National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

B -- CRYOPRESERVATION OF WHOLE BLOOD SAMPLES SOL RFQ-NCI-80210-NV DUE 091198 POC Debbie Moore, Purchasing Agent, 301-402-4509, Todd Cole, Contracting Officer 301-402-4509 This is a combined synopsis/solicitation for Commercial Items, prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation, No. RFQ-NCI-80210-NV, includes all applicable provisions and clauses in effect through FAR FAC 97-06. The acquisition will be made pursuant to the authority in FAR 13.6 to use simplified procedures for commercial acquisitions. This requirement is set-aside for small businesses. The Standard Industrial Classification Code is 8071, and the business size standard is $5.0 Million. employees. BACKGROUND: Approximately 5% of breast cancers may be due to inheritance of germ-line mutations in genes such as BRCA1 and BRCA2. Individuals diagnosed with pre-menopausal and bilateral breast cancer are more likely to carry a mutation in these genes. Determining the proportion of cancer cases due to germ-line mutations in genes like BRCA1/2, and unraveling the interacting effects of lower penetrance genes and environmental factors will require large, representative cohorts in which both genetic material and comprehensive epidemiologic factors are collected. A national cohort of approximately 146,000 radiologic technologists currently under study by the National Cancer Institute provides a population in which these issues may be addressed. Detailed epidemiologic information has already been obtained (Boice 1992). Anonymous testing for mutations in BRCA1 was previously conducted on a subset of the members using a very limited mutation testing technique (Struewing 1996). Plans include testing for genes that may predispose to cancer, such as BRCA1, and genes that may be involved in DNA repair or repair of radiation damage, such as ATM and rad51. References: Boice JD Jr, Mandel JS, Doody MM, Yoder RC, McGowan R. A health survey of radiological technologists. Cancer 1992; 69:586-98. Struewing JP, Tarone RE, Brody LC, LiFP, Boice JD Jr. BRCA1 mutations in young women with breast cancer. Lancet 1996; 347:1493. Because of the large size of genes such as BRCA1 and BRCA2, and the need for a source of RNA for doing cDNA-based analyses, a renewable source of genetic material is needed. Objectives of this project are to collect blood samples from a subset of radiologic technologists and to cryopreserve whole blood as a resource for future genetic studies of cancer. GOVERNMENT RESPONSIBILITIES: The National Cancer Institute will provide support through the University of Minnesota to enlist subject participation, obtain informed consent, send out blood collection kits, and coordinate blood drawings. The Government will review and approve all of the contractor's progress and financial reports, and shall be responsible for inspection and acceptance of cryopreserved samples. REQUIREMENTS: 1. Coordinate with the University of Minnesota to ensure proper specimen collection and transport. This effort between the Contractor and the University of Minnesota shall result in four 10 ml tubes of whole blood being collected from each of approximately 750 technologists and cryopreserved in a manner that will allow for future transformation by Epstein-Barr Virus [EBV]. The Contractor shall provide all supplies of blood collection kits with appropriate vacutainers, shipping materials, and instructions to the University of Minnesota in order to allow for appropriate drawing, shipping, receipt, and ultimately cryopreservation by the Contractor to allow for EBV transformation. Prior to and upon receipt of the kits, staff from the University of Minnesota will contact subjects (the technologists) by telephone to enlist participation, obtain informed consent, send out the blood collection kits, and coordinate blood drawings. The Contractor shall furnish enough airbills with each kit in order to send collection kits to the selected radiologic technologists and for overnight return of kits to the Contractor laboratory. The Contractor shall maintain detailed specifications concerning data collection and shipping requirements (time of blood draw, shipping temperature, days of week, and receipt time and temperature, etc.) and other pertinent restrictions required to allow for EBV transformation. In addition, all supplies and instructions to the University of Minnesota and the subjects shall provide for shipping conditions that maximize success rates for cryopreservation and transformation by Epstein-Barr Virus. 2. Cryopreserve whole blood samples from approximately 750 subjects. The Contractor shall divide the four 10 ml tubes of whole blood into multiple cryovials containing 5-10 million cells per nunc. To accomplish this task, the Contractor shall work out a reasonable schedule with the University of Minnesota to receive the samples and cryopreserve all samples over the contract period of performance. While the schedule is discretionary, a constant stream of samples shall be received by the Contractor, divided out, and cryopreserved over the period of performance. All samples shall be completed and in contractor storage by the expiration date of the contract. The Contractor shall cryopreserve all samples in a manner that allows for future transformation by Epstein-Barr Virus. The Contractor shall maintain appropriate standard operating procedures for processing, cryopreserving, and maintaining the samples, including proposed quality control measures (e.g., how often specimens are checked, measurements, and documentation). In addition, the Contractor shall have equipment and facilities to perform the above requirement, including but not limited to, appropriate location, type of storage, and available back-up measures in the event of a facility power failure. 