SOLICITATION NOTICE
99 -- Blood Product
- Notice Date
- 5/27/2005
- Notice Type
- Solicitation Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, MD, 20817
- ZIP Code
- 20817
- Solicitation Number
- RFQ5025
- Response Due
- 6/6/2005
- Archive Date
- 6/21/2005
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is issued as a Request For Quotes; RFQ5025. This RFQ is not a small business set aside. This solicitation and its incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 05-03. This acquisition will be processed under Simplified Acquisition Procedures. The associated North American Industry Classification System (NAICS) Code for this acquisition is 325414 and the small-business size is 500. SCHEDULE: The NIAID is soliciting quotations from offerors to acquire suitable fetal bovine serum (FBS) for use in tissue culture for the production and evaluation of numerous viruses. The objective is to ensure that the viral vaccine candidates produced in tissue culture containing FBS are safe for the eventual administration to humans. The contractor shall provide fetal bovine serum (FBS) that is suitable for research and further manufacturing of live attenuated vaccine candidates intended for administration to humans. In harmony with FDA document Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products - 1/9/2002, FBS must be from a country certified by USDA to be free from bovine spongiform encephalitis (BSE), such as the United States. For this reason and for other safety and practical considerations, FBS must meet the following standards: (a) all serum collected within the US and not blended with non-US product; (b) available as a single manufactured lot of at least 200 liters; (c) gamma irradiated (25 ? 40 kGy) by a validated process; (d) sterile filtered; (e) low endotoxin level (< 5 EU/ml), low hemoglobin level (<20 mg/dl); (f) supplied with Certificate of Analysis and Raw Material Traceability Report; (g) supplied with Certificate of Suitability of Monographs of the European Pharmacopoeia and (h) tested for viral contamination according to 9CFR 113.53. The offeror shall provide to NIH an evaluation sample of FBS and Certificate of Analysis from selected lot prior to procurement. NIH will be responsible for determining the suitability of the product by testing its functionality in tissue culture assays. As described above, serum is to be supplied with a Certificate of Analysis, Raw Material Traceability Report, and Certificate of Suitability of Monographs of the European Pharmacopoeia. The deliverable product is 450 units (500 ml per unit) FBS meeting the standards outlined above. The product is to be shipped frozen to NIH (or its contract freezer facility) in a single shipment. Shipment should be made within 30 days upon receipt of the order and FBS is expected to have a frozen shelf life of at least 5 years. Upon receipt of shipment, the NIAID Staff Scientist will review, inspect, functionally test, and approve all documentation and serum lots to guarantee that this product meets the standards of NIAID and is suitable for the scope of work outlined. The following Federal Acquisition Regulations (FAR) provisions and clauses apply to this acquisition: FAR 52.212-1 Instructions to Offerors - Commercial Items; FAR 52.212-2 Evaluation - Commercial Item; FAR 52.212-3 Offerors Representations and Certifications - Commercial Items ; FAR 52.212-4 Contractor Terms and Conditions - Commercial Items; FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes of Executive Orders ? Commercial Items; and FAR 52.204-7 Central Contractor Registration (www.ccr.gov). The Government intends to select the offer that represents the best value to the Government, price and all other factors considered. In order to be considered for an award, offeror must have completed the online electronic Representatives and Certifications located at http://orca.bpn.gov/ in accordance with FAR 4.1201(a). By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the CCR at: www.ccr.gov/ prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. Offers must be submitted no later than 5:00 P.M. Eastern Daylight Time (EDT), June 6, 2005 to Ms. Roshawn Simpson. Copies of the aforementioned clauses are available upon request by telephone to Ms. Roshawn Simpson at (301) 594-3419. For delivery through the Postal Service, the address is NIH/NIAID/AMOB, 10401 Fernwood Drive, Room 2NE-70-A, MSC: 4811, Bethesda, MD 20892-4811. Electronic transmissions will not be accepted. Requests for information concerning this requirement are to be addressed to Ms. Roshawn Simpson at (301) 594-3419. Collect calls will not be accepted. All responsible sources may submit an offer that will be considered by this agency.
- Place of Performance
- Address: NIH/NIAID, Bethesda
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN00817544-W 20050529/050528093106 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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