Introduction The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases (DMID) has a requirement for a statistical and data coordinating center. Description Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, medical devices and diagnostics, which are funded through a variety of research grants and contracts. The evaluation of new and improved vaccine, device and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of DMID. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center clinical research and Phase 0 through 4 clinical trials evaluating bacterial, viral and parasitic vaccines, therapeutics, and other biologics, drugs, diagnostics, medical devices, and approaches as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories. Support is also provided for a variety of other studies, examples include: targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery. Clinical trials and clinical studies are also supported to evaluate the safety and efficacy of vaccines, medical devices and therapeutics for a wide variety of emerging and re-emerging infectious diseases (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) which includes NIAID Category A-C Priority Pathogens to meet critical public health needs. The contract will provide for the establishment and management of a Statistical and Data Coordinating Center (SDCC) to support DMID's extramural clinical research programs through the provision of: computerized systems for the collection, storage, management, reporting and quality control of study data; preparation of study- related materials; clinical study websites; statistical design and analysis expertise; data management user training; clinical site capability assessment for data management; electronic specimen tracking system; data storage facility; and project/site management. It is anticipated that one (1) cost reimbursement, Level of Effort-type contract will be awarded for a Base year and six (6) one-year term Options, with the period of performance beginning on or about December 31, 2020. It is estimated that 60 Full-Time Equivalents (FTEs)/2080 work hours per year, including subcontractor and consultant personnel, will be required. It is estimated that the Government may exercise options for increased level of effort that may result from unanticipated increases in demand, with the services required under these Options to be of the same scope provided during the base year. Should the Government elect to exercise any of these options, these options may be exercised within the base period (and within each year of the proposed contract), up to a maximum of 60 FTEs using any combination of Options 7 or 8. If the offeror's work-year is less than the 2080 hours, the offeror must understand that it is required to provide the exact number of hours required per year for its proposal to be considered responsive. This information is furnished to offerors for information purposes only and is not to be considered restrictive for proposal purposes. Any responsible offeror may submit a proposal, which will be considered by the Agency. This RFP will be available electronically on/about November 22, 2019 and may be accessed through SAM https://beta.sam.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. The NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."
