Multinational Natural History Study of AFM in Pediatric Patients

Introduction This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources, including small and small disadvantaged businesses, to perform a potential R&D requirement. Background 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. Purpose and Objectives The purpose of this R&D Sources Sought Notice is to discern whether or not there are potential sources, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP) if deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID's use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. 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. 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. Project requirements This project is to implement a multicenter, multinational natural history study of AFM in pediatric patients to coincide with this year's outbreak cycle. An approved natural history study of AFM protocol will encompass sites in the U.S., United Kingdom, and Peru. 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. Anticipated period of performance This work is anticipated to start on August 1, 2019 and will complete on March 20, 2022. Other important considerations N/A Capability Statement / Information Sought Tailored Capability Statements submitted as a result of this announcement should demonstrate the offerors' experience, qualifications, and facilities, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following areas: 1) Documented access and relationship to at least 30 hospital sites with a substantial pediatric patient base in the U.S., United Kingdom, and Peru at time of award for the implementation of a natural history study of AFM protocol and have documented experience collaborating in multicenter infectious disease clinical studies or trials; 2) Documented experience in successfully enrolling large multinational natural history studies or clinical trials in hospitalized pediatric patients with rare or emerging viral diseases; 3) Documented evidence of successfully conducting and completing multicenter, multinational clinical trials/studies for rare and/or emerging viral diseases in pediatric subjects; 4) Documented experience in submitting and obtaining timely regulatory approvals in the U.S., United Kingdom, and Peru; 5) Documented experience in serving as a statistical and data collection center with documented evidence of adherence to high-quality data management practices and the production of high-quality clinical study reports and datasets; 6) Documented experience as a central laboratory facility for the collection, tracking, and analysis of clinical samples from multicenter studies, including experience collecting samples from domestic and international sites; 7) Documented experience in successfully processing, tracking, and analyzing clinical samples that may be of limited quantity; 8) Documented experience with establishing quality management plans for conduct of multicenter studies. Interested offerors must submit a capability statement (five-page limitation, excluding resumes), which must include the following: a. Organization name, address, and Point of Contact, DUNS #, and type of company (such as, large business, non-profit, educational institute, small business, 8(a), woman-owned, etc); b. A summary list of similar work previously performed as described in items 1-8 above; c. Professional qualifications and specific experience of proposed staff; d. Resumes for proposed key personnel, including the Principal Investigator/co-PI, reflecting education and previous work relevant to the proposed requirement; e. A general description of the facilities and other resources needed to perform the work; f. Demonstrated ability to carry out the work. Responses must be submitted no later than March 22, 2019, 3:00 PM ET. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via e-mail) to Swee L. Teo, Contracting Officer, at teosl@niaid.nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify HHS-NIH-NIAID-RDSS-19- NIHAI2019012. Facsimile responses will not be accepted. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.