NOTICE OF INTENT to Sole Source.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: NIMH25008893

2. TITLE: This purchase is required for administrative services to allow The Usona Institute to provide administrative support to the NIA towards submitting an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for a clinical trial investigating psilocybin’s effects in aging and Alzheimer’s disease

3. CLASSIFICATION CODE:R499 – SCIENTIFIC CONSULTING SERVICES

4. NAICS CODE: 541714 – Research and Development in Biotechnology

5. RESPONSE DATE: August 9, 2025, at 12:00 PM EST

6. PRIMARY POINT OF CONTACT:

Joe Kennedy Joseph.kennedy@nih.gov Phone: 262-391-7630

7. DESCRIPTION:

INTRODUCTION

This is a notice of intent, not a request for a quotation.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR

OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Mental Health (NIMH) intends to negotiate on a sole source basis with Usona Institute, Inc., for one year.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

and SET ASIDE STATUS The intended procurement is classified under NAICS code 541714 – Research and Development in Biotechnology with a Size Standard of $1000 employees.

This intended procurement will be a small business set-aside requirement.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2025-04, dated May 12, 2025.

DESCRIPTION OF REQUIREMENT

Purchase Description

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.

Specific Requirements

This purchase is required for 1. administrative services to allow The Usona Institute to provide administrative support to the NIA towards submitting an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for a clinical trial investigating psilocybin’s effects in aging and Alzheimer’s disease, including providing their Investigators’ Brochure and a letter allowing the NIA to cross-reference their existing IND; and 2. supply capsules of 25 mg Good Manufacturing Practice (GMP)-grade synthetic psilocybin for use in a clinical trial at the NIA. The clinical trial is called “Neuroplasticity Enhancement from Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer’s Disease” and aims to investigate the effects of psilocybin in healthy older adults and patients with Alzheimer’s Disease. The goal is for the NIA to apply to the FDA for a new IND, cross-referencing Usona’s existing one and acquire a consistent, GMP-grade supply of psilocybin manufactured for clinical use to ensure dosing uniformity, safety, and regulatory compliance throughout the duration of the trial.

Salient Characteristics:

• Must be produced in compliance with Good Manufacturing Practice

(GMP) standards suitable for human clinical trials.

• Dose-specific formulation: 25 mg psilocybin per capsule.

• Must be DEA Schedule I-compliant and labeled appropriately for investigational use.

• Must be manufactured under IND-enabling conditions suitable for FDA-regulated trials.

• Must be chemically stable, properly labeled, and shipped in secure packaging with certificates of analysis and stability data.

• Supply must be batch-consistent for use across all study participants and dosing visits.

• Supplier must be authorized and licensed to produce and ship psilocybin for clinical use in the United States.

Quantity: 80 capsules (40 participants randomized to psilocybin group × 2 doses per participant)

Delivery Date

Within 60 days of receipt of purchase order

Period of Performance

The proposed period of performance shall be one base year.

Base: 9/1/2025 – 9/31/2026

Level of Effort N/A

Government Responsibilities

Reporting Requirements

OTHER CONSIDERARTIONS:

Data Rights

Section 508—Electronic and Information Technology Standards

Confidentiality of Information:

(INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted.

Specifically, Usona Institute, Inc., is the only vendor in the marketplace that can provide the services required by the National Institute of Mental Health.

The intended source is:

Usona Institute Inc.

2881 Woods Hollow Road Fitchburg WI 53711

Brand-name or Items peculiar to one manufacturer:

The essential characteristics of the psilocybin that limit the availability to a sole source are:

• GMP-grade quality manufactured in accordance with IND-enabling FDA standards

• Supported by a Drug Master File (DMF) filed with the FDA

• Suitable for clinical administration in NIH-sponsored human trials Only Usona Institute can furnish this requirement due to its unique regulatory status, manufacturing capability, and willingness to supply GMP-grade psilocybin to NIH for research use, as well as allow the NIA to cross-reference their IND.

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purpose of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID UEI), the Taxpayer Identification Number (TIN), and the certification of business size.

Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH25008893.

Responses must be submitted electronically to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov

U.S. Mail and fax responses will not be accepted.

mailto:joseph.kennedy@nih.gov