MOD | B | Measurement of Arsenic, Selenium and Zinc in Toenail Samples from a Case-Control Study of Bladder Cancer in New England using Neurton Activation Analysis.

FBO DAILY ISSUE OF MARCH 25, 2006 FBO #1580
MODIFICATION

B -- Measurement of Arsenic, Selenium and Zinc in Toenail Samples from a Case-Control Study of Bladder Cancer in New England using Neurton Activation Analysis.

Notice Date: 3/23/2006
Notice Type: Modification
NAICS: 541710 — Research and Development in the Physical, Engineering, and Life Sciences
Contracting Office: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
ZIP Code: 20852
Solicitation Number: RFQ-NCI-60047-NG
Response Due: 3/23/2006
Archive Date: 4/12/2006
Point of Contact: Malinda Holdcraft, Contract Specialist, Phone (301) 402-4509, Fax (301) 402-4513, - Renita Smith, Contract Specialist, Phone 301-496-8612, Fax 301-480-0241,
E-Mail Address: holdcram@exchange.nih.gov, rs442i@nih.gov
Description: 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 and is being made in accordance with the test program for commercial items as authorized in Far Part 13. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE WRITTEN SOLICITATION WILL NOT BE ISSUED. This solicitation No., RFQ-NCI-60047-NG, includes all applicable provisions and clauses in effect through FAR FAC 2005-08 (January 2006). The North American Industry Classification Code is 541710 and the business size standard is 500 employees. STATEMENT OF WORK: Measurement of Arsenic, Selenium, and Zinc in Toenail Samples from a Case-Control Study of Bladder Cancer in New England using Neutron Activation Analysis. BACKGROUND INFORMATION: Exposure to inorganic arsenic in drinking water is associated with elevated risk of several internal cancers, and in particular, bladder cancer. The observation that bladder cancer risk is elevated subsequent to arsenic ingestion comes from studies in several populations worldwide, including Southwest Taiwan, Northeast Taiwan, Northern Chile, and Cordoba Province of Argentina. These populations historically have been exposed to very high levels of arsenic in their drinking water, and dramatic risk elevations are observed, with relative risks ranging from 3 or 4 to 15, compared to populations with low levels of arsenic in their drinking water. Exposures in these regions of the world ranged between 200 ug/L to 1500 ug/L. The National Cancer Institute, in collaboration with Dartmouth Medical School and several state Departments of Health, has completed the field work in a large case-control study of bladder cancer in Northern New England (Vermont, Maine, New Hampshire). This study was motivated by the persistent elevated rates of bladder cancer mortality and incidence in these three states. Reasons for this elevation are poorly understood. Arsenic in drinking water has emerged as a leading hypothesis that may explain the excess bladder cancer in New England. Low- to moderate levels of arsenic in bedrock aquifers used for drinking water, especially in private wells, occur in extended parts of the region. Based on what is known about the distribution of arsenic in Northern New England, and assuming a straight line extrapolation from the well-established risk of bladder cancer observed at high levels of exposure, the excess risk in rural areas appears to fit the expected level of risk. However, to date there have been no reliable assessments of bladder cancer risk in populations exposed to the lower levels of arsenic in water that are found in New England, and evaluation of this is an important part of the design of the NCI epidemiologic study. PURPOSE AND OBJECTIVES OF THE PROCUREMENT: The main objective is to determine levels of arsenic, selenium, and zinc in toenail samples collected from subjects who participated in a case-control study of bladder cancer. The data will be used to estimate exposure to these elements in the context of the case-control study. CONTRACTOR REQUIREMENTS: The contractor shall: 1 Analyze samples for the presence and concentration of arsenic (As), selenium (Se), and Zinc (Zn) using nuclear activation analysis (NAA). 2 Prepare all samples as necessary (routine analysis) prior to NAA analysis. 3 Contractor shall specify whether cleaning of samples prior to analysis is included in the proposal. If cleaning is included in the proposal, the cost shall be identified as a separately priced line item. 4 In the case-control study, toenail samples were collected from 2,545 participants. The weight of each sample is not yet available, and some samples may fall below the minimum required for adequate NAA analysis. Under the assumption that all samples meet the minimum weight requirements for analysis, 2,545 sample analyses will be required. In addition, 10% (255 samples) randomly selected samples of adequate size will be split and blindly submitted for quality assurance (QA) purposes. Thus the maximum number of analyses, including QA samples will be 2,800. All analyses must be completed, with results submitted, no later than eight (8) months after the start date of this contract. Higher throughput, which would permit completion of analyses no later than six (6) months after contract initiation, will be to the advantage of the contracting laboratory. The contractor shall provide a detailed description of quality control/quality assurance procedures that are used for preparation and analysis of blanks and standardized samples. REPORTING REQUIREMENTS: 1 The Contractor shall electronically communicate results of all analyses, including quality control information, to the NCI Project Officer on a weekly basis, using an Excel format to be provided by NCI. Problems or delays relating to any aspect of these analyses shall be reported to the NCI Project Officer as soon as noted by the contractor. 2 Contractor shall provide a summary report of progress, study management, problems, and their resolution, to NCI on a monthly basis, to commence the beginning of the first month after samples have been received by the contractor. 