SOLICITATION NOTICE
Q -- Procurement of Biosamples for the Analysis of the Gut Microbiome in Patients with Hepatocellular Carcinoma
- Notice Date
- 7/21/2017
- 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
- N02RC72594-76
- Archive Date
- 8/1/2017
- 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, UNITED STATES. Description: National Cancer Institute (NCI), Center for Cancer Research (CCR), Thoracic and GI Oncology Branch, GI Tumor Section, plans to procure on a sole source basis biosample collection services from the Icahn School of Medicine at Mount Sinai; One Gutave L. Levy Place, Box 1104; New York, NY 10029. 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 thirteen (13) months from the date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Thoracic and Gastrointestinal (GI) Oncology Branch (TGIB) was established to integrate and synergize multidisciplinary clinical and basic research pertaining to cancers of the lungs and airways, chest cavity (thorax), and gastrointestinal tract. Our team approach to thoracic and gastrointestinal malignancies is designed to hasten the development of novel treatments for a wide range of cancers that affect more than a half million patients per year. These include, but are not limited to, cancers of the lung, thymus, pleura and chest wall, esophagus, stomach, liver, bile ducts, pancreas and intestines. The TGIB is a large branch of NCI that spans the spectrum of basic research, clinical trials and patient care all aimed at better detection, prevention and treatment of patients with these cancers. The TGIB is studying pathogenesis of hepatocellular carcinoma and develops novel treatment options for patients with cancer. There is accumulating data that the gut microbiome may affect anti-tumor immunity. Commensal gut microbiota play an important role in inflammation and cancer. The human gut flora consists of approximately 100 trillion microbial cells which their disruption leads to many diseases including inflammatory bowel disease and colorectal cancer to name a few. Recent studies have shown that cancer patients have an altered gut flora when compared to healthy controls. Intestinal microbiota have been proposed to contribute to the start and progression of a number of liver diseases, such as alcoholic liver disease (ALD), non-alcoholic steatohepatitis (NASH), liver cirrhosis, hepatic encephalopathy (HE), and hepatocellular carcinoma (HCC). It has also been shown in mice that gut microbiota can change the response to cancer as well as anti-cancer therapy through modulating the tumor microenvironment. Human tumor, blood, urine and stool samples are essential to perform laboratory studies with the aim to better understand how the microbiome affects anti-tumor immunity in patients with liver cancer. Most patients with HCC are diagnosed with advanced disease and do not undergo surgical resection. The specific aims of this project are to perform analysis of the interaction of tumors, immune responses and the gut microbiome; to identity novel mechanisms how tumors may affect immune responses and gut microbiota, and to study how the microbiome may influence patients' clinical outcome. Contractor shall perform the following: SCOPE Patients undergoing surgery for primary liver tumors shall be identified. In order to assess the changes in microbiome over time in these patients, blood, stool, urine and tumor samples shall be taken and sent to the NCI, via coordination with the NCI Technical Point of Contact. The following samples and information shall be provided: • Blood, stool, urine and tumor samples shall be collected from no less than fifty (50) consenting subjects at the initial visit and at follow-up visits, if and as they occur. • Tumor samples shall only be obtained from patients undergoing surgery. • Patients shall be asked to answer questionnaires. • Ship samples to the NCI via the coordination with the NCI Technical Point of Contact identified in the order. Samples will be shipped frozen on dry ice and provide a specimen manifest in the shipment. The Contractor shall provide to the NCI Technical Point of Contact any issues with samples and will inform the NCI Technical Point of Contact if samples from subjects are not available in order to determine if replacement subjects are needed. • In addition, a clinical trial protocol shall be submitted and/or amended to local IRB and the patient consent form will be translated into Chinese and Spanish so that non English speaking patients may enroll into this study, since Mount Sinai has a relatively large Chinese patient population with HCC. This will facilitate rapid acquisition of patient samples. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS Our contract follows the Protocol #16-CN-012 B. This protocol is followed by both groups at Mount Sinai as well as at the NCI and both centers will adhere to the protocol. PLACE OF PERFORMANCE National Institutes of Health, National Cancer Institute Bldg 10 Rm 3B43 Bethesda MD 20892 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE Samples will be collected at Mt Sinai and sent in batches upon enrollment of patients on the study to the NCI via coordination with the NCI Technical Point of Contact. The deliverables defined above will be scrutinized and subsequently accepted by the NCI Technical Point of Contact within 30 days of receipt. PAYMENT 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. This support services are provided by the Icahn School of Medicine at Mount Sinai. The required technical requirements can only be completed by the proposed source since it is uniquely positioned as a center with the highest numbers of surgical resections of HCC amongst a very small number of patients in the U.S. that undergo HCC surgical resections. Other medical centers with such patient load are all outside of the U.S. (mainly China) however, do not represent the same patient population the GI Tumor Section sees at the NIH Clinical Center in Bethesda. Therefore, there is no known alternative to the proposed source for fulfilling the technical requirements of this procurement. 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 12:30PM EDT, on July 31, 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: N02RC72594-76 on all correspondence.
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