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.