Notice Number: NOT-OD-09-085

Update: The following updates relating to this announcement have been issued:

• 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.
• December 2, 2009 - See Notice NOT-OD-10-020 First Human Embryonic Stem Cells Approved for use under the NIH Guidelines for Human Stem Cell Research.
• July 15, 2009 - See Notice NOT-OD-09-123 Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research.
• July 6, 2009 - See Notice NOT-OD-09-116 NIH Guidelines for Human Stem Cell Research.
• April 24, 2009 - See Notice NOT-OD-09-086 Public Comment Period Open for Draft Stem Cell Guidelines through May 26, 2009.

Key Dates
Release Date: April 17, 2009

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

On March 9, 2009, President Barack Obama issued Executive Order (EO)13505 authorizing the Secretary of Health and Human Services, through the Director of NIH, to support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law. The EO also directs the Secretary, through the Director of NIH, to review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and within 120 days from the date of the EO, issue new NIH Guidelines on such research (Guidelines). NIH will be releasing draft Guidelines in the Federal Register for public comment and expects to promulgate final Guidelines within the 120 day limit set by the President. This Notice informs the community of the status of ongoing research, and of applications pending review or to be submitted, prior to the issuance of final Guidelines.

• Ongoing NIH-supported research: Pending issuance of new Guidelines, all ongoing NIH-funded research involving approved uses for human stem cells, including human embryonic stem cells, may continue. However, until the Guidelines are issued in final, no new uses of human embryonic stem cells may be initiated in NIH funded studies unless previously reviewed and approved by the NIH for the ongoing supported research projects. Further, NIH will not consider requests for either administrative supplements or revisions to any grants that include costs for, or involve the study of, human embryonic stem cells until the Guidelines are finalized.
  
  
• Peer reviewed competing applications: Pending issuance of new Guidelines, any applications previously submitted to the NIH and already reviewed, which propose to use human embryonic stem cells, will be held for funding decisions until the final Guidelines are issued. At that time, highly ranked applications can be modified, as necessary, to comply with the Guidelines, to receive full consideration for funding.
  
  
• Competing applications pending submission and/or peer review: NIH will accept applications for research proposing to use human embryonic stem cells during the period of Guidelines development, but the review and funding of these applications will be deferred until NIH issues final Guidelines. Such applications should identify illustrative cells for the purposes of the research plan. Once the Guidelines have been issued in final, applicants will have the opportunity to revise their application as necessary to comply with the Guidelines, including utilization of eligible cells. These modified applications will then be peer reviewed and considered for funding.

After the Guidelines are issued in final, all subsequent requests for funding are expected to comply with the new Guidelines.

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
Telephone: (301) 435-0938
FAX: (301) 435-3059
Email: [email protected]