NOI SS Gwinn.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER:

75N95025Q00008

2. TITLE:

Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Neurology

3. CLASSIFICATION CODE:

R499 - Support Professional: Other

4. NAICS CODE:

541990 - All Other Professional, Scientific, and Technical Services

5. RESPONSE DATE:

November 4, 2024 at 3:00 pm EST

6. PRIMARY POINT OF CONTACT:

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

7. DESCRIPTION:

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN

COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of intends to award a sole source contract under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1

(b) Soliciting from a single source. For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. This contract(s) will be awarded to Katrina Gwinn, 10009 Menlo Ave Silver Spring, Md 20910, Woman Owned Small Business (WOSB) to procure Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative.

mailto:Tracy.cain@nih.gov

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET

ASIDE STATUS

The intended procurement is classified under NAICS code 541990 with a Size Standard of $16.5 million.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2024-07 dated September 30, 2024.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

The purpose of this requirement is to procure medical device consulting services with appropriate expertise in support of the Blueprint MedTech Initiative, a multi-IC effort to support development of translational neurological medical device technologies. The NIH seeks to procure a highly experienced subject matter expert with expertise in the areas of neurology and medical device regulation. The consultant must be a neurologist board-certified to practice in the United States; the consultant must possess experience in both clinical treatment of patients with various neurological conditions and clinical use of neurological devices. Additionally, the consultant must have previous experience in medical device regulation, specifically in reviewing clinical trial applications and marketing applications for neurological medical devices. The consultant shall provide feedback to the NIH program leadership and technical guidance on medical device development projects within the Blueprint MedTech initiative portfolio. The Contractor will serve as Blueprint MedTech External Oversight Committee member, providing strategic guidance on Blueprint MedTech projects and grants funded through the Blueprint MedTech initiative.

SCOPE OF WORK

The Contractor shall provide consulting support services to the Blueprint MedTech EOC and Blueprint MedTech Program Leadership in relation to the neurological medical device development programs as follows:

• Review operations and processes of Blueprint MedTech grantees/program participants and provide recommendations regarding advancing medical device development studies, validation activities, clinical trials, and directing collaborative research among multiple institutions or teams (if applicable).

• Advise regarding suitability and relevance of proposed Blueprint MedTech program milestones, recommend revised milestones for Blueprint MedTech programs as needed, and evaluate project progress relative to established milestones.

• Analyze potential opportunities and concerns for future Blueprint MedTech program projects under consideration.

• Recommend potential solutions and assist in implementation of selected strategies to resolve programmatic challenges related to medical device development as they arise.

• Mentor Blueprint MedTech program participants executive team and project leaders in scientific entrepreneurship, including but not limited to managing medical device development projects, directing collaborative research among multiple institutions or teams, and regulatory regulations and guidelines, for continued development and improvement of the Blueprint MedTech program.

• Provide feedback to assist in successful work towards scientific and business goals and aspirations of program projects

• Participate in web-enabled virtual meetings and teleconference calls with Blueprint MedTech staff on both a monthly and an ad-hoc-as-required basis.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted.

The intended source is:

Katrina Gwinn 10009 Menlo Ave Silver Spring, Md 20910

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size.

All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95025Q00008. Responses must be submitted electronically Tracy Cain, Contract Officer, at Tracy.cain@nih.gov U.S. Mail and Fax responses will not be accepted.

mailto:Tracy.cain@nih.gov