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)

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 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.

The Blueprint MedTech (BPMT or BP MedTech) initiative is a collaborative program 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 BP MedTech program 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 BP MedTech is to accelerate patient access to groundbreaking, safe, and effective medical devices. The initiative 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 Contractor shall provide NIDA with a full range of services to support regulatory documentation and compliance for medical devices in the BP MedTech program. Tasks orders will be tailored to the needs of the specific grantee and may include some or all of the following activities:

1. 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;
2. Establishing a Quality System;
3. Development of regulatory compliance program;
4. Assistance with market/user research and commercialization strategy;
5. Assistance with evaluating and obtaining reimbursement/payer coverage.

The Contractor shall provide services related to regulatory affairs support and strategies for medical devices under development in the following areas: preparation of regulatory submissions; support for interactions with the US 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. Examples of activities in these areas are provided below. Task orders may include activities in one or more areas.

The following requirements apply to every task order issued under this ID/IQ as applicable.

1. Defining a regulatory strategy and providing support to the device development plan that is clearly aligned to meet project goals, including a Target Product Profile (TPP) and gap analysis as requested.
2. Optimizing preclinical and clinical regulatory timelines and costs, providing risk mitigation plans.
3. Ensuring that all key studies required for regulatory filings are included and strategically planned at the appropriate stage of development.
4. Ensuring compliance with all regulations, policies, and protocols.
5. Providing proven SOPs, templates, and industry best practice for regulatory services.
6. Conducting appropriate communication with regulatory agencies and different stakeholders that is accurate and timely.
7. Submitting documents to appropriate regulatory body(ies) in the required format (e.g., electronic submission).
8. Adhering to the requisite quality control for all documents and activities.

Performance Area 1: Preparation of Medical Device Pre-Submissions and 513(g) Request for Information

The Contractor shall provide services related to the preparation of all necessary pre-market regulatory submissions for medical devices including traditional pre-submissions, breakthrough device designation requests, study risk determination requests, and 513(g) Request for Information. Anticipated activities under this area include but are not limited to:

1. Obtaining and reviewing preclinical and clinical information needed for the submission.
2. Preparing, drafting, reviewing, and/or submitting the pre-submission meeting request and briefing package and other supporting documentation as needed.
3. Managing post-meeting responses and communications.
4. Conducting a debriefing meeting.

Performance Area 2: Preparation and Filing of Investigational Device Exemption (IDE) Submissions

The Contractor shall provide services related to the preparation and filing of an IDE. Anticipated activities under this area include but are not limited to:

1. Conducting IDE kick-off meeting.
2. Defining IDE filing strategy, scope, timeline, and responsibilities.
3. Preparing all modules of the IDE, which includes tasks such as:
4. Collecting all study reports, summaries, synopses, and other required documentation.
5. Drafting and writing regulatory documents of the submission.
6. Preparing all forms necessary for submission.
7. Providing post-IDE filing support, including formal responses and maintenance activities as needed.

Performance Area 3: Regulatory Services for Clinical Studies

The Contractor shall provide regulatory services related to clinical studies. Such studies may be clinical trials, natural history studies, patient finding studies, or others. Anticipated activities under this area include but are not limited to:

1. Planning, requesting, and preparing materials for additional types of informal and formal meetings.
2. Tracking and managing study-related regulatory documentation (e.g., protocol amendments, severe adverse event [SAE] reporting).
3. Supporting clinical protocol(s) and clinical trial(s) to ensure compliance with Good Clinical Practice (GCP). This may include tasks such as reviewing study regulatory files and subject specific documents such as informed consent, case report forms, medical records, and communication with the regulatory agency and Investigational Review Board (IRB).

Performance Area 4: Regulatory Support for Medical Device Marketing Submissions

The Contractor shall provide services related to marketing submissions including 510(k), De Novo, PMA, HDE, Q-submissions, and post-approval studies. Anticipated activities under this area include but are not limited to:

1. Determining the regulatory requirements.
2. Preparing, drafting, reviewing, and/or submitting documentation to the appropriate regulatory body (e.g., FDA/CDRH, ).
3. Providing post-submission filing support including communications, responses, and maintenance activities as needed.
4. Providing technical guidance and subject matter expertise, which may include tasks such as reviewing data, overseeing studies at Clinical Research Organization (CROs), and preparing and reviewing study reports and summaries.

Performance Area 5: Regulatory Support for Establishing a Quality System

The contractor shall provide regulatory services related to establishment of a Quality System. Anticipated activities under this area may include but are not limited to:

1. Creation / establishment of Quality System.
2. Improvement of existing Quality System.
3. Quality System software validation.
4. Audit and Inspection preparation.
5. Design change support.

Performance Area 6: Establishing a Regulatory Compliance Program

The contractor shall provide regulatory services related to establishment of a regulatory compliance program. Anticipated activities under this area may include but are not limited to:

1. Development of compliance program.
2. Compliance and ethics training for staff.
3. Conflict of Interest management.
4. Preparation for audits and investigations.
5. Establishing a compliance manual.
6. Assisting with compliance management outsourcing, if applicable.

Performance Area 7: Assistance with market/user research and commercialization strategy

The contractor shall provide assistance with market and user research and commercialization strategy for the medical device product. Anticipated activities under this area include but are not limited to:

1. Market analysis, including market size, market drivers and barriers to entry.
2. Competitive landscape analysis.
3. Clinical adoption analysis.
4. Commercialization/marketing strategy.

Performance Area 8: Assistance with evaluating and obtaining reimbursement/payor coverage.

The contractor shall provide assistance with assessing strategies for reimbursement and payor coverage of the medical device. Anticipated activities under this area include but are not limited to:

1. Engaging with CMS and private payors to obtain necessary information about the organization’s needs for coverage decisions.
2. Developing evidence generation plan to support payor coverage.
3. Establishing medical coverage codes.

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 May 13, 2022. You can access the RFP through the SAM.gov (URL: https://www.sam.gov) 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 45 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.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

Inquiries

Please direct all inquiries to:

Tracy Cain, Contracting Officer
NIDA/OA
Phone: (301) 443-6677
[email protected]

Secondary Point of Contact:

KJ Shaikh, Contracting Officer
NIDA/OA
Phone: (301) 443-6677
[email protected]