National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations, 62542-62543 [2015-26408]
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62542
Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Dr. Sarah Glavin,
Acting Director, Office of Science
Policy, Analysis, and Communications,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of
Health, 31 Center Dr., Bldg. 31, Rm.
2A28, Bethesda, MD 20892, or call nontoll-free number (301) 496–7898, or
email your request, including your
address to: glavins@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Application for
Consideration for the Media-Smart
Youth Leaders Program (A Local Health
Education Program and Leadership
Opportunity): 0925—New, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: Media-Smart Youth: Eat,
Think, and Be Active!® is an interactive
program designed to teach youth ages
11–13 about how media can affect their
health. Developed by the NIH’s Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD), the program includes 10
lessons on media analysis, nutrition,
and physical activity, plus a final
capstone project. The Media-Smart
Youth® Leaders Program is designed for
teens and adults, ages 15 years and up,
who are interested in bringing the
Media-Smart Youth program to their
community. In return for recruiting
youth participants, teaching the 10
lessons, and leading the final project,
Media-Smart Youth Leaders will receive
leadership experience, community
service hours, and recognition from the
NICHD. To help Leaders succeed, the
NICHD will provide training, ongoing
assistance, and a small funding amount
for program expenses.
The purpose of this information
collection is to solicit information from
applicants about their qualifications that
would make them effective Leaders,
their reason for wanting to pursue this
opportunity, and the details of their
proposed program (including, but not
limited to, location, community
partner(s), and proposed budget). This
information will help NICHD staff select
the candidates for the program who are
most likely to succeed in implementing
the full curriculum and teaching youth
effective lessons about nutrition,
physical activity, and media.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
800.
ESTIMATED ANNUALIZED BURDEN HOURS
Average burden per response
(in hours)
Type of
respondent
Media-Smart Youth Leaders Program Application
Form.
Media-Smart Youth Leaders Program Application
Form.
Media-Smart Youth Leaders Program Application
Form.
Applicants ................
300
1
2.5
750
Advisors ..................
300
1
5/60
25
Community partners
300
1
5/60
25
Dated: October 10, 2015.
Sarah Glavin,
Project Clearance Liaison, NICHD, NIH.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSK5SPTVN1PROD with NOTICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke, Interagency Pain
Research Coordinating Committee Call
for Committee Membership
Nominations
The Department of Health and
Human Services (HHS) (Department)
has created the Interagency Pain
Research Coordinating Committee and
is seeking nominations for this
committee.
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18:54 Oct 15, 2015
Jkt 238001
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: https://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;
DATES:
[FR Doc. 2015–26389 Filed 10–15–15; 8:45 am]
SUMMARY:
Number of
respondents
Number of
responses per
respondent
Form name
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burden hour
(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 painrelated 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
E:\FR\FM\16OCN1.SGM
16OCN1
Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices
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: https://
iprcc.nih.gov/about/IPRCCNomination.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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Action Under the NIH
Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines)
National Institutes of Health
(NIH), HHS.
ACTION: Notice of proposed changes to
the NIH Guidelines.
AGENCY:
The NIH seeks public
comment on its proposal to amend the
NIH Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines) to
incorporate the recommendations of the
Institute of Medicine (IOM) regarding
human gene transfer clinical research
protocols. The NIH proposes
amendments to the following: (A) The
criteria for selecting protocols for indepth review and public discussion by
the NIH Recombinant DNA Advisory
Committee (RAC), (B) the process by
which human gene transfer protocols
srobinson on DSK5SPTVN1PROD with NOTICES
SUMMARY:
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18:54 Oct 15, 2015
Jkt 238001
are reviewed and registered with the
NIH, and (C) the streamlining of the NIH
protocol registration submission
requirements under Appendix M–I–A of
the NIH Guidelines.
DATES: To ensure consideration,
comments must be submitted in writing
by November 30, 2015.
