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The National Heart, Lung, and Blood Institute (NHLBI) does not intend to award a contract based on responses nor otherwise pay for the preparation of any information submitted. As a result of this sources sought notice, the NHLBI may issue a request for quote (RFQ). There is no solicitation available now. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this sources sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.
The NHLBI is seeking capability statements from all eligible small business concerns under the North American Industry Classification System (NAICS) code 541990 with a size standard $15.0M. Based on the responses received from this sources sought announcement, the proposed acquisition may be solicited as a total small business set-aside. All eligible small business concerns responding to this sources sought announcement must have the capabilities to provide the services as stated below.
Background
The National Heart, Lung, and Blood Institute's Division of Intramural Research (DIR) is anxiously engaged in furthering technological advances in the way people diagnose, treat and assess cardiovascular, pulmonary, hematologic, and sleep diseases in humans. The DIR's Cardiovascular Intervention Program (referred to hereafter as "Program") has designed an investigational MRI catheterization suite dedicated to performing radiation-free heart catheterization in human patients. More advanced catheter procedures having a more significant clinical impact will require the purchase of custom catheter devices.
Purpose and Objectives
Program requires a contractor to manufacture an active guidewire for Interventional Cardiovascular Magnetic Resonance (iCMR) according to Program's design specifications. Program will use the guidewires to perform careful animal studies in its laboratories as part of its ongoing development of iCMR as a safe alternative for treating cardiovascular disease in humans.
Tasks to be Performed
The contractor shall manufacture 200 Active Guidewires for MRI-guided cardiovascular catheterization according to Program's design specifications (only provided after award of contract). Contractor's tasks shall be divided into three distinct, independent phases as follows:
Phase I - Plan
Task 1. Contractor shall assemble a project team comprised of Contractor staff and Program staff to communicate project objectives and verify Program's design specifications.
Task 2. Contractor shall prepare a comprehensive project build plan and present to project team and Program.
Phase II - Initial Build
Task 3. Upon Program's approval of the project plan, Contractor shall perform an initial build. The initial build shall produce 20 guidewires which Contractor shall test for structural integrity, tensile strength, and maneuverability using Contractor's internal QA/QC standards and procedures.
Task 4. Contractor shall present results of initial build and testing to project team and Program.
Phase III - Final Build
Task 5. Upon Program's approval of initial build, Contractor shall perform the final build. The final build shall produce 200 fully functional active guidewires.
Task 6. Contractor shall perform QA/QC on final build.
Task 7. Contractor shall present results of final build and testing to project team and Program and deliver all 200 active guidewires to Program.
Period of Performance
The period of performance will be for one (1) base period (Phase I) and two (2) option periods (Phases II and III). The total estimated period of performance will be September 28, 2018 through September 27, 2019.
Capability Statement / Information Sought
Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement:
- A general overview of the respondents' opinions about the difficulty and / or feasibility of the potential requirement, and any information regarding innovative ideas or concepts.
- Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information.
- The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the North American Industry Classification System (NAICS) code: 541990 with a small business size standard of $15.0M.
- Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition.
Capability statements must demonstrate experience with similar projects and will be evaluated by the following criteria:
- The offeror's capability statement provides evidence of access to materials, supplies, equipment (both manufacturing and testing equipment), and facilities necessary to perform the work.
- The offeror's capability statement provides evidence of being able to provide qualified and competent personnel in the field of manufacturing, cardiovascular catheterization, and medical imaging physics to lead the project.
Closing Statement
Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five (5) single-sided pages (including all attachments) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner.
All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Jonathan Lear, Contracting Officer, at [email protected] in either MS Word or Adobe Portable Document Format (PDF), by August 1, 2018 at 12:00PM, EST and must reference synopsis number 75N92018Q0249. All responses must be received by the specified due date and time to be considered.
Disclaimer and Important Notes
This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality
No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).