3 The report shall include, but not be limited to: Counts of the numbers of samples received, analyzed, and whose results were reported in the monthly reporting period, as well as totals to date. 4 The Contractor shall provide a final report to NCI at the conclusion of all analyses which shall include summaries of these same data. GOVERNMENT RESPONSIBILITIES: NCI will provide to the contractor toenail samples collected from study subjects in the period 2002-2005. If cleaning of samples is not included in an offeror?s proposal, this will be done by the Government prior to shipment. In addition to original samples, an additional 10% of the samples will be blinded replicates, indistinguishable from the original samples. These blinded replicates will be submitted to the contractor for quality control purposes. Samples will be shipped to the contractor from NCI's sample repository in batches to be determined by consultation and agreement between NCI and the contractor, and at a frequency to be determined in like manner. Prior to shipment of samples from the NCI repository to the contractor, the batch size used in analysis will be communicated to NCI to permit the rational organization of QA samples. The weight of each sample shipped from NCI shall be no less than 10 mg. INSPECTION AND ACCEPTANCE CRITERIA: Within two weeks of submission of data to NCI, the Project Officer will review the data submitted to NCI by the contractor, and inform the contractor of any anomalies found and/or corrective action required PERIOD OF PERFORMANCE: May 1, 2006 ? January 31, 2007. NOTE: Offerors may propose a shorter delivery schedule and will be given additional technical points if this shorter delivery schedule is proposed. ADDITIONAL INFORMATION TO QUOTERS: BASIS FOR AWARD: Award will be made, subject to available funding and quoter responsibility, to that acceptable quote, the price or cost of which is not necessarily the lowest, but which is sufficiently more advantageous to the Government than the lowest offer so as to justify the payment of additional amounts, based on the evaluation criteria described in this section. The Evaluation Process: The Government will award a contract resulting from this quotation to the responsible contractor whose quote conforming to the quotation will be the most advantageous to the Government, price and other factors considered. The following evaluation factors shall be used to evaluate the prospective contractors: 1) Technical Approach, 2) Facilities, 3) Experience, 4) Quality Control, and 5) Price. Of the five (5) technical evaluation factors listed below, factor one (1) Technical Approach and factor two (2) Facilities, are considered to be more important than factors three (3) Experience four (4) Quality Control and five, (5) Price. FORMAT AND INFORMATION FOR SUBMITTING A QUOTE: Please submit one (1) original plus one (1) copy of entire quotation. Please submit proposals in the following: TWO SEPARATELY BOUND VOLUMES: Please mark originals ?ORIGINAL? and copy ?Copy.? VOLUME 1: CONTRACT AND PRICING DOCUMENTS: 1) Signed 1449 (page 1, blocks 12,17a, 23, 24, 26, 30a, 30b and 30c) and any other pricing related information, 2) Signed amendments (if applicable), 3) Representations and Certifications (Contractors must be registered in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) in order to receive an award) Please provide a copy of the CCR registration and the ORCA certification. 001-Line Item Number: Analysis of toenail samples: Quantity 2,800 samples. Total number of samples includes an additional 10% for quality control/quality assurance purposes. NOTE: IF cleaning is included, please exclude it from the analysis of samples pricing. It shall be included as a separate price under line item, 002 below. 002-Line Item Number: Cleaning: Quantity 2,800 samples (if applicable) 003-Line Item Number: Shipping and Handling charges (if applicable) VOLUME 2: Technical Approach, Facilities, Past Performance and Quality Control (100 points) 1 Technical Approach: 1) Adequacy and feasibility of the proposed methods for analysis of arsenic, selenium, and zinc in cleaned toenail samples and plans for timely delivery of analytical results (20 points). 2) Demonstrated ability to complete all analyses and provide results within six (6) months of contract initiation (10 points). 2 Facilities (30 points): Adequacy and availability of suitable laboratory facilities and equipment to perform all of the items stated in the Statement of Work. 3 Experience (25 points): Resumes of key personnel that will be assigned to this project, adequacy of the qualifications and past experience of the key personnel in the analysis of biological samples, including toenails, by neutron activation analysis. 4 Quality Control Procedures (15): The contractor shall provide a detailed description of the quality control / quality assurance procedures that are used for preparation and analysis of blanks and standardized samples regarding the services stated in this statement of work. 5 Price (Price will be evaluated but, will not be scored.) PROVISIONS AND CLAUSES: The following FAR provisions and clauses apply to this acquisition: FAR 52.212-1, INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS FOR SIMPLIFIED ACQUISITION; FAR 52.212-3, OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS-WITH DUNS NUMBER ADDENDUM, FAR 52.212-4, CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES, OR EXECUTIVE ORDERS-COMMERCIAL ITEMS-FOR SIMPLIFIED ACQUISITION. The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition; Far Clause 52.203-6 RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT. 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 REPORTS ON DISABLED VETERANS AND VETERANS OF VIETNAM ERA; FAR 52.225-3, BUY AMERICAN ACT SUPPLIES; AND 52.232-34, PAYMENT BY ELECTRONIC FUNDS TRANSFER-OTHER THAN CENTRAL CONTRACTING REGISTRATIONS. Additional NIH Provisions: HUMAN MATERIALS: The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI website at http://amb.nci.nih.gov or from Malinda Holdcraft, Contract Specialist, at holdcram@exchange.nih.gov or phone (301) 402-4509. OFFERS: Offers must be submitted on a SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with Duns Number Addendum, signed by an authorized representative of the offeror OR certification/validation of Central Contractor Registration (CCR) and Online Representations and Certifications Applications (ORCA). Offers/Quotations must be received in the National Cancer Institute, Office of Acquisition by 1:00 PM EST on March 28, 2006. Please refer to the solicitation number RFQ-NCI-60047-NG. Proposals submitted after this date and time will be considered non-responsive.
Place of Performance: Address: Contractor site; Country: USA
Record: SN01013226-W 20060325/060323211841 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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B -- Measurement of Arsenic, Selenium and Zinc in Toenail Samples from a Case-Control Study of Bladder Cancer in New England using Neurton Activation Analysis.