Preclinical Medications Discovery and Abuse Liability Testing

Description:

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to perform the following: organizations must have in-house capability to perform in vivo rodent and primate pharmacology studies on potential pharmacotherapies for substance use disorders and on new drugs of abuse. This contract will be utilized by the Addiction Treatment Discovery Program (ATDP) within NIDA's Division of Therapeutics and Medical Consequences (DTMC).

The present contract represents the competitive renewal of an existing NIDA contract.  It provides support for evaluation of potential pharmacotherapies for drug use disorders using rodents.  It also provides support for abuse liability testing of new street drugs, medications, or potential medications in rodents.  The primary emphasis is on testing conducted for NIDA’s Addiction Treatment Discovery Program (ATDP).  To a lesser extent, the contract will generate abuse liability data for use in decisions pertaining to scheduling of drugs under domestic laws (Controlled Substances Act) and international treaties (Single Convention and Psychotropic Convention).

Organizations must have in-house capability to perform in vivo rodent and primate pharmacology studies on potential pharmacotherapies for substance use disorders and on new drugs of abuse. This contract will be utilized by the Addiction Treatment Discovery Program (ATDP) within NIDA's Division of Therapeutics and Medical Consequences. Data gathered on potential pharmacotherapies will be used by the ATDP and NIDA's Medications Development Program. The data generated with new drugs of abuse will be provided to the DEA and FDA by NIDA.

Testing shall include but shall not be limited to assessment of the in vivo receptor activity of novel opioid compounds, evaluation of compounds for their ability to produce or prevent physical dependence in rodents and/or primates, evaluation of compounds for their ability to ameliorate withdrawal symptoms in drug dependent animals, evaluation of compounds in operant models of behavior, including responding for food reinforcement and intracranial self-stimulation, and evaluation of compounds in other animal models relevant to drug abuse and addiction. Contractors will be blinded to the identity of proprietary test compounds, and all compounds will be evaluated using protocols and experimental parameters as specified by the NIDA Contracting Officer's Representative. Standardized, detailed reports with graphs will be prepared and submitted promptly to the ATDP for each compound tested. It is expected that 10-20 compounds will be evaluated per year in operant behavioral models. The number of compound evaluations in other models will vary significantly from year to year. The successful offeror must indicate possession of current DEA registration for Schedule II-V substances prior to award and apply for appropriate Schedule I registration.

Offerors shall meet the following Mandatory Criteria:

1. DEA RESEARCH REGISTRATION:  This project involves the use of scheduled drugs under the Controlled Substances Act of 1970.  Due to the nature of compounds which will be evaluated, the Offeror shall indicate possession of a current DEA registration for Schedule II-V substances prior to award, and must obtain DEA registration for Schedule I controlled substances after contract award.
2. ANIMAL WELFARE:  This research involves the use of animals.  The Offeror must demonstrate its understanding and compliance with the NIH Guide for Care and Use of Laboratory Animals.  The Offeror shall submit evidence that its proposal was reviewed and approved by the institution and that the institution has Animal Welfare Assurances in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals prior to award.

NIDA anticipates that one (1) cost-reimbursement, level of effort type contract will be awarded with a base period of 12 months with four 12-month options. Furthermore there will be additional option quantities for each period for additional labor hours and costs (supplies, animal purchases, animal per diem, equipment, etc.) related to completing the statement of work. The options will be exercised in accordance with FAR Clauses 52.217-7 Option for Increased Quantity-Separately Priced Line Item and 52.217-9 Option to Extend the Term of the Contract.

RFQ No. 75N95021R00048 will be available electronically on or about September 06, 2021. You can access the RFP through the Beta.SAM. All information required for the submission of a quote will be contained in or accessible through the RFQ package. Responses to the RFQ will be due on or around October 21, 2021. NIDA will consider quotes 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.

This advertisement does not commit the Government to award a contract.