Agricultural Exposures and Tyroid Dysfunction among Male Farmers in the Biomarkers of Exposure and Effect in Agriculture (BEEA) Study.

National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational and Environmental Epidemiology Branch, plans to procure on a sole source basis services to measure thyroid hormones in 437 serum samples (397 individuals + 10% blinded QC) from the BEEA study for an analysis of pesticide exposure and risk of subclinical thyroid disease from The University of Chicago, Ahsan/CCEP Laboratory, 900 East 57th St., Room 6240 Chicago, IL 60637. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541380 and the business size standard is $14.0 Millions. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. NCI/DCEG is measuring thyroid hormones in 437 serum samples (397 individuals + 10% blinded QC) from the BEEA study for an analysis of pesticide exposure and risk of subclinical thyroid disease. In this study, NCI proposes to measure serum levels of thyroid stimulating hormone (TSH), free thyroxine (FT4), total triiodothyronine (T3) and thyroperoxidase antibodies (anti-TPO). Thyroid dysfunction is common, with an estimated 0.8%-7.5%of adults having clinically manifested disease and an estimated 5%-9% having subclinical disease. Known risk factors for thyroid disease include female sex, increasing age, prior benign thyroid nodules or goiter, autoimmunity, iodine deficiency and ionizing radiation exposure. There is also growing evidence that some environmental exposures, including certain pesticides and pesticide classes, may have endocrine disrupting properties or other biological activities that could influence thyroid disease risk. In limited investigation, pesticide exposures, specifically fungicides, have demonstrated associations with both thyroid disease and thyroid cancer. Exposure to organochlorine pesticides and herbicides has demonstrated associations with self-reported hypothyroidism among participants in the Agricultural Health Study. The evidence of associations between pesticide exposures and thyroid dysf unction is intriguing, although somewhat inconsistent. Previous research has been limited by investigating only broad classifications of pesticides, a small number of specific pesticides, non -specific biomarkers of exposure, or reliance on self-reported thyroid disease. The purpose of this procurement is to measure thyroid hormones in 437 serum samples (397 individuals + 10% blinded QC) from the BEEA study for an analysis of pesticide exposure and risk of subclinical thyroid disease. In this study, NCI proposes to measure serum levels of thyroid stimulating hormone (TSH), free thyroxine (FT4), total triiodothyronine (T3) and thyroperoxidase antibodies (anti-TPO). The University of Chicago is the only laboratory known that is able to run all thyroid hormones and antibody assays, which are specialty assays, in the same laboratory within NCI's restriction of a 0.5mL aliquot. The PI's in charge of BEEA allowed access to 0.5ml of serum for use in this study. The University of Chicago was able to perform the requested services using 0.35ml. Blood serum is a valuable resource and performing the services at the smallest volume possible is of great value, making efficient use of a rare resource. The Contractor will conduct the analyses using no more than 0.35 ml of serum from 437 samples coded with no personal identifiers attached and shipped to the contractor in dry ice by NCI. The Contractor shall: 1. Receive and catalog blood samples sent in two batches on dry ice from the NCI staging laboratory. The contractor shall store the samples frozen until analysis. 2. Conduct measurements of serum concentrations of thyroid stimulating hormone (TSH) using single multiplexing kit from Millipore (The Human Pituitary panel, Cat # STTHMAG-21K), free thyroxine (FT4) and total triiodothyronine (T3) using a another multiplexing assay kit from the same manufacturer (Steroid/Thyroid Hormone Magnetic Bead Panel, Cat # STTHMAG-21K) and thyroperoxidase antibodies (anti-TPO) using ADVIA Centaur anti-TPO assay (using chemiluminescent methodology). Data from the first batch should be sent to the NCI Contracting Officer's Technical Representative (COR) and analyzed by NCI for quality assurance before proceeding with subsequent batches. 3. Deliver data to the NCI COR as tables containing sample ID, test-date, test results (summary result and individual replicate results). This will be delivered by e-mail as either an Excel file or text file. 4. Provide support for questions about the data deliveries. The contractor shall provide to the NCI COR the tables containing test-date, test results (summary result and individual replicate results), all linked to sample IDs. NCI will provide 437 samples in two shipments beginning September 25, 2013. Data shall be in Excel or text file. The contractor shall deliver to the NCI the results of the assays for the first batch December 1st, 2013 and the results of assays from all subsequent samples by April 1st, 2013. In addition to the results of analyses carried out on NCI study samples, the contractor shall provide to the Project Officer internal quality control data that shall include the same data as for the NCI study samples. NCI will have 60 days in which to review and accept "the deliverable." The contractor shall have 60 days in which to correct any discrepancies and re-submit "the deliverable." The period of performance shall be for 12 months from September 25, 2013 to September 24, 2014. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quotation. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 2:00 PM EST, on September 12, 2013. All responses and questions must be in writing and faxed +1 (555) 000-0000 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at contact@example.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: NCI-130144-RR on all correspondence.