NIH Administrative Revisions for Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources

Notice Number: NOT-NS-08-013

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: January 17, 2008
Receipt Date:    April 1, 2008 

Issued by
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD) http://www.nidcd.nih.gov/)
National Heart Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm)
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)

Purpose

The National Institute of Health (NIH) announces the availability of one-year administrative revisions (previously referred to as supplements) for NIH-funded grantees to encourage research into the derivation and/or characterization of human pluripotent stem cells (hPSCs) from non-embryonic sources.  This opportunity for administrative revisions addresses Executive Order 13435 issued by President George W. Bush on June 20, 2007.  The Executive Order requires that “The Secretary of Health and Human Services shall conduct and support research on the isolation, derivation, production, and testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo.”

Background

Human embryonic stem cells (hESCs) have been recognized as a valuable tool for advancing our knowledge of human development and biology, and for their great potential to be a medically valuable resource.  Recent technical innovations in stem cell biology suggest that there are now new opportunities for scientific progress with pluripotent stem cells obtained from sources other than human embryos.  For example, recent studies using human fibroblast cells have shown that these cells can be directly reprogrammed to behave like human embryonic stem cells.  For the purposes of this NOT, pluripotency is defined as the ability of cells to divide without differentiating for a prolonged period and to give rise to derivatives of all three embryonic germ layers.  This supplement program is meant to provide an opportunity for NIH grantees to conduct research on both the derivation of hPSC as well as research on the molecular, cellular, and genetic properties of hPSC derived from non-embryonic sources and to encourage investigators not currently working on hPSCs to pursue hPSC research.  Work that advances this goal by developing new methodologies and approaches in non-human mammalian model systems will be eligible for consideration.  The proposed studies must be within the scope of the aims of the NIH parent award.

Eligibility

This program will support administrative revisions to any grant mechanism that is normally eligible for an administrative revision at the NIH institute or center (IC) that awarded the parent grant.  Principal investigators (PIs) are strongly encouraged to contact the NIH Program Director who administers the parent grant to inquire as to whether their grant is eligible to receive an administrative revision.  Parent awards must be actively funded through August 3, 2009 in order to be eligible.  Grants that are in a no-cost extension period will not be considered for support under this program.  Only one revision request may be submitted per PI.
How to Apply
Before submitting a formal request for an administrative revision, it is highly advisable to first discuss your request with the NIH Program Director who manages your grant or the IC Program contact listed below under “Inquiries.”  Once it has been determined that the supplement request is within the scope of the parent award, a formal request can be made.  Formal requests must be received on or before April 1, 2008.

This is a one-time announcement.  Do not send applications to the Center for Scientific Review.

Review Criteria

Revision requests will be reviewed administratively by staff at the NIH IC that holds the parent grant.  The proposed studies must be within the scope of the aims of the NIH parent award.  Awards will be determined on the basis of programmatic relevance and availability of funds.  All funding decisions are final and not subject to appeal.

Post-Award Requirements:  A short, 1-page progress report addressing the results of the revision will be required.  It should be included as an addition to the next progress report of the parent grant, submitted after completion of the one year revision. 

Budget Information

The maximum allowable request in direct costs is up to $75,000 for the one year duration of the revision. However, direct cost amounts may vary between participating ICs; it is highly recommended to contact the IC Program contact listed below under “Inquiries” to discuss budget requests.

Submitting an Application

Applications for an administrative revision under this program should use the PHS 398 form (rev. 4/2006; available at http://grants.nih.gov/grants/funding/phs398/phs398.html, and must include the following:

1) A cover letter citing this Notice and including the PI name, grant number and title, amount of the requested revision, the name and title of the Authorized Organizational Representative (AOR), and the phone, email, and address information for both the PI and the AOR. 

The cover letter must be signed by the AOR.

2) Face page
The title of the project (Box 1) should be the title of the parent award.
This Notice (number and title) should be cited in Box 2, and the “yes” box should be checked.
The remaining items on the face page should be filled out according to the PHS 398 application instructions.

3) Form page 2 (Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells) from PHS 398. The project description is that of the administrative supplement, not the parent grant.

4) Proposed budget for the supplement with a budget justification that details the items requested. 

5) A Biographical Sketch of the PI.

