SOLICITATION NOTICE
Q -- Procurement of Biosamples for Analysis of suspected endometrial cancer and precursors
- Notice Date
- 9/4/2017
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- 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
- N02CP72701-76
- Archive Date
- 9/15/2017
- Point of Contact
- Catherine Muir, Phone: (240) 276-5434
- E-Mail Address
-
muirca@mail.nih.gov
(muirca@mail.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 1E144, Bethesda, MD 20892, USA. Description: National Cancer Institute (NCI Division of Cancer Epidemiology and Genetics (DCEG), Clinical Genetics Branch (CGB), plans to procure on a sole source basis biosample collection services from the Mayo Clinic; 200 First St SW; Associated Bank Building; Rochester, MN 55905. 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 621511 and the business size standard is $32.5M. 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 estimated to be twelve (12) months from the date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. Clinical Genetics Branch (CGB) investigators study individuals at high genetic risk of cancer in order to improve our understanding of cancer etiology and to advance clinical care. This work is carried out through two major research approaches: familial studies and clinical genetics. The CGB's research mission is to conduct multidisciplinary research to advance our understanding of the molecular pathogenesis of cancer and to translate this knowledge into effective clinical applications for cancer-prone individuals and families, and for individuals at increased risk of cancer from the general population. Endometrial cancer is the most common gynecological cancer in the U.S., with an estimated 61,380 new cases and 10,920 deaths expected in 2017. In contrast to the declining trends observed for many cancers, the incidence of endometrial cancer has been increasing over time, with rates projected to double by the year 2030. Obesity is a strong risk factor for endometrial cancer, and data in some populations suggest that increasing rates of endometrial cancer and its precursors mirror the growing prevalence of obesity. Most endometrial cancers develop slowly through progression of well characterized precursors, many of which regress with progesterone treatment or are curable with hysterectomy. Thus, risk prediction and early detection of endometrial cancer precursors could enable prevention of many endometrial cancers and reduce mortality. Researchers at the National Cancer Institute have developed risk prediction models to evaluate endometrial cancer risk based on risk factor data such as BMI and parity. Furthermore, researchers at NCI have conducted molecular profiling studies of endometrial cancers. Preliminary analyses demonstrate that DNA methylation and mutation markers that are present in endometrial cancer tissue are also detectable in tampons and endometrial brushings obtained from the same woman. Additional data suggest that the markers can be detected in endometrial cancer precursors. NCI seeks to collect risk factor information, vaginal tampons and endometrial brushings from women with suspected endometrial cancer and endometrical cancer precursors, and to use these samples to test for DNA methylation and DNA mutation markers. The goal of the project directed by NCI is to use risk factors and molecular markers to predict risk of endometrial cancer and its precursors. Contractor shall perform the following: TECHNICAL REQUIREMENTS: • The contractor shall obtain biological specimens (Tampon, tao brush, tissue) from 175 women attending various clinics in the Departments of Obstetrics and Gynecology and Gynecologic Oncology with suspected endometrial cancer or cancer precursors. • The contractor shall abstract risk factor information (including BMI, smoking, hormonal and reproductive risk factors, family history, medications, and history of bleeding, discharge) in an Excel sheet • The contractor shall store the DNA specimens at -70C until methylation and mutation measurement will be conducted by NCI. REPORTING REQUIREMENTS AND DELIVERABLES: After completing collection of biological specimens, the contractor shall submit a final report and a database with all collected variables in Excel format. Deliverables: The deliverables include specimens and data from 200 women attending various clinics. After completing enrollment, the contractor shall transfer the collected data to NCI in Excel format. The specimens shall be stored at the Mayo biospecimen repository until the biomarker testing will be conducted by NCI. INSPECTION AND ACCEPTANCE CRITERIA: The NCI COR will await confirmation that covariate data have been received by the data managers. After collection of specimens is completed, the NCI COR will await confirmation that samples have been received at the repository. The NCI COR will have one month in which to review and accept delivery. If no comments or request for revisions are provided within one month, the deliverables shall be considered acceptable. PAYMENT: The contractor shall send bi-monthly invoices according to the number of subjects enrolled. NET 30 days from date of invoice. Payment shall be made in arrears, after receipt and acceptance of deliverables stated above, and submission of an invoice to the address shown in the order. Payment authorization requires submission and approval of invoices to the NCI Technical Point of Contact and the NIH Office of Financial Management (OFM), in accordance with the attached payment provisions listed below: The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2013) FAR 52.232-25. These support services are provided by the Mayo Clinic. Together with the proposed contractor, NCI has developed a protocol to sample biospecimens from women at increased risk of endometrial cancer. The NCI has conducted a previous study with the proposed contractor to study risk prediction for endometrial cancer using risk factors and molecular markers and has successfully enrolled over 1000 women into that study. The contractor is uniquely qualified to carry out the proposed tasks for several reasons: (1) Mayo Clinic has pioneered the clinical procedures for this type of research and has successfully enrolled a large number of women into a previous study using these approaches. (2) The Mayo Clinic has an established infrastructure for enrolling patients into clinical studies, sampling blood, and sampling tissues, that was successfully used for the previous study. (3) Mayo nurses and clinicians are trained to use the novel sampling approaches previously established. (4) Conducting the procurement in the same population allows to pool data from the same institution, using the same medical records and follow-up strategies. No other site has this experience and it would require a considerable effort to establish these procedures at other sites, furthermore, performing these tasks at a different institution would not allow to accumulate the results with the previous study, severely limiting the scientific output from this effort. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities 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 5:00PM EDT, on Sept. 14, 2017. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@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. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference N02CP72701-76 on all correspondence.
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