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Special Notice 8AN Expired 1 notice 1 document

Usona NIMH25008893

Solicitation NIMH25008893 Copied Notice ID 9faf73ba35ab493598a3701a15e642f8 Copied HEALTH AND HUMAN SERVICES, DEPARTMENT OF — NATIONAL INSTITUTES OF HEALTH
SAM.gov
Posted
Jul 25, 2025
Deadline
Aug 09, 2025
Set-aside
8AN
NAICS
541714
PSC
R499

Summary

AI-generated · Aug 24, 2025

procure the primary investigational product psilocybin for an NIH/NIA-sponsored study evaluating psilocybin-assisted cognitive training in healthy older adults and individuals with Alzheimer's disease. Psilocybin is a Schedule I compound and must be sourced from a limited number of qualified manufacturers under GMP conditions for human research.

Usona Institute is the only U.S.-based nonprofit with DEA licensure, GMP manufacturing capacity, IND-enabling material suitable for NIH-sponsored human trials, and an existing IND, and will allow NIA to cross-reference its IND in FDA submissions. This purchase supports the primary investigational product required to fulfill the study’s scientific aims.

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.

From Special Notice posted on Jul 25, 2025

Notice history

1
  1. Special Notice LATEST Posted Jul 25, 2025

Details

Solicitation number NIMH25008893
Notice ID 9faf73ba35ab493598a3701a15e642f8
Notice type Special Notice
Product / Service (PSC) R499
NAICS 541714
Set-aside 8(a) Sole Source
Place of performance Bethesda, Maryland
Archive date Aug 24, 2025

Award Information

Not yet awarded

Documents

1
View on SAM.gov

Contacts

primary
Joseph Kennedy

Email

Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF
NATIONAL INSTITUTES OF HEALTH

Place of Performance

Bethesda, Maryland 20892
USA

Dates

Posted Jul 25, 2025 1 year ago
Last Updated Aug 06, 2026 1 day ago
Due Aug 09, 2025 11 months ago