Principles 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.

ACTION:

Notice.

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]. 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.

DATES:

Comments must be received by NIH on or before October 12, 2000.