83 FR 11221 - Laboratory Animal Welfare: Coordination and Harmonization of Regulations and Policies
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 50 (March 14, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 50 (March 14, 2018)
| Page Range | 11221-11221 | |
| FR Document | 2018-05173 |
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)] [Notices] [Page 11221] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05173] [[Page 11221]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Laboratory Animal Welfare: Coordination and Harmonization of Regulations and Policies AGENCY: National Institutes of Health, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The National Institutes of Health (NIH) is seeking information to improve the coordination of regulations and policies with respect to research with laboratory animals as required by the 21st Century Cures Act, Section 2034(d). The request for information is a coordinated effort of the Director of the National Institutes of Health in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. DATES: The Request for Information regarding the proposed actions that the agencies have identified to improve coordination and harmonization of regulations and policies is open for public comment for a period of 90 days. Comments must be submitted electronically at https://grants.nih.gov/grants/rfi/rfi.cfm?ID=71 and must be received by June 12, 2018 to ensure consideration. FOR FURTHER INFORMATION CONTACT: Patricia Brown, Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research, National Institutes of Health, Suite 360, 6705 Rockledge Drive, Bethesda, MD 20892-7982, phone: 301-496-7163, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background This request for information is a coordinated effort of the Director of the National Institutes of Health in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. Section 2034(d) of the 21st Century Cures Act (Pub. L. 114-255) was enacted December 13, 2016 and requires that the NIH in collaboration with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions to reduce administrative burden on investigators. In carrying out this effort, the law requests that NIH seek put to identify ways to ensure regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative. In carrying out the review, NIH OLAW, USDA, and FDA are currently reviewing the following reports and surveys:Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden, 2017, Report of an April 17, 2017 workshop organized by Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges, and the Council on Governmental Relations, with support from the National Association for Biomedical Research, http://www.faseb.org/Portals/2/PDFs/opa/2017/FASEB-Animal-Regulatory-Report-October2017.pdf. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century, 2016, National Academies, https://www.nap.edu/catalog/21824/optimizing-the-nations-investment-in-academic-research-a-new-regulatory. Reducing Investigators' Administrative Workload for Federally Funded Research, 2014, National Science Board, National Science Foundation, https://www.nsf.gov/pubs/2014/nsb1418/nsb1418.pdf. 2012 Faculty Workload Survey Research Report, 2014, Federal Demonstration Partnership (FDP), https://sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/pga_087667.pdf. Findings of the FASEB Survey on Administrative Burden, 2013, FASEB, http://www.faseb.org/portals/2/pdfs/opa/6.7.13%20FASEB%20NSB%20Survey%20findings.pdf. We are seeking the input of interested stakeholders concerning proposed actions that the agencies have identified to improve coordination and harmonization of regulations and policies. The responses received will provide critical information for final recommendations and implementation. II. Information Requested Input is sought on each of the following proposed actions that the agencies are considering: 1. Allow investigators to submit protocols for continuing review using a risk-based methodology. 2. Allow annual reporting to OLAW and USDA on the same reporting schedule and as a single report through a shared portal. 3. Harmonize the guidance from NIH and USDA to reduce duplicative considerations of alternatives to painful and distressful procedures. 4. Provide a minimum 60-day comment period for new OLAW policy guidance. 5. Other approaches not previously mentioned. Feedback is sought on whether the following tools and resources are or would be helpful for reducing burden on investigators: 1. Encourage the use of sections of the AAALAC International program description in applicable parts of the OLAW Animal Welfare Assurance, for institutions accredited by AAALAC International. 2. Encourage the use of the FDP Compliance Unit Standard Procedures as a repository of best practices for standard procedures used for research with animals. 3. Encourage the use of the IACUC Administrators Association repository of best practices by IACUCs. 4. Encourage the use of new or existing tools to streamline protocol review through use of designated member review (DMR), DMR subsequent to full committee review, and/or Veterinary Verification and Consultation. 5. Expanded IACUC training activities that focus on reducing burden on investigators. Dated: March 8, 2018. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2018-05173 Filed 3-13-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices 11221
DEPARTMENT OF HEALTH AND policies for the care and use of schedule and as a single report through
HUMAN SERVICES laboratory animals and make revisions a shared portal.
to reduce administrative burden on 3. Harmonize the guidance from NIH
National Institutes of Health investigators. In carrying out this effort, and USDA to reduce duplicative
the law requests that NIH seek put to considerations of alternatives to painful
Laboratory Animal Welfare: identify ways to ensure regulations and and distressful procedures.
Coordination and Harmonization of policies are not inconsistent, 4. Provide a minimum 60-day
Regulations and Policies overlapping, or unnecessarily comment period for new OLAW policy
AGENCY: National Institutes of Health, duplicative. guidance.
