75N95022R00003_Q and A Document.pdf

This document provides details on a pre-solicitation notice for a Pharmacology and Toxicology for Therapeutics Program contract opportunity. The National Institute of Neurological Disorders and Stroke and the NIH Blueprint Neurotherapeutics Network have established a program to enable therapeutic development in the NIH research community. The goal of the contract is to assess the pharmacokinetics, toxicology, and safety of promising therapeutic candidates to support their eventual use. Services may include analytical method development and validation, in vivo pharmacokinetic studies, acute and long-term toxicity evaluations, safety pharmacology studies, and in vitro predictive ADME/TOX assays. Non-GLP services are required for up to 10 projects per year in lead optimization, and GLP IND-enabling toxicology services are required for up to 5 projects annually. Offerors must have a GLP-compliant facility, AAALAC accreditation, an animal welfare assurance, and the ability to conduct studies in rodents, dogs, rabbits, and non-human primates. The solicitation will be available on SAM.gov approximately 15 days after this pre-solicitation notice. The Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse will issue the award.