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]

Download as PDF 8154 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. VerDate Mar<15>2010 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 http://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 http://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; http://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 http:// 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 (http:// 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 (http:// 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 http://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. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 8155 How to Submit a Response: All comments should be submitted electronically to http://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 05FEN1

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]


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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 http://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 http://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; http://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 http://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 (http://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 (http://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 
http://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 http://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