Notice Number: NOT-OD-10-136

Key Dates
Release Date: September 10, 2010

Related Notices

• June 11, 2012 - See Notice NOT-OD-12-111. Notice of Impending Change in Peer Review Criteria and Submission Requirements for NIH Applications Involving Human Embryonic Stem Cells.
• 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 NOT-OD-10-063 Status of Certain Human Embryonic Stem Cell Lines
• February 19, 2010 - See NOT-OD-10-056 Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research
• December 2, 2009 - See 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 NOT-OD-09-123: Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research
• July 6, 2009 NIH Guidelines for Human Stem Cell Research
• April 24, 2009 - See NOT-OD-09-086 Public Comment Period Open for Draft Stem Cell Guidelines through May 26, 2009
• April 17, 2009 - See NOT-OD-09-085 Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells

Issued by
National Institutes of Health (NIH)

Purpose

On September 9, 2010 an Order issued by the US Court of Appeals for the D.C. Circuit (No. 10-5287, Filed on September 9, 2010) provided a temporary administrative stay of the district court’s August 23, 2010 preliminary injunction (PI) in the matter of Dr. James L. Sherley, et. al. v. Kathleen Sebelius, et al., The Court of Appeals has requested quick briefing of the motion for a stay pending appeal of the PI and could decide as early as September 20th as to whether to grant or deny a stay.

In light of this new Order, the guidance issued by the NIH previously (NOT-OD-10-126) is rescinded. The receipt, processing, review, and awarding of NIH applications and proposals, involving human embryonic stem cells will continue and NIH Human Embryonic Stem Cell Registry will resume.

Specifically:

• The suspension of further NIH activity to implement, apply or act pursuant to the NIH Guidelines is hereby lifted.
• The suspension of the issuance of all pending competing, and noncompeting continuation hESC awards and contracts approved for funding is hereby lifted.
• The suspension of the peer review of all pending competing hESC applications and proposals is hereby lifted.
• The NIH Human Embryonic Stem Cell Registry will resume accepting submissions of information about hESC lines for the purpose of establishing eligibility for funding under the NIH Guidelines. The NIH review of hESC lines for inclusion on the Registry under the NIH Guidelines will also resume.

Inquiries

Please direct inquiries concerning:

Peer Review to: [email protected]

Receipt and Referral to: 301-435-0715

Grants Policy to: [email protected]