SOLICITATION NOTICE
Q -- "Laboratory Testing Services for ‘Helicobacter pylori infection in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL)’”
- Notice Date
- 8/29/2016
- 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
- N02CP62685-76
- Archive Date
- 9/9/2016
- 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), Metabolic Epidemiology Branch (MEB), plans to procure on a sole source basis laboratory support services to aliquot and test baseline samples related to the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), from the University of Minnesota (UMN), Department of Laboratory Medicine and Pathology, Molecular Diagnostics Laboratory, 515 Delaware Street S.E., 807 Mayo, Minneapolis, MN 55455. 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. 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. MEB's research mission is to define causal relationships between diet, energy balance, hormones, tobacco, and cancer. The MEB conducts interdisciplinary research to understand the role of diet, energy balance, hormones, tobacco, and other exposures in causing and preventing cancer. It studies how these exposures relate to a broad variety of cancers with researchers focusing on breast, colon, endometrium, esophagus, liver, stomach, ovary, pancreas, and prostate. It uses traditional epidemiological methods combined with a variety of molecular methods including genomic analysis, metabolomics, microbiomics, and molecular pathology. Helicobacter pylori infection is the strongest known risk factor for gastric cancer, which disproportionately affects Hispanic populations in the U.S. and Latin America. Hispanics from Mexico and Puerto Rico have gastric cancer incidence rates 2.2 and 3.6 times that of non-Hispanic whites, while Hispanics from South or Central America have rates 4.3 to 5.1 times higher. Findings from NHANES suggest that age-standardized H. pylori seroprevalence remains higher in Mexican Americans than in non-Hispanic whites. Differences in H. pylori seroprevalence are not explained by socioeconomic factors alone and suggest factors such as age at migration to the U.S. and degree of acculturation may influence seropositivity and subsequent gastric cancer risk. Based on questionnaire data and standardized spirometry, the HCHS/SOL study reported that asthma was more prevalent among Puerto Ricans, other Hispanics born in the U.S., and those who had immigrated as children than among other Hispanics (Barr et al.). Previous epidemiologic studies have reported a protective effect of H. pylori infection on development of asthma using self-reported status. Mayerle et al. reported genome-wide associations of high levels of anti-H. pylori antibodies with variants in the toll-like receptor locus at 4p14. Our replication study in the ATBC Study (Sung et al.) confirmed the association with high antibody levels but not with seropositivity overall, supporting a novel interpretation that these variants may be linked to host immune response to H. pylori rather than to acquisition of infection per se. Using available genotyping data (Conomos et al.), the proposed GWAS will help us to identify potential genetic protection in this setting of high H. pylori infection pressure encountered by Hispanic populations. The H. pylori results generated by this service will be used to achieve the following research aims: 1) To determine the seroprevalence of H. pylori infection and its risk factors 2) To evaluate the association between H. pylori infection and spirometric diagnosis of asthma. 3) To conduct a genome-wide association study (GWAS) for anti-H. pylori antibodies Contractor shall perform the following: A. TECHNICAL REQUIREMENTS (non-severable effort): The Contractor will retrieve, aliquot and test 14,975 blood samples for anti-H. pylori antibodies. The sample size includes both study and quality control sets. A blinded quality control set has already been selected by the HCHS/SOL Coordinating Center. B. CONTRACTOR QUALIFICATIONS: The contractor must have current custodial access the HCHS/SOL study samples. The contractor needs to be proficient in ELISA assays as demonstrated by reputation in the field, scientific reports or other evidence of appropriate knowledge and capacity. C. REPORTING AND/OR DELIVERABLES: The contractor will provide every six (6) months cumulative excel files sent electronically to the NCI Contracting Officer's Representative (COR), and a final electronic file (in an accessible format such as xlsx,.dta, or.csv) reporting quantitative levels of immunoglobulin G antibodies against H. pylori to the NCI (COR). D. GOVERNMENT RESPONSIBILITIES: The Government will be responsible for purchasing and providing commercial H. pylori antibody assay kits for this project. E. PERFORMANCE PERIOD: The Period of Performance shall be twenty-four (24) months from the effective date of the order. F. INSPECTION AND ACCEPTANCE: The deliverables defined in section E will be scrutinized and subsequently accepted within 30 days of receipt. The Government will review data for consistency of quality assurance sample measurements prior to final acceptance of delivered data. G. PAYMENT: Payment shall be made in arrears upon receipt and acceptance of each deliverable. Payment authorization requires submission of an invoice per the Invoice & Payment Provision included in the order. This support services are provided by the University of Minnesota. The University of Minnesota is the only known laboratory that can perform all of the technical requirements of the SOW particularly the testing of H. pylori as they are the official custodians of HCHS/SOL samples and no other laboratory has access to these biospecimens. The proposed source is uniquely experienced in running ELISA assays. The MEB has used this laboratory with their specific methods and specimen access for some time for this study. MEB's study is ongoing, and the performance characteristics and quality of the needed services are required for maintaining the integrity of the stated study. A change would be disruptive to the ability to analyze MEB's 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 EDT, on Sept. 8, 2016. 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: N02CP62685-76 on all correspondence.
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