80 FR 62542 - National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 200 (October 16, 2015)

Page Range		62542-62543
FR Document		2015-26408

The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee and is seeking nominations for this committee.

Federal Register, Volume 80 Issue 200 (Friday, October 16, 2015)

[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62542-62543]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26408]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Neurological Disorders and Stroke, 
Interagency Pain Research Coordinating Committee Call for Committee 
Membership Nominations

SUMMARY: The Department of Health and Human Services (HHS) (Department) 
has created the Interagency Pain Research Coordinating Committee and is 
seeking nominations for this committee.

DATES: Nominations are due by 5 p.m. on November 19, 2015.

ADDRESSES: Nominations must be submitted through the web form on the 
IPRCC Web site: http://iprcc.nih.gov/about/IPRCC-Nomination.htm.

FOR FURTHER INFORMATION CONTACT: Linda Porter, porterl@ninds.nih.gov.

SUPPLEMENTARY INFORMATION: As specified in Public Law 111-148 
(``Patient Protection and Affordable Care Act'') the Committee will: 
(a) Develop a summary of advances in pain care research supported or 
conducted by the Federal agencies relevant to the diagnosis, 
prevention, and treatment of pain and diseases and disorders associated 
with pain; (b) identify critical gaps in basic and clinical research on 
the symptoms and causes of pain; (c) make recommendations to ensure 
that the activities of the National Institutes of Health and other 
Federal agencies are free of unnecessary duplication of effort; (d) 
make recommendations on how best to disseminate information on pain 
care; and (e) make recommendations on how to expand partnerships 
between public entities and private entities to expand collaborative, 
cross-cutting research.
    Membership on the committee will include six (6) non-Federal 
members from among scientists, physicians, and other health 
professionals and six (6) non-Federal members of the general public who 
are representatives of leading research, advocacy, and service 
organizations for individuals with pain-related conditions. Members 
will serve overlapping three year terms. It is anticipated that the 
committee will meet at least once a year.
    The Department strives to ensure that the membership of HHS Federal 
advisory committees is fairly balanced in terms of points of view 
represented and the committee's function. Every effort is made to 
ensure that the views of diverse ethnic and racial groups and

[[Page 62543]]

people with disabilities are represented on HHS Federal advisory 
committees, and the Department therefore, encourages nominations of 
qualified candidates from these groups. The Department also encourages 
geographic diversity in the composition of the Committee. Appointment 
to this Committee shall be made without discrimination on the basis of 
age, race, ethnicity, gender, sexual orientation, disability, and 
cultural, religious, or socioeconomic status.
    The Department is soliciting nominations for two non-federal 
members from among scientists, physicians, and other health 
professionals and for one non-federal member of the general public who 
is a representative of a leading research, advocacy, or service 
organization for people with pain-related conditions. These candidates 
will be considered to fill positions opened through completion of 
current member terms. Nominations are due by 5 p.m. on November 19, 
2015, using the IPRCC nomination web form: http://iprcc.nih.gov/about/IPRCC-Nomination.htm.

    Dated: October 8, 2015.
Walter J. Koroshetz,
Director, National Institute of Neurological Disorders and Stroke, 
National Institutes of Health.
[FR Doc. 2015-26408 Filed 10-15-15; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices 62543

