COVID-19 MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (MIS-C) PILOT PROJECT

The Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to extend at no additional cost for 9 months on a sole source basis, under the authority of 41 U.S.C. 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements, a COVID-19 project to complete the Multi-Inflammatory Syndrome in Children (MIS-C) Data Platform Pilot project - COVID-19 Related Action that is currently being performed under the Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) existing contract with EMMES Corporation, Inc., Rockville, MD. The EMMES Company, LLC currently serves as the DCC for the BPCA Clinical program and provides data coordinating and management services in support of ongoing BPCA Phase 1-3 pediatric clinical trial activities. EMMES has developed an electronic data capture system (EDC) that serves as the data HUB of clinical trials conducted by the Pediatric Trials Network (PTN). As the DCC, EMMES provides statistical and regulatory expertise to the BPCA clinical program and conducts the review of all study data for quality, conducts data analyses, and ultimately submits study reports to the FDA for potential label change of drugs studied in the BPCA program. The PTN is currently performing studies under one of its standard studies called the Pediatric Opportunistic Pharmacology of Understudied Drugs Study (POPS) that include drug and clinical data for patients affected and infected by SARS-CoV-2 virus and subsequent COVID-19 disease. In August of 2020, as a response to the syndrome identified in children termed Multi Inflammatory Syndrome in Children (MIS-C) associated with COVID-19, the NICHD had the urgent requirement to conduct research efforts in collaboration with other NIH Institutes to identify, prevent, treat and follow pediatric patients affected by MIS-C. To accelerate these efforts in response and recovery to the national emergency created by the COVID-19 pandemic, a modification to the existing BPCA DCC contract was processed to leverage the expertise and MIS-C data collected within the BPCA DCC infrastructure to implement the necessary services of managing, directing and coordinating the submission of all clinical data from BPCA Clinical Program into the MIS-C Project as mandated by NICHD policies and procedures for all sponsored research. This proposed modification is to extend the end date of the - COVID-19 / MIS-C Project incorporated as part of the contract number HHSN275201700002C "BPCA Data Coordinating Center" for a period of nine months from September 23, 2021, to June 23, 2022. The initial period of performance of the COVID-19/MIS-C Project was for 12 months. The objective of this project has been to make data collected under an ongoing BPCA study (POP02) that is enrolling pediatric participants with suspected or confirmed diagnoses of MIS-C and SARS-CoV-2 available to the public via NIH data sharing platforms including the Kids First Data Resource, BioData Catalyst, and Imm Port. With the continuation of COVID-19 pandemic, a large number of children are testing positive for SARS CoV-2 and being diagnosed with MIS-C. Data from CDC show that during the week of August 12 -19, 2021, 22.4% of new cases were in children. Thus, data collection of new cases of MIS-C and SARS-CoV-2 positive patients has unexpectedly continued beyond the original targeted end date of this project. Extending the project end date will allow NICHD to acquire and share data from this important population under the BPCA program via the NIH data sharing platforms. This is crucial to successfully, succinctly, and efficiently accelerate MIS-C research to enhance new discoveries and the development of treatments. The work is essential to the success of the entire MIS-C data platform program and congruent with the current services provided by the EMMES Corporation under the BPCA DCC contract. No additional funding will be required. EMMES is providing the expertise and managing, directing and coordinating the submission of all clinical data from BPCA Clinical Program into the MIS-C Project. It is critical that these essential services and data coordination not be interrupted, as this operation is vital to the success of the MIS-C and SARS-CoV-2 project. Interrupting and failing to complete this pilot program and services would result in unacceptable delays in fulfilling this NICHD initiative in support of the COVID-19 recovery efforts. Therefore, NICHD intends to continue and finalize this pilot project with EMMES as a single sole source at no additional cost for 9 additional months until June 23, 2022, in order to reach its important goal of sharing this data and piloting this data via the NIH data sharing platforms from its pediatric clinical trials of the Multi-Inflammatory Syndrome in Children and SARS-CoV-2 trials in children. There will not be a solicitation or Request for Proposals (RFP) issued. Any responses or inquiries to this notice must demonstrate clear and convincing evidence that competition will be advantageous to the Government. All information received from this notice shall be used for planning and market research purposes only. The determination to refrain from competing proposed contracts based on responses to this notice is solely within the discretion of the Government. The Government will not pay for the preparation of any information submitted or use of such information. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the evaluation of the information received. Interested parties may respond and provide a capability statement no later than 12:00 p.m. EST, September 23, 2021, via email to Elizabeth Osinski, Contracting Officer, at elizabeth.osinski@nih.gov and Alice Pag'n, Contracting Officer, at alice.pagan@nih.gov.