SOLICITATION NOTICE
Q -- Laboratory Services for HDV antibody (anti-HDV), RNA and genotype testing
- Notice Date
- 3/10/2017
- 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
- N02CP79999-76
- Archive Date
- 3/21/2017
- 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), Division of Cancer Epidemiology and Genetics (DCEG), Infections and Immunoepidemiology Branch (IIB), plans to procure on a sole source basis the services for HDV antibody (anti-HDV), RNA and genotype testing from the Center for Hepatitis and Liver Tissue Engineering at Stanford University School of Medicine 269 Campus Drive, Stanford, CA 94305-5171, U.S.A. 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, Indefinite Delivery Indefinite Quantity (IDIQ) type contract. The period of performance of the IDIQ contract is thirty-six (36) 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 a research program of the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). The Division is the world's most comprehensive cancer epidemiology research group. Its renowned epidemiologists, geneticists, and biostatisticians conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The Division's research impacts public health policy in the United States and around the world. Investigators in the Infections and Immunoepidemiology Branch (IIB) conduct multidisciplinary studies of carefully selected domestic and foreign populations, with the goal of clarifying the relationship of infectious agents, especially viruses, to human cancer and other conditions. IIB's research mission is to discover infectious causes of cancer, to elucidate the determinants of malignancy for established oncogenic infections, to uncover novel infection-cancer associations, and to clarify how alterations in immunity and inflammation relate to cancer risk. IIB investigators collaborate with researchers from a variety of disciplines in the U.S. and abroad. In addition to epidemiologic and clinical data, many IIB field studies include an extensive biological specimen collection component that allows for careful molecular testing to better define both exposures and outcomes of interest. The purpose of this procurement is to provide HDV antibody (anti-HDV), RNA and genotype testing. Hepatitis D virus (HDV) infection can cause liver cancer, as well as hepatic cirrhosis and end-stage liver disease. The National Cancer Institute (NCI) Division of Cancer Epidemiology and Genetics is conducting a study to evaluate the contribution of HDV to the risk of liver cancer in The Gambia and a study of the prevalence of HDV among injection drug users in the San Francisco Bay area. Contractor shall perform the following: Contract requirements and deliverables The Contractor shall deliver the following data derived from the tests enumerated below. The data shall be received in an Excel document and delivered via email to the NCI Technical Point of Contact The tests will be performed in the order stated below and delivered respectively to the NCI Technical Point of Contact. The NCI Technical Point of Contact will be in contact with the lab throughout the testing process and will receive monthly email reports from the Contractor. The testing will occur as soon as the Contractor receives the samples and it will take three (3) months to complete each type of test. 1) Results for HDV antibody (anti-HDV) testing 2) Results for HDV RNA testing. All samples (excluding replicates) that test positive for anti-HDV will be tested for HDV RNA. For this work, RNA will be extracted from plasma or serum samples and HDV RNA will be detected by real time PCR. 3) Results for HDV genotype testing. From among specimens from The Gambia Liver Cancer study that test positive for HDV RNA and have sufficient remaining RNA for this testing, NCI will randomly select 20 samples to be tested for HDV genotype. For this work, HDV genotype will be determined by viral sequencing. This work may require developing PCR primers that are specific for HDV strains found in Africa. Government Responsibilities The Government will notify the Contractor prior to shipment of specimens so that the recipient will be available to receive the shipment. Period of Performance The period of performance will be a thirty-six (36) months from initiation of the IDIQ contract. Inspection and Acceptance The reports defined in section C will be scrutinized and subsequently accepted within 30 days of receipt. Payment The number of samples will be indefinite delivery indefinite quantity (IDIQ). The minimum quantity is one (1) of the HDV Anti-HDV testing, the minimum quantity is one (1) of the HDV RNA testing, and the minimum quantity is one (1) of the HDV Genotype testing, and the maximum quantity is six hundred seventy-five (675) of the HDV Anti-HDV testing, the maximum quantity is one hundred seventy-five (175) of the HDV RNA testing, and the maximum quantity is thirty (30) of the HDV Genotype testing during the period of performance of the IDIQ contract. Payment will occur at the ordering level and will be made in arrears after receipt and acceptance of requested tasks for each task order. This laboratory testing services are provided by the Center for Hepatitis and Liver Tissue Engineering at Stanford University School of Medicine. The volume of archived specimen available for this testing is limited. To minimize the amount of specimen required for the testing, all testing needs to be performed in a single laboratory capable of performing all testing required. Doing so will ensure the study is conducted in a timely fashion. The Center for Hepatitis and Liver Tissue Engineering at Stanford Medical School is uniquely qualified to provide these required services because of its expertise and capacity to perform all three tests that are required for this study (HDV antibody, HDV RNA and HDV genotyping). Dr. Jeffrey Glenn, who is the Director of the Center, has worked on HDV for more than 20 years and his laboratory has extensive experience in developing quantitative viral assays for HDV, as well as assays for HDV genotyping. While there are three (3) known commercial laboratories located in the United States that perform testing for HDV, none perform HDV genotyping. Thus, there is no other known qualified vendor with the ability to perform all required work in the Statement of Work. The IIB's study is ongoing, and the performance characteristics and quality of the needed services are required for maintaining the integrity of the on-going study. A change would be disruptive to the ability to analyze cumulative results. 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 12:00PM EST, on March 20, 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: N02CP79999-76 on all correspondence.
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