RELEASE DATE:  January 29, 2002

NOTICE:  NOT-HL-02-009

Update: July 7, 2009 – This Notice is superseded by NIH-OD-09-116 NIH Guidelines
for Human Stem Cell Research

National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm) The National Heart, Lung, and Blood Institute (NHLBI) announces the availability of administrative supplements to NHLBI grantees to conduct research using human embryonic stem (ES) cell lines. The ES cell line used must be listed on the NIH Human Embryonic Stem Cell Registry (http://escr.nih.gov, additional guidance may be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html). NHLBI-funded investigators may request an administrative supplement not to exceed $50,000 in direct costs (two modules) per year for the purpose of conducting research for a one or two year period. The applicant must have an existing NHLBI funded award during the time of the supplement, and therefore must have at least a one or two year funding period remaining at the time the supplement is awarded. Administrative supplements can only be awarded for research that is within the scope of an existing, funded grant. For example, investigators carrying out murine ES cell work may elect to request funding to extend their investigations to human ES cell lines. Other investigators carrying out stem cell research, developmental studies, or other related studies may also apply. In all cases, a careful explanation and justification for the supplement must be included. Investigators must contact the human ES cell line providers listed on the NIH Registry independently and make arrangements to obtain the cell lines, including any required material transfer agreements (MTA). Applicants must indicate which human ES cell line or lines will be used. A letter indicating the provider will supply the human ES cell line must be furnished either with the application or just prior to the award. The investigators should also demonstrate either prior ability to work with human ES cell lines or outline plans for obtaining training to culture human ES cells. The human ES cell line providers, other laboratories with ES cell experience, or laboratory training courses on ES cell methods are potential means of obtaining this training. Other means for acquiring human ES cell expertise may be proposed. NHLBI intends to commit up to $3,000,000 in FY 2002 to fund up to 40 supplements. This is a one-time announcement. However, the NHLBI may re- release the announcement, depending on the needs of the NHLBI scientific community, and the availability of funds. There will be four receipt dates for administrative supplements: March 15, 2002, April 15, 2002, May 15, 2002 and July 15, 2002. Up to 10 awards will be made for the first three receipt dates with the remainder of the awards to be made after the fourth receipt date. Awards will be made depending on the receipt of a sufficient number of qualified applications and the availability of funds. Awards will be made within 6 to 8 weeks after the receipt dates. To apply for an administrative supplement, send an original letter countersigned by the grantee institution=s authorized business official and one copy to Dr. Thomas, Kelley, or Berberich at the addresses below. The letter (5 page limit) must include: 1) an abstract of the proposed supplemental activity and how it is related to the parent grant, 2) expected overall impact of the requested supplement on ongoing research results, 3) the NIH code for the human ES cell line(s), 4) a justification of budget request and funding period, and 5) current contact information for the principal investigator, including mailing and e-mail address. Although these descriptions should be as concise as possible, sufficient detail must be provided to allow the NHLBI to determine if the request qualifies as an administrative supplement. NHLBI will consider supplement requests from all eligible applicants. Requests will be evaluated according to the following criteria: o The proposed research falls within the scope of the parent grant and is a logical extension of the goals and objectives, but not sufficiently different to constitute new research or program expansion. o The applicant"s proposal will provide the resources and expertise necessary to design and perform the experiments using human ES cells. o Documentation and justification of the requested budget. Supplement requests will be reviewed by a committee of NHLBI program staff. The applicant will be notified of the evaluation decision within 4 weeks following the submission date. If not furnished with the application, a letter indicating the human ES cell line provider(s) will supply the cell line(s) will be required prior to award. Guidance regarding research involving human ES cells is available from the Office for Human Research Protections (http://www.hhs.gov/ohrp/references/HESCGuidance.pdf). Any human subjects issues must be addressed prior to award. Award decisions will be based upon the criteria provided above, availability of funds, and NHLBI programmatic priorities and balance across heart, lung, and blood disorders. Direct inquiries regarding program issues to: Dr. John W. Thomas Division of Blood Diseases and Resources / NHLBI 6701 Rockledge Drive / Room 10154 /Mail Stop 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0050 E-mail: ThomasJ@nhlbi.nih.gov FAX: (301) 451-5453 Dr. Christine Kelley Division of Heart and Vascular Diseases / NHLBI 6701 Rockledge Drive / Room 9142 / Mail Stop 7940 Bethesda, MD 20892-7940 Telephone: (301) 435-0513 E-mail: KelleyC@nhlbi.nih.gov FAX: (301) 480-1335 Dr. Mary Ann Berberich Division of Lung Diseases / NHLBI 6701 Rockledge Drive /Room 10102 / Mail Stop 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 E-mail: BerberiM@nhlbi.nih.gov FAX: (301) 480 - 3557 Direct inquiries regarding fiscal issues to: Suzanne White National Heart, Lung, and Blood Institute 6701 Rockledge Drive / Room 7154 / Mail Stop 7926 Bethesda, MD 20817-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: WhiteSA@nhlbi.nih.gov

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