analysis of the genetic variants associated with persistence of hepatitis B virus among Alaska Natives

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to ALASKA NATIVE TRIBAL HEALTH CONSORTIUM for the analysis of the genetic variants associated with persistence of hepatitis B virus among Alaska Natives. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 with a Size Standard of $16.50. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2020-07 effective August 31, 2020. This acquisition is conducted under the procedures as prescribed in FAR subpart 13'Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13'Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6'Competition Requirements. BACKGROUND The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. The Institute's Division of Intramural Research encompasses the broad spectrum of metabolic diseases such as diabetes, obesity, inborn errors of metabolism, endocrine disorders, mineral metabolism, digestive and liver diseases, nutrition, urology and renal disease, and hematology. Basic research studies include biochemistry, biophysics, nutrition, pathology, histochemistry, bioorganic chemistry, physical chemistry, chemical and molecular biology, and pharmacology. NIDDK extramural research is organized into 4 divisions: Diabetes, Endocrinology, and Metabolic Diseases; Digestive Diseases and Nutrition; Kidney, Urologic, and Hematologic Diseases; and Extramural Activities. The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts. ? PURPOSE AND OBJECTIVES Despite the availability of an effective vaccine, chronic hepatitis B (CHB) remains a substantial public health problem with health disparities. Globally, there are an estimated 257 million persons with chronic hepatitis B virus (HBV) infection accounting for over 887,000 deaths annually primarily from complications of cirrhosis and hepatocellular carcinoma (HCC). Indeed, chronic HBV and hepatitis C virus infections now rank as the leading infectious cause of death worldwide surpassing malaria, tuberculosis and cholera. Within the U.S., Asian Americans and Alaskan Natives are disproportionately affected by CHB. There is currently no curative therapy for CHB due to the persistence of episomal DNA (covalently closed circular DNA) in the hepatocyte nucleus. The presence of hepatitis B surface antigen (HBsAg) in serum for a period or 6 months or longer is the defining feature of CHB. Clearance of HBsAg is associated with improvement in outcome (lower rates of cirrhosis, hepatocellular carcinoma and liver-related death) but is rarely achieved. Spontaneous- or treatment-related HBsAg loss occurs at a rate of 0.5-1% per year. HBsAg loss or functional cure is the endpoint of novel treatments in development for chronic hepatitis B. Therefore, it is critical to identify factors that influence the rate of HBsAg loss. Factors that have been shown to be associated with HBsAg loss include older age, male gender, non-Asian race and lower levels of HBsAg in serum. As a viral infection it is highly likely that host genetic variants can modify the course of the infection including its persistence. Indeed, genome wide association studies (GWASs) have identified single nucleotide polymorphisms (SNPs) at eleven loci linking genetic susceptibility to persistent HBV infection in populations of Asian ancestry (Chinese, Japanese and Korean). However, it is unknown whether the genetic differences identified in East Asian populations are relevant to other populations with CHB. A thorough assessment of candidate genetic markers between Asian and Alaskan Native populations, an ethnically homogenous population, would address this issue. Among the U.S. population, the Alaskan Native population is at increased risk for complications of CHB and disproportionately affected by HCC. Our collaborator, Dr. Brian McMahon has prospectively followed a cohort of >1500 Alaskan Natives with CHB over 4 decades and carefully documented and recorded outcomes of the cohort including HBsAg loss. Approximately 250 subjects have spontaneously cleared HBsAg, the marker of disease resolution. A candidate gene analysis of Alaskan Natives with CHB will inform whether there is a genetic contribution to HBsAg loss among this population. Further comparisons will be conducted among East Asian and European populations with CHB to understand if there are racial differences in viral persistence. We will integrate clinical and virological data with the results of the genetic analysis to develop risk models to predict HBsAg loss. The overarching goals of the research are to improve understanding of the pathogenesis of CHB, improve risk stratification models for clearance of HBsAg, and ultimately a personalized management approach to improve health disparities which will translate to lower health care costs and improved patient outcomes of CHB. Specifically, the NIDDK requires the following: Task Area 1 - The contractor will amend an existing protocol to allow for the collection of genetic material using saliva and whole blood samples from Alaska Natives with chronic hepatitis B and provide those samples to the Liver Diseases Branch (LDB) at NIDDK. Task Area 2 - The contractor will generate a de-identified list of potential participants who are infected with hepatitis B who are consented to their long-term natural history study and provide accompanying demographic, laboratory and outcome data to NIDDK/LDB. The data will be in a common electronic format e.g. Excel spreadsheet numbers. Task Area 3 - NIDDK/LDB will utilize the clinical data to complement the data generated from the candidate gene analysis on the DNA samples provided by the contractor at a later date. Given the complexity of the analysis, the interpretation of the results of these analyses may not be straightforward. It is expected that a collaborator and the contractor will provide the expertise to aid in the interpretation, for example, by reviewing analytic plans, tables of results and drafts of manuscripts or other research reports. Our collaborator may also facilitate the comparison of results with those from other populations (e.g. East Asian and European) and suggest alternate analytic strategies. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10'Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined ALASKA NATIVE TRIBAL HEALTH CONSORTIUM to be the only reasonably available source to provide the analysis of genetic variants associated with persistence of hepatitis B virus among Alaska Natives the NIDDK requires. Dr. McMahon has conducted the only prospective natural history study of Alaskan Natives with chronic hepatitis B and has access to the clinical and outcome data of this cohort that is essential to complement the genetic analysis. The size of the state, the remoteness of the villages where the population resides and the time required (40-50 years of follow-up) to assemble a similar cohort of Alaskan Natives with chronic hepatitis B, were viewed as insurmountable barriers to conducting the research if another source had to start afresh. PERIOD OF PERFORMANCE 9/21/2020 - 9/20/2021 Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda MD 20814 CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. - All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Tuesday, September 15, 2020 to the Contract Specialist, Amber Harris, at contact@example.gov . Assessment of Capability Lowest Price Technically Acceptable