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 http://escr.nih.gov (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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
       
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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-050.html no 
longer apply for research on human embryonic stem cells 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-007.html.

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) 
http://www.hhs.gov/ohrp/references/HESCGuidance.pdf.
        
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 DDER@nih.gov.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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