Notice Number: NOT-OD-10-020

Key Dates
Release Date: December 2, 2009

Other Relevant Notices

• September 10, 2010 See NOT-OD-10-136 Amended Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration
• August 30, 2010 - See NOT-OD-10-126 Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration.
• February 19, 2010 - See Notice NOT-OD-10-063 Status of Certain Human Embryonic Stem Cell Lines.
• February 19, 2010 - See Notice NOT-OD-10-056 Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research.
• December 14, 2009 - See Notice NOT-OD-10-029 Clarification of Terms and Conditions of Awards using Human Embryonic Stem Cells.
• April 17, 2009 - See NOT-OD-09-085 Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells
• April 24, 2009 - See NOT-OD-09-086 Public Comment Period Open for Draft Stem Cell Guidelines through May 26, 2009
• July 6, 2009 NIH Guidelines for Human Stem Cell Research
• July 15, 2009 See NOT-OD-09-123 Status of Applications and Awards under the new NIH Guidelines for Human Stem Cell Research

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

The first human embryonic stem cell lines (hESCs) to be approved under the NIH Guidelines for Human Stem Cell Research now appear on the NIH Human Embryonic Stem Cell Registry. The lines were approved by the NIH Director on December 2, 2009 and are eligible for use by NIH grantees in NIH funded research. It is expected that additional lines will become eligible and posted on the Registry as they are reviewed and approved.

Background

The NIH Guidelines implement President Barack H. Obama’s Executive Order 13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, and became effective on July 7, 2009. The Guidelines establish policy and procedures under which the NIH will fund hESC research, and establish a new NIH Registry of hESCs eligible for use in NIH funding. On September 21, 2009 NIH announced that it was accepting requests for hESC lines to be approved for use in NIH-funded research. Only hESC lines that have been submitted to and approved by NIH will appear on the Registry and may be used in NIH-funded research.

This Notice provides information concerning currently restricted awards, applications pending NIH review, new applications proposing to use hESCs, ongoing awards, and hESC Challenge ARRA applications.

Currently Restricted Awards

Grantees with currently restricted awards should examine the list of approved hESCs on the NIH Registry and determine if a line on the list is scientifically appropriate for use in their NIH funded research. If lines on the Registry are appropriate then the grantee must provide a letter signed by the Authorized Organizational Representative (AOR) stating which hESC line(s) from the Registry are available to the grantee and will be used on the award. The letter should be submitted to the NIH Grants Management Specialist listed on the Notice of Award. The Specialist will review the letter with the relevant NIH Program Officer and, if appropriate, issue a revised Notice of Award (NoA) that removes the restriction. Upon receipt of the revised NoA, the grantee may draw down NIH funds for the use of the approved hESCs.

Investigators may choose to wait for additional lines to be approved that are more appropriate for their research, in which case the funds will remain restricted. It is not necessary to notify the NIH awarding Institute/Center until such time as an appropriate line becomes available. However, at that time the information noted above should be submitted.

Applications Pending NIH Peer Review

Institutions with applications proposing to use hESCs that are pending NIH peer review or funding decisions should examine the list of approved hESCs on the NIH Registry and determine if any lines on the list are scientifically appropriate for use in the proposed research. If an award is to be made, NIH will request, under Just in Time procedures, a letter signed by the AOR indicating which hESC line(s) from the Registry are available to the grantee and will be used in the research. If there are no lines on the Registry appropriate for use in the proposed research at the time of award, the award will be restricted from using funds for hESC research until the grantee identifies an eligible hESC line that appears on the NIH Registry and will be used in the research conducted under the award. The approval status of a hESC line will not affect the individual criterion scores, assessments of overall merit, or overall impact/priority scores.

New Applications Proposing the Use of hESCs

Applicants should review the list of approved hESCs on the NIH Registry and determine if any hESCs are scientifically appropriate for use in their proposed research, and if so, identify the specific line(s) from the Registry using the NIH Registration Number (e.g., 0001), in the specified location in the application:

• For grant applications using the SF424(R&R) electronic application packages, section 4 of the PHS398 Cover Page Supplement component provides fields in which to identify approved cell lines.
• For grant applications using the SF424(R&R) Individual Fellowship electronic application packages, section C of the PHS Fellowship Supplemental Form component provides fields in which to identify approved cell lines.
• For grant applications using the PHS 398 paper application form, the Human Embryonic Stem Cells section on page 3 provides a location in which to identify approved cell lines.

If there are not lines on the Registry that are appropriate for use in the proposed research at the time of application, the applicant should follow the instructions specified in NIH Guide NOT-OD-09-123 under New Applications Proposing to Use hESCs.

Ongoing Awards

As indicated in NIH Guide NOT-OD-09-123, ongoing NIH-supported research involving hESC lines approved before April 17, 2009 may continue through the remainder of the currently approved competitive segment of the award. No new uses of hESCs may be initiated in ongoing funded studies unless hESCs are on the new Registry, and the grantee notifies NIH which stem cell line(s) from the Registry are available to the grantee and will be used in the research. When these projects are competitively renewed or submitted for any competing revision, they must use only approved cell lines listed in the new Registry.

hESC Challenge (RC1) ARRA Applications

Initial peer review of all hESC Challenge/RC1 applications has been completed and they will be considered for funding in the January/February 2010 Council rounds. Since these applications are for ARRA funding but awards will be issued in FY2010, they will be multiyear-funded for 24 months. This applies only to hESC Challenge/RC1 grants.

Additional Information
For additional information see: http://stemcells.nih.gov/

Inquiries

Inquiries should be directed to:

Division of Grants Policy
Office of Policy for Extramural Research Administration
National Institutes of Health
6705 Rockledge Drive, Suite 350
Bethesda, MD 20892
Email: [email protected]