.health.gov/paguidelines. paguidelines. After registration, and Human Services, 1101 Wootton
SUPPLEMENTARY INFORMATION: The individuals will receive videocast Parkway, Suite 200, Rockville,
inaugural Physical Activity Guidelines access information via email. To request Maryland 20852; telephone: 240–453–
for Americans (PAG), issued in 2008, a special accommodation, please email 8141; fax: 240–453–6909; email address:
represents the first comprehensive jennifer.gillissen@kauffmaninc.com. SACHRP@hhs.gov.
guidelines on physical activity issued Public Comments and Meeting SUPPLEMENTARY INFORMATION: Under the
by the federal government. The PAG Documents: Written comments from the authority of 42 U.S.C. 217a, Section 222
asabaliauskas on DSKBBXCHB2PROD with NOTICES

serves as the benchmark and primary, public to the Committee will continue of the Public Health Service Act, as
authoritative voice of the federal to be accepted until November 10, 2017; amended, SACHRP was established to
government for providing science-based they can be submitted and/or viewed at provide expert advice and
guidance on physical activity, fitness, www.health.gov/paguidelines/pcd/. recommendations to the Secretary of
and health for Americans. The second Documents pertaining to Committee Health and Human Services, through
edition of the PAG will build upon the deliberations, including meeting the Assistant Secretary for Health, on
first edition and provide a foundation agendas and summaries are available on issues and topics pertaining to or
for federal recommendations and www.health.gov/paguidelines. Meeting associated with the protection of human
education for physical activity programs information will continue to be research subjects.

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45034 Federal Register / Vol. 82, No. 186 / Wednesday, September 27, 2017 / Notices

