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

B -- EXTRACTION AND CHEMICAL ANALYSIS OF DUST SAMPLES FOR CONDUCTING A MULTI-CENTER CASE CONTROL STUDY OF RISK FACTORS FOR NON-HODGKIN;S LYMPHOMA (NHL) SOL RFQ-NCI-80160-NV DUE 080498 POC Debbie Moore, Purchasing Agent, 301/402-4509, Todd Cole, Contracting Officer 301/402-4509 RFQ-NCI-80160-NV for "Extraction and Chemical Analysis of Dust Samples for Conducting a Multi-Center Case Control Study of Risk Factors For Non-Hodgkin's Lymphoma (NHL)", which was issued as a combined synopsis/solicitation in the Commerce Business Daily (CBDNet) on June 23, 1998, is amended to provide answers to questions raised by prospective offerors. As a result of the questions, a deadline for any additional questions has been set for July 20, 1998 at 3:00 p.m. EST. After the foregoing deadline has passed, there is no guarantee that a timely response will be forthcoming prior to the due date of proposals which is now changed to August 4, 1998 at 3:00 p.m. EST. The following questions were submitted to NCI, and answers immediately follow as designated: 1. Is there a deadline for questions regarding this project? Answer: See above notice. Please confirm the due date for proposals. Answer: See above notice. Please ensure, by extending the due date if necessary, that there is sufficient time following the issuance of answers to questions, to prepare a responsive proposal. Answer: Under the FAR, this acquisition requires advertisement for at least 15 days. We allowed 30 days because of the complex attributes of the work. Because of the large number of questions we have received to date, we are extending the due date for proposals from July 23 to August 4. We will commit to answering only those questions received prior to 3:00 p.m.on July 20; 2. This question refers to the following sentence cited from the Commerce Business Daily announcement: "The results shall be available no later than six weeks after the specific samples to be analyzed are identified by NCI." Question: What is the maximum number of samples in a batch? Answer: NCI anticipates that its SEER centers will send dust samples to the Contractor laboratory as they make the collections. Thus, no large batch shipments are expected. With regard to the extraction and analysis of the dust samples, the maximum number of samples that NCI will ask the laboratory to analyze within any six-week period is not expected to exceed 50. If NCI identifies more than 50 samples for extraction and analysis at any time, NCI will arrange a reasonable schedule for this work with the Contractor laboratory; 3. This question refers to the following phrases cited from the Commerce Business Daily announcement: "...the laboratory shall extract and analyze duplicate aliquots of 10% of the dust samples..." and "....the laboratory shall analyze duplicate aliquots of 10% of the extracts..." and "...extraction and chemical anlyses: 400 samples + 20 duplicates = 420 samples." Question: We are confused by these statements because 10% of 400 = 440 instead of 420 as indicated in the announcement. Please clarify. Answer: The Schedule of Work Elements, which must be completed by every offeror, correctly specifies the number of extractions and analyses to be performed during the base and each option period. In order to clarify the situation, 400 dust samples shall be extractedand analyzed each year, with 10% of them (i.e., 40 samples) extracted and analyzed in duplicate. However, for 20 of the duplicate samples, only a neutral extraction/analysis is necessary (it is for this reason that "420 samples" appears in the "Neutral Extraction and Chemical Analysis" column of the Schedule of Work Elements). For the remaining 20 duplicate samples, only an acid extraction/analysis is necessary (thus, "420 samples" appears in the "Neutral Extraction and Chemical Analysis" column of the Schedule of Work Elements). In addition, the Contractor laboratory shall analyze duplicate aliquots of 10% of the extracts (i.e., 40 extracts), comprising 20 neutral extracts and 20 acid extracts. This is reflected in the "Chemical Analysis of Duplicate Extracts" column of the Schedule of Work Elements; 4. NCI received several questions from offerors with regard to the methodologies specified in the synopsis/solicitation for extracting and analyzing the dust samples. With regard to the extraction requirements set forth in the synopsis/solicitation, extractions are necessary to recover compounds from the dust matrix. Both a neutral extraction and an acid extraction are specified because it is NCI's experience that neutral compounds require a different extraction method than acid compounds. With regard to the requirement for GC/MS, the Contractor laboratory may propose gas chromatography (GC) or any other appropriate method for separation, such as high performance liquid chromatography (HPLC), provided that the proposed method