Notices

OLAW welcomes comments on any of its policy guidance. Comments may be emailed to OLAW at: olaw@mail.nih.gov (please insert the title of the specific guidance document in the subject field). All relevant comments will be considered in OLAW decisions on timing and content of revisions to guidance documents, or development of new guidance documents. Comments generally will not result in direct responses from OLAW.

Disclaimer:
OLAW develops, monitors, and exercises compliance oversight relative to the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). One of OLAW's primary functions is to advise awarding units and awardee institutions concerning the implementation of the PHS Policy. OLAW often provides this advice by responding to policy-related questions submitted by such units and institutions. The following Notices provide guidance that represents OLAW's current thinking on these topics. This guidance is based on OLAW's experience with the subject matter and draws on best practices followed by the biomedical community regarding the use of research animals. Unless specific statutory or regulatory requirements are cited, the Notices should be viewed as recommendations in that an institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy.

 

 
Notice Number Title Date
NOT-OD-22-006 Notice of Clarification of Offeror Responsibilities Regarding Contract to Protocol Congruence Review October 18, 2021
NOT-OD-22-005 Notice of Clarification of Institutional Responsibilities Regarding NIH Grant to Protocol Congruence Review October 18, 2021
NOT-OD-22-002 Reminder: Annual Reports to the Office of Laboratory Animal Welfare due December 1, 2021 October 13, 2021
NOT-OD-21-164 Guidance on Flexibilities for Conducting Semiannual Inspection of Animal Facilities August 2, 2021
NOT-OD-21-161 Request for Information (RFI) on Clarifying the Reporting Requirements for Departures from the Guide for the Care and Use of Laboratory Animals July 20, 2021
NOT-OD-21-130 Notice to Encourage Using AAALAC International Program Description Sections to Complete Parts of the OLAW Domestic Animal Welfare Assurance June 4, 2021
NOT-OD-21-022 Notice of Office of Laboratory Animal Welfare Statement on Oversight of NIH-owned Chimpanzees November 5, 2020
NOT-OD-20-143 Grant and Contract Submission Requirements Regarding the Updated AVMA Guidelines for the Euthanasia of Animals: 2020 Edition July 13, 2020
NOT-OD-20-132 Public Comments on the Implementation of the Updated AVMA Guidelines for the Euthanasia of Animals: 2020 Edition June 30, 2020
NOT-OD-20-109 Notice of Update to the Reporting Period of the Annual Report to OLAW May 21, 2020
NOT-OD-20-095 Notice of Memorandum of Understanding Between NIH and NASA Concerning Laboratory Animal Welfare April 16, 2020
NOT-OD-20-088 Flexibilities for Assured Institutions for Activities of Institutional Animal Care and Use Committees (IACUCs) Due to COVID-19 March 16, 2020
NOT-OD-19-136 Report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research August 28, 2019
NOT-OD-19-069 Report on Site Visits to the Veterans Affairs Medical Centers with Focus on Canine Care and Use in Research January 31, 2019
NOT-OD-17-010 Reports on Site Visits to the National Primate Research Centers and the Federally Supported Chimpanzee Sanctuary October 25, 2016
NOT-OD-16-125 Notice of Change in Animal Welfare Assurance Numbering System August 2, 2016
NOT-OD-16-006 Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals October 13, 2015
NOT-OD-15-139 Notice of Memorandum of Understanding Between NIH and NSF Concerning Laboratory Animal Welfare August 10, 2015
NOT-OD-15-109 Guidance on Qualifications of IACUC Nonscientific and Nonaffiliated Members June 9, 2015
NOT-OD-15-079 Notice of Update to the Public Health Service Policy on Humane Care and Use of Laboratory Animals March 17, 2015
NOT-OD-15-028 Notice of Office of Laboratory Animal Welfare Policy on Shared Animal Welfare Concerns December 1, 2014
NOT-OD-14-126 Guidance on Significant Changes to Animal Activities August 26, 2014
NOT-OD-14-099 Notice of Change in Criteria for Renewal of Domestic Animal Welfare Assurances May 29, 2014
NOT-OD-13-096 Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals August 2, 2013
NOT-OD-13-044 Notice of Change to Electronic Submission of Final Noncompliance Reports to the Office of Laboratory Animal Welfare February 21, 2013
NOT-OD-12-148 Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals September 10, 2012
NOT-OD-12-081 Change in Criteria for Renewal of Animal Welfare Assurances for Foreign Institutions March 8, 2012
NOT-OD-12-020 Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition December 2, 2011
NOT-OD-12-021 Update of Sample Interinstitutional Assurance December 1, 2011
NOT-OD-11-053 Guidance to Reduce Regulatory Burden for IACUC Administration Regarding Alternate Members and Approval Dates March 18, 2011
NOT-OD-10-128 Clarification on the Roles of NIH Scientific Review Groups (SRG) and Institutional Animal Care and Use Committees (IACUC) in Review of Vertebrate Animal Research September 1, 2010
NOT-OD-10-121 Report on Site Visits to Chimpanzee Facilities and Associated Resources to Aid Grantee Institutions August 6, 2010
NOT-OD-10-114 Update on Applicability of the Shelf Life Extension Program (SLEP) July 14, 2010
NOT-OD-10-102 Update of the Guide for the Care and Use of Laboratory Animals June 4, 2010
NOT-OD-10-049 Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals April 19, 2010
NOT-OD-10-083 Update of Sample Animal Welfare Assurance for Foreign Institutions April 16, 2010
NOT-OD-10-081 Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals April 15, 2010
NOT-OD-10-027 Instructions for Completion and Peer Review of the Vertebrate Animal Section (VAS) in NIH Grant Applications and Cooperative Agreements March 17, 2010
NOT-OD-09-035 Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR) January 8, 2009
NOT-OD-08-049 Update of Sample Animal Welfare Assurance February 15, 2008
NOT-OD-07-044 NIH Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld January 26, 2007
NOT-OD-06-052 Guidance on Use of Telecommunications for IACUC Meetings March 24, 2006
NOT-OD-05-034 Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals February 24, 2005
NOT-OD-03-046 Revised Guidance Regarding IACUC Approval of Changes in Personnel Involved in Animal Activities June 6, 2003
NOT-OD-01-017 Guidance Regarding Administrative IACUC Issues (alternate IACUC members, IACUC review at collaborating institutions) and Efforts to Reduce Regulatory Burden February 12, 2001
NOT-OD-00-019 Guidance Concerning the Production of Monoclonal Antibodies in Animals February 3, 2000
NOT-OD-00-007 Guidance Regarding Reduction of Regulatory Burden December 21, 1999
NOT-OD-98-01 Production of Monoclonal Antibodies Using Mouse Ascites Method

