Synthesis and Distribution of Drugs of Abuse and Related Compounds

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. 75N95022D00016 WITH RESEARCH TRIANGLE INSTITUTE. The National Institute on Drug Abuse (NIDA) Division of Therapeutics and Medical Consequences (DTMC) at the National Institutes of Health (NIH) intends to modify the Single Award Indefinite Delivery, Indefinite Quantity (IDIQ) Contract No. 75N95022D00016 “Synthesis and Distribution of Drugs of Abuse and Related Compounds” to increase the Single Award IDIQ maximum by $3,718,289 from $14,004,330 to $17,722,619 during the five (5) year ordering period from June 9, 2022 to June 8, 2027; there are no other changes. The increase to the IDIQ maximum will allow for the continuation of work begun under the Synthesis and Distribution of Drugs of Abuse and Related Compounds contract and prevent any delays or disruption of support services for scientific research working on problems of substance use and drug dependence with authentic and pure supplies of controlled drugs and research chemicals essential for ongoing and upcoming pre-clinical and clinical trials while a new contract is properly planned and competed. To support efforts in addressing the national public health crisis from substance use, NIDA through this contract modification also addresses an increased need for drug product to support clinical trials. The increase in the IDIQ maximum will, therefore, allow for the continuation of work initiated under this contract in addition to purchasing drug product to support new and ongoing clinical trials. The contract provides contract support services in the following areas to: Produce and distribute labeled and unlabeled drugs of abuse and other research compounds to researchers as approved by the NIDA COR; Analyze, test, and maintain the purity of drugs of abuse and other chemical compounds in the NIDA drug supply inventory; replenish existing drug supply inventory with synthesis or acquisition of depleted drug/chemical substances; ; identify, acquire, store and update the drug supply inventory with newly discovered chemical compounds useful for drug abuse research; and use, maintain, and update the NIDA drug supply database, known as Drug Inventory Supply Control System (DISCS). 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 Revolutionary FAR Overhaul (RFO) Initiative, in accordance with Executive Order 14275 and OMB Memorandum M-25-26. STATUTORY AUTHORITY This modification is conducted under the authority of 10 U.S.C. 3204(a)(1) or 41 U.S.C. 3304(a)(1) and in accordance with FAR 6.103-1 Only one responsible source and no other supplies or services will satisfy agency requirements.. DESCRIPTION Background For over three decades, the National Institute on Drug Abuse (NIDA) (or its predecessor, Center for Studies of Narcotics and Drug Abuse) has been providing the scientific research community working on problems of drug abuse and drug dependence with authentic and pure supplies of controlled drugs and research chemicals. These drugs and research chemicals include hallucinogens, heroin, amphetamines, cannabinoids, marijuana, and many other research chemicals essential for pre-clinical and clinical research. The number of controlled drug substances and other chemicals including peptides that are currently supplied for research, has grown significantly because of increasing demand due to a combination of factors including increased regulatory requirements that tend to discourage commercial availability and rapidly expanding research efforts in the area of drug abuse. The NIDA Drug Supply & Analytical Services Program maintains an inventory of several DEA controlled and uncontrolled drugs and other research chemical compounds. Simultaneously continuous efforts are made to synthesize new chemical compounds and add to the drug supply inventory. The stability and purity of all these compounds are periodically monitored. Research investigators are provided with pure drugs and/or chemical compounds along with their respective data sheets. Many of these drugs and chemical compounds are synthesized, stored and supplied to support basic research and are produced in quantities ranging from milligram to kilogram quantities. Radio-labeled compounds are prepared with specific activity ranging from 75 Ci/mmole for tritium labeled to 300 Ci/mmole for iodine 125 labeled. The higher specific activity compounds are used in receptor binding studies and in radio-immunoassays. However, lower specific activity compounds are used in metabolic studies and usually labeled to avoid metabolic scrambling. About 70 radioactive compounds are presently stocked in the NIDA drug supply inventory. A broad range of deuterium labeled compounds are synthesized as standards for quantification of drugs by mass-spectrometry. Thus, about 35 deuterium labeled compounds are stocked in the NIDA drug supply inventory. Since several of these drugs/chemical compounds are Schedule I and II compounds under the Controlled Substances Act, an extensive inventory and shipment tracking system is maintained in an ORACLE Database system. Goals and Objectives Contract No. 75N95022D00016 provides the synthesis and distribution of drugs of abuse and related compounds. The NIDA Drug Supply Program has played an important role in promoting and supporting the drug abuse research by providing to the drug abuse research community a wide variety of authentic and pure, controlled drugs and other chemical compounds (both unlabeled and labeled with deuterium, tritium, carbon -14, and iodine-125 isotopes) for basic research. These drugs and research chemicals are either: very expensive to buy, or are controlled by the U.S. Drug Enforcement Administration (DEA) or commercially unavailable. They are generally procured by chemical synthesis through contract mechanism. In order to continue to supply authentic and pure drugs and research chemicals, NIDA intends to maintain the drug supply inventory, periodically check chemical purity and supply to research investigators according to the NIDA drug supply guidelines. Period of Performance The IDIQ contract proposed for modification has an ordering period of June 9, 2022 to June 8, 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 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 Unique Entity Identifier (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. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. All responses must be received by 1:00 p.m. Eastern Daylight Time, Thursday, May 28, 2026, and reference notice number 75N95022D00016SB. Responses must be submitted electronically to Shaun Rostad, Contract Specialist, at [email protected]. Fax responses will not be accepted.