Pre-Sol Synopsis 75N95024R00006.pdf

Document Type: Presolicitation Synopsis Solicitation No.: 75N95024R00006 Project Title: Quantification of Drugs of Abuse and Related Substances in Biological

Specimens Classification Code: AN11 – Health R&D NAICS Code: 541715 -- including Research and Development in the Physical, Engineering and Life Sciences (except Nanotechnology and Biotechnology)

A. Objectives:

The National Institute on Drug Addiction (NIDA), Division of Therapeutics and Medical Consequences (DTMC), intends to solicit proposals UNDER FULL AND OPEN COMPETITION procedures from qualified organizations certified under NAICS Code 541715; to identify and quantify drugs and their metabolites in biological fluids and tissues such as plasma/serum, urine, sweat, saliva, hair, brain and other tissues.

The purpose of this contract is to provide the NIDA DTMC with analytical services and facilities to serve as a reference laboratory by which new methodologies currently under development can be assessed and validated. One of NIDA's primary program objectives is to stimulate and support research on drugs of abuse in pharmacokinetics, metabolism, pharmacology and toxicology. It is essential to identify and quantify drugs and their metabolites in biological fluids and tissues such as plasma/serum, urine, sweat, saliva, hair and brain and other tissues. These drugs may include cannabinoids, opiates, amphetamines, l alpha acetyl methadol (LAAM), naltrexone, methadone, cocaine, phencyclidine, anabolic steroids, opioid peptides and peptidomimetics, benzodiazepines and other drugs and their metabolites. The concentrations of such drugs and metabolites usually appear in biological materials at ng/g or ng/ml levels and therefore require the use of state-of-the-art chromatography methods for separation and highly sensitive instrumentations for identification and quantification, such as gas chromatography mass spectrometry (GC MS), liquid chromatography-mass spectrometry (LC-MS), and LC-MS/MS. There are a number of NIDA research investigators, especially those in the area of biology, who may not have access to the state-of-the art analytical instrumentation for quantifying very small quantities of drugs of abuse and their metabolites in biological specimens. Such analytical instruments are very expensive and specialized expertise is required to operate and maintain them. Moreover, the need for this type of analysis arises a few times a year from of our NIDA research researchers.

B. General Requirements:

Independently, and not as an agent of the Government, the Contractor shall (1) analyze experimental samples for drug concentrations in biological fluids and/or tissues, (2) develop more specific and sensitive methods for existing drugs or compounds and provide analytical validations for such methods, and (3) develop assays for compounds that are not currently available for which specific and sensitive assays are required by the drug abuse research community and perform the work set forth below. The Government COR shall monitor all work under this contract.

The Contract activities will support NIDA in the following Task Areas:

(1) The Contractor shall quantify variety of drugs of abuse and other chemical substances and/or their metabolites in biological fluids such as plasma, urine, saliva, sweat and various tissues specimens upon NIDA authorization. Specimen for analysis will be provided by research investigators.

(2) The Contractor shall routinely research and modify existing methods to improve specificity and sensitivity for analyzing drugs and their metabolites (at least two per year).

(3) The Contractor shall develop and validate a new assay for existing and new compounds (at least one compound per year) upon authorization by the NIDA COR.

(4) The Contractor shall develop analytical methods that shall provide sensitivity and specificity for pharmacokinetic studies, usually in ng/mL, or ng/g range. For example, for analysis of LSD in urine and serum, sensitivity of 0.10 ng is required.

(5) The NIDA COR may substitute analyses of 150 samples with analytical method development for one drug or compound.

(6) The Contractor shall provide relevant literature, data search, and information to the NIDA COR as and when needed.

(7) The Contractor shall provide an electronic copy of the monthly, half-yearly, and yearly report regularly to the NIDA COR as specified elsewhere in this statement of work. In addition, the Contractor shall provide an electronic copy of the yearly report regularly to the NIDA Contracting Officer. At the end of the contract an electronic copy of the progress report shall be provided to the NIDA COR and Contracting Officer.

This is a follow-on procurement to Contract Number 75N95019C00016 titled “Quantification of Drugs of Abuse and Related Substances in Biological Specimens”. NIDA anticipates a cost reimbursement, level of effort type contract will result from this procurement. NIDA also anticipates the need for Options to extend the period of performance and Options for increased quantity. NIDA estimates this requirement will include a one (1) year Base Period and four (4) one

(1) year options to extend performance.

C. Mandatory Criteria:

This acquisition includes special or unique performance or capability requirements. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess a DEA Research Registration. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess prior to award US Department of Justice Drug Enforcement Administration (DEA) Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970. In addition, the successful offeror must either possess or demonstrate the ability to obtain prior to award DEA registration for Schedule I controlled substances prior to awarding the contract.

D. Additional Information:

RFP No. 75N95024R00006 will be available electronically on or about November 14, 2023.

Interested vendors will can access the RFP through www.SAM.gov or through the NIDA website (URL: https://nida.nih.gov/funding/nida-office-acquisitions-contracting#RFP) . All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due approximately 30 days from the release date.

NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

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.

Points of Contact

Primary Point of Contact:

Alexander Beraud Contract Specialist

Secondary Point of Contact:

Joshua Lazarus Contracting Officer