6) Research Plan for the revision, items 2-5 (not to exceed five pages).  Applicants should describe the proposed experiments and their relationship to the original project Specific Aims and a brief discussion of the significance of the proposed research.  Although these descriptions should be as concise as possible, sufficient detail must be provided to allow the NIH to evaluate the request. Font size restrictions apply as designated within the PHS398 (rev. 4/2006) instructions. 

This is a one-time announcement.  Applications must be received on or before April 1, 2008.  Do not send applications to the Center for Scientific Review.  Applications must be signed by the Authorized organizational Representative and submitted to the appropriate IC Program contact listed below under “Inquiries.  Applicants are strongly encouraged to submit applications electronically as an e-mail attachment in PDF format; however the signature of the AOR must be clearly visible.  Applicants may also submit applications in paper format to the appropriate IC Program contact. ”

Inquiries

Applicants are strongly encouraged to discuss their plans for responding to this Notice by phone or e-mail.  Inquiries should be directed to either the Program Director at the NIH IC who oversees the parent grant associated with the administrative supplement request or the Program contact listed below.

David Owens, Ph.D.
Program Director
NIH/NINDS
Neuroscience Center, Room 2204
6001 Executive Blvd MSC 9525
Bethesda, MD 20892-9525
Phone: (301) 496-1447
Fax: 301-480-1080
Email: do47h@nih.gov

Barry J. Davis, Ph.D.
Director
Taste and Smell Program
NIH / NIDCD
EPS/400C
6120 Executive Blvd.
Bethesda, MD 20892-7180
Rockville, MD 20852 (courier mail)
Phone:  301-402-3464
Fax:  301-402-6251
Email:  Davisb1@nidcd.nih.gov

John W. Thomas, Ph.D.
Division of Blood Diseases and Resources
Stem Cell and Cell-based Therapy Coordinator
National Heart, Lung, and Blood Institute
Rockledge II Centre, Room 9150
6701 Rockledge Drive, Mail Stop 7950
Bethesda, MD 20892
Phone: 301-435-0065   
Fax: 301-451-5453
E-mail:  ThomasJ@nhlbi.nih.gov

Marion M. Zatz, Ph.D.
Program Official
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive Room 2AS-25E, MSC 6200
Bethesda, MD 20892-6200
Phone: (301) 594-0943
Email: zatzm@mail.nih.gov

Sam Zakhari, Ph.D.
Director
Division of Metabolism and Health Effects
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, Room 2031
Bethesda, MD 20892-9304
Phone: 301-443-0799
Fax: 301-594-0673
For FedEx please use:
Rockville, MD 20852-1705
E-mail: sw14w@nih.gov

Carl C. Baker, M.D., Ph.D.
Program Director
Division of Skin and Rheumatic Diseases
8th floor Room 888
NIAMS Extramural Program
NIH
6701 Democracy Blvd
Bethesda, MD 20892-4872
Phone: 301-594-5017
Fax: 301-480-4543
E-mail: ccb@nih.gov

Andrea C. Beckel-Mitchener, Ph.D.
Chief, Functional Neurogenomics Program
National Institute of Mental Health
Division of Neuroscience and Basic Behavioral Science
Molecular, Cellular, and Genomic Neuroscience Research Branch
Neuroscience Center/Room 7187/MSC 9641
6001 Executive Boulevard
Bethesda, MD 20892-9641
[Rockville, MD 20852 (courier mail)]
Phone:  301-443-5288
Fax:  301-402-4740
Email: amitchen@mail.nih.gov

Grace L. Shen, Ph.D.
Group Leader
Corneal Diseases and
Ocular Immunology, Inflammation, & Infection
Division of Extramural Research
National Eye Institute
National Institutes of Health
Suite 1300
5635 Fishers Lane, MSC-9300
Bethesda, MD  20892-9300
(Courier services use Rockville, MD  20852)
Phone: 301-435-8169
Fax: 301-402-0528
Email: ShenG@nei.nih.gov

Rosemarie Hunziker, Ph.D.
Program Director, Tissue Engineering and Regenerative Medicine
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health
6707 Democracy Boulevard
Room 235 
Bethesda, MD  20892
Phone: 301-451-1609
Email: hunzikerr@mail.nih.gov


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