[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Page 11221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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