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Vascular Intervention/Innovations and Therapeutic Advances (VITA) Program Coordinating Center

Solicitation Number: RFP-NHLBI-CSB-HV-2013-04-JS
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD
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Added: May 15, 2012 9:41 am Modified: Jun 06, 2012 12:17 amTrack Changes

The overall objective of the Vascular Interventions/Innovations and Therapeutic Advances (VITA) Program is to enable and accelerate the development of promising diagnostic and therapeutic modalities for vascular diseases, thrombotic disorders, and pulmonary hypertension. Proposed project areas of interest may include 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.

The VITA Program will provide support for early-stage translational development of diagnostic and therapeutic product candidates. In this program, "product candidate" refers to new diagnostics, new therapeutic agents, or novel applications of existing agents and/or therapeutic interventions. The product candidate(s) under study and development can include, but are not limited to: small molecules, small peptides, proteins or antibodies, imaging probes, devices, diagnostic tests, genetic markers, and cell or gene agents.

VITA is designed to fund proposals that fall under one of two broad early stages of product development: 1.) those projects seeking support for experimental research in the window between discovery and the demonstration of "proof of principle (POP) in the form of various preclinical efficacy assessments and preliminary safety evaluations, and 2.) those proposals for further development and testing of product candidates with established proof of principle, such as studies that are required to support an application for the initiation of human clinical trials (such as an IND or IDE application).

Companion to this RFP solicitation, is a Broad Agency Announcement (BAA) solicitation to award up to six (6) contracts, to enable and accelerate development of promising diagnostic and therapeutic modalities for certain diseases within the purview of the National Heart, Lung and Blood Institute (NHLBI). The BAA solicitation was synopsized in a separate pre-solicitation notice (BAA-NHLBI-CSB-2013-02-JS). Interested Offerors are highly encouraged to locate and review the BAA solicitation. Contract proposals for the BAA and the RFP solicitations will be due in late August 2012. Awards are planned for August 2013.

The purpose of this solicitation is to acquire the services of a Program Coordinating Center (PCC) for the VITA program. The primary objective of the PCC is to serve as the focal point for the coordination of the VITA Program. The PCC will work with the investigative sites and the NHLBI to ensure that the funded research projects are on track to meet defined milestones along the translational pathway. The responsibilities of the PCC include, but are not limited to, the coordination of Program meetings, teleconferences, and possible site visits; logistical management of the EAC (External Advisory Committee); providing Project Management guidance and oversight to the research sites; providing Regulatory Support to the research site investigators; assisting investigators in identifying and securing additional research and development resources; and conducting in-service training/instruction sessions as needed to the various Program components.

The main roles of the PCC will be to ensure efficient project management at the research sites, provide regulatory support to the research sites, and to coordinate the meetings and overall workings of the VITA Program. As long as the PI/Supervisory Project Manager and the Primary Project Manager have demonstrated track records of successful experience in the management and oversight of multi-component scientific or clinical programs, certification in the field of project management is not required. Additionally, while potentially helpful, it is not imperative that the PI/Supervisory Project Manager or the Primary Project Manager have a background in the biological sciences.

Specifically the PCC shall:

1. Schedule and coordinate the logistics of the VITA Investigators meetings, meetings of the External Advisory Committee (EAC), teleconferences, any site visits conducted by PCC and NHLBI staff, and any other face-to-face meetings between NHLBI, the EAC, and PCC, and research investigators as needed.

2. The PCC will work with the NHLBI to establish an External Advisory Committee (EAC) composed of up to seven members who are not affiliated or in conflict with the research sites. The PCC will be responsible for ensuring that the proper Conflict of Interest forms/disclosures have been obtained from EAC members.

3. From the outset of the program, the PCC should work with all of the investigative sites to facilitate the establishment of accepted standards for terminologies, data elements, methodologies, and assessments to the extent feasible in the projects.

4. Provide Project Management assistance and oversight to the investigative sites, by participating as a member on each individual Steering Committee. The PCC Contractor shall maintain an updated summary of the activities related to the research projects and regularly apprise the NHLBI of the progress towards the milestones on each research project.

5. Establish a plan for regular meetings or teleconferences with NHLBI to review and discuss the status of the ongoing projects and any outstanding matters in the VITA program.

6. The PCC should develop a system for receiving, reviewing, prioritizing, and tracking requests for regulatory or other types of assistance from the investigative centers. When necessary, the NHLBI can assist the PCC in prioritizing these requests. The PCC must get NHLBI approval before beginning work on any request(s) that could potentially consume an inordinate amount of time and resources.

7. Develop and maintain a private, password-protected website for internal use only to facilitate communications between the VITA Program participants, NHLBI, and EAC members

8. Gather the information from investigators and maintain a database of information regarding publications, presentations, invention disclosures, companies formed, and patents, copyrights, or trademarks applied for or awarded, or any other significant achievements that resulted from work supported by or conducted in the VITA Program

9. Ensure that the investigative sites have up-to-date versions of all required certifications, inspections, and assurances required for the type of work they are performing (e.g., animal or human protections certifications) and ensure that these are available for review if NHLBI were to conduct a site visit. At a minimum, these updates should be on a yearly basis, but more frequent updates may be required.

