Request for Comment: Input on Recommendations from the Council of Councils Working Group on Use of Chimpanzees in NIH-Supported Research, 8154-8155 [2013-02507]
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Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / Notices
Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Males and females 16
years old or older. The annual reporting
burden is as follows: Estimated Number
of Respondents: 6,882; Estimated
Number of Responses per Respondent:
Focus Groups: 1 per respondent;
Cognitive Interviews: 2 per respondent;
Respondent Surveys: 3 per respondent.
Average Burden of Hours per Response:
Focus Groups: 1.5 hours per respondent;
Cognitive Interviews: 1 hour per
respondent; Respondent Surveys: 20
minutes per respondent Estimated Total
Annual Burden Hours Requested: 7,532.
The annualized total costs to all
respondents are $66,288. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
ESTIMATED BURDEN HOURS FOR PROPOSED EXAMPLE STUDIES TO BE CONDUCTED UNDER THIS CLEARANCE
Annual
frequency
per response
Number of
respondents
Type of collection
Hours per
response
Total hours
300
500
6,082
1
2
3
1.5
1.0
.33
450
1,000
6,082
Total ........................................................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Focus Groups ................................................................................................
Cognitive Interviews .......................................................................................
Respondent Surveys .....................................................................................
6,882
........................
..........................
7,532
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and the assumptions used;
(3) Ways to enhance the quality, utility,
and clarity of the information collected;
and (4) Ways to minimize the burden of
the collection of 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.
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: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Simone
Glynn, MD, Project Officer/ICD Contact,
Two Rockledge Center, Suite 9142, 6701
Rockledge Drive, Bethesda, MD 20892,
or call 301–435–0065, or Email your
request to: glynnsa@nhlbi.nih.gov.
Comments 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.
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17:18 Feb 04, 2013
Jkt 229001
Dated: January 13, 2013.
Keith Hoots,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, NIH.
Dated: January 13, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2013–02480 Filed 2–4–13; 8:45 am]
BILLING CODE 4141–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Comment: Input on
Recommendations from the Council of
Councils Working Group on Use of
Chimpanzees in NIH-Supported
Research
The National Institutes of
Health (NIH) Council of Councils
received and adopted the
recommendations and Report of the NIH
Council of Councils Working Group on
the Use of Chimpanzees in NIHSupported Research on January 22,
2013. The report is posted on the NIH
Web site at https://dpcpsi.nih.gov/
council/working_group_message.aspx.
The agency will consider the
recommendations contained in the
report as the agency formulates policy.
The NIH also announces the opening of
a Request for Comment (RFC) period to
collect input on the recommendations
from interested parties. Comments will
be accepted until Saturday, March 23,
2013, via the comment database at
https://grants.nih.gov/grants/rfi/
rfi.cfm?ID=31. In the interim, NIH will
continue to apply its policy on Research
Involving Chimpanzees (see NOT–OD–
12–025; https://grants.nih.gov/grants/
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Responses to this RFC will be
accepted through 11:59 p.m. EST
Saturday, March 23, 2013.
DATES:
All comments should be
submitted electronically to https://
grants.nih.gov/grants/rfi/rfi.cfm?ID=31.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
The
Division of Program Coordination,
Planning, and Strategic Initiatives,
Office of the Director, National
Institutes of Health at
dpcpsi@od.nih.gov.
The use of
animals in biomedical and behavioral
research has enabled scientists to
identify new ways to treat illness,
extend life, and improve health and
well-being. Chimpanzees are our closest
relatives in the animal kingdom,
providing exceptional insights into
human biology and requiring special
consideration and respect. While used
very selectively and in limited numbers
for biomedical research, chimpanzees
have served an important role in
advancing human health in the past.
However, new methods and
technologies developed by the
biomedical community have provided
alternatives to the use of chimpanzees
in several areas of research.
