B.8 AP Attach 8 - FBO SSS Draft Pre-Sol LD.doc

Acquisition Plan Attachment #8

FEDERAL BUSINESS OPPORTUNITIES SSS/DRAFT PRE-SOL

Document Type:

Source Sought Notice

Solicitation No.:

N01DA-22-1235

Project Title:

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

Classification Code:

A – Research & Development

NAICS Code:

541715 – Research and Development in Physical, Engineering and Life

Sciences (except Biotechnology)

Contracting Office Address

NIDA Office of Acquisitions NIDA Section, Contracts Management Branch Red c/o 3WFN MSC 6012

301 N Stonestreet Ave

Bethesda, MD 20892 Description

This is a SOURCES SOUGHT NOTICE to determine the availability of businesses, including small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having 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.

The Blueprint MedTech (BPMT) initiative is a collaborative framework through which 14 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 Blueprint 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.

Specifically, NIDA is seeking capability statements from vendors with the capabilities to perform the following tasks:

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.

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 US Food and Drug Administration 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 Contractor shall work closely with the Contracting Officer’s Representative (COR) and other NIH staff, as applicable, in addition to the BPMT grantee during the performance of these services. The Contractor shall also work closely with other key stakeholders, which may include but are not limited to the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).

The following requirements apply to every task order issued under this IDIQ 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.

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.

Area 2: Preparation and Filing of IDE Submissions The Contractor shall provide services related to the preparation and filing of an Investigational Device Exemption (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:

a. Collecting all study reports, summaries, synopses, and other required documentation.

b. Drafting and writing regulatory documents of the submission

c. Preparing all forms necessary for submission.

4. Providing post-IDE filing support, including formal responses and maintenance activities as needed.

Area 3: Regulatory Services for Clinical Studies The Contractor shall provide services related to clinical studies. Such studies may be human 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 file sand subject specific documents such as informed consent, case report forms, medical records, and communication with the regulatory agency and Investigational Review Board (IRB).

Area 4: Regulatory Support for Medical Device Marketing Submissions The Contractor shall provide services related to marketing submissions including 510(k), de novo, Pre-market approval (PMA), Humanitarian Device Exemption (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 (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 writing protocols, reviewing data, overseeing studies at CROs, and preparing and reviewing study reports and summaries.

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

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

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

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

NIDA is requesting capability statements from businesses, including small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses), demonstrating their ability to perform the requirements described above. Capability statements should include any relevant experience as either prime or sub-contractor performing work of a similar type and scale either for the government or in the private sector. Vendors are encouraged to provide a list of any relevant contracts they have performed that provided them with experience in performing the above tasks, including what their level of effort was for the performance. NIDA will evaluate the capability of vendors based on relevant experience in work of a similar type and scale, as well as any additional information provided by the vendor to demonstrate their capability.

THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. All capability statements must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.), if applicable.

Written capability statements must be SUBMITTED NO LATER THAN December 13, 2021 to the above Contracting Office Address, Attn: Llakim Dubroff. Electronic capability statements will be accepted by the primary point of contact.

Points of Contact

Primary Point of Contact:

Llakim Dubroff Contract Specialist Llakim.dubroff@nih.gov Phone: (301) 443-6677

Secondary Point of Contact:

Tracy Cain Contracting Officer

Tracy.cain@nih.gov Phone: (301) 443-6677