83 FR 48318 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 185 (September 24, 2018)

Page Range		48318-48319
FR Document		2018-20676

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

Federal Register, Volume 83 Issue 185 (Monday, September 24, 2018)

[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48318-48319]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20676]


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

DATES: The meeting will be held on Tuesday, October 16, 2018, from 8:30 
a.m. until 5 p.m., and Wednesday, October 17, 2018, from 8:30 a.m. 
until 4 p.m.

ADDRESSES: 6700B Rockledge Drive, Bethesda, MD 20817.

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 (HHS), 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

[[Page 48319]]

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 16, 2018, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair.
    The SAS and SOH subcommittees will present their recommendations 
regarding the description of ``key information,'' as required by the 
revised Common Rule at Sec.  46.116(a)(5)(i). This will be followed by 
a discussion of recommendations of the interpretation of the revised 
Common Rule's exemptions Sec.  46.104(d)(1) and (2) for HHS funded 
research. Lastly, the committee will continue its July discussions on 
the Office of Inspector General Report, July 7, 2017: ``OHRP Generally 
Conducted Its Compliance Activities Independently, But Changes Would 
Strengthen Its Independence.''
    The Wednesday, October 17, meeting will begin at 8:30 a.m. The SAS 
subcommittee will present and discuss recommendations on the 
interpretation of ``reasonably available'' at Sec.  46.408(b), as well 
as discuss issues surrounding payment of subjects for participation in 
research. Modifications to the previous day's work will be discussed 
and finalized. The meeting will adjourn at approximately 4:00 p.m., 
October 17, 2018.
    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 topics 
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 14, 2018.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2018-20676 Filed 9-21-18; 8:45 am]
 BILLING CODE 4150-36-P

Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices 48319

would benefit from harmonization, DEPARTMENT OF HEALTH AND Musculoskeletal and Skin Diseases Research,
consistency, clarity, simplification, and/ HUMAN SERVICES National Institutes of Health, HHS)
or coordination. Dated: September 18, 2018.
National Institutes of Health Sylvia L. Neal,
The SACHRP meeting will open to the
public at 8:30 a.m., on Tuesday, October National Institute of Arthritis and Program Analyst, Office of Federal Advisory
16, 2018, followed by opening remarks Committee Policy.
Musculoskeletal and Skin Diseases;
from Dr. Jerry Menikoff, Director of Notice of Closed Meetings [FR Doc. 2018–20666 Filed 9–21–18; 8:45 am]
OHRP and Dr. Stephen Rosenfeld, BILLING CODE 4140–01–P
SACHRP Chair. Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
The SAS and SOH subcommittees amended, notice is hereby given of the DEPARTMENT OF HEALTH AND
will present their recommendations following meetings. HUMAN SERVICES
regarding the description of ‘‘key The meetings will be closed to the
information,’’ as required by the revised public in accordance with the National Institutes of Health
Common Rule at § 46.116(a)(5)(i). This provisions set forth in sections
will be followed by a discussion of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Government-Owned Inventions;
recommendations of the interpretation as amended. The grant applications and Availability for Licensing
of the revised Common Rule’s the discussions could disclose AGENCY: National Institutes of Health,
exemptions § 46.104(d)(1) and (2) for confidential trade secrets or commercial HHS.
HHS funded research. Lastly, the property such as patentable material, ACTION: Notice.
committee will continue its July and personal information concerning
discussions on the Office of Inspector individuals associated with the grant SUMMARY: The invention listed below is
General Report, July 7, 2017: ‘‘OHRP applications, the disclosure of which owned by an agency of the U.S.
Generally Conducted Its Compliance would constitute a clearly unwarranted Government and is available for
Activities Independently, But Changes invasion of personal privacy. licensing to achieve expeditious
Would Strengthen Its Independence.’’ Name of Committee: National Institute of commercialization of results of
The Wednesday, October 17, meeting Arthritis and Musculoskeletal and Skin federally-funded research and
will begin at 8:30 a.m. The SAS Diseases Special Emphasis Panel; T32 development. Foreign patent
subcommittee will present and discuss Institutional Training Grants. applications are filed on selected
recommendations on the interpretation Date: October 10, 2018. inventions to extend market coverage
Time: 8:00 a.m. to 5:00 p.m. for companies and may also be available
of ‘‘reasonably available’’ at § 46.408(b), Agenda: To review and evaluate grant
as well as discuss issues surrounding for licensing.
applications.
payment of subjects for participation in Place: Canopy by Hilton, 940 Rose Avenue, FOR FURTHER INFORMATION CONTACT:
research. Modifications to the previous North Bethesda, MD 20852. Yogikala Prabhu, Ph.D., 301–761–7789;
day’s work will be discussed and Contact Person: Nakia C. Brown, Ph.D., prabhuyo@niaid.nih.gov. Licensing
finalized. The meeting will adjourn at Scientific Review Officer, 6701 Democracy information and copies of the patent
approximately 4:00 p.m., October 17, Blvd., RM 816, Bethesda, MD 20892, 301– applications listed below may be
827–4905, brownnac@mail.nih.gov. obtained by communicating with the
2018.
Name of Committee: Arthritis and indicated licensing contact at the
Time for public comment sessions Musculoskeletal and Skin Diseases Initial Technology Transfer and Intellectual
will be allotted both days. On-site Review Group; Arthritis and Musculoskeletal Property Office, National Institute of
registration is required for participation and Skin Diseases Clinical Trials Review
Committee. Allergy and Infectious Diseases, 5601
in the live public comment session.
Date: October 16–17, 2018. Fishers Lane, Rockville, MD 20852; tel.
Note that public comment must be
Time: 8:00 a.m. to 5:00 p.m. 301–496–2644. A signed Confidential
relevant to topics currently being Disclosure Agreement will be required
Agenda: To review and evaluate grant
addressed by the SACHRP. Individuals applications. to receive copies of unpublished patent
submitting written statements as public Place: Hilton Garden Inn, 7301 Waverly applications.
comment should email or fax their Street, Bethesda, MD 20814. SUPPLEMENTARY INFORMATION:
comments to SACHRP at SACHRP@ Contact Person: Nakia C. Brown, Ph.D.,
Technology description follows.
hhs.gov at least five business days prior NIAMS/Scientific Review Officer, 6701
to the meeting. Democracy Blvd., RM 816, Bethesda, MD A New Class of Immunomodulatory
20892, 301–827–4905, brownnac@ Drugs for Multiple Sclerosis
Public attendance at the meeting is mail.nih.gov.
limited to space available. Individuals Name of Committee: National Institute of Description of Technology: Multiple
who plan to attend and need special Arthritis and Musculoskeletal and Skin sclerosis (MS) is an autoimmune disease
assistance, such as sign language Diseases Special Emphasis Panel; AMSC caused by activated autoimmune T
interpretation or other reasonable Member Conflict. lymphocytes in patients resulting in
accommodations, should notify one of Date: October 29, 2018. inflammatory demyelination in the
the designated SACHRP points of Time: 10:00 a.m. to 2:00 p.m. central nervous system. Current
contact at the address/phone number Agenda: To review and evaluate grant treatments are focused on functional
listed above at least one week prior to applications. control of these activated autoimmune T
Place: Democracy One, 6701 Democracy
the meeting. cells, but these treatments are non-
amozie on DSK3GDR082PROD with NOTICES1

Blvd., Bethesda, MD 20892.
Contact Person: Yasuko Furumoto, Ph.D., specific T cell inhibitors and have
Dated: September 14, 2018.
NIAMS/Scientific Review Officer, 6701 serious, sometimes fatal side effects. A
Julia G. Gorey, specific therapy aimed at eliminating
Democracy Blvd., RM 816, Bethesda, MD
Executive Director, Secretary’s Advisory 20892, 301–451–6520, yasuko.furumoto@ these autoimmune T cells through
Committee on Human Research Protections. nih.gov. restimulation-induced cell death (RICD)
[FR Doc. 2018–20676 Filed 9–21–18; 8:45 am] (Catalogue of Federal Domestic Assistance could cure the disease and overcome the
BILLING CODE 4150–36–P Program Nos. 93.846, Arthritis, fatal side effects of current therapies.

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Document Created: 2018-09-22 00:33:01
Document Modified: 2018-09-22 00:33:01

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 16, 2018, from 8:30 a.m. until 5 p.m., and Wednesday, October 17, 2018, from 8:30 a.m. until 4 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		83 FR 48318