Blueprint MedTech (BPMT) Biocompatibility, Sterilization, and Animal Studies   4

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified organizations (NAICS Code 541715) having in-house capability to support and provide resources to the participating grantees for completing biocompatibility studies, in vivo animal testing compliant with good laboratory (GLP) guidelines, and sterilization and shelf life testing. This contractor will provide support for research protocol development, research staff training, and conduct all testing necessary to support biocompatibility, sterilization, and animal safety studies.

Blueprint (BP) MedTech is an accelerator initiative aimed at catalyzing the development of cutting-edge medical technologies to diagnose or treat nervous system disorders. By providing resources and funding, MedTech facilitates the translation of novel neurotechnologies through early-stage development and to first in human clinical studies. The program funds medical device development activities led by investigators and complemented by additional resources and expertise provided by MedTech. Funding will support services including but not limited to:

• Access to translational services and expertise (e.g. large animal testing, sterilization testing, biocompatibility assessment, manufacturing, medical monitoring).
• Assistance from consultants (e.g. regulatory, reimbursement, intellectual property, commercialization, strategic partnerships).
• Access to NIH staff for assistance with funding questions.

The overall goal is to provide support in order to sufficiently de-risk technologies to the point where industry partners and/or investors will be enticed to bring these new diagnostic and therapeutic products to market.

The Contractor shall provide NIDA with a broad and flexible range of administrative and research support and related services in support of the BP MedTech program.

The National Institute on Drug Abuse invites you to submit a proposal responding to the requirements of this RFP No. 75N95022R00021 titled Biocompatibility Testing, Animal Studies, and Sterilization Testing in the Blueprint MedTech (BPMT) Initiative. .

This RFP is prepared in accordance with the Uniform Contract Format (UCF) prescribed for Government wide application by the Federal Acquisition Regulation (FAR). The UCF is both an RFP and contract award document. The resulting contract will consist of Parts I, II, III of the Uniform Contract Format.

We expect to award multiple-award (MAC) indefinite-delivery, indefinite-quantity (IDIQ) contracts with cost reimbursement or fixed price type task orders. NIDA anticipates these MACS will have a five-year ordering period that commences on the date of award or shortly thereafter. All contracts will contain a guaranteed minimum of $100,000 and a maximum value of $35,000,000 for the ordering period.

Offerors shall respond with separate technical and cost/price proposals based on the assumptions provided in Sections C and L. Your proposal must clearly state which performance areas of the Statement of Work are included, and you must respond with technical and pricing proposals for all included performance areas and the total period of performance.

This RFP does not commit the Government to pay the costs for the preparation and submission of a proposal. The Contracting Officer is the only individual who legally can commit the Government to the expenditure of public funds in connection with this acquisition. Any contract award for this requirement is contingent on the availability of funds (see FAR 52.232-18, Availability of Funds April 1984).

The National Institute on Drug Abuse appreciates your interest in this RFP and looks forward to receipt of your proposal. Requests for any information concerning this RFP should be directed to Tracy Cain, at the NIDA Section, Contracts Management Branch Red, who may be reached at (301) 443-6677; collect calls will not be accepted. Discussions with any other individual outside the NIDA Section, Contracts Management Branch Red should not occur.

Please see Amendment No. 1 to this solicitation for responses to Offeror's questions.