CTN Clinical Coordinating Center

INTRODUCTIONPURSUANT 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. 75N95020D00012 (NIDA REF. NO. N01DA-20-2251) WITH EMMES COMPANY, LLC, THE.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. 75N95020D00012 “CTN Clinical Coordinating Center” (CCC) to increase the maximum dollar amount of services the Government will acquire under this contract by $8,500,000 million from $37,500,000 to $46,000,000 during the five (5) year ordering period from August 14, 2020 to August 13, 2025; there are no other changes.The increase to the cost ceiling will allow for the continuation of work provided under this 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.The CCC contract provides contract support services and resources to the CTN in managing and carrying out multiple trials in drug abuse research. This contractor provides support for research protocol development, regulatory oversight; monitoring protocol implementation; research staff training; supplying pharmaceutical services and clinical support; drug testing and analytical laboratory services; committee and subcommittee participation; and expert consultation and support services. Specific task areas are:Providing support for regulatory functions and requirements;Reviewing and monitoring protocol implementation;Providing training to research staff;Supplying pharmaceutical services and clinical support;Providing drug testing and analytical laboratory services;Providing support for protocol development in the areas related to the tasks specified in this Statement of Work;Participating in relevant committee and subcommittee meetings and conference calls; andProviding other expert consultation and support services as needed.REGULATORY AUTHORITYThe resultant modification will include all applicable provisions and clauses of the Federal Acquisition Regulation (FAR) in effect through the Federal Acquisition Circular (FAC) 2022-08 with effective date 10/28/2022.STATUTORY AUTHORITYThis 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.DESCRIPTIONBackgroundNIDA’s Clinical Trial Network (CTN) was established in 1999 to bridge the gap between research and practice to improve treatment of substance use disorders (SUD) nationwide. The CTN seeks to address critical research questions with direct relevance to clinical practice and the needs of patients. Over the last two decades, 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 facilitates collaboration between NIDA, research scientists at universities, and treatment providers in the community with the aim of developing, testing, and implementing new addiction treatments. The network has contributed to broad reaching changes in medical practice, including the development of the opioid treatment medication buprenorphine.The CTN conducts single and multi-site clinical trials through grants, contracts and cooperative agreements 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. In support of efforts to address the national opioid public health crisis, the CTN plans a significant expansion of its opioid research portfolio.Development and implementation of studies to improve access to high-quality addiction treatment, for example, by facilitating delivery of opioid use disorder treatment in general medical settings is expected. These studies could be Phase I, Phase II, Phase III, and/or Phase IV type trials. They may also include registry type trials or surveys.Goals and ObjectivesContract No. 75N95020D00012 provides support and provide resources to the CTN in managing and carrying out multiple trials in drug abuse research. This contractor will provide support for research protocol development, regulatory oversight; monitoring protocol implementation; research staff training; supplying pharmaceutical services and clinical support; drug testing and analytical laboratory services; committee and subcommittee participation; and, expert consultation and support services. The project includes the following tasks:Providing support for regulatory functions and requirements;Reviewing and monitoring protocol implementation;Providing training to research staff;Supplying pharmaceutical services and clinical support;Providing drug testing and analytical laboratory services;Providing support for protocol development in the areas related to the tasks specified in this Statement of Work;Participating in relevant committee and subcommittee meetings and conference calls; andProviding other expert consultation and support services as neededPeriod of PerformanceThe IDIQ contract proposed for modification has an ordering period of August 14, 2020 to August 13, 2025, which remains unchanged.CLOSING STATEMENTThis synopsis is not a request for competitive proposals and the Government is not committed to award a contract pursuant to this announcement. However, interested parties 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 Dun & Bradstreet Number (DUNS), 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 12:00 p.m. Eastern Daylight Time, Thursday, January 5, 2022, and reference notice number 75N95020D00012. Responses must be submitted electronically to Tracy Cain, Contract Specialist, at tracy.cain@nih.gov. Fax responses will not be accepted.Contracting Office Address:National Institutes of HealthNational Institute on Drug AbuseOffice of Acquisitionsc/o 3WFN MSC 6012301 N Stonestreet AveBethesda, MD 20892All responsible sources may submit a capability statement which shall be considered by the agency.