Analytical Services Center for Medications Development Program

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 National Institute on Drug Abuse (NIDA), Division of Therapeutics and Medical Consequences (DTMC) supports research and development of new medications for the treatment of substance use disorders (SUDs). The purpose of this contract is to provide the NIDA DTMC with a centralized bioanalytical facility services to support the preclinical PK/toxicokinetic studies, clinical pharmacology/PK studies and clinical trials for assessing the efficacy and safety of the study medications. The Contractor shall carry out qualitative and/or quantitative assays for a variety of compounds in biological specimens collected from preclinical and clinical studies using validated analytical methods. The analytes include, but are not limited to, new medications and/or their metabolites, abused drugs/metabolites, potential concomitant medications/compounds, and surrogate outcome measures and/molecular biomarkers (small molecules, peptides, proteins, enzymes, etc). The Contractor shall also develop and validate new assay methods for medications/compounds for which established assays do not exist. The data generated by this contract will be utilized by the NIDA DTMC in the evaluation of new medications under development for the treatment of SUDs. The data will generally be integral to Investigational New Drug (IND) and New Drug Application (NDA) submissions for the Medications Development program and as such must abide by published/appropriate procedures and in a format suitable for this purpose.

B. General Requirements:

Independently, and not as an agent of the Government, the Contractor shall provide the following services: 1) expertise in evaluation and personnel with the knowledge of, and experience in a) developing and validating new quantitative assay methods; b) state-of-the-art assay methodologies; 2) equipment, instrumentation, facility, and personnel to perform the Tasks. The Contractor shall also perform the work and meet the following qualifications set forth below. The Government COR shall monitor all work under this contract.

Program Requirements:

The work involves quantitative and/or qualitative determination of a variety of compounds, including but are not limited to, new medications and/or their metabolites, abused drugs/metabolites, potential concomitant medications/compounds, and molecular biomarkers (small molecules, peptides and proteins, etc.) in biological specimens collected from preclinical and clinical studies. The Contractor shall also develop and validate new quantitative assay methods for medications/compounds for which no established methods exist. These compounds may appear in biological specimens at concentrations of low nanogram/mL (ng/mL) or subnanogram/ml and therefore require the use of state of the art analytical methods including mass spectrometric methods and immunoassays.

The Contractor shall carry out all the assays in compliance with pertinent and current Good Laboratory Practice (GLP) regulations unless designated otherwise by the COR. The Contractor shall also follow the pertinent Food and Drug Administration (FDA) guidelines regarding analytical methods validation. The data will generally be integral to IND and NDA submissions for the Medications Development program and as such must abide by published/appropriate procedures and be produced in a format suitable for this purpose.

The Contactor shall also provide biological sample collection/storage and shipment supplies to the sites designated by the COR. Samples to be analyzed will be sent to the Contractor's laboratory from various sites and the COR will determine the priority of analyses. The Contractor shall store the retaining samples in the freezer for up to 3 years after completion of assays or until the destruction of the samples is authorized by COR. Specific Tasks to be performed include:

Task A. Assay Development and Validation;

Task B. Quantitative Assays;

Task C. Qualitative Screening and Quantitative Assay of Abused Drugs in Biological Samples Collected from Clinical Trials;

Task D. Acquisition and Distribution of On-site Testing Devices;

Task E. Supplies for Sample Collection/Storage and Shipment for Clinical Trials;

Task F. Results and Database Maintenance; and

Task G. Archival Maintenance of Records.

This is a follow-on procurement to Contract Number 75N95019D00037 titled “Quantification of Drugs of Abuse and Related Substances in Biological Specimens”. NIDA anticipates an indefinite delivery indefinite quantity type contract using both fixed-price and/or cost-reimbursement task orders will result from this procurement.

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. Offeror must be able to provide proof that it can and has conducted analytical services under GLP conditions.

D. Additional Information:

RFP No. 75N95024R00032 will be available electronically on or about March 01, 2024. 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 entities 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.