B.8 AP Attach 8 - FBO SSS Draft Pre-Sol-SD_final.pdf

Acquisition Plan Attachment #8

FEDERAL BUSINESS OPPORTUNITIES SSS/DRAFT PRE-SOL

Document Type: Source Sought Notice

Solicitation No.: NO1DA-22-1234

Project Title: Research and Development for Clinical Studies in the Blueprint MedTech (BPMT)

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 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.

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

The Contractor shall provide a Principal Investigator (PI) who is primarily responsible and accountable for the overall implementation of the awarded contract, who serves as the central contact for scientific and technical aspects of the contract, and one who has significant experience in the conduct of medical device clinical studies and trials.

The Contractor shall provide an investigative team with all the required core expertise including but not limited to project management, medical writing, clinicians, research associates, data manager, data management support staff, regulatory associates, and other personnel with medical device clinical study expertise. The Contractor shall provide established facilities and the clinical research infrastructure, with the appropriate number and mix of clinical, laboratory and support personnel to conduct these clinical studies. Subcontracted facilities and subcontractors can be utilized as needed to meet contract needs.

All clinical studies to be conducted under this contract must be completed as per the protocols developed and finalized for each study requirement. Time duration for a clinical study from recruitment initiation to the last subject’s protocol exit will vary based on the specific device being investigated. All devices will be provided by the Sponsor/Contributor manufacturing the device.

Performance Area A: Contract Kick-Off

i. Conduct Teleconferences and in-person Meetings for the following.

a. Contract kick-off meeting to review the task order requirements, timelines, milestones and deliverables; discuss task order plans and approaches and identify any anticipated difficulties in completing the task order requirements;

b. Ad hoc Site Visits: Host a one-day meeting as requested by COR and/or CO. It is anticipated that this will occur no more than once or twice per year;

c. Ad hoc teleconference as requested by the COR and/or CO.

Performance Area B: Clinical Project

i. Collaborate with Sponsor/Contributor to finalize a protocol and submit to NIH and the Sponsor/Contributor for review and approval in compliance with the timelines specified within the task order.

ii. Throughout the process essential regulatory documents as specified in ICH guideline should be generated and stored in files/folders and be available for monitors and for use in the subsequent quantity option when executed.

iii. Prepare and deliver a Project Management Plan (PMP) within 60 calendar days after task order award and before consenting of the first subject.

iv. Develop and validate a database for the clinical study for relevant data.

Quality Option “Study Implementation”

A) Protocol Implementation: Compliance and Oversight

i. The Contractor’s clinical study team and support staff shall participate in a clinical study initiation meeting at the Contractor’s clinical research facility.

ii. Prepare all protocol amendments and modifications.

iii. Oversee and ensure adherence to the protocol all clinical activities conducted at the clinical research facility and all collaborating sites.

iv. For each Task Order protocol:

a. Track subject enrollment and adherence to defined recruitment goals;

b. Review and assess participant data as specified within the data management plan, protocol requirements and/or quality assurance requirements.

c. If the study is either an NIH-defined or FDA-defined clinical trial, update clinicaltrials.gov as required by NIH policy and Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (summarized here:

https://prsinfo.clinicaltrials.gov/FinalRuleChanges-16Sept2016.pdf)

v. Maintain and update the clinical database throughout the study

B) Investigational Devices and Clinical Specimens

i. Maintain inventory records of investigational device in accordance to SOPs

ii. Ensure collection, processing, labeling, temporary storage under appropriate conditions and management of all collected biological specimens

C) Clinical Study Analysis, Close-out

i. Conduct statistical analysis and close-out

D) Facilities, Equipment and Other Resources

The Contractor shall be responsible for the adequacy and availability of all facilities, equipment, and other resources necessary for the conduct of a clinical study.

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 10, 2021 to the above Contracting Office Address, Attn: Tracy Cain. Electronic capability statements will be accepted by the primary point of contact.

Points of Contact

Primary Point of Contact:

Scott Duernberger

Contract Specialist Scott.duernberger@nih.gov Phone: (301) 594- 0670

Secondary Point of Contact:

Tracy Cain Contracting Officer tracy.cain@nih.gov Phone: (301) 443-6677