NOTICE OF EXTENDED RECEIPT DATE AND SUPPLEMENTAL INFORMATION GUIDANCE FOR APPLICATIONS REQUESTING FUNDING THAT PROPOSES RESEARCH WITH HUMAN EMBRYONIC STEM CELLS Release Date: November 7, 2001 NOTICE: NOT-OD-02-006 Office of the Director, NIH The NIH is preparing to accept requests for funding of research using human embryonic stem cells. Federal funding is available only for research using those lines included on the NIH Human Embryonic Stem Cell Registry (hereafter referred to as the Registry ) which confirms that the stem cell lines are in compliance with the President’s criteria as stated on August 9, 2001 Principal investigators and their applicant institutions are urged to read this guidance carefully and follow the steps outlined for the specific types of funding requests that follow. The NIH is operating in accordance with the President’s guidance. The NIH Guidelines for the Use of Human Pluripotent Stem Cells no longer apply for research on human embryonic stem cells Applicants who wish to submit for the Oct. 1 receipt date for new, competing applications or Nov. 1 for competing renewals and competing supplements may do so. The Registry will be posted in the immediate future. Applicants should either indicate the specific cell line they plan to use and include this information in the DESCRIPTION section of the grant application or note that they cannot specify the line, but will use one from the Registry, once the Registry is posted. In the latter case, they will have to provide the specific information in a letter prior to the initial scientific review. Bearing in mind the timing of this Notice, applications for the use of human embryonic stem cells will be considered as late as November 27, 2001 for this one round only. Grantees who wish to submit requests for administrative supplements to their funding Institute or Center may do so. The request should include information about which cell lines in the Registry will be used. Grantees who plan to request administrative supplements should be in contact with their project officers for further information. These requests should follow the usual procedures for the specific Institute or Center in regard to administrative supplements. Final action on such a request and authorization to spend federal funds cannot occur until 30 days after the publication of this Notice. Grantees who wish to rebudget existing funds may do so, but the cell line to be used must be one that is presently on the NIH Registry. Even when funds already exist in the grant, they may not be expended until 30 days after the publication of this Notice. All stem cell lines that are listed on the Registry were obtained with informed consent of the donors. Such research is subject to the Common Rule (45 CFR 46) if it involves individually identifiable private information such that the identity of the donors is or may readily be ascertained by the investigator or associated with the information. Further clarification of the application of the Common Rule can be obtained from the Office of Human Research Protections (OHRP) The NIH anticipates issuing several RFAs and PAs over the next few months that would encompass research using human embryonic stem cells. In all cases, applicants must use cell line(s) from the Registry and include the information about which cell line is proposed for use in the description portion of their application. Questions about the implementation of these guidelines should be directed to the Deputy Director for Extramural Research

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