In December 2010, the NIH
commissioned a study by the Institute of
Medicine (IOM) to assess whether
chimpanzees are or will be necessary for
NIH-funded biomedical and behavioral
research. A year later on December 15,
2011, the IOM issued its findings, with
a primary recommendation that the use
of chimpanzees in research be guided by
a set of principles and criteria. The
committee proposed three principles to
analyze current and potential future
research using chimpanzees:
SUPPLEMENTARY INFORMATION:
National Institutes of Health
SUMMARY:
guide/notice-files/NOT–OD–12–
025.html.)
E:\FR\FM\05FEN1.SGM
05FEN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / Notices
1. That the knowledge gained must be
necessary to advance the public’s
health;
2. There must be no other research
model by which the knowledge could be
obtained, and the research cannot be
ethically performed on human subjects;
and
3. The animals used in the proposed
research must be maintained either in
ethologically appropriate physical and
social environments (i.e., as would
occur in their natural environment) or
in natural habitats.
Based on its deliberations, the IOM
committee concluded that ‘‘while the
chimpanzee has been a valuable animal
model in past research, most current use
of chimpanzees for biomedical research
is unnecessary.’’ The committee
generated case studies of predominant
areas of chimpanzee research
exemplifying the committee’s vision for
applying the criteria it developed. The
case studies concluded that the
following areas of the research they
assessed may continue to require the
use of chimpanzees: some ongoing
research on monoclonal antibody
therapies, research on comparative
genomics, and important studies of
social and behavioral factors that affect
the development, prevention, or
treatment of disease. The committee was
unable to reach consensus on the
necessity of the chimpanzee for the
development of prophylactic hepatitis C
virus vaccine. It also acknowledged that
new, emerging, or re-emerging diseases
may present challenges that may require
the use of chimpanzees. To assist the
NIH in considering future requests to
use chimpanzees in research, the IOM
committee provided the set of principles
and criteria as a framework to guide
NIH’s assessment.
In December 2011, NIH accepted the
IOM Recommendations (https://
www.nih.gov/news/health/dec2011/od15.htm) contained in the report
Chimpanzees in Biomedical and
Behavioral Research: Assessing the
Necessity and issued interim policy in
notice NOT–OD–12–025, which
indicated that NIH would not fund any
new or other competing projects
(renewal and revisions) for research
involving chimpanzees and will not
allow any new projects to go forward
with NIH-owned or -supported
chimpanzees. However, currently
funded research was allowed to
continue. The policy remains in effect
until NIH considers and issues policy
implementing the IOM
recommendations.
NIH assembled a working group of the
NIH Council of Councils on February 1,
2012, to provide advice on
VerDate Mar<15>2010
17:18 Feb 04, 2013
Jkt 229001
implementation of the IOM
recommendations and to consider the
size and placement of the active and
inactive populations of NIH-owned or
-supported chimpanzees. The Working
Group was charged with (1) Developing
a plan for implementation of the IOM’s
guiding principles and criteria; (2)
Analyzing currently active NIHsupported research using chimpanzees
to advise on which studies currently
meet the principles and criteria defined
by the IOM report and to advise on the
process for closing studies if any do not
comply with the IOM recommendations;
(3) Advising on the size and placement
of active and inactive populations of
NIH-owned or -supported chimpanzees
that may need to be considered as a
result of implementing the IOM
recommendations; and (4) Developing a
review process for considering whether
potential future use of the chimpanzee
in NIH-supported research is
scientifically necessary and consistent
with the IOM principles.
The Working Group’s efforts
culminated in the report containing 28
recommendations to NIH. In developing
its recommendations, the Working
Group considered public comments
received in response to a previous
Request for Information (https://
dpcpsi.nih.gov/council/
working_group.aspx#Summary),
considered the scientific use of
chimpanzees in currently funded
research, obtained advice from external
experts, and visited several facilities
that house and care for chimpanzees.
The Working Group submitted its
recommendations and the report to the
NIH Council of Councils in open session
on January 22, 2013, and the Council of
Councils adopted the report. The report
is available at https://dpcpsi.nih.gov/
council/working_group_message.aspx.
