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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
PRINCIPLES AND GUIDELINES FOR RECIPIENTS OF NIH RESEARCH GRANTS
AND CONTRACTS ON OBTAINING AND DISSEMINATING BIOMEDICAL
RESEARCH RESOURCES: REQUEST FOR COMMENTS
AGENCY: National Institutes of Health (NIH), Public Health
Service, DHHS
INTRODUCTION:
On December 23, 1999, the National Institutes of Health (NIH) published
in the Federal Register its final notice of a policy entitled Sharing
Biomedical Research Resources: Principles and Guidelines for Recipients
of NIH Research Grants and Contracts [64 FR 72090 - PDF]. The policy is
designed to provide recipients of NIH funding with guidance concerning
appropriate terms for disseminating and acquiring unique research
resources developed with federal funds and assist recipients in complying
with their obligations under the Bayh-Dole Act and NIH funding policy. This
Notice is to obtain public comment on experience realized in implementing
the Principles and Guidelines.
PURPOSE:
The subject policy document set forth fundamental principles and guidelines
for implementation by patenting and licensing professionals and sponsored
research administrators. The intent of the document is to assist Recipients
in ensuring that the conditions they impose and accept on the transfer of
research tools will facilitate further biomedical research, consistent
with the requirements of the Bayh-Dole Act and NIH funding agreements.
REQUEST FOR COMMENTS:
NIH is seeking comments from NIH recipients, academic, not-for-profit
, government, and private sector participants (both individuals and
institutions or organizations) in biomedical research and development
on their experience in implementing and utilizing the Principles and
Guidelines included in the subject document. It is the intent of the
NIH to use the comments and anecdotal information received from
Recipients throughout this first year of implementation to provide
the basis for a report to the Advisory Council to the Director, NIH.
Respondents should provide their views on the value of the NIH document
and their experience in implementing the document within their institution
and with other entities when providing or receiving research tools. We
would appreciate receiving information as to the issues or situations
encountered, the effect on operations or research, any specific terms
or actions in the Guidelines and/or in institution/company documents
that were found to be of assistance or problematic, and the name or
type of organizations involved (educational institution, for-profit
, etc.). Comments offered in confidence should be marked as such.
Comments should be addressed to: Research Tools Guidelines Project, Theodore
J. Roumel, NIH Office of Technology Transfer, 6011 Executive Boulevard
, Suite 325, Rockville, MD 20852-3804. Comments may also be sent by
facsimile transmission to Research Tools Guidelines Project, Attention:
Theodore J. Roumel, at 301-402-3257, or by e-mail to nihott@od.nih.gov.
DATE:
Comments must be received by NIH on or before October 12, 2000.
/s/ 29 August 2000
Maria C. Freire, Ph.D.
Director, Office of Technology Transfer
National Institutes of Health
Certified to be a true copy of the original document
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