Loren Data Corp.

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COMMERCE BUSINESS DAILY ISSUE OF JUNE 25,1996 PSA#1623

National institutes of Health, Office of Purchasing & Contracts, OPM/ OD, Suite 311, 6006 Executive Blvd MSC 7058, Bethesda, MD 20892

66 -- PURCHASE OF A CGMP HIGH VACUUM STERILIZER SOL CC-96-10 DUE 072696 POC Anthony S. Gaither, Contract Specialist or Sarah L. Cosey, Sarah L. Cosey, Contracting Officer, (301) 496-3704. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemental with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation #CC-96-10 is hereby issued as an invitation to bid (IFB). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 90-32. This acquisition is a 100% set-aside for small business concerns. The associated standard industrial classification code is 3821, with a small business size standard of 500 employees. The National Institutes of Health (NIH) has a requirement to procure one cGMP High Vacuum Sterilizer, with optional equipment that will meet required specifications (available upon request via mail or fax to (301) 496-7007). The required specifications describes the minimum design and performance requirements for cGMP, a microprocessor-controlled high vacuum steam sterilizer package to be used for sterlizing liquid and solid products, metal and glass containers, and equipment used in the manufacturing of pharmaceutical products. The purpose of this procurement is to purchase a cGMP High Vacuum Steam Sterlizer for the manufacturing of celluar components for transplantation, adoptive immunotherapy and gene therapy. The offeror shall submit evidence that they have provided and installed this equipment in a Federal Drug Administration inspected and approved area by providing at least (5) references on recently installed, validated cGMP autoclaves, possibly size comparable to that stated in the required specifications. Experience in installing this equipment in pharmaceutical manufacturing facilities who have passed FDA inspection is imperative. Line item #1 shall include cGMP Sterilizer and all optional equipment needed to meet required specifications. Line item #2 shall state delivery charges. Line item #3 shall state installation and related charges. Line Item #4 shall state start-up and demonstration charges. Standard approval drawings shall be submitted two (2) weeks after written purchase order. Equipment to be shipped 12 weeks after receipt of approval drawings. Estimated delivery time is October 31, 1996. Equipment shall be delivered F.O.B. Destination to: NIH, Clinical Center, Department of Transfusion Medicine, Building 10, Room 1C711, Bethesda, MD 20892. (a) The FAR provisions at 52-212-1, instructions to Offerors-Commercial Items is applicable. (b) The FAR provisions at 52-212-2, Evaluation-Commercial Items is applicable. (c) The offeror shall include a completed copy of the FAR provisions at 52-212-3, Offeror Representations and Certifications-Commercial Items. (d) The FAR provisions at 52-212-4, Contract Terms and Conditions is applicable. (e) The FAR provisions at 52-212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items is applicable. (f) The FAR provisions at 52-214-21, Descriptive Literature is applicable. The offeror must warrant that sterilizer was factory tested, inspected, is in working order and free of defects in material and workmanship for a period of 12 months from date of installation and acceptance. Warranty shall not commence until completely installed, tested and accepted by the National Institutes of Health. Sealed bids are due no later than 11:00 AM on July 26, 1996. Each offeror must submit an original and two (2) copies of the bid to: National Institues of Health, OPM, OD, Office of Purchasing and Contracts, Suite 311, MSC 7058, 6006 Executive Blvd., Bethesda, MD 20892-7058 (if using U.S. Postal Services), ''or'' National Institutes of Health, OPM, OD, Office of Purchasing and Contracts, Suite 311, 6006 Executive Blvd., Rockville, MD 20852 (if hand delivered or delivery services). Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration. Information regarding this solicitation can be obtained from Anthony S. Gaither, (301) 496-3704. See numbered Note 1. (0173)

Loren Data Corp. http://www.ld.com (SYN# 0301 19960624\66-0002.SOL)


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