3. Maintain program management and control requirements. All sample cryovials shall be individually labeled with an ID number, the date frozen, and any other pertinent information required for successful transformation by Epstein-Barr Virus in the future. A receipt-control system shall be maintained to track the receipt, process, and storage of all samples. REPORTING REQUIREMENTS AND DELIVERABLES: The Contractor shall submit a schedule to the NCI Project Officer to coordinate all activities under this project within 30 days of the purchase order issuance date. In addition, a progress report shall be due within 15 days after the first six-month period from the issuance date of the purchase order. In addition, a final report shall be due on the expiration date of the purchase order. Both reports shall detail cumulative achievements to date during the entire twelve month period of performance, problems encountered and their resolutions, and future plans for the project. Specifically, these reports shall detail the: 1) Number of blood samples received; 2) Results of efforts to cryopreserve samples, including any failures; 3) Number and location of cryovials of preserved whole blood (by subject); and 4) Quality control procedures maintained. At the Government Project Officer's request, previously cryopreserved samplesshall be shipped F.O.B. Destination to the National Cancer Institute [within the Washington, D.C. metropolitan region]. At the expiration date of the purchase order, all remaining cryopreserved samples shall be shipped F.O.B. Destination to the National Cancer Institute [within the Washington, D.C. metropolitan region]. MANDATORY INFORMATION AND QUESTIONS In order to evaluate proposals, all offerors must address the following questions and requests in order to demonstrate knowledge and experience relative to this requirement (Particular emphasis should be placed on maintaining conditions that allow for cryopreservation and transformation by Epstein- Barr Virus): 1) Describe and demonstrate your approach, understanding, and management of the total requirement; 2) Describe how shipping conditions affect success rates; 3) Describe your laboratory's standard operating procedures for processing, cryopreserving, and maintaining the samples, including proposed quality control measures. 4) Provide details on the anticipated number (and amount) of cryopreserved samples, location and type of storage available, necessary equipment and facilities, how often specimens are checked, and whether any back-up measures are in place in the event of a facility power failure. 5) Describe your laboratory's previous experience for the organization and key staff (i.e., laboratory scientists, technicians) in performing the tasks described in the requirement herein. 6) Document success rates for EBV-transformation of samples that were cryopreserved in your laboratory. INSTRUCTIONS AND EVALUATION CRITERIA: This is a competitive procurement and a fixed price contract with a one-year period of performance is anticipated. Therefore, offers shall include the proposed price per subject . The amount per subject shall be based on all tasks required under the above requirements, including: supplies (blood collection kits and other items); shipping of supplies to Minneapolis; airbills (for sending kits to subjects and blood samples to the Contractor laboratory); processing of samples (dividing samples and cryopreservation of samples); storage (per tube per annum); shipping of cryopreserved samples to the National Cancer Institute (or designated lab), and any other anticipated costs. The technical portion of quotations will receive paramount consideration in selecting a vendor. However, price will also be a significant factor in the event that two or more vendors are determined to be essentially equal following the evaluation of technical factors. The Government may award a contract on the basis of initial offers received, without discussion, and therefore waive minor irregularities in offers received.. Therefore, each initial offer should contain the vendor's best terms from a cost and technical standpoint. The Government reserves the right to make an award for a quantity less than the quantity offered, at the unit price (per subject) offered, unless the offeror specifies otherwise. In any event, the Government reserves the right to make award tothe responsible vendor whose offer provides the greatest overall value to the Government. Offers will be evaluated based on the following technical evaluation criteria which are listed in the order of relative importance: A. Technical Approach (60 points): 1) Demonstrated understanding of the requirements; 2) Quality and soundness of the proposed approaches and effective management of the the tasks to be accomplished, including quality control measures. B. Staff, Corporate Resources, and Facilities/Equipment (40 points): 1) Background and relevant experience of key staff in performing tasks similar to those required by the requirement; and 2) Demonstrated availability and adequacy of offeror's facilities and equipment. NCI has not yet determined the precise number of samples, but it is anticipated that between 600 and 750 samples shall be cryopreserved under this project. Offerors shall propose a price per sample based on this range, and offers will be evaluated based on the high end figure of 750 samples.NCI will determine the precise sample size prior to award, and the final purchase order amount will be determined by multiplying the number of samples to be cryopreserved by the per unit (per sample) cost. Therefore to accurately evaluate pricing, offerors shall complete the following pricing formula that reveals the total per unit cost and the total bottom line price for 750 samples: Per Sample Price: $________ per sample Total Price: 750 samples * price per sample = $___________ final price The following FAR provisions and clauses apply to this acquisition: FAR 52.212-1, INSTRUCTION TO OFFERORS -- COMMERCIAL ITEMS; FAR 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS -- COMMERCIAL ITEMS -- WITH DUNS NUMBER ADDENDUM; FAR 52.212-4, CONTRACT TERMS AND CONDITIONS -- COMMERCIAL ITEMS; and FAR 52.212-5, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS -- COMMERCIAL ITEMS -- DEVIATION FOR SIMPLIFIED ACQUISITIONS. The following FAR clauses cited in paragraph(b) of the clause at FAR 52.212-5 are also applicable to this acquisition: FAR 52.222-26, EQUAL OPPORTUNITY; FAR 52.222-35, AFFIRMATIVE ACTION FOR DISABLED VETERANS AND VETERANS OF THE VIETNAM ERA; FAR 52.222-36, AFFIRMATIVE ACTION FOR WORKERS WITH DISABILITIES; FAR 52.222-37, EMPLOYMENT RECORDS ON DISABLED VETERANS AND VETERANS OF VIETNAM ERA; and FAR 52.225-3, BUY AMERICAN ACT -- SUPPLIES. Full text copies of the representations and certifications or other cited provisions and clauses may be obtained from Debbie Moore, Purchasing Agent, on (301) 402-4509 or by fax on (301) 402-4513. Offers must be submitted on an SF-18 or SF-1449 with a completed "Schedule of Offered Supplies/Services." Offers must be accompanied by a completed "Offeror Representations and Certifications- Commercial Items -- with Duns Number Addendum," signed by an authorized representative of the offeror. Offers must also be accompanied by a technical proposal and/or descriptive literature, warranty information, and/or other information that demonstrates that the offer meets the foregoing requirements and information on the offeror's experience in providing similar services. Offers and related materials must be received in this office no later than 3:00 pm EST on September 11, 1998. Please cite the solicitation number, RFQ-NCI-80210-NV, in your offer. Posted 08/24/98 (W-SN240971). (0236)

Loren Data Corp. http://www.ld.com (SYN# 0014 19980826\B-0003.SOL)