MODIFICATION
B -- Measurement of Sex-Hormone Binding Globulin (SHBG) in a Case-Control Study of Breast Cancer Nested in the PLCO Cohort.
- Notice Date
- 9/12/2017
- Notice Type
- Modification/Amendment
- 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
- N02CP72692-61
- Archive Date
- 9/28/2017
- Point of Contact
- KATHY D. ELLIOTT, Phone: 240-276-5570, Reyes Rodriguez, Phone: 240-276-5442
- E-Mail Address
-
ELLIOTTK@MAIL.NIH.GOV, reyes.rodriguez@nih.gov
(ELLIOTTK@MAIL.NIH.GOV, reyes.rodriguez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E226, Rockville, MD 20850, UNITED STATES Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Epidemiology and Biostatistics Program (EBP) plans to procure on a sole source basis service to determine how Measurement of Sex-Hormone Binding Globulin (SHBG) in a Case-Control Study of Breast Cancer Nested in the PLCO Cohort from The Children's Hospital Corporation, 300 Longwood Avenue, Boston, MA 02115. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541990 and the business size standard is $15.0M. 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. The Division of Cancer Epidemiology and Genetics (DCEG) is an intramural research program of the National Institutes of Health (NIH), National Cancer Institute (NCI), that conducts population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The purpose of this agreement is to determine how sex-hormone binding globulin (SHBG) will be measured in a large nested case-control study of breast cancer nested in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) cohort. Measuring SHBG allows the circulating concentrations of total, non-SHGB bound, and free (not bound to SHBG or albumin) estradiol and testosterone can be calculated. Non-SHBG bound estradiol and testosterone are believed to be the bioactive forms of these hormones. 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 large case-control study of breast cancer nested in the PLCO cohort. All women will be postmenopausal and not currently using exogenous hormones at time of blood draw. 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 Qualifications: The Contractor shall be a member of a breast cancer consortium, and shall have an extensive and successful track record with generating data on low frequency genetic variants associated with breast cancer susceptibility. This specialized project requires that the results generated must be as comparable as possible to the results generated in the BRIDGES consortium. The Contractor shall perform the following tasks: 1) Provide the current performance characteristics of the SHBG assay used by the laboratory, including accuracy, reproducibility, and sensitivity. 2) Measure SHBG in 1728 serum samples from postmenopausal women using a FDA-approved method. The assay must not require more than 150 microL of serum per subject. Across-batch coefficients of variation must be < 5% for SHBG concentrations in the range of 10 - 50 nmol/L. 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 will ensure that the NCI ships the 1728 serum samples to be assayed directly to the Contractor within three months after the award. Aliquots of 150 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. The NCI will cover expenses related to shipping samples from the collaborating centers to the testing laboratory. This will allow the NCI four months to review the deliverables and sort out any concerns with the Contractor. Reporting Requirements and Deliverables The Contractor shall provide SHBG concentrations for each of the 1728 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 SHBG assay methodology and the current performance characteristics of the assay, including accuracy, reproducibility, and sensitivity. The Contractor shall return residual serum 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. Privacy Act FAR clauses 52.224-1 and 52.224-2 apply to this contract. 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 11:00 AM EST, on September 13, 2017. All responses and questions must be submitted via email to Kathy Elliott, Contracting Specialist at Elliottk@mail.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 in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02CP72692-61on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP72692-61/listing.html)
- Place of Performance
- Address: 9609 Medical Center Drive, Rockville, Maryland, 20890, United States
- Zip Code: 20890
- Zip Code: 20890
- Record
- SN04673396-W 20170914/170912232321-97fa9a111215ca8ea0d2583f5f54cad2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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