B.10 Presolicitation Clinical.pdf

Document Type: Presolicitation Notice

Solicitation No. 75N95022R00050

Project No. N01DA-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 Contracts Management Branch Red, NIDA Section

National Institute on Drug Abuse (NIDA), Office of Acquisitions

National Institutes of Health c/o 3WFN MSC 6012

301 N STONESTREET AVE

BETHESDA MD 20892

Description

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

C) Clinical Study Analysis, Close-out

i. Conduct statistical analysis and close-out

D) Facilities, Equipment and Other Resources

i. 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.

Mandatory Criteria:

The offeror must demonstrate its understanding and compliance with the NIH Guide for

Care and Use of Laboratory Animals (https://olaw.nih.gov/home.htm). The Offeror shall submit evidence that its protocols will be reviewed and approved by the Institution’s

Animal Care and Use Committee (IACUC). The Assurance number shall be provided with the proposal.

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 2, 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 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.

https://beta.sam.gov/search?index=opp

Points of Contact

Primary Point of Contact:

Scott Duernberger

Contract Specialist scott.duernberger@nih.gov

Phone: (301) 594-0670

Secondary Point of Contact:

KJ Shaikh

Contracting Officer

Kj.shaikh@nih.gov

Phone: (301) 443-6677 mailto:Llakim.dubroff@nih.gov mailto:Kj.shaikh@nih.gov