Period of Performance Extension Modification for the NIMH Protocol 20-M-0082 Support Contract 75N95022P00323

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIH-NIMH-NOI-24-75N95022P00323 TITLE: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease (Protocol 20-M-0082) CLASSIFICATION CODE: 65 -- Medical, dental & veterinary equipment & supplies NAICS CODE: 325998 - All Other Miscellaneous Chemical Product and Preparation Manufacturing RESPONSE DATE: January 7, 2024, at 5:00 PM EST PRIMARY POINT OF CONTACT: Michael Horn Michael.horn@nih.gov INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD AN OUT-OF-SCOPE MODIFICATION 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 addition of 32 doses of Amyloid Imaging Agent, 18F-Florbetaben (Neuraceq) to NIH Purchase Order 75N95022P00323. 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 650 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 Officers 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). DESCRIPTION OF REQUIREMENT: The NIMH'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 FDAapproved radioligand, with an injectable activity of at least 8.1 mCi. SPECIFIC REQUIREMENTS: The vendor shall provide brand name or equal items as listed below. 32 Doses of 18F-Florbetaben (Neuraceq), to be delivered on specific days for human imaging. The doses shall be delivered within seven (7) working days after notification by the NIMH. Part Number: 18F-Florbetaben (Neuraceq) Salient characteristics/product functionalities include FDA-approved Injectable activity of at least 8.1 mCi Delivery Date: Doses of 18F-Florbetaben (Neuraceq), to be delivered on specific days for human imaging. The doses shall be delivered within seven (7) working days after notification by the NIMH. Period of Performance: To correlate with Protocol 20-M-0082, the expected period of performance is three years from date of award of the out of scope modification. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract action without providing for full and open competition is based upon the market research conducted. Specifically, Life Molecular Imaging is the only vendor in the marketplace that can provide the products required by NIMH. The intended source is: Life Molecular Imaging (LMI) 75 State St. Boston, MA 01209 Life Molecular Imaging is the only source that can furnish the requirements, to the exclusion of other sources. Life Molecular Imaging is the only vendor who can provide this necessary FDA-approved amyloid imaging agent, 18F-florbetaben (Neuraceq), in order to properly follow the above-mentioned protocol. 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 action 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. Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). 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, January 7, 2024, at 5:00 PM EST, and must reference the solicitation number, NIH-NIMH-NOI-24-75N95022P00323. Responses must be submitted electronically to Michael Horn, Contract Specialist, at michael.horn@nih.gov . U.S. Mail and fax responses will not be accepted.