November 17, 1997

OPRR REPORTS 97-03 Maintenance of Properly Constituted IACUCs June 2, 1997
OPRR REPORTS 97-02 NASA Principles for the Ethical Care and Use of Animals May 30, 1997
OPRR REPORTS 95-03 Sources of Custom Antibody Production March 8, 1995
OPRR REPORTS 94-01 Internal Distribution of Your Animal Welfare Assurance January 11, 1994
OPRR REPORTS 90-01 Use of Expedited Protocol Review Procedures by IACUCs May 21, 1990
 

  Current Requests for Information (RFIs)

 

11/01/2021 08/20/2021 NOT-OD-21-161 Request for Information (RFI) on Clarifying the Reporting Requirements for Departures from the Guide for the Care and Use of Laboratory Animals July 20, 2021

   Administrative

    NOT-OD-16-125 Notice of Change in Animal Welfare Assurance Numbering System August 2, 2016
    NOT-OD-10-114 Update on Applicability of the Shelf Life Extension Program (SLEP) July 14, 2010

   Animal Use and Management

    NOT-OD-00-019 Guidance Concerning the Production of Monoclonal Antibodies in Animals February 3, 2000
    OPRR Reports 98-01 Production of Monoclonal Antibodies Using Mouse Ascites Method November 17, 1997
    OPRR Reports 95-03 Sources of Custom Antibody Production March 8, 1995

   Animal Welfare Assurances

  07/07/2021 NOT-OD-21-130 Notice to Encourage Using AAALAC International Program Description Sections to Complete Parts of the OLAW Domestic Animal Welfare Assurance June 4, 2021
    NOT-OD-14-099 Notice of Change in Criteria for Renewal of Domestic Animal Welfare Assurances May 29, 2014
    NOT-OD-12-081 Change in Criteria for Renewal of Animal Welfare Assurances for Foreign Institutions March 8, 2012
    NOT-OD-12-021 Update of Sample Interinstitutional Assurance December 1, 2011
    NOT-OD-10-083 Update of Sample Animal Welfare Assurance for Foreign Institutions April 16, 2010
    NOT-OD-08-049 Update of Sample Animal Welfare Assurance February 15, 2008
    OPRR Reports 94-01 Internal Distribution of Your Animal Welfare Assurance January 11, 1994

   IACUC Composition, Functions, and Authority

  09/02/2021 NOT-OD-21-164 Guidance on Flexibiltiies for Conducting Semiannual Inspections of Animal Facilities August 2, 2021
    NOT-OD-15-109 Guidance on Qualifications of IACUC Nonscientific and Nonaffiliated Members June 9, 2015
    NOT-OD-11-053 Guidance to Reduce Regulatory Burden for IACUC Administration Regarding Alternate Members and Approval Dates March 18, 2011
    NOT-OD-06-052 Guidance on Use of Telecommunications for IACUC Meetings March 24, 2006
    NOT-OD-01-017 Guidance Regarding Administrative IACUC Issues (alternate IACUC members, IACUC review at collaborating institutions) and Efforts to Reduce Regulatory Burden February 12, 2001
    OPRR Reports 97-03 Maintenance of Properly Constituted IACUCs June 2, 1997