HHS. In carrying out the review, NIH 5. Other approaches not previously
ACTION: Notice; request for comments. OLAW, USDA, and FDA are currently mentioned.
reviewing the following reports and Feedback is sought on whether the
SUMMARY: The National Institutes of surveys: following tools and resources are or
Health (NIH) is seeking information to • Reforming Animal Research would be helpful for reducing burden
improve the coordination of regulations Regulations: Workshop on investigators:
and policies with respect to research Recommendations to Reduce Regulatory 1. Encourage the use of sections of the
with laboratory animals as required by Burden, 2017, Report of an April 17, AAALAC International program
the 21st Century Cures Act, Section 2017 workshop organized by Federation description in applicable parts of the
2034(d). The request for information is of American Societies for Experimental OLAW Animal Welfare Assurance, for
a coordinated effort of the Director of Biology (FASEB), the Association of institutions accredited by AAALAC
the National Institutes of Health in American Medical Colleges, and the International.
collaboration with the Secretary of Council on Governmental Relations, 2. Encourage the use of the FDP
Agriculture and the Commissioner of with support from the National Compliance Unit Standard Procedures
Food and Drugs to reduce Association for Biomedical Research, as a repository of best practices for
administrative burden on investigators http://www.faseb.org/Portals/2/PDFs/ standard procedures used for research
while maintaining the integrity and opa/2017/FASEB-Animal-Regulatory- with animals.
credibility of research findings and Report-October2017.pdf. 3. Encourage the use of the IACUC
protection of research animals. • Optimizing the Nation’s Investment Administrators Association repository
DATES: The Request for Information in Academic Research: A New of best practices by IACUCs.
regarding the proposed actions that the Regulatory Framework for the 21st 4. Encourage the use of new or
agencies have identified to improve Century, 2016, National Academies, existing tools to streamline protocol
coordination and harmonization of https://www.nap.edu/catalog/21824/ review through use of designated
regulations and policies is open for optimizing-the-nations-investment-in- member review (DMR), DMR
public comment for a period of 90 days. academic-research-a-new-regulatory. subsequent to full committee review,
Comments must be submitted • Reducing Investigators’ and/or Veterinary Verification and
electronically at https://grants.nih.gov/ Administrative Workload for Federally Consultation.
grants/rfi/rfi.cfm?ID=71 and must be Funded Research, 2014, National 5. Expanded IACUC training activities
received by June 12, 2018 to ensure Science Board, National Science that focus on reducing burden on
consideration. Foundation, https://www.nsf.gov/pubs/ investigators.
FOR FURTHER INFORMATION CONTACT:
2014/nsb1418/nsb1418.pdf. Dated: March 8, 2018.
• 2012 Faculty Workload Survey Francis S. Collins,
Patricia Brown, Office of Laboratory
Research Report, 2014, Federal Director, National Institutes of Health.
Animal Welfare (OLAW), Office of
Demonstration Partnership (FDP),
Extramural Research, National Institutes [FR Doc. 2018–05173 Filed 3–13–18; 8:45 am]
https://sites.nationalacademies.org/cs/
of Health, Suite 360, 6705 Rockledge BILLING CODE 4140–01–P
groups/pgasite/documents/webpage/
Drive, Bethesda, MD 20892–7982,
pga_087667.pdf.
phone: 301–496–7163, email: olaw@ • Findings of the FASEB Survey on
od.nih.gov. DEPARTMENT OF HEALTH AND
Administrative Burden, 2013, FASEB,
SUPPLEMENTARY INFORMATION:
HUMAN SERVICES
http://www.faseb.org/portals/2/pdfs/
I. Background opa/6.7.13%20FASEB%20NSB%20 National Institutes of Health
Survey%20findings.pdf.
This request for information is a We are seeking the input of interested National Institute of Arthritis and
coordinated effort of the Director of the stakeholders concerning proposed Musculoskeletal and Skin Diseases;
National Institutes of Health in actions that the agencies have identified Notice of Closed Meeting
collaboration with the Secretary of to improve coordination and
Agriculture and the Commissioner of harmonization of regulations and Pursuant to section 10(d) of the
Food and Drugs to reduce policies. The responses received will Federal Advisory Committee Act, as
administrative burden on investigators provide critical information for final amended, notice is hereby given of the
while maintaining the integrity and recommendations and implementation. following meeting.
credibility of research findings and The meeting will be closed to the
protection of research animals. II. Information Requested public in accordance with the
Section 2034(d) of the 21st Century Input is sought on each of the provisions set forth in sections
daltland on DSKBBV9HB2PROD with NOTICES
Cures Act (Pub. L. 114–255) was following proposed actions that the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
enacted December 13, 2016 and requires agencies are considering: as amended. The grant applications and
that the NIH in collaboration with the 1. Allow investigators to submit the discussions could disclose
United States Department of Agriculture protocols for continuing review using a confidential trade secrets or commercial
(USDA) and the Food and Drug risk-based methodology. property such as patentable material,
Administration (FDA) complete a 2. Allow annual reporting to OLAW and personal information concerning
review of applicable regulations and and USDA on the same reporting individuals associated with the grant
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Document Created: 2018-03-14 01:06:54
Document Modified: 2018-03-14 01:06:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; request for comments. | |
| Dates | The Request for Information regarding the proposed actions that the agencies have identified to improve coordination and harmonization of regulations and policies is open for public comment for a period of 90 days. Comments must be submitted electronically at https:// grants.nih.gov/grants/rfi/rfi.cfm?ID=71 and must be received by June 12, 2018 to ensure consideration. | |
| Contact | Patricia Brown, Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research, National Institutes of Health, Suite 360, 6705 Rockledge Drive, Bethesda, MD 20892-7982, phone: 301-496-7163, email: [email protected] | |
| FR Citation | 83 FR 11221 |
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