Custom design and manufacturing of surgical clamp based on filed Patent

PRE-SOLICITATION NOTICE OF INTENT TO SOLE SOURCE SYNOPSIS 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, Office of Logistics and Acquisition Operations (OLAO), Office of Acquisitions (OA) on behalf of the National Eye Institute NEI intends to award a purchase order without providing for full and open competition (Including brand-name) to CRESTPOINT MANAGEMENT LTD the only authorized distributor of Geuder products in the U.S. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 339112 with a Size Standard 1000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-95 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 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 13.106-1(b) -Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1). PERIOD OF PERFORMANCE Deliver 5 days from the award. Place of Performance National Institutes of Health, Bldg. 10, Rm.10B04, MSC 1861 10 Center drive BETHESDA MD 20892 USA ? DESCRIPTION OF REQUIREMENT Custom design and manufacturing of surgical clamp based on filed Patent, which will be used in upcoming Human trials for RPE transplantation in Geographic Atrophy Patients (See attached sole source justification for more details) 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: 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." 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 to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Monday, September 24, 2018 to the Contracting Specialist, Arash Seddique at arash.seddique@nih.gov Assessment of Capability Best Value Tradeoff Source Selection Procedures