CRO Support for Blueprint MedTech (BPMT) Regulatory Affairs Support and Related Services   4

The Blueprint MedTech (BP MedTech) initiative is a collaborative framework through which 11 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/).

Innovators developing groundbreaking medical device technologies face a number of challenges along the translational path from bench to bedside. The Blueprint MedTech program is an NIH incubator that aims to address such challenges and support the innovators by accelerating the development of cutting-edge medical devices to diagnose and treat disorders of the nervous system. The mission of the program is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to:

• Planning resources to support concept development, team building, needs assessment, and other early translational activities.
• Streamlined access to translational services and expertise (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring).
• Assistance from consultants (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).
• Advice from industry experts (e.g., meetings with an external oversight committee).

The overarching goal of the BP MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. 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 objective of this contract is to support the BP MedTech program by providing regulatory affairs services that can support medical device development projects from pre-clinical through clinical phases. BP MedTech requires a contract research organization (CRO) to provide resources to the participating grantees in support of regulatory documentation and regulatory compliance. This contractor will provide support for regulatory consulting advice, preparation and submission of regulatory documents, interaction with US Food and Drug Administration, establishment of a Quality System, and setup of regulatory compliance program.

1. Scope

The scope of activities to be performed by the Contractor shall include the provision of a full range of services to support regulatory documentation and compliance for medical devices in the BPMT program. Tasks orders will be tailored to the needs of the specific grantee and may include some or all of the following activities:

• Preparation of regulatory submissions including Q-submissions, Investigational Device Exemption (IDE), 510(k), De Novo, Pre-market approval (PMA), Humanitarian Device Exemption (HDE), and post-approval studies. Support for interactions with US Food and Drug Administration (FDA) as necessary;
• Establishing a Quality System;
• Development of regulatory compliance program;
• Assistance with market/user research and commercialization strategy;
• Assistance with evaluating and obtaining reimbursement/payer coverage.

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.