Submission for OMB Review; 30-Day Comment Request Chimpanzee Research Use Form (OD), 49331-49332 [2014-19820]
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Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Notices
selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
´
´
current curriculum vitae or resume.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
emcdonald on DSK67QTVN1PROD with NOTICES
IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations should include a
cover letter and a current curriculum
´
´
vitae or resume for each nominee,
including a current business and/or
home address, telephone number, email
address if available, and a list of
consumer or community-based
organizations for which the candidate
can demonstrate active participation.
Nominations should also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations should include
confirmation that the nominee is aware
of the nomination, unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms up to 4 years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. Upon
selecting qualified nominees for the
ballot, FDA will provide those
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
Dated: August 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19696 Filed 8–19–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Office of Tribal Self-Governance
Program; Negotiation Cooperative
Agreement; Correction
Indian Health Service, HHS.
ACTION: Notice; correction.
AGENCY:
The Indian Health Service
published a document in the Federal
Register on July 29, 2014, for the FY
2014 Office of Tribal Self-Governance
Program, Negotiation Cooperative
Agreement Announcement. The notice
contained an incorrect date.
FOR FURTHER INFORMATION CONTACT: Mr.
Jeremy Marshall, Policy Analyst, Office
of Tribal Self-Governance, Indian Health
Service, 801 Thompson Avenue, Suite
240, Rockville, MD 20852, Telephone
(301) 443–7821. (This is not a toll-free
number.)
SUMMARY:
Correction
In the Federal Register of July 29,
2014, in FR Doc. 2014–17800, on page
44049, in the second column, under the
heading Key Dates, the correct date
should read as follows:
Signed Tribal Resolutions Due Date:
September 8, 2014.
Dated: August 13, 2014.
Yvette Roubideaux,
Acting Director, Indian Health Service.
[FR Doc. 2014–19700 Filed 8–19–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Office of Tribal Self-Governance
Program; Planning Cooperative
Agreement; Correction
Indian Health Service, HHS.
Notice; correction.
AGENCY:
ACTION:
The Indian Health Service
published a document in the Federal
Register on July 29, 2014, for the FY
2014 Office of Tribal Self-Governance
Program, Planning Cooperative
Agreement Announcement. The notice
contained an incorrect date.
FOR FURTHER INFORMATION CONTACT: Mr.
Jeremy Marshall, Policy Analyst, Office
of Tribal Self-Governance, Indian Health
Service, 801 Thompson Avenue, Suite
240, Rockville, MD 20852, Telephone
(301) 443–7821. (This is not a toll-free
number.)
SUMMARY:
PO 00000
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49331
Correction
In the Federal Register of July 29,
2014, in FR Doc. 2014–17801, on page
44043, in the first column, under the
heading Key Dates, the correct date
should read as follows:
Signed Tribal Resolutions Due Date:
September 8, 2014.
Dated: August 13, 2014.
Yvette Roubideaux,
Acting Director, Indian Health Service.
[FR Doc. 2014–19699 Filed 8–19–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Chimpanzee
Research Use Form (OD)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on May 13, 2014,
page 27318, and allowed 60 days for
public comment. The NIH received two
requests to view the form and one
comment expressing the opinion that
chimpanzee research should be
discontinued but did not receive any
public comments on the form itself. The
purpose of this notice is to allow an
additional 30 days for public comment.
The NIH Office of the Director (OD),
Division of Program Coordination,
Planning, and Strategic Initiatives
(DPCPSI), may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Direct Comments To OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the OMB
Office of Regulatory Affairs at OIRA_
submission@omb.eop.gov; or by fax to
202–395–6974, Attention: NIH Desk
Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
SUMMARY:
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49332
Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Notices
To
obtain a copy of the data collection
plans and instruments or to request
more information on the proposed
project contact: DPCPSI, OD, NIH,
Building 1, Room 260, 1 Center Drive,
Bethesda, MD 20892; or call non-tollfree number 301–402–9852; or email the
request, including address, to dpcpsi@
od.nih.gov. Requests for plans and
instruments must be made in writing.
Proposed Collection: Chimpanzee
Research Use Form, 0925–NEW,
Division of Program Coordination,
Planning, and Strategic Initiatives
(DPCPSI), Office of the Director (OD),
National Institutes of Health (NIH).
FOR FURTHER INFORMATION CONTACT:
Chimpanzees in Biomedical and
Behavioral Research: Assessing the
Necessity, and as implemented through
agency policy. The NIH, the CRUP, and/
or the Council will consider the
information submitted through this form
prior to the agency making funding
decisions or otherwise allowing the
research to begin. Completion of this
form is a mandatory step toward
receiving NIH support or approval for
research involving chimpanzees.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
40.
Need and Use of Information
Collection: The purpose of this form is
to obtain information needed by the NIH
to assess whether proposed research
triggers consideration by the
Chimpanzee Research Use Panel (CRUP)
and the NIH Council of Councils
(Council), and if so, whether the
research satisfies the agency’s policy for
research involving chimpanzees. The
CRUP is a working group of the Council
that has been charged with considering
whether research proposing to use
chimpanzees is consistent with
principles and criteria for research
involving chimpanzees, as discussed in
the 2011 Institute of Medicine report,
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hour
Chimpanzee Research Use Form ....
Research Community .......................
20
1
2
40
Dated: August 14, 2014.
Lawrence A. Tabak,
Principal Deputy Director, NIH.
[FR Doc. 2014–19820 Filed 8–19–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of NIH Pathways to Prevention
Workshop: The Role of Opioids in the
Treatment of Chronic Pain
Notice is hereby given of the
National Institutes of Health (NIH)
‘‘Pathways to Prevention Workshop:
The Role of Opioids in the Treatment of
Chronic Pain,’’ which is open to the
public.