  Institutional Reporting to OLAW

  12/13/2021 NOT-OD-22-002 Reminder: Annual Reports to the Office of Laboratory Animal Welfare due December 1, 2021 October 13, 2021
    NOT-OD-20-109 Notice of Update to the Reporting Period of the Annual Report to OLAW May 21, 2020
    NOT-OD-13-044 Notice of Change to Electronic Submission of Final Noncompliance Reports to the Office of Laboratory Animal Welfare February 21, 2013
    NOT-OD-12-148 Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals September 10, 2012
    NOT-OD-05-034 Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals February 24, 2005

 Institutional Responsibilities

    NOT-OD-20-088 Flexibilities for Assured Institutions for Activities of Institutional Animal Care and Use Committees (IACUCs) Due to COVID-19 March 16, 2020
    NOT-OD-10-081 Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals April 15, 2010
    NOT-OD-07-044 NIH Policy on Allowable Costs for Grant Activities Involving Animals when Terms and Conditions are not Upheld January 26, 2007

  Memoranda of Understanding (MOUs)

    NOT-OD-20-095 Notice of Memorandum of Understanding Between NIH and NASA Concerning Laboratory Animal Welfare April 16, 2020
    NOT-OD-15-139 Notice of Memorandum of Understanding Between NIH and NSF Concerning Laboratory Animal Welfare August 10, 2015
    NOT-OD-15-028 Notice of Office of Laboratory Animal Welfare Policy on Shared Animal Welfare Concerns December 1, 2014
    OPRR Reports 97-02 NASA Principles for the Ethical Care and Use of Animals May 30, 1997

   Policy and Regulation

    NOT-OD-20-143 Grant and Contract Submission Requirements Regarding the Updated AVMA Guidelines for the Euthanasia of Animals: 2020 Edition July 13, 2020
    NOT-OD-20-132 Public Comments on the Implementation of the Updated AVMA Guidelines for the Euthanasia of Animals: 2020 Edition June 30, 2020
    NOT-OD-15-079 Notice of Update to the Public Health Service Policy on Humane Care and Use of Laboratory Animals March 17, 2015
    NOT-OD-13-096 Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals August 2, 2013
    NOT-OD-12-020 Adoption and Implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition December 2, 2011
    NOT-OD-10-102 Update of the Guide for the Care and Use of Laboratory Animals June 4, 2010
    NOT-OD-00-007 Guidance Regarding Reduction of Regulatory Burden December 21, 1999

   Protocol Review

    NOT-OD-22-006 Notice of Clarification of Institutional Responsibilities Regarding NIH Grant to Protocol Congruence Review October 18, 2021
    NOT-OD-22-005
 
Notice of Clarification of Offeror Responsibilites Regarding Contract to Protocol Congruence Review October 18, 2021
    NOT-OD-14-126 Guidance on Significant Changes to Animal Activities August 26, 2014
    NOT-OD-10-128 Clarification on the Roles of NIH Scientific Review Groups (SRG) and Institutional Animal Care and Use Committees (IACUC) in Review of Vertebrate Animal Research September 1, 2010
    NOT-OD-09-035 Guidance to IACUCs Regarding Use of Designated Member Review (DMR) for Animal Study Proposal Review Subsequent to Full Committee Review (FCR) January 8, 2009
    NOT-OD-03-046 Revised Guidance Regarding IACUC Approval of Changes in Personnel Involved in Animal Activities June 6, 2003
    OPRR Reports 90-01 Use of Expedited Protocol Review Procedures by IACUCs May 21, 1990

   Reports and Statements

    NOT-OD-21-022 Notice of Office of Laboratory Animal Welfare Statement on Oversight of NIH-owned Chimpanzees November 5, 2020
    NOT-OD-19-136 Report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research August 28, 2019
    NOT-OD-19-069 Report on Site Visits to the Veterans Affairs Medical Centers with Focus on Canine Care and Use in Research January 31, 2019
    NOT-OD-17-010 Reports on Site Visits to the National Primate Research Centers and the Federally Supported Chimpanzee Sanctuary October 25, 2016
    NOT-OD-10-121 Report on Site Visits to Chimpanzee Facilities and Associated Resources to Aid Grantee Institutions August 6, 2010

   Vertebrate Animals Section (VAS)

    NOT-OD-16-006 Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals October 13, 2015
    NOT-OD-10-049 Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section (VAS) in NIH Contract Proposals April 19, 2010
    NOT-OD-10-027 Instructions for Completion and Peer Review of the Vertebrate Animal Section (VAS) in NIH Grant Applications and Cooperative Agreements March 17, 2010

 

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