277-23-0646 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 Office of Prevention Innovation and Division of Workplace Programs intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to Rocky Mountain Poison & Drug Safety located at 1391 Speer Boulevard, Suite 600, Denver, CO 80204, for professional services that have a working knowledge, skills, and relevant experience to develop a tool for a Psychedelic Online Motivations & Contextual Use Survey (POMCUS).

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541990, All Other Professional, Scientific, And Technical Services with a Size Standard of 19.5 million.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-04, effective 06/02/2023.

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 of $250,000.00.

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. The results of the market research concluded that The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System stood out as the only mosaic approach, within Colorado or Oregon, that captures data from multiple sources (e.g., Poison Control Centers, National Surveys, Darkweb, Drug User Forums, Street Sales, etc.) to create a more complete picture of drug abuse patterns. The unique features of the RADARS System include product- and geographic-specificity, and data are available near-real-time (typically available within 6 months of the end of quarter).

RADARS is a leading non-governmental surveillance contractor for non-medical drug use surveys.

RADARS is the only national non-governmental entity with a non-medical drug use survey comparable in size to that of SAMHSA’s NSDUH survey (I.e., greater than 50,000 respondents). They are the optimal organization, uniquely positioned in Colorado, with connection to all critical stakeholders needed to effectively develop a survey for data collection and harm reduction efforts. Market research found out that no other entity, situated in Colorado or Oregon, has resources like RADARS to complete the work.

Thus, the proposed source is the only company that can meet the Government’s requirement.

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 in Households and Monitoring the Future there is expanding use of psychedelics (e.g., hallucinogens) to 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 but also increasingly in decriminalized contexts in an increasing 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 of rising 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 potentials of these drugs for therapeutic benefit and well-being has been hyped in the population press, while the FDA reviews 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. And as states are moving 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 readied 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 harm reduction strategies are urgently needed as well as focused data collection/surveillance to drive their development.

Oregon and Colorado have become the first two states to decriminalize personal use of hallucinogenic plants, while moving rapidly toward legalization and licensure of regulated use 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 2024.

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 and perceptions of risk and risk-taking behaviors is unknown and 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 must be specifically designed, validated and pre-tested.

Purpose and Objectives The purpose of this Purchase Order (PO) is to provide professional services that have a working knowledge, skills, and relevant specialized experience to develop, validate, pilot and 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: Develop, test, and inaugurate 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) A questionnaire will be developed by experts addressing the various contextual and motivational domains of psychedelic drug use.

2) The questionnaire will be validated using participants and probing questions.

3) Pre-testing/piloting should be conducted among Colorado and/or Oregon populations.

Scope Of Work As Oregon became the first state to legalize regulated adult use of psilocybin, with Colorado beginning similar services in 2024 and a dozen states moving towards accelerated and expanded access programs, there is a need for survey development from the Contractor.

Study Design & Content Validity Questionnaire Development - The Contractor will design the study and develop the content validity questionnaire. The Contractor will work collaboratively with SAMHSA and advisors and seek input from them on question development and study design. This work will include performing validity with focus groups recruited from Colorado. This also allows the Contractor to study the Colorado setting in detail, which may be a precursor to national trends since psychedelic possession has been decriminalized and state licensed healing centers are being authorized to administer natural medicines in Colorado. Focus groups in Oregon should also be considered.

No later than one (1) business day before the PO kick-off meeting, the Contractor shall submit one (1) draft Work Plan of task activities to the COR for discussion. The Contractor shall review the preliminary draft Work Plan with the COR as needed, by phone or email, and make revision as requested by the

COR.

All work under this purchase order will be monitored by the Contracting Officer’s Representative (COR).

Contract Requirements There is an urgent need for a Contractor to develop a context-of-use based psychedelic survey to compile data, tools and lived experience to inform the development of relevant resources and strategies for harm reduction.

1) A survey tool addressing the use and contextual factors surrounding the use of psychedelics (with methodology) will be developed by experts addressing the various motivational domains of psychedelic drug use. Illustrative questionnaire examples may include the following questions:

Detailing how, where and why the general population uses different psychedelics, including frequency and source

a. What is the interface between pharmaceutical and illicit psychedelic use?

b. Are there perceived barriers to psychedelic therapy access?

c. What adverse events or risks are observed in the broader community?

d. What are the psychedelic users’ perceived benefits?

e. What factors, like setting, affect perceived efficacy?

f. Has state de-criminalization or legislation surrounding regulated use of psychedelics impacted

Tribal Communities either directly or indirectly?

Demographic factors will be needed for disaggregation of the data to understand context of use;

meaning, to understand how to develop appropriate harm reduction strategies.

2) The questionnaire will be validated using participants and probing questions.

Focus groups and interviews with key populations (e.g., veterans, youth, educational levels, etc) to determine if they understand the language used in the survey tool will be conducted. The specificity of the tool will be validated through these qualitative methods. Different ethnographic considerations will need to be part of the validation process to ensure different audiences understand the questions.

3) Pre-testing/piloting should be conducted among Colorado and/or Oregon populations.

Pilot testing should be ideally collected in both states and further validated through populations in these geographic areas. Validation within Oregon and Colorado versus other states will be conducted in order to make comparisons across states. Data from this pilot testing should be compiled, analyzed, and reported with key stakeholders in order to have a baseline understanding of the preliminary results.

These analyses will be documented and can be used to disseminate the methodology through the scientific forum. Defining methodology will be imperative to continued application in these settings as well as for potential regional/national assessments in the future.

Following the PO kick-off meeting, the Contractor shall provide quarterly updates via formal virtual meeting forums with SAMHSA. This will allow for collaborative input from SAMHSA as questionnaire domains are developed and subsequently pilot tested. Prior to the Contractor’s completion of work, a formal PO close-out report shall be submitted to SAMHSA. To ensure the collection and analysis of the survey data are consistent with appropriate survey administration, analysis, and reporting practices, raw data sets should be made available to SAMHSA.

Anticipated Period of Performance Base Year: September 2023 - August 2024

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 07/31/2023 at 10:00 AM EST and must reference solicitation number 277-23-0646 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