Comments Requested: The NIH is
seeking input on the recommendations
from the Council of Councils from the
public and the biomedical research
community, including foundations,
scientific societies, government and
regulatory agencies, industry, and NIH
grantee institutions. Input is sought for
each of the report’s recommendations.
Response to this RFC is voluntary.
Responders are free to address any or all
of the recommendations.
Please note that the government will
not pay for response preparation or for
the use of any information contained in
the comments. The NIH may make all
comments available, including name of
the responder. In addition, NIH may
prepare and make available a summary
of all input received that is responsive
to this RFC.
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8155
How to Submit a Response: All
comments should be submitted
electronically to https://grants.nih.gov/
grants/rfi/rfi.cfm?ID=31. Comments
should pertain to the specific
recommendation for which feedback is
requested and should conform to the
word limit indicated. You will see an
electronic confirmation acknowledging
receipt of your response, but will not
receive individualized feedback on any
suggestions. No basis for claims against
the U.S. government shall arise as a
result of a response to this request for
information or from the government’s
use of such information.
Dated: January 28, 2013.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2013–02507 Filed 2–4–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant
applications\contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Omnibus Cancer Biology 1.
Date: March 11–12, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda,
(Formerly Holiday Inn Select), 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Zhiqiang Zou, MD, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Blvd., Room 8055A, MSC
8329, Bethesda, MD 20892, 301–594–3124,
zouzhiq@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Cancer
Immunology.
E:\FR\FM\05FEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Notices]
[Pages 8154-8155]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02507]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Comment: Input on Recommendations from the Council of
Councils Working Group on Use of Chimpanzees in NIH-Supported Research
SUMMARY: The National Institutes of Health (NIH) Council of Councils
received and adopted the recommendations and Report of the NIH Council
of Councils Working Group on the Use of Chimpanzees in NIH-Supported
Research on January 22, 2013. The report is posted on the NIH Web site
at https://dpcpsi.nih.gov/council/working_group_message.aspx. The
agency will consider the recommendations contained in the report as the
agency formulates policy. The NIH also announces the opening of a
Request for Comment (RFC) period to collect input on the
recommendations from interested parties. Comments will be accepted
until Saturday, March 23, 2013, via the comment database at https://grants.nih.gov/grants/rfi/rfi.cfm?ID=31. In the interim, NIH will
continue to apply its policy on Research Involving Chimpanzees (see
NOT-OD-12-025; https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-025.html.)
DATES: Responses to this RFC will be accepted through 11:59 p.m. EST
Saturday, March 23, 2013.
ADDRESSES: All comments should be submitted electronically to https://grants.nih.gov/grants/rfi/rfi.cfm?ID=31.
FOR FURTHER INFORMATION CONTACT: The Division of Program Coordination,
Planning, and Strategic Initiatives, Office of the Director, National
Institutes of Health at dpcpsi@od.nih.gov.
SUPPLEMENTARY INFORMATION: The use of animals in biomedical and
behavioral research has enabled scientists to identify new ways to
treat illness, extend life, and improve health and well-being.
Chimpanzees are our closest relatives in the animal kingdom, providing
exceptional insights into human biology and requiring special
consideration and respect. While used very selectively and in limited
numbers for biomedical research, chimpanzees have served an important
role in advancing human health in the past. However, new methods and
technologies developed by the biomedical community have provided
alternatives to the use of chimpanzees in several areas of research.
In December 2010, the NIH commissioned a study by the Institute of
Medicine (IOM) to assess whether chimpanzees are or will be necessary
for NIH-funded biomedical and behavioral research. A year later on
December 15, 2011, the IOM issued its findings, with a primary
recommendation that the use of chimpanzees in research be guided by a
set of principles and criteria. The committee proposed three principles
to analyze current and potential future research using chimpanzees:
[[Page 8155]]
1. That the knowledge gained must be necessary to advance the
public's health;
2. There must be no other research model by which the knowledge
could be obtained, and the research cannot be ethically performed on
human subjects; and
3. The animals used in the proposed research must be maintained
either in ethologically appropriate physical and social environments
(i.e., as would occur in their natural environment) or in natural
habitats.
