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 Oregon Health and Science University (OHSU) located at 3181 SW Sam Jackson Park Rd, Portland, Oregon 97239, for professional services to build data and resources for harm reduction within the expanding psilocybin context of Measure 109 rollout in Oregon.

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.

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 OHSU is the leading medical training institution in Oregon. They have already generated expertise on data measurement and collaboration for psilocybin access through previous work with SAMHSA. As the only medical research and training site in Oregon that addresses psychedelics, they are uniquely positioned to collect and analyze data for harm reduction programming for psilocybin in alignment with the Oregon Health Authority.

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 (NSDUHMF) there is expanding use of psychedelics (e.g., hallucinogens) to record levels in the United States, particularly striking 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 state-regulated frameworks, such as Oregon’s Measure 109. This is occurring while the FDA reviews clinical trials for psilocybin and Methylenedioxymethamphetamine (MDMA) for major depression / treatment resistant depression and PTSD, respectively, which have both received FDA designations as Breakthrough Therapies. In this rapidly changing policy and use environment, local, state, and federal governments are looking for guidance – for public health programming, for prevention, and risk reduction, as well as thoughtful consideration of care models as states expand access through research and expanded access legislation.

Oregon Measure 109 (now codified as ORS 475A), was passed in November 2020 and directs the Oregon Health Authority (OHA) to license and regulate the manufacturing, transportation, delivery, sale, and purchase of psilocybin products and the provision of psilocybin services. The Oregon Psilocybin Services Section began accepting applications for 4 licensure categories (facilitators, service centers, manufacturers, and testing labs) on January 2, 2023, and the first psilocybin services center was licensed by OHA in May 2023. Additional psilocybin service centers are awaiting application approval by OHA, and licensed facilitators and centers are expected to begin offering psilocybin services to clients by summer of 2023. Several service centers have reported amassing long waiting lists (in the hundreds of clients), demonstrating significant demand.

Meanwhile, decriminalization of personal use of psilocybin through Oregon Measure 110 is already in effect, and its impact on unregulated use is unknown; however, anecdotal reports suggest that use is rising. There is an urgent public health need to monitor data and trends in Oregon regarding the context of use of psilocybin, and to develop targeted harm reduction education and programming.

Purpose and Objectives The purpose of this contract is to secure a sole-source award to OHSU for professional services to build data and resources for harm reduction within the expanding psilocybin context of Measure 109 rollout in Oregon.

This requirement will consist of these three sub-objectives:

• A consultative process will be developed to bring together community-based organizations focused on harm reduction, licensed providers/facilitators, researchers, and psilocybin users in-order to review and compile data, tools, efforts, and priorities to support psilocybin use in Oregon.

• Data from these consultative interviews and focus groups will be compiled and analyzed and will be further reviewed with stakeholders to interpret findings.

• Following data analysis and feedback, a guidance document will be developed along with key slogans for health communication on risk reduction messaging segmented to the different user profiles.

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 an urgent need for resource development and sharing around harm reduction programming in Oregon. Oregon Health and Science University (OHSU) is uniquely placed to lead consultation with key stakeholders in-order to compile data, tools and lived experience to inform the development of relevant resources and strategies for harm reduction in Oregon.

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 07/17/2023 at 12:00pm EST and must reference solicitation number 280-23-0644 on your electronic request.

Responses must be submitted electronically to Ahmed.Hassan@samhsa.hhs.gov

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

mailto:Ahmed.Hassan@samhsa.hhs.gov