Notice Number: NOT-HL-11-111

Key Dates
Release Date:   July 15, 2010
Response Date:  September 15, 2010

Issued by
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)

Purpose

The NHLBI has released a Request for Applications (RFA), R34 Planning Grants for Pivotal Clinical Trials in Hemoglobinopathies (RFA-HL-11-009), to stimulate the production of more competitive clinical trial grant applications and more robust and successful clinical trials in the hemoglobinopathies.  The R34 Planning Grant encourages applicants to use a multiple Principal Investigator mechanism which includes investigators in trial design, statistics, regulatory issues, bioethics and other disciplines relevant to the specific aims and conduct of the proposed trial.

Information is needed to determine the number and location of potential clinical trial design, monitoring, and analysis experts who are qualified and interested in participating in multi-center clinical research pivotal clinical trials in hemoglobinopathies.  Previous experience in hemoglobinopathy clinical trials is not required.

Information Requested

We seek to identify investigators and organizations with expertise in clinical trial design, conduct, and analysis.

Responses:
Please E-mail your responses to:
Erin Smith
smithee@nhlbi.nih.gov

In your response please provide the following information (and include the Notice number HL-11-111 in the subject line):

• Name of the institution/organization/site.
• Contact person(s), title, and contact information.
• Description of ability to conduct and successfully complete pivotal  clinical trial design, monitoring, and analysis (for example, bibliography).
• Indicate if your information could be shared with potential clinical trial investigators.
• Is your organization on the General Service Administration schedule?

This RFI is for information and planning purposes only and should not be construed as a solicitation, an obligation, or endorsement on the part of NHLBI.  The NHLBI does not intend to award a grant or contract to pay for the preparation of any information submitted or for the NHLBI’s use of such information.  Acknowledgement of receipt of responses may not be made, nor will respondents be notified of the NHLBI evaluation of the information received.  No basis for claims against the NHLBI shall arise as a result of a response to this request for information or the NHLBI’s use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement.  Responses will be held confidential unless permission for sharing information with potential clinical trial collaborators is granted by the respondent.  Any proprietary information should be so marked.

Inquiries

Erin Smith
Blood Diseases Branch, Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Phone:  301-435-0050
FAX:  301-480-1046
E-mail:  smithee@nhlbi.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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