H -- LABORATORY TESTING SERVICES

Notice Date

August 31, 2001

Contracting Office

Acquisitions Management Operations Branch, NIAID, 6700-B Rockledge Drive, Room 1130, Bethesda, MD 20892-7605

ZIP Code

20892-7605

Solicitation Number

NOI1012

Response Due

September 20, 2001

Point of Contact

Sylvia Robinson, Purchasing Agent (301) 496-2814/Carolyn Sentz, Contracting Officer (301) 402-2282

Description

17. This is a combined synopsis/notice of intent to procure commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are not being requested for solicitation number NOI1012. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular 97-27. The Government intends to procure sample testing and assay analysis from Bayer Reference Testing Laboratory. Bayer has designed an assay to specifically quantitate strains of HIV and SIV in blood and tissue samples. This assay has been used for previous studies. In order to correlate data among studies, it is necessary that this analysis be continued for ongoing and future studies. This acquisition will be processed under Simplified Acquisition Procedures (SAP) and is not a small business set-aside (NAICS-325414). The primary purpose of this testing is for the Vaccine Research Center (VRC) to develop an effective AIDS vaccine. Studies are in progress to assess the immunogenicity and protection afforded by VRC recombinant adenovirus and plasmid DNA constructs in non-human primates. Experimental infection of non-primates with the simian immunodeficiency virus (SIV) provides a useful and relevant model for studying the pathogenesis and treatment of AIDS and the development of effective vaccines. In order to examine the immune response to novel vaccine constructs, blood samples from vaccinated non-human primates are obtained and analyzed for levels of viral load. An increase in viral load has been shown to correlate with progression of SIV disease. Analysis of 1,280 blood samples is required to determine the viral load and thus the effectiveness of the vaccine regimen. The contractor is to perform SIV mac RNA bDNA assays and report results on samples provided by the government. The contractor will notify the designated NIH contact person immediately upon arrival of the shipment. Any overt problems with the shipment, such as damage to the package or thawing will be reported to the NIH contact person immediately. Written results will be reported to the government within six weeks of receipt of the samples. Test results will be reported for each animal identification and date collected in copies/ml and LOG copies/ml. Where applicable; the contractor shall include appropriate positive and/or negative controls to ensure accuracy of the data. The government will provide to the contractor primate samples for SIV mac RNA bDNA testing as follows: 1) Plasma samples (1.0 minimum/sample) will be packaged in unbreakable containers and shipped directly to the contractor on dry ice via an overnight shipping service such as Federal Express, United Postal Service, or Airborne Express. 2) All applicable procedures for shipping of infectious materials will be adhered to. 3) Samples will be labeled with the animal identification and the date of collection. 4) A completed "Test Request Form" will be sent with each shipment. If necessary, verification of data may be required/requested by the government. Data will be inspected and analyzed by personnel designated by the government. Any problems noted will be addressed directly to the contractor by government designated personnel. The total number of samples is 3040. Testing is to start in year 2001 and continue through FY 2002. The following FAR provisions and clauses apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items; FAR 52.212.3 Offeror 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 or Executive Orders Commercial Items. A completed copy of provisions at FAR 52.212-3 Offerors Representations and Certifications Commercial Items must be included. Copies of the aforementioned clauses are available upon request by telephone to Ms. Sylvia Robinson at (301) 496-2814. For delivery through the Postal Service, the address is NIH/NIAID/AMOB, 6700B Rockledge Drive/MSC7605, Room 1130; Bethesda, Maryland 20817-7605. Electronic submission will not be accepted. Requests for information concerning this requirement are to be addressed to Ms. Sylvia Robinson at (301) 496-2814. Collect calls will not be accepted. All responsible sources may submit an offer that will be considered by this agency.

Record

Loren Data Corp. 20010905/HSOL001.HTM (W-243 SN50W698)