The Subpart A Subcommittee (SAS) interpretation or other reasonable • Email: Evonne.Bennett-Barnes@
was established by SACHRP in October accommodations, should notify one of ihs.gov.
2006 and is charged with developing the designated SACHRP points of • Fax: 301–594–0899.
recommendations for consideration by contact at the address/phone number Comments submitted in response to
SACHRP regarding the application of listed above at least one week prior to this notice will be made available to the
subpart A of 45 CFR part 46 in the the meeting. public by publishing them in the 30 day
current research environment. Dated: September 21, 2017. Federal Register notice for this
The Subcommittee on Harmonization information collection. For this reason,
Julia G. Gorey,
(SOH) was established by SACHRP at its please do not include information of a
July 2009 meeting and charged with Executive Director, Secretary’s Advisory
confidential nature, such as sensitive
Committee on Human Research Protections.
identifying and prioritizing areas in personal information or proprietary
which regulations and/or guidelines for [FR Doc. 2017–20651 Filed 9–26–17; 8:45 am]
information. If comments are submitted
human subjects research adopted by BILLING CODE 4150–36–P
via email, the email address will be
various agencies or offices within HHS automatically captured and included as
would benefit from harmonization, part of the comment that is placed in the
consistency, clarity, simplification and/ DEPARTMENT OF HEALTH AND
public docket and made available on the
or coordination. HUMAN SERVICES
Internet. Please note that responses to
The SACHRP meeting will open to the this public comment request containing
public at 8:30 a.m., on Tuesday, October Indian Health Service
any routine notice about the
17, 2017, followed by opening remarks Request for Public Comment: 60 Day confidentiality of the communication
from Dr. Jerry Menikoff, Director, Office Notice for Extension of Fast Track will be treated as public comments that
for Human Research Protections (OHRP) Generic Clearance for the Collection of may be made available to the public
and Dr. Stephen Rosenfeld, SACHRP Qualitative Feedback on Agency notwithstanding the inclusion of the
Chair. Service Delivery: IHS Customer routine notice.
The SAS will present their
Service Satisfaction and Similar FOR FURTHER INFORMATION CONTACT: To
recommendations regarding the revised
Surveys request additional information, please
Common Rule’s (https://www.gpo.gov/
fdsys/pkg/FR-2017-01-19/html/2017- contact Evonne Bennett-Barnes,
AGENCY: Indian Health Service, HHS. Evonne.Bennett-Barnes@ihs.gov or 301–
01058.htm) expedited review ACTION:Notice and request for
requirements, followed by a discussion 443–4750.
comments. Request for extension of SUPPLEMENTARY INFORMATION: The IHS is
of the meaning of ‘‘context’’ when
approval. submitting the proposed information
considering requirement for single IRB
review. This will be followed by a collection to OMB for review, as
SUMMARY: In compliance the Paperwork
discussion of SOH recommendations on required by section 3507(a)(1)(D) of the
Reduction Act of 1995, the Indian
the revised Common Rule’s HIPAA Paperwork Reduction Act of 1995. This
Health Service (IHS) invites the general
exemption, section 104(d)(4)(iii), and a notice is soliciting comments from
public to take this opportunity to
panel discussion with a representative members of the public and affected
comment on the information collection
of the Office for Civil Rights. The day agencies as required by 44 U.S.C.
Office of Management and Budget
will conclude with a presentation by 3506(c)(2)(A) concerning the proposed
(OMB) Control Number 0917–0036,
OHRP staff on a new public outreach collection of information to: (1) Evaluate
‘‘Generic Clearance for the Collection of
Web site, About Participation. The whether the proposed collection of
Qualitative Feedback on Agency Service
Tuesday meeting will adjourn at information is necessary for the proper
Delivery’’ for approval under the
approximately 5:00 p.m. performance of the functions of the
Paperwork Reduction Act. This
The Wednesday, October 18, meeting agency, including whether the
collection was developed as part of a
will begin at 8:30 a.m. with a information will have practical utility;
Federal Government-wide effort to
presentation and discussion led by FDA (2) Evaluate the accuracy of the agency’s
streamline the process for seeking
staff on a recent FDA experience with estimate of the burden of the proposed
feedback from the public on service
IRB review under 21 CFR 50.54, and the collection of information; (3) Enhance
delivery. This notice announces our
lessons learned. Time is allotted for the quality, utility, and clarity of the
intent to submit this collection to the
review of the previous day’s information to be collected; and (4)
Office of Management and Budget
recommendations. The meeting will Minimize the burden of the collection of
(OMB) for approval and solicits
adjourn at approximately 4:00 p.m., information on those who are to
comments on specific aspects for the
October 18, 2017. respond; including through the use of
proposed information collection.
Time for public comment sessions appropriate automated collection
A copy of the draft supporting
will be allotted both days. On-site techniques of other forms of information
statement is available at
registration is required for participation technology, e.g., permitting electronic
www.regulations.gov (see Docket ID
in the live public comment session. submission of responses.
IHS_FRDOC_0001-[insert number]).
Note that public comment must be Title: Generic Clearance for the
relevant to issues currently being DATES: Consideration will be given to all Collection of Qualitative Feedback on
addressed by the SACHRP. Individuals comments received by November 27, Agency Service Delivery: IHS Customer
2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES

submitting written statements as public Service Satisfaction and Similar
comment should email or fax their For Comments: Submit comments to Surveys.
comments to SACHRP at SACHRP@ Evonne Bennett-Barnes by one of the Type of Information Collection
hhs.gov at least five business days prior following methods: Request: Three year extension approval
to the meeting. • Mail: Evonne Bennett-Barnes, of this information collection.
Public attendance at the meeting is Information Collection Clearance OMB Control Number: 0917–0036.
limited to space available. Individuals Officer, Indian Health Service, 5600 Abstract: The proposed information
who plan to attend and need special Fishers Lane, Rockville, MD 20857. collection activity provides a means to
assistance, such as sign language • Phone: 301–443–4750. garner qualitative customer and

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Document Created: 2018-10-24 14:48:00
Document Modified: 2018-10-24 14:48:00

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 Tuesday, October 17, 2017, from 8:30 a.m. until 5:00 p.m., and Wednesday, October 18, 2017, from 8:30 a.m. until 4:00 p.m.
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 45033