Notice Number: NOT-HL-11-160

Key Dates
Release Date: October 13, 2011
Response Due Date:  November 21, 2011

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The National Heart, Lung and Blood Institute (NHBLI) seeks feedback from potential Offerors and other interested parties relative to initiation of a new product development program.

Background

As part of its mission to improve the health of the American public, NHLBI is establishing the VITA Program to stimulate the advancement of medical product development in two specific opportunity gaps; (1) between the conceptualization of potential medical advances and the experimental validation of those concepts as medical product candidates (the window between principle discovery and the demonstration and confirmation of  “proof of principle”(POP)), and (2) between the demonstration of proof of principle and the completion of studies required for the assessment of a product candidate in human clinical trials (testing of product candidates with demonstrated proof of principle, such as studies to support an IND or IDE application.) 

In the context of the VITA program, the term “product candidate” is used to refer to new diagnostics, new therapeutic agents, or novel applications of existing agents and/or therapeutic interventions in the fields of vascular and lymphatic disorders, thrombotic diseases, and pulmonary hypertension. Diseases of the coronary and intracranial arteries are excluded. The product(s) under study and development can include, but are not limited to: small molecules, small peptides, proteins or antibodies, devices, diagnostic tests, genetic markers, and cell or gene agents.  

Questions and Points of Consideration

NHBLI invites interested parties with potential product candidates in the designated applicable medical fields to respond to the questions listed below. 

1. Within the scope of disease conditions listed above for the VITA Program, what unmet medical need(s) will your proposed product candidate(s) address? (max. 250 words)
2. Describe your product candidate and how it will address the unmet medical need(s) to benefit public health. (max. 250 words)
3. Please describe the current state of development of your proposed product candidate(s). Which stage of the VITA Program (“Principle to POP” or “POP to IND/IDE”) would be most appropriate for your proposed product candidate(s)? (max. 250 words)
4. Please describe your own level of experience with product development.  Other than additional funding, what kind of additional resources and/or expertise are needed in order to advance your product candidate(s) toward human clinical evaluation? (max. 250 words)

Response Guidelines

This Request for Information (RFI) is covered under the Privacy Act System of Records 09-25-0156, “Records of Participants in Programs and Respondents in Surveys Used to Evaluate Programs of the Public Health Service, HHS/PHS/NIH/OD.” 

This RFI is for collecting information to improve the planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Government.  The Government does not intend to award a grant or contract on the basis of the responses to this RFI.  Nor does it otherwise pay for the preparation of any information submitted or for the Government’s use of such information.  Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the Government’s evaluation of the information received. All responses will be regarded as confidential.  No basis for claims against the Government shall arise as a result of a response to this request for information or the Government’s use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement.  Not responding to this RFI does not preclude participation in any related future solicitations. Responses will be held in a confidential manner.  Any proprietary information should be so marked. NHLBI appreciates your input.

Responses should include this Notice identifier and are due no later than 4 PM EST, Monday, November 21, 2011.

Please indicate “Responses” in the subject line and send responses to:

Inquiries

Specific questions regarding this request for information may be directed to:

Paul D. McFarlane, Contracting Officer, NHLBI, National Institutes of Health
(NHLBIVITA@NHLBI.NIH.GOV)

Please indicate “Questions” in the subject line.

Updates and frequently asked questions (FAQs) regarding VITA will be available on the following website:
http://www.nhlbi.nih.gov/funding/inits/faq-NHLBIVITA.htm

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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