Key Dates

Related Announcements

None

Issued by

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Purpose

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 clinical feasibility studies of novel medical devices in the neurotechnology field. The clinical studies may include both feasibility and larger safety and efficacy assessments in patients affected by the condition being studied. BPMT anticipates running 5 to 15 clinical studies per year over the next 5 years. Most, but not all, are likely to be NIH-defined Clinical Trials https://grants.nih.gov/policy/clinical-trials/definition.htm.

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:

• Planning resources to support concept development, team building, needs assessment, and other early translational activities.
• 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).
• Advice from industry experts (e.g., meetings with an external oversight committee).
• The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.

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 scope of activities to be performed by the Contractor shall include the provision of a clinical research unit, the conduct of clinical studies, and the provision of a full range of services to support the clinical studies for investigational diagnostic and/or therapeutic neurological medical devices, safety monitoring, and reporting of the results to NIH. The contractor will be responsible for developing the study design and obtaining approval before starting the study. The contractor will also manage policies and regulations regarding human subjects protections, including, but not limited to, Institutional Review Board (IRB) approvals, informed patient consent, and applicable security and privacy standards in handling study data.

These studies shall be designed to evaluate biological effects and/or assess safety and efficacy of the investigational medical device, which will be used to inform regulatory filings for market approval and reimbursement. All clinical studies shall be carried out in a timely fashion and in compliance with all FDA regulations and International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidelines. Studies involving more than one site are expected to comply with the NIH Single Institutional Review Board for Multi-Site Research policy.

Notice:

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for a period of performance of five (5) years. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. These individual task orders may include options and/or option quantities. If options or option quantities are utilized for an individual task order the will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one or more task orders will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds. Various task orders will be issued to support distinct tasks and studies which will support the BP MedTech Initiative.

The RFP will be available electronically on or about June 22, 2022. You can access the RFP through the SAM.gov (URL: https://beta.sam.gov/search?index=opp) or through the NIDA website: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 60 days from the release date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

Inquiries

Please direct all inquiries to:

Tracy Cain, Contracting Officer
NIDA/OA
Phone: (301) 443-6677
Email: Tracy.cain@nih.gov

Secondary Point of Contact:

KJ Shaikh, Contracting Officer
NIDA/OA
Phone: (301) 443-6677
Email: Kj.shaikh@nih.gov