Based on its deliberations, the IOM committee concluded that
``while the chimpanzee has been a valuable animal model in past
research, most current use of chimpanzees for biomedical research is
unnecessary.'' The committee generated case studies of predominant
areas of chimpanzee research exemplifying the committee's vision for
applying the criteria it developed. The case studies concluded that the
following areas of the research they assessed may continue to require
the use of chimpanzees: some ongoing research on monoclonal antibody
therapies, research on comparative genomics, and important studies of
social and behavioral factors that affect the development, prevention,
or treatment of disease. The committee was unable to reach consensus on
the necessity of the chimpanzee for the development of prophylactic
hepatitis C virus vaccine. It also acknowledged that new, emerging, or
re-emerging diseases may present challenges that may require the use of
chimpanzees. To assist the NIH in considering future requests to use
chimpanzees in research, the IOM committee provided the set of
principles and criteria as a framework to guide NIH's assessment.
In December 2011, NIH accepted the IOM Recommendations (https://www.nih.gov/news/health/dec2011/od-15.htm) contained in the report
Chimpanzees in Biomedical and Behavioral Research: Assessing the
Necessity and issued interim policy in notice NOT-OD-12-025, which
indicated that NIH would not fund any new or other competing projects
(renewal and revisions) for research involving chimpanzees and will not
allow any new projects to go forward with NIH-owned or -supported
chimpanzees. However, currently funded research was allowed to
continue. The policy remains in effect until NIH considers and issues
policy implementing the IOM recommendations.
NIH assembled a working group of the NIH Council of Councils on
February 1, 2012, to provide advice on implementation of the IOM
recommendations and to consider the size and placement of the active
and inactive populations of NIH-owned or -supported chimpanzees. The
Working Group was charged with (1) Developing a plan for implementation
of the IOM's guiding principles and criteria; (2) Analyzing currently
active NIH-supported research using chimpanzees to advise on which
studies currently meet the principles and criteria defined by the IOM
report and to advise on the process for closing studies if any do not
comply with the IOM recommendations; (3) Advising on the size and
placement of active and inactive populations of NIH-owned or -supported
chimpanzees that may need to be considered as a result of implementing
the IOM recommendations; and (4) Developing a review process for
considering whether potential future use of the chimpanzee in NIH-
supported research is scientifically necessary and consistent with the
IOM principles.
The Working Group's efforts culminated in the report containing 28
recommendations to NIH. In developing its recommendations, the Working
Group considered public comments received in response to a previous
Request for Information (https://dpcpsi.nih.gov/council/working_group.aspx#Summary), considered the scientific use of chimpanzees in
currently funded research, obtained advice from external experts, and
visited several facilities that house and care for chimpanzees. The
Working Group submitted its recommendations and the report to the NIH
Council of Councils in open session on January 22, 2013, and the
Council of Councils adopted the report. The report is available at
https://dpcpsi.nih.gov/council/working_group_message.aspx.
Comments Requested: The NIH is seeking input on the recommendations
from the Council of Councils from the public and the biomedical
research community, including foundations, scientific societies,
government and regulatory agencies, industry, and NIH grantee
institutions. Input is sought for each of the report's recommendations.
Response to this RFC is voluntary. Responders are free to address any
or all of the recommendations.
Please note that the government will not pay for response
preparation or for the use of any information contained in the
comments. The NIH may make all comments available, including name of
the responder. In addition, NIH may prepare and make available a
summary of all input received that is responsive to this RFC.
How to Submit a Response: All comments should be submitted
electronically to https://grants.nih.gov/grants/rfi/rfi.cfm?ID=31.
Comments should pertain to the specific recommendation for which
feedback is requested and should conform to the word limit indicated.
You will see an electronic confirmation acknowledging receipt of your
response, but will not receive individualized feedback on any
suggestions. No basis for claims against the U.S. government shall
arise as a result of a response to this request for information or from
the government's use of such information.
Dated: January 28, 2013.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2013-02507 Filed 2-4-13; 8:45 am]
BILLING CODE 4140-01-P