10. The PCC will schedule and coordinate the logistics of meetings and teleconferences for the NHLBI-appointed EAC. The annual face-to-face EAC meeting will be held in conjunction with the annual VITA Investigator's meeting in the general Bethesda-Rockville-Gaithersburg, Maryland area. The PCC will be responsible for ensuring that the proper Conflict of Interest forms/disclosures have been obtained from EAC members.

11. Manage and coordinate travel-related expense reimbursements (airfare, hotel, and the standard government per diem and honoraria payments as applicable) for up to seven EAC members attending face-to-face meetings or participating in teleconferences

12. Assist investigators as needed in identifying and applying for services or support from other NIH resource programs such as, but not limited to, Clinical and Translational Science Award (CTSA) centers, the Gene Therapy Resource Program (GTRP), Science Moving towArds Research Translation and Therapy (SMARTT), and resources offered by the NIH National Center for Advancing Translational Sciences (NCATS)

13. Assist Investigators as needed to identify sources for capabilities or services not readily available at the research site or through an NIH program such as, but not limited to, pharmacokinetic or toxicology testing, high throughput screening, chemical libraries, product formulation or production, or provision of a marketed drug or placebo matching services.

14. Develop and maintain a Manual of VITA Operations and Procedures (MOP) describing the operating procedures of the VITA program, including any standard operating procedures (SOPs) related to the PCC's interactions with the research sites, the EAC, and the NHLBI.

15. Arrange the logistics for one potential "for cause" site visit by the NHLBI and up to two PCC staff to one research site per year.

16. Work with the NHLBI to develop any informational materials about the VITA Program for display and distribution; securing exhibitor space and staffing an exhibit booth if requested by NHLBI for up to one scientific meeting per year; work with other NIH Institutes, Centers, or Offices on collaborative efforts to advance translational research on vascular diseases; assist NHLBI in the preparation of materials for presentation by NLHBI staff at various meetings; and assisting the NHLBI in planning and executing the logistics of meetings, seminars, or symposia related to the VITA Program or other NIH translational research programs

17. Provide Regulatory Affairs support to the research investigators as requested. Such support may include, but is not limited to:

a. Assisting investigators in scheduling meetings and preparing the materials for the meetings/teleconferences with oversight bodies such as the FDA (e.g. pre-pre-IND or pre-IND meetings), IRB, IBC, NIH-OBA, DSMB, and the EAC.

b. Assisting the investigators in the preparation and submission of required reports to the oversight bodies.

c. Assisting investigators in the preparation and submission of an IND or IDE application in compliance with 21CFR312 and 21CFR812, respectively.

d. Ensure that all required approvals from oversight bodies are in place prior to the conduct of the relevant research.

e. Assist investigators at research sites with the preparation or management of materials for the conduct of a clinical study or trial such as, but not limited to: a Manual of Operations/Procedures (MOP); other site management materials; submission of copies of the clinical protocol to the relevant oversight bodies and the NHLBI, and ensuring submission of the required reports to the oversight bodies.

f. Assist research sites conducting clinical trials by offering regulatory support services such as pre-initiation site visits, study monitoring, site-initiation and periodic site visits by the PCC, close-out visits, or other technical regulatory support, even if this requires the PCC to sub-contract these services.

g. Ensure that any applicable clinical trials are registered on the web site.

h. Providing general instruction or education in regulatory affairs matters to the investigative sites as needed or requested by either the site or by NHLBI

This announcement is not a request for proposals (RFP) and, although one award is anticipated, the Government is not committed to award a contract pursuant to this announcement. The requirement will cover 72 months and a "Cost-Reimbursement-Completion" type contract with options pricing is being considered. The ultimate contract type and funding mechanism will be determined by the NHLBI, based on what best fits the project's goals and the available funding. Potential Offerors are responsible for downloading the RFP and any/all attachments. It is also Offerors' responsibility to monitor the FEDBIZOPPS for any amendments to the RFP. It has been determined that this acquisition will be set aside for small business concerns under the North American Industry Classification System (NAICS) code 541712.


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Solicitation 1

Posted Date:
May 30, 2012
Description: RFP Solicitation (RFP-NHLBI-CSB-HV-2013-04-JS)

Amendment 1

Posted Date:
June 15, 2012
Description: This Amendment includes information regarding the webinar and updates Section L, paragraph 2, sub-paragraph a. item 1 (Page 38) Contract Type and General Clauses

Amendment 2

Posted Date:
June 18, 2012
Description: Amendment 2 provides the date and time of the pre-proposal webinar

Amendment 3

Posted Date:
July 5, 2012
Description: This amendment to the solicitation provides clarification of the solicitation and attaches the webinar PowerPoint Presentation and Questions and Answers.

Amendment 4

Posted Date:
August 2, 2012
Description: This amendment updates sections K and L of the solicitation.
Office of Acquisitions
6701 Rockledge Dr RKL2/6100 MSC 7902
Bethesda, Maryland 20892-7902
Office of Acquisitions
6701 Rockledge Dr, RKL2/6100 MSC7902
Bethesda, Maryland 20892-7902
United States
Jennifer Swift,
Contract Specialist
Phone: 3014350658
Cornelius Moore,
Contracting Officer
Phone: (301) 435-0343
Fax: (301) 480-3432