ADDRESSES: Comments may be
submitted by email at OBA-osp@
od.nih.gov, by fax at 301–496–9839, or
by mail to the Office of Science Policy,
National Institutes of Health, 6705
Rockledge Drive, Suite 750, Bethesda,
Maryland 20892–7985. All written
comments received in response to this
notice will be available for public
inspection at the NIH Office of Science
Policy (OSP), 6705 Rockledge Drive,
Suite 750, Bethesda, MD 20892–7985,
weekdays between the hours of 8:30
a.m. and 5 p.m. and may be posted to
the NIH OSP Web site.
FOR FURTHER INFORMATION CONTACT: If
you have questions, or require
additional background information
about these proposed changes, please
contact the NIH by email at OBA-osp@
od.nih.gov, or telephone at 301–496–
9838.
SUPPLEMENTARY INFORMATION: The NIH
Office of the Director requested that the
IOM review whether gene transfer
research raises issues of concern that
warrant the current level of RAC
oversight of individual clinical trials
involving gene transfer techniques. The
IOM noted that the RAC has served a
valuable role, but concluded that the
current level of oversight over
individual clinical trials is no longer
justifiable. In an effort to maximize the
benefits of the RAC review process, the
IOM recommended that the NIH
maintain its protocol submission and
safety reporting requirements, but
restrict individual gene transfer protocol
reviews to exceptional cases that meet
specified criteria (full recommendations
are listed in the IOM report Oversight
and Review of Clinical Gene Transfer
Protocols: Assessing the Role of the
Recombinant DNA Advisory Committee
(https://www.iom.edu/Reports/2013/
Oversight-and-Review-of-Clinical-GeneTransfer-Protocols.aspx)).
After careful consideration of the
IOM’s recommendations, the NIH
proposes amendments to the NIH
Guidelines in the following areas:
A. Criteria and process for selecting
protocols for RAC review. The following
criteria (subsequently referred to as the
NIH RAC review criteria) are proposed
for initiating RAC review of individual
human gene transfer protocols (criteria
listed in both items 1 and 2 must be
met):
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1. An oversight body (an Institutional
Biosafety Committee (IBC) or an
Institutional Review Board (IRB))
determines that a human gene transfer
protocol submitted to it for approval
would significantly benefit from RAC
review; and
2. One or more of the criteria below
are satisfied:
a. The protocol uses a new vector,
genetic material, or delivery
methodology that represents a first-inhuman experience, thus presenting an
unknown risk.
b. The protocol relies on preclinical
safety data that were obtained using a
new preclinical model system of
unknown and unconfirmed value.
c. The proposed vector, gene
construct, or method of delivery is
associated with possible toxicities that
are not widely known and that may
render it difficult for oversight bodies to
evaluate the protocol rigorously.
The chair of an oversight body or an
authorized oversight body
representative may submit a request for
RAC review by sending the request to
the NIH as part of the submission
materials provided by the PI. This
request must include the rationale for
why the protocol satisfies both items 1
and 2 of the NIH RAC review criteria.
The NIH will review the request and
notify the requestor of a decision in no
more than ten working days.
1. If the NIH determines that the
criteria listed in both 1 and 2 above are
satisfied, the NIH Director will convene
the RAC.
2. If the NIH receives a request for
RAC review of a protocol that the NIH
determines does not meet both of these
criteria, the NIH would:
a. Inform the requestor that RAC
review is not warranted, and
b. offer to provide the requestor with
information about previous protocols
that have used similar products, the
outcome of those studies, if available,
and a summary of relevant safety data.
3. Even if the protocol does not meet
the proposed criteria listed in both
items 1 and 2 above, the NIH Director,
in consultation (if necessary) with
appropriate regulatory authorities (e.g.,
the Office for Human Research
Protections, the Food and Drug
Administration), can select protocols for
review that may present significant
scientific, societal, or ethical concerns.
B. Process by which human gene
transfer protocols are registered with the
NIH. All human gene transfer protocols
subject to Section III–C of the NIH
Guidelines will continue to be registered
with the NIH. However, the following
changes are being proposed:
E:\FR\FM\16OCN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62542-62543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://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: https://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