SUMMARY:
The workshop will be held
September 29–30, 2014. Sessions will
begin at 8:30 a.m. on both days of the
workshop.
ADDRESSES: The workshop will be at the
NIH Natcher Conference Center, 45
Center Drive, Bethesda, Maryland
20892.
DATES:
emcdonald on DSK67QTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Registration and workshop information
is available at the NIH Office of Disease
Prevention Web site: https://
prevention.nih.gov/programs-events/
pathways-to-prevention/upcomingworkshops/opioids-chronic-pain; or by
sending email to
prevention@mail.nih.gov.
Chronic
pain is a major public health problem
SUPPLEMENTARY INFORMATION:
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that is estimated to affect more than 100
million people in the United States and
about 20 to 30 percent of the population
worldwide. The prevalence of persistent
pain is expected to rise in the near
future as the incidence of associated
diseases (including diabetes, obesity,
cardiovascular disorders, arthritis, and
cancer) increases in the aging U.S.
population.
Opioids are powerful analgesics that
are commonly used and found to be
effective for many types of pain.
However, opioids can produce
significant side effects, including
constipation, nausea, mental clouding,
and respiratory depression, which can
sometimes lead to death.
In addition, long-term opioid use can
also result in physical dependence,
making it difficult to discontinue use
even when the original cause of pain is
no longer present. Furthermore, there is
mounting evidence that long-term
opioid use for pain can actually produce
a chronic pain state, whereby patients
find themselves in a vicious cycle in
which opioids are used to treat pain
caused by previous opioid use.
Data from the Centers for Disease
Control and Prevention indicate that the
prescribing of opioids by clinicians has
increased threefold in the last 20 years,
contributing to the problem of
prescription opioid abuse. Today, the
number of people who die from
prescription opioids exceeds the
number of those who die from heroin
and cocaine, combined.
Health care providers are in a difficult
position when treating moderate to
severe chronic pain; opioid treatments
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may lessen the pain, but may also cause
harm to patients. Additionally, there has
not been adequate testing of opioids in
terms of what types of pain they best
treat, in what populations of people,
and in what manner of administration.
With insufficient data, and often
inadequate training, many clinicians
prescribe too much opioid treatment
when lesser amounts of opioids or nonopioids would be effective.
Alternatively, some health care
providers avoid prescribing opioids
altogether for fear of side effects and
potential addiction, causing some
patients to suffer needlessly.
The 2014 ‘‘NIH Pathways to
Prevention Workshop: The Role of
Opioids in the Treatment of Chronic
Pain’’ will seek to clarify:
• Long-term effectiveness of opioids
for treating chronic pain;
• Potential risks of opioid treatment
in various patient populations;
• Effects of different opioid
management strategies on outcomes
related to addiction, abuse, misuse,
pain, and quality of life;
• Effectiveness of risk mitigation
strategies for opioid treatment; and
• Future research needs and priorities
to improve the treatment of pain with
opioids.
The workshop is sponsored by the
NIH Office of Disease Prevention and
the NIH Pain Consortium.
Initial planning for each Pathways to
Prevention workshop is coordinated by
a Working Group that nominates
panelists and speakers and develops
and finalizes questions that frame the
workshop. After finalizing the
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]]>Agencies
[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Pages 49331-49332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19820]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Chimpanzee
Research Use Form (OD)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on May 13, 2014, page 27318, and allowed 60 days for public
comment. The NIH received two requests to view the form and one comment
expressing the opinion that chimpanzee research should be discontinued
but did not receive any public comments on the form itself. The purpose
of this notice is to allow an additional 30 days for public comment.
The NIH Office of the Director (OD), Division of Program Coordination,
Planning, and Strategic Initiatives (DPCPSI), may not conduct or
sponsor, and the respondent is not required to respond to, an
information collection that has been extended, revised, or implemented
on or after October 1, 1995, unless it displays a currently valid OMB
control number.
Direct Comments To OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the OMB Office of Regulatory Affairs at OIRA_submission@omb.eop.gov; or by fax to 202-395-6974, Attention: NIH Desk
Officer.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
[[Page 49332]]
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or to request more information on the
proposed project contact: DPCPSI, OD, NIH, Building 1, Room 260, 1
Center Drive, Bethesda, MD 20892; or call non-toll-free number 301-402-
9852; or email the request, including address, to dpcpsi@od.nih.gov.
Requests for plans and instruments must be made in writing.
Proposed Collection: Chimpanzee Research Use Form, 0925-NEW,
Division of Program Coordination, Planning, and Strategic Initiatives
(DPCPSI), Office of the Director (OD), National Institutes of Health
(NIH).
Need and Use of Information Collection: The purpose of this form is
to obtain information needed by the NIH to assess whether proposed
research triggers consideration by the Chimpanzee Research Use Panel
(CRUP) and the NIH Council of Councils (Council), and if so, whether
the research satisfies the agency's policy for research involving
chimpanzees. The CRUP is a working group of the Council that has been
charged with considering whether research proposing to use chimpanzees
is consistent with principles and criteria for research involving
chimpanzees, as discussed in the 2011 Institute of Medicine report,
Chimpanzees in Biomedical and Behavioral Research: Assessing the
Necessity, and as implemented through agency policy. The NIH, the CRUP,
and/or the Council will consider the information submitted through this
form prior to the agency making funding decisions or otherwise allowing
the research to begin. Completion of this form is a mandatory step
toward receiving NIH support or approval for research involving
chimpanzees.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 40.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chimpanzee Research Use Form.................... Research Community................ 20 1 2 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: August 14, 2014.
Lawrence A. Tabak,
Principal Deputy Director, NIH.
[FR Doc. 2014-19820 Filed 8-19-14; 8:45 am]
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