Multinational Natural History Study of AFM in Pediatric Patients

Research supported and conducted by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten the health and lives of millions of humans. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, with the exception of the human immunodeficiency virus (HIV). This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics. AFM is a rare but serious condition that affects the nervous system, particularly in the area of the spinal cord, which causes the muscles and reflexes in the body to become weak. AFM has been described as a "polio-like" illness. The U.S. Centers for Disease Control and Prevention (CDC) thinks viruses likely play a role in AFM; however, they have not identified the cause of most of the AFM cases or what triggers this condition. Most cases of AFM occur between August and October. At this same time of year, many viruses commonly circulate, including enteroviruses, and will be temporarily associated with AFM. CDC has seen increases in AFM cases every two years since 2014 and mostly in young children. Additionally, the Public Health England (PHE), the United Kingdom government's executive health agency, is also investigating a sudden unexplained increase in the number of acute flaccid paralysis (AFP) cases, which is similar to AFM, since September 2018. Similarly, health authorities in Peru are investigating cases of AFM and AFP as part of their polio surveillance. It is not known whether the types of cases seen in the U.S. and United Kingdom are similar to those seen in low to moderate income countries. Currently there is no specific treatment for AFM and AFP. The objective of this acquisition is to conduct a natural history study of acute flaccid myelitis (AFM) in pediatric patients in the U.S., United Kingdom, and Peru to coincide with the predicted outbreak cycles beginning in August 2019. Description Under the authority of FAR Part 6.302-1, the NIAID intends to negotiate with the University of Alabama at Birmingham (UAB) on a sole source basis to implement a multicenter, multinational natural history study of AFM in pediatric patients to coincide with this year's outbreak cycle. Specifically, performance of this acquisition will require the Contractor to: - Select and recruit sites/hospitals with a substantial pediatric patient base in the U.S., United Kingdom, and Peru prior to the August 2019 outbreak cycle to implement an approved natural history study of AFM protocol; - Enroll and follow 350 subjects with suspected or confirmed AFM; - Obtain and submit all necessary national and international regulatory approvals for the AFM natural history study; - Complete all site initiation requirements for approving sites and conduct start up activities and training with the investigators on the protocol prior to August 2019; - Coordinate and participate in regular, as well as ad hoc, meetings and teleconferences with all sites, NIAID, and other government partners necessary for conduct of AFM natural history study; - Conduct and/or participate in site visits to oversee subcontracts with the U.S., United Kingdom, and Peruvian sites; - Develop and implement a data sharing plan; - Identify and minimize potential problems and difficulties associated with conducting this study, including those related to recruitment and retention and identify and implement risk mitigation strategies; - Implement data quality assurance processes to ensure data integrity from the study; - Collect, track, and store laboratory samples acquired; - Act as the central statistical and data management center to collect, query and analyze data from the natural history study using approved electronic data collection forms; - Complete all required follow-up visits and procedures for enrolled subjects; - Complete laboratory specimen processing, tracking, testing, analysis, and/or disposition; - Complete final study data set analysis; - Transfer laboratory specimens to a NIAID approved repository; - Complete and submit draft and final clinical study reports; - Submit a copy of the final dataset for the studies to NIAID; - Complete all study close-out activities. This procurement is being conducted in accordance with FAR Part 6.302-1. UAB possesses the facilities, resources, and expertise that make it uniquely qualified to perform this work, and is the only source identified that possesses all the necessary elements to perform the services required by NIAID. This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement. All capability statements received within fifteen days from the date of the publication of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract action 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. This proposed acquisition was previously published under a Research and Development Sources Sought Notice that was posted on the Federal Business Opportunities website on March 7, 2019 as notice number HHS-NIH-NIAID-RDSS-19-NIHAI2019012.