people with disabilities are represented are reviewed and registered with the 1. An oversight body (an Institutional
on HHS Federal advisory committees, NIH, and (C) the streamlining of the NIH Biosafety Committee (IBC) or an
and the Department therefore, protocol registration submission Institutional Review Board (IRB))
encourages nominations of qualified requirements under Appendix M–I–A of determines that a human gene transfer
candidates from these groups. The the NIH Guidelines. protocol submitted to it for approval
Department also encourages geographic DATES: To ensure consideration, would significantly benefit from RAC
diversity in the composition of the comments must be submitted in writing review; and
Committee. Appointment to this by November 30, 2015. 2. One or more of the criteria below
Committee shall be made without ADDRESSES: Comments may be are satisfied:
discrimination on the basis of age, race, submitted by email at OBA-osp@ a. The protocol uses a new vector,
ethnicity, gender, sexual orientation, od.nih.gov, by fax at 301–496–9839, or genetic material, or delivery
disability, and cultural, religious, or by mail to the Office of Science Policy, methodology that represents a first-in-
socioeconomic status. National Institutes of Health, 6705 human experience, thus presenting an
The Department is soliciting Rockledge Drive, Suite 750, Bethesda, unknown risk.
nominations for two non-federal Maryland 20892–7985. All written b. The protocol relies on preclinical
members from among scientists, comments received in response to this safety data that were obtained using a
physicians, and other health notice will be available for public new preclinical model system of
professionals and for one non-federal inspection at the NIH Office of Science unknown and unconfirmed value.
member of the general public who is a Policy (OSP), 6705 Rockledge Drive, c. The proposed vector, gene
representative of a leading research, Suite 750, Bethesda, MD 20892–7985, construct, or method of delivery is
advocacy, or service organization for weekdays between the hours of 8:30 associated with possible toxicities that
people with pain-related conditions. a.m. and 5 p.m. and may be posted to are not widely known and that may
These candidates will be considered to the NIH OSP Web site. render it difficult for oversight bodies to
fill positions opened through FOR FURTHER INFORMATION CONTACT: If evaluate the protocol rigorously.
completion of current member terms. you have questions, or require The chair of an oversight body or an
Nominations are due by 5 p.m. on additional background information authorized oversight body
November 19, 2015, using the IPRCC about these proposed changes, please representative may submit a request for
nomination web form: http:// contact the NIH by email at OBA-osp@ RAC review by sending the request to
iprcc.nih.gov/about/IPRCC- od.nih.gov, or telephone at 301–496– the NIH as part of the submission
Nomination.htm. 9838. materials provided by the PI. This
Dated: October 8, 2015. SUPPLEMENTARY INFORMATION: The NIH request must include the rationale for
Walter J. Koroshetz, Office of the Director requested that the why the protocol satisfies both items 1
Director, National Institute of Neurological IOM review whether gene transfer and 2 of the NIH RAC review criteria.
Disorders and Stroke, National Institutes of research raises issues of concern that The NIH will review the request and
Health. warrant the current level of RAC notify the requestor of a decision in no
[FR Doc. 2015–26408 Filed 10–15–15; 8:45 am] oversight of individual clinical trials more than ten working days.
BILLING CODE 4140–01–P involving gene transfer techniques. The 1. If the NIH determines that the
IOM noted that the RAC has served a criteria listed in both 1 and 2 above are
valuable role, but concluded that the satisfied, the NIH Director will convene
DEPARTMENT OF HEALTH AND current level of oversight over the RAC.
HUMAN SERVICES individual clinical trials is no longer 2. If the NIH receives a request for
justifiable. In an effort to maximize the RAC review of a protocol that the NIH
National Institutes of Health benefits of the RAC review process, the determines does not meet both of these
IOM recommended that the NIH criteria, the NIH would:
Proposed Action Under the NIH a. Inform the requestor that RAC
maintain its protocol submission and
Guidelines for Research Involving review is not warranted, and
safety reporting requirements, but
Recombinant or Synthetic Nucleic Acid b. offer to provide the requestor with
restrict individual gene transfer protocol
Molecules (NIH Guidelines) information about previous protocols
reviews to exceptional cases that meet
AGENCY: National Institutes of Health specified criteria (full recommendations that have used similar products, the
(NIH), HHS. are listed in the IOM report Oversight outcome of those studies, if available,
ACTION: Notice of proposed changes to and Review of Clinical Gene Transfer and a summary of relevant safety data.
the NIH Guidelines. Protocols: Assessing the Role of the 3. Even if the protocol does not meet
Recombinant DNA Advisory Committee the proposed criteria listed in both
SUMMARY: The NIH seeks public (http://www.iom.edu/Reports/2013/ items 1 and 2 above, the NIH Director,
comment on its proposal to amend the Oversight-and-Review-of-Clinical-Gene- in consultation (if necessary) with
NIH Guidelines for Research Involving Transfer-Protocols.aspx)). appropriate regulatory authorities (e.g.,
Recombinant or Synthetic Nucleic Acid After careful consideration of the the Office for Human Research
Molecules (NIH Guidelines) to IOM’s recommendations, the NIH Protections, the Food and Drug
incorporate the recommendations of the proposes amendments to the NIH Administration), can select protocols for
Institute of Medicine (IOM) regarding Guidelines in the following areas: review that may present significant
human gene transfer clinical research A. Criteria and process for selecting scientific, societal, or ethical concerns.
srobinson on DSK5SPTVN1PROD with NOTICES

protocols. The NIH proposes protocols for RAC review. The following B. Process by which human gene
amendments to the following: (A) The criteria (subsequently referred to as the transfer protocols are registered with the
criteria for selecting protocols for in- NIH RAC review criteria) are proposed NIH. All human gene transfer protocols
depth review and public discussion by for initiating RAC review of individual subject to Section III–C of the NIH
the NIH Recombinant DNA Advisory human gene transfer protocols (criteria Guidelines will continue to be registered
Committee (RAC), (B) the process by listed in both items 1 and 2 must be with the NIH. However, the following
which human gene transfer protocols met): changes are being proposed:

VerDate Sep<11>2014 18:54 Oct 15, 2015 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1

Document Created: 2015-12-14 15:24:03
Document Modified: 2015-12-14 15:24:03

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
Dates		Nominations are due by 5 p.m. on November 19, 2015.
Contact		Linda Porter, [email protected]
FR Citation		80 FR 62542

80 FR 62542 - National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 200 (October 16, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health