SPECIAL NOTICE
A -- Vascular Interventions/Innovations and Therapeutic Advances (VITA) Program
- Notice Date
- 10/3/2011
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NOT-NHLBI-HV-13-00
- Point of Contact
- Paul D McFarlane,
- E-Mail Address
-
nhlbivita@nhlbi.nih.gov
(nhlbivita@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Vascular Interventions/Innovations and Therapeutic Advances (VITA) Program PURPOSE The National Heart, Lung and Blood Institute (NHBLI) is seeking feedback from potential Offerors and other interested parties relative to initiation of a new product development program. This is a special notice in advance of a Broad Agency Announcement (BAA) solicitation planned to be issued during the third quarter of fiscal year 2012. The Government is not obligated to award a contract pursuant to this announcement. The new program, named "VITA", is intended to provide funding for early-stage translational development of product candidates in the fields of vascular and lymphatic disorders, thrombotic diseases, and pulmonary hypertension. This may include, but is not limited to, conditions under the Mission of NHLBI such as: peripheral arterial disease, aortic aneurysms and dissections, pulmonary vascular disorders, venous and arterial thrombosis, thromboembolic disorders, and disorders of the lymphatic system. Not included as specific topics in this program are diseases of the coronary and intracranial arteries. 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. 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. The VITA program is designed to fund proposals that fall under one of two broad early stages of product development: 1) proposals seeking support for work in the window between principle discovery and the demonstration and confirmation of "proof of principle"(POP) in the form of various preclinical efficacy assessments and preliminary safety evaluations, and 2) proposals for further development and testing of product candidates with demonstrated proof of principle, such as studies to support an IND or IDE application. This contract will be open to all Offerors with a product candidate in the applicable medical fields regardless of institutional affiliation or prior product development experience. Awards in either stage will be up to three years in duration and project funding through the VITA Program does not preclude supplemental outside funding from academia or the private sector on that same project. The VITA contract program will also support a separate Program Coordinating Center (PCC) that will provide project management, meeting coordination, and regulatory advice for funded Offerors who require such services. However, this Request For Information (RFI) is not seeking information from parties interested in the PCC; rather responses should come only from parties interested in the described product development. BACKGROUND NHLBI has identified "opportunity gaps" for two stages of translation: (1) between the conceptualization of potential medical advances and the experimental validation of those concepts as medical product candidates, 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. 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 these two specific opportunity gaps. 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. Contact Information - Provide name and email address and employment affiliation related to your product candidate. (This is optional, but inclusion of your contact information ensures that you will be informed about any updates regarding this solicitation.) 2. 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) 3. Describe your product candidate and how it will address the unmet medical need(s) to benefit public health. (max. 250 words) 4. 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) 5. 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 NOT-NHLBI-HV-13-00 and are due no later than 4 PM EST, Monday, November 21, 2011. Updates and additional information will be available on a website, which is currently under development. A link to the VITA initiative website will be sent to those who respond to this RFI. Questions regarding this request for information may be directed to Paul D. McFarlane, Contracting Officer, NHLBI, National Institutes of Health E-mail: NHLBIVITA@NHLBI.NIH.GOV
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NOT-NHLBI-HV-13-00/listing.html)
- Place of Performance
- Address: NHLBI, NIH, DHHS, Attn: Paul D. McFarlane, CSB, OA, DERA, 6701 Rockledge Drive, Two Rockledge Centre, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN02600626-W 20111005/111003234453-7abcbf69d3aa8207ef545951614b4741 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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