is supported by performance data. (NOTE: This represents a change from the specifications set forth in the original synopsis/solicitation). However, mass spectrometry (MS) remains an absolute requirement for the identification of compounds, as it is the only method available for the unambiguous detection and identification of a broad spectrum of analytes in an unknown sample; 5. Do you have an estimate of the number of samples expected per month? Answer: Our estimates of the number of samples to be collected each month are given below. Until we are actually in the field, however, it will be impossible to predict with certainty the rates at which samples will be collected at each SEER center. Be advised that the numbers given here are rough estimates only. Base Period: 49 samples per month for the first 3 months 98 samples per month for the last 9 months Option #1: 91 samples per month for the first 2 months 73 sampples per month for the next 4 months 45 samples per month for the next 3 months 36 samples per month for the next 1 month 23 samples per month for the next 2 months Option #2: 23 samples per month for the first 1 month 17 samples per month for the next 1 month 11 samples per month for the next 2 months 8 samples pe month for the next 1 month 0-5 samples per month for the next 7 months; 6. Will NCI provide the bar code scanning equipment specific to the project samples bar code requirements? Answer: NCI will not provide the scanning equipment to the laboratory. Standard scanning equipment is required; 7. What detection limits does NCI require for each target analyte? Answer: As stated in the Commerce Business Daily announcement, the analytical methods shall have the capability of detecting most analytes at levels as low as 0.10 ug per g of dust; 8. Which quantity should we use in determining our total price if there is a range (e.g., 975 to 1,025 samples for receiving, sieving, and storage in the base period)? Answer: You may select any quantity within this range as a basis for determining your total price. Because this is a fixed-price contract, you will be paid the total price that you offer, regardless of the number of samples that are ultimately sent to you, within the stated range of samples; 9. Please confirm the size of the dust fraction for analysis. Answer: It is up to the Contractor laboratory to determine how much dust it requires for the particular methods being proposed for extraction and analysis, from the vacuum cleaner bags of dust furnished by the SEER Centers. As stated in the Commerce Business Daily announcement, the laboratory shall store whatever quantity will be needed for the extractions and analyses, plus an additional 10 grams (or less, if 10g are not available); 10. What weights are assigned to the evaluation criteria? For the purposes of technical evaluation of proposals, the evaluation criteria will be assigned the following weights: Answer: (1) Demonstration that proposed techniques for conducting extractions and analysis will meet the required detection capability and precision -- 40% (2) Experience in analyzing carpet dust samples for the full range of analytes identified, at the specified analytic detection limits -- 25% (3) Experience in analyzing carpet dust samples in a large-scale study with a comparable number of samples -- 20% (4) Experience and qualifications of personnel -- 15%; 11. Will this be a fixed price contract? Yes, this will be a fixed-price contract; 12. Is experience in analyzing carpet dust samples an absolute requirement for receiving consideration for award? Answer: Experience in analyzing carpet dust samples is not an absolute requirement. However, the evaluation criteria set forth in the Commerce Business Daily announcement specify that experience in analyzing carpet dust samples for the full range of listed analytes, at the specified detection limits, in a large-scale study, will be major considerations in source selection. This is because there are many issues and problems that arise in the processing and analysis of carpet dust samples that do not arise in the processing and analysis of other types of samples, and the ability to anticipate these problems and address them appropriately will be crucial to the validity of the results; 13. Have you had this analysis done before? Is this work a follow-up to a previous study? Answer: This is a new study; 14. Please provide more information, including the method of analysis, with regard to PCB- 126, PCB-138, PCB-153, PCB-170, and PCB-180. In addition, please provide information on how to obtain the standards for these methods. Information of this type will not be provided to offerors. Offerors are expected to providethis information to NCI in their proposals as part of the description of methods that are being proposed to conduct the work. Posted 07/13/98 (W-SN222103). (0194)

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