INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine, Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to: Draeger Medical, Inc., NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The Intended procurement is classified under NAICS code 334512 with a Size Standard 500 # of Employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-101 January 22, 2019. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: To Procure monitoring APC device DTM is needed in CCE to meet the increased demands for nonviable particle counts in the 2J and 3T cleanroom manufacturing facilities. Currently, there are only two nonviable samplers for CCE and this is insufficient to provide timely results in performing dynamic and static environmental monitoring for both facilities. Failure to meet this need will cause in a delay in the collection of nonviable particle counts The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The intended sole source is the only known source to meet the technical needs of the scientific equipment/supplies. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10- 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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, 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. 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. 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. All responses must be received by April 7,2021, at 10:00 AM Eastern time and must reference solicitation number 19-006442. Responses may be submitted electronically to Priscilla Abalos, Contracting Specialist at
[email protected]. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."