NOTICE OF INTENT TO AWARD A SOLE SOURCE MODIFICATION UNDER CONTRACT NO. 75N95022D00017 WITH THE EMMES COMPANY, LLC.

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A NOTICE OF A PROPOSED CONTRACT ACTION.   

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE MODIFICATION UNDER CONTRACT NO. 75N95022D00017 (NIDA REF. NO. N01DA-22-2253) WITH THE EMMES COMPANY, LLC. 

The National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) and the Center for the Clinical Trials Network (CTN) intends to modify the Single Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract No. 75N95022D00017  “CTN Data, Statistics, and Clinical Trial Support Center” (DSC6) to increase the maximum dollar amount of services the Government will acquire under this contracts by $13,158,436 million from $31,154,646 to $44,313,082 during the five (5) year ordering period from September 5, 2022, to September 4, 2027; there are no other changes.

The increase to the cost ceiling will allow for the continuation of work begun under the DSC6 contract and prevent any delays or disruption of support services for ongoing and upcoming clinical trials while a new contract is properly planned and competed.  To support efforts to address the national opioid public health crisis, the CTN through this contract modification also address a significant expansion of its opioid research portfolio. 

The DSC6 contract provides contract support services in the following areas:

• Establish and administer state-of-the-art, secured web-based systems for the collection, storage, management, quality assurance, and reporting of study data as well as systems to facilitate the collection and management of participant and site level electronic health records data.
• Assist in the design and analysis of clinical trials, including the development of the statistical sections of protocols, study design, randomization and stratification methods, power and sample size calculations, interim monitoring and analysis plans, and data analytic plans.
• Review and monitor the quality of study data including the development and management of a computerized data monitoring system that executes quality assurance and quality control procedures to evaluate accuracy, timeliness and completeness of data submitted by the clinical sites, including verification of the clinical and laboratory data used to determine that study participants have reached protocol-defined endpoints.
• Monitor trial performance and progress and maintain a secure web-based clinical trial performance monitoring system to track key trial performance metrics (e.g. key dates, recruitment, availability of primary outcomes, missing data, etc.).
• Coordinate meetings of study Data and Safety Monitoring Boards (DSMB) to include the preparation and presentation of reports on safety, data integrity, and site performance as well as coordination of meeting sites, materials, travel support, etc.).
• Participate in relevant committee and subcommittee meetings including representation by the contract Principal Investigator on the CTN Steering Committee and representation by other senior data and statistical experts on other relevant CTN committees, subcommittees and workgroups.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541715 with a small business size standard of 1,000 employees

REGULATORY AUTHORITY

The resultant modification will include all applicable provisions and clauses of the Federal Acquisition Regulation (FAR) in effect through the Federal Acquisition Circular (FAC) 2025-06 with effective date 10/01/2025.

STATUTORY AUTHORITY

This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 3304(a)(1) under provisions of the statutory authority of FAR Subpart 6.302-1.

DESCRIPTION

Background
NIDA’s CTN was established in 1999 to bridge the gap between research and practice to improve treatment of substance use disorders (SUD) nationwide. CTN conducts clinical trials in sites located across the nation and in other countries. These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients.  These studies are typically Phase III clinical trials, but can also include Phase I, Phase II, Phase IV, and/or registry trials or surveys. The CTN seeks to address critical research questions with direct relevance to clinical practice and the needs of patients. 

Over the last twenty-five years, the CTN’s research infrastructure and agenda have evolved to reflect the changing landscape of the SUD treatment community, transformation of health care systems, and emerging scientific advancements.  The CTN has been engaging providers in general medical settings and healthcare systems, and in 2015 the Network built upon and expanded its research portfolio encouraging adoption of innovative bioinformatics approaches, new technology, and "learning healthcare system" principles to enhance the efficiency of SUD clinical research and clinical care.

The CTN conducts clinical trials in sites located across the nation and in other countries.  These are usually studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in rigorous, clinical trials to determine efficacy, effectiveness, practicality, and feasibility across a broad range of treatment settings and diversified patient populations and to transfer research results to physicians, clinicians, providers, and patients.  These studies are typically Phase III clinical trials, but can also include Phase I, Phase II, Phase IV, and/or registry trials or surveys.  More information on the CTN and the CTN’s research portfolio is available at https://www.drugabuse.gov/about-nida/organization/cctn/ctn. 

Goals and Objectives

Contract No. 75N95022D00017  provides data and clinical research support and resources to the CTN in managing and carrying out multiple trials in drug abuse research, which in part includes the NIH HEAL Initiative to address the national opioid public health crisis.  The Contractor provides support for systems, procedures, and expertise in data management, statistical support, and information support and services.  The systems are then used to support data collection, data analysis, document management, information exchange, scientific discovery efforts and clinical evaluation of promising new anti-addiction therapies and companion behavioral interventions to further NIDA’s mission.  The project includes the following tasks:

• Establish and administer state-of-the-art, secured web-based systems for the collection, storage, management, quality assurance, and reporting of study data as well as systems to facilitate the collection and management of participant and site level electronic health records data.
• Assist in the design and analysis of clinical trials, including the development of the statistical sections of protocols, study design, randomization and stratification methods, power and sample size calculations, interim monitoring and analysis plans, and data analytic plans.
• Review and monitor the quality of study data including the development and management of a computerized data monitoring system that executes quality assurance and quality control procedures to evaluate accuracy, timeliness and completeness of data submitted by the clinical sites, including verification of the clinical and laboratory data used to determine that study participants have reached protocol-defined endpoints.
• Monitor trial performance and progress and maintain a secure web-based clinical trial performance monitoring system to track key trial performance metrics (e.g. key dates, recruitment, availability of primary outcomes, missing data, etc.).
• Coordinate meetings of study Data and Safety Monitoring Boards (DSMB) to include the preparation and presentation of reports on safety, data integrity, and site performance as well as coordination of meeting sites, materials, travel support, etc.).
• Participate in relevant committee and subcommittee meetings including representation by the contract Principal Investigator on the CTN Steering Committee and representation by other senior data and statistical experts on other relevant CTN committees, subcommittees and workgroups.

Period of Performance

The IDIQ contract proposed for modification has an ordering period of September 5, 2022 to September 4, 2027 which remains unchanged.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals and the Government is not committed to award a contract pursuant to this announcement.  However, interested entities may respond by identifying their interest, submitting capability statements, and or submitting objections to the proposed contract modification.  The Government will consider responses; however, a determination by the Government to proceed with the proposed contract modification is solely within the discretion of the Government.

Any potential offeror must have an active registration in the System for Award Management (SAM) www.sam.gov. In addition, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response.

A determination by the Government not to compete this proposed modification 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 3:00 p.m. Eastern Daylight Time, Tuesday, December 30, 2025, and reference notice number 75N95022D00017.  Responses must be submitted electronically to Llakim Dubroff, Contract Specialist, at Llakim.Dubroff@nih.gov and Josh Lazarus at josh.lazarus@nih.gov.  Fax responses will not be accepted.

Contracting Office Address:
National Institutes of Health
National Institute on Drug Abuse
Office of Acquisitions
c/o 3WFN MSC 6012
301 N Stonestreet Ave
Bethesda, MD 20892

All responsible sources may submit a capability statement which shall be considered by the agency.