277-24-0660_Sole_source_intent_notice.pdf

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-

NAME).

The Substance Abuse and Mental Health Administration (SAMHSA), Division of Contract Management (DCM) on behalf of the Center for Substance Abuse Prevention (CSAP) intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to RADARS/ Rocky Mountain Poison & Drug Safety located at 1391 Speer Boulevard, Suite 600, Denver, CO 80204, to launch a survey focused on tracking the changing motivations and contextual factors associated with the use of psychedelics/hallucinogens.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541690, Other Scientific and Technical Consulting Services with a Size Standard of 19.0 million.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2024-05, effective 05/22/2024.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13— Simplified Acquisition and is not expected to exceed the simplified acquisition threshold.

STATUTORY AUTHORITY FAR 6.302-1

This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

DESCRIPTION OF REQUIREMENT

The determination by the Government to make this a single-sole source requirement is based upon the market research conducted as prescribed in FAR Part 10-Market Research. Market research has determined that only Denver Health’s Rocky Mountain Poison and Drug Safety (RMPDS) data collection system provides a unique set of features essential for performing psychedelic surveillance. RMPDS operates the Researched Abuse Diversion and Addiction Related Surveillance (RADARS) System. RADARS is the only real-world evidence (RWE), multi-perspective, post-marketing surveillance tool available for the assessment of prescription drugs abuse. No other suitable sources are available to provide this specialized technical service that requires specific knowledge and experience of non-medical use of psychoactive drugs including psychedelics/hallucinogens. RADARS has generated expertise on the requirement through previous work with SAMHSA.

Background SAMHSA’s mandate is to reduce the impact of substance abuse and mental illness on America's communities. According to survey research from the National Survey on Drug Use and Health and Monitoring the Future, the expanding use of psychedelics (e.g., hallucinogens) has reached record levels in recent years in the United States, particularly striking increases among young adults. This expanding use is happening in various ways: through indigenous and faith-based settings, underground use in tacitly illegal settings and increasingly in decriminalized contexts in an expanding number of cities and states. Further, increased interest in regulated use within FDA’s Right to Try (signed into law May 30, 2018) and Expanded Access programs under Investigational New Drug (IND) applications as well as an evolving policy shift toward state regulated frameworks (Oregon’s Measure 109, Colorado’s Proposition

122) add to this landscape. This dramatic shift is happening in an environment where the potential therapeutic benefit of these substances has been hyped in the population press. Meanwhile, the FDA is reviewing clinical trials for psilocybin and MDMA for major depression / treatment resistant depression and PTSD, respectively, and both of these drugs received FDA designations as Breakthrough Therapies, and dozens of other clinical trials with psychedelics are being initiated.

Given this recent shift in public perception of these drugs, we need to better understand the context for their use – whether it is intended for therapeutic use (i.e., veterans), spiritual connection directed through indigenous or faith-based ritual, or purely for recreational / well-being. As states move decisively toward decriminalization and/or regulated above-ground use frameworks, we must prepare to monitor the risk environment in order to plan how our public health response can be ready to enact risk mitigation strategies.

While these substances remain Schedule I, with the notable exception of ketamine, under the Controlled Substances Act, SAMHSA’s mandate is to lead public health and service delivery efforts that promote mental health, prevent substance misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes. Within the context of increased national trends around psychedelic use, novel risk reduction strategies are urgently needed as well as focused data collection and surveillance to drive their development.

Oregon and Colorado have become the first two states to initiate regulated use of psilocybin in service centers/healing centers. The Oregon Health Authority (OHA)/Center for Health Protection/Psilocybin Services Section is currently implementing Ballot Measure 109, which passed in November 2020, and requires that OHA license and regulate the cultivation, delivery, sale and administration of psilocybin products. Applications for licensure opened in January 2023 and Oregon is the first state in the nation set up this type of framework for psilocybin. Under Proposition 122, Colorado just passed a similar framework during the 2022 mid-term elections and regulated access begins for psilocybin mushrooms in

2025. Starting in 2026, Colorado will further decide whether to create additional regulated access to DMT, ibogaine and mescaline (excluding peyote). How this complex and rapidly changing political and policy environment impacts changes in intentions, perceptions of risk and risk-taking behaviors is unknown. This data is urgently needed in order design harm mitigation messages and programs.

Current data sources are unable to reflect these dynamic trends in how and why people are using psychedelics/hallucinogens. Neither the NIH Monitoring the Future survey nor SAMHSA’s NSDUH survey are equipped to answer the contextual factors around knowledge, intentions and practices of use surrounding psychedelics. Given this dearth of critical and urgently needed data for targeted program strategies, new data instruments are necessary. Such data collection tools must be validated through evidence-based pre-testing that includes content validity.

Purpose and Objectives The purpose of this Purchase Order (PO) is to provide professional services with the necessary knowledge, skills, and relevant specialized experience to launch a survey focused on tracking the changing motivations and contextual factors associated with the use of psychedelics/hallucinogens.

The objectives of this purchase order are to: launch a self-administered, cross-sectional survey tool focused on psychedelic use. This tool may be used to monitor long term trends in psychedelic use with an eye towards providing analysis at multiple levels including local, state, and national trends. To accomplish this goal, the project is divided into three specific aims.

1. Administer a nationally representative survey, over one year, to a minimum of 6,000 individual respondents and provide prevalence data assessing psychedelic use in the United States. Note:

CO and OR data should be additionally monitored for new trends and combined if quantitative enrichment is necessary to establish statistically significant comparison power.

2. Continue survey refinement by reducing bias in survey estimates, conducting validation testing, and addressing underdeveloped content in pilot data collection tool.

3. Assess the effects of psychedelics on mental health through triangulation of survey data with non-user data from other national surveys.

Anticipated Period of Performance Base Year: 12 Months from contract award

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. 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 SAM Unique Entity ID

(UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management

(SAM).

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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by 08/06/2024 at 12:00pm EST and must reference solicitation number 277-24-0660 on your electronic request.

Responses must be submitted electronically to arun.mathur@samhsa.hhs.gov

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

mailto:arun.mathur@samhsa.hhs.gov