Notice_of_Intent_to_Sole_Source_4168564.doc

General Information

Short Title: Measure of Estrogens, Androgens, and Progestagens in a Case-Control Study of Breash Cancer Nested in the PLCO Cohort.

Document Type:

Notice of Intent to Sole Source Solicitation Number:

N02CO62663-78

Posted Date: 8/17/2016 Response Date: 8/29/2016 3PM ET Classification Code: R499

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

The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis services for the measure of estrogens, androgens, and progestogens in a case-control study of breast cancer nested in the PLCO cohort, from the National Foundation Center for Disease Control and Prevention, Inc. 55 Park Pl Ne Ste 400, Atlanta, FA 30303-2539.

This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.501(a). The North American Industry Classification System code is 541990 and the business size standard is 15 Million.

Only one award will be made as a result of this notice. This will be awarded as a firm fixed price type contract.

The Period of Performance is for one year after date of award.

It has been determined there are no opportunities to acquire green products or services for this procurement.

Contractor Requirements are:

B. 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, prolactin, IGF-I and IGFBP-3, and vitamin D metabolites. In addition, the EBP plans to include the additional breast cancer cases who were postmenopausal and not using exogenous hormones at time of blood draw and were diagnosed since completion of the initial study, 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.

The Contractor shall:

1) Provide the 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 950 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 950 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 950 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.

Sole Source The 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. No other laboratory measures this range of hormones in a single serum sample less than 1.0 mL with the sensitivity to measure each hormone in nearly all postmenopausal women. Additionally, no other laboratory has demonstrated for a comparable multiple steroid hormone assay accuracy for both testosterone and estradiol in the CDC Hormone Standardization Program.

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 the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3 PM ET, on August 29, 2016. All responses and questions must be via email to Francisco Mendoza, Contracting Specialist 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 and the Online Representations and Certifications Applications through sam.gov. Reference N02CO62663-78 on all correspondence.