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Abierto

Special notice, 8(a) sole source

Usona

NIMH25008893

National Institutes of Health, National Institutes of Health. Research and Development in Biotechnology (except Nanobiotechnology).

Response deadline

August 9, 2025 at 12:00 PM EDT

Closed 404 days ago. Posted July 25, 2025. Scheduled to archive August 24, 2025.

Description

As published on SAM.gov.

This study is an NIH/NIA–sponsored investigation examining the potential of psilocybin-assisted cognitive training in healthy older adults and individuals with Alzheimer’s disease. Psilocybin is a Schedule I compound that can only be sourced from a limited number of qualified manufacturers authorized to produce it under GMP conditions for human research.

Usona Institute is the only U.S.-based non-profit organization with Drug Enforcement Administration (DEA) licensure, GMP manufacturing capacity, IND-enabling material suitable for NIH-sponsored human trials, and holder of an existing IND, who agrees to allow the NIA to cross-reference it in our own application to the FDA. This purchase supports the primary investigational product required to fulfill the scientific aims of the clinical study.

Publications

Every notice SAM.gov issued under this solicitation number, oldest first. Each is a separate record on SAM.

  1. July 25, 2025

    Special notice

    Due August 9, 2025 at 12:00 PM EDT. SAM.gov, notice 9faf73ba35ab493598a3701a15e642f8

Points of contact