SPECIAL NOTICE
B -- Measurement of Estrogens, Androgens, and Progestagens in an Expanded Case-Control Study of Breast Cancer Nested in the PLCO Cohort.
- Notice Date
- 8/2/2017
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CO72636-78
- Archive Date
- 9/1/2017
- Point of Contact
- Francisco Mendoza, Phone: 2402765668
- E-Mail Address
-
francisco.mendoza@nih.gov
(francisco.mendoza@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- General Information Short Title: Measurement of Estrogens, Androgens, and Progestagens in an Expanded Case-Control Study of Breast Cancer Nested in the PLCO Cohort. Document Type: Notice of Intent to Sole Source Solicitation Number: N02CO72636-78 Posted Date: 8/2/2017 Response Date: 08/08/2017 10:00 AM ET Classification Code: B529 NAICS Code: 541990 Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD 20850, UNITED STATES Description National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Epidemiology and Biostatistics Program (EBP) plans to procure on a sole source, services for the measurement of estrogens, androgens, and progestagens in an expanded case-control study of breast cancer nested in the PLCO Cohort, from the Centers for Disease Control and Prevention Fundation, Inc., 55 Park Place, Suite 400, Atlanta, GA 30303. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1)(i). The North American Industry Classification System code is 541990 and the business size standard is $15 million. The period of performance is for a 1-year Base Period from the date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. Project Objectives: The Division of Cancer Epidemiology and Genetics (DCEG), Epidemiology and Biostatistics Program (EBP) plans to apply the liquid chromatography-tandem mass spectrometry (LC-MS/MS) multiple steroid hormone assay developed by the Centers for Disease Control and Prevention (CDC) in a case-control study of breast cancer nested in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) cohort. All women will be postmenopausal and not currently using exogenous hormones at time of blood draw. The EBP plans to include the breast cancer cases and matched controls in the PLCO cohort for whom the EBP has already measured estrogen metabolism profiles,IGF-I and IGFBP-3, vitamin D metabolites, and prolactin. In addition, the EBP plans to include additional breast cancer cases diagnosed since completion of the initial study who have prediagnostic serum samples, along with matched controls. PLCO has recently made available breast cancer cases diagnosed during an additional five years of followup. To increase the power of this study, we EBP isare adding the newly accrued breast cancer cases with prediagnostic serum samples, along with matched controls. The EBP will investigate interrelationships of estrogens, androgens, progestogens, and BMI with postmenopausal breast cancer risk, including independent, joint, and mediating effects. The EBP anticipates that unusually accurate and precise data will facilitate disentangling these complex relationships. Contractor Requirements: 1) Provide updated performance characteristics of the LC-MS/MS assay, including accuracy, reproducibility, and sensitivity. 2) Measure a panel of steroid hormones (estrone sulfate, estrone, estradiol, DHEAS, androstenedione, testosterone, progesterone, and 17-hydroxyprogesterone) in 775 serum samples using an accurate, precise, sensitive isotope dilution LC-MS/MS method. 3) Provide the results of the assays to the NCI Technical Point of Contact (TPC). Results shall be provided within one month of completion of the assays. Government Responsibilities: The NCI TPC shall ensure that the NCI ships the 775 serum samples to be assayed directly to the Contractor within two months after the award. Aliquots of 600 microL will be frozen at -70°C, packed with dry ice, and shipped, via overnight courier, to the Contractor. The NCI TPC will provide the Contractor with an electronic manifest containing anonymized identification numbers for each sample at the time the samples are shipped. The NCI TPC will review the assay results within one month of receiving the data. Reporting Requirements and Deliverables: The Contractor shall provide steroid hormone concentrations for each of the 775 serum samples within one month of completing the assays. The report shall be submitted in a Microsoft-compatible electronic format to the TPC. The Contractor shall provide a description of any problems that develop during the assay procedures. The Contractor shall provide a brief description of the LC-MS/MS steroid hormone assay methods and the current performance characteristics of the assay, including accuracy, reproducibility, and sensitivity. No residual serum needs to be returned to the NCI. Inspection and Acceptance Criteria: The NCI TPC will review the data within one month of its receipt and determine if the objective of the procurement is met, based on the data provided by the Contractor. Payment: The payment shall be issued after the deliverables are made. A submission of an invoice per the Invoice and Payment Provisions is required. A copy of the invoice shall be sent concurrently to the NCI TPC. I. Clearances IRB Approval: The IRB determined that this project is NOT human studies research. Privacy Act: FAR clauses 52.224-1 and 52.224-2 apply to this requirement. Sole Source: DCEG's EBP needs to measure the range of steroid hormones potentially involved in breast cancer etiology (estrone sulfate, estrone, estradiol, DHEAS, androstenedione, testosterone, and progesterone) in a single low-volume serum sample with a LC-MS/MS method. The assay must be accurate, reproducible, and sensitive enough to measure circulating steroid hormones in postmenopausal women. The assay must be validated for estradiol and testosterone through the CDC Hormone Standardization Program. After several years of assay development, the CDC has developed an accurate, reproducible LC-MS/MS assay for measuring estrone sulfate, estrone, estradiol, DHEAS, androstenedione, testosterone, progesterone, 17-hydroxyprogesterone, and possibly some additional steroid hormones in a 0.6 mL serum sample. Approximately 120 samples can be assayed in a week. Therefore, the assay is rapid enough to be used with the multiple samples required by a large epidemiologic study. The assay is sensitive enough to measure serum concentrations for the eight steroid hormones listed above in nearly all postmenopausal women. Average coefficients of variation, a measure of reproducibility, are below 10% for each hormone in serum samples from postmenopausal women. CDC has demonstrated the accuracy of the testosterone and estradiol measurements through the Hormone Standardization Program. CDC was encouraged to develop this assay because no equivalent assay existed commercially and this type of assay was needed for national US health surveys and etiologic research. The Hormone Standardization Program at the CDC, is the only external validation program for circulating estradiol and testosterone assays. Therefore, CDC is the only source known to meet the Government's needs at this time. 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 quote for the Government to consider. 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 10 AM ET, on August 8, 2017. All responses and questions must be via email to Francisco Mendoza, Contracting Officer at francisco.mendoza@nih.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. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have complete Representations and Certifications. Reference: N02CO72636-78on all correspondence.
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