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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 of Mental Health (NIMH) intends to negotiate on a sole source basis with Life Molecular Imaging Limited for an Amyloid Imaging Agent.
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS
The intended procurement is classified under NAICS code 325998 – All Other Miscellaneous Chemical Product and Preparation Manufacturing with a Size Standard of 500 employees.
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) 2021-07 dated September 10, 2021.
DESCRIPTION OF REQUIREMENT
PURPOSE AND OBJECTIVES:
The National Institute of Mental Health’s Molecular Imaging Branch will perform an amyloid scan with 18F-Florbetaben (Neuraceq) in all the Alzheimer’s Disease (AD) subjects included in protocol 20-M-0082. Other disorders will not have amyloid scans, because they are often not associated with amyloid deposition.
SPECIFIC REQUIREMENTS:
The Contractor shall provide 20 doses of 18F-Florbetaben (Neuraceq), an FDA-approved radioligand, with an injectable activity of at least 8.1 mCi.
DELIVERY OR DELIVERABLES:
The Contractor shall provide the following deliverables:
PERIOD OF PERFORMANCE:
The expected period of performance is one year from date of award.
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. Specifically, Life Molecular Imaging Limited is the only vendor in the marketplace that can provide the products required by the NIMH.
The intended source is:
Life Molecular Imaging Limited
Langstone Technology Park, Langstone Road
Havant, Hampshire
P09 1SA, United Kingdom
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 Dun & Bradstreet Number (DUNS), 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, NIMH-22-000231. Responses must be submitted electronically to Sarah Adan, Contract Specialist, at [email protected] and Valerie Whipple, Contracting Officer, at [email protected]. U.S. Mail and fax responses will not be accepted.