ToxIC Registry Online Access/ COVID-19 Sub-Registries

The Food and Drug Administration intends to award a modification to continue to obtain access to real world drug adverse event and product toxicity data that may result from prescribed drug therapy, off-label drug use or intentional overdose with the objective of supporting the agency’s public health surveillance activities. The award will be made to: The American College of Medical Toxicology (ACMT) 1901 N Roselle RD STE 920 Schaumburg, Illinois 60195-3187, United States In accordance with FAR 6.302-1 the solicitation contains circumstances permitting other than full and open competition. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within 4 days after the publication of this synopsis which shall be considered by the agency. Responses received after 4 days or without the required information may not be considered. For information concerning this proposed modification: 1) Provide access to the ToxIC Registry and licenses for a minimum of eight (8) FDA/CDER reviewers. 2) Access to the COVID-19 Sub-registry for safety data related to drug therapies used in or by patients with COVID-19 or as prophylactic therapy to prevent COVID-19. Kimberly DeLong Contracting Officer [email protected]