Inactive
Notice ID:75N95023R00019
Pre-solicitation notice 75N95023R00019 (NIDA Ref. No. N01DA-23-8939) Toxicological Evaluations of Potential Medications to Treat Drug Abuse The National Institute on Drug Abuse (NIDA) intends to solic...
Pre-solicitation notice 75N95023R00019 (NIDA Ref. No. N01DA-23-8939) Toxicological Evaluations of Potential Medications to Treat Drug Abuse The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to perform the following: A. General Requirements: Offerors would conduct systematic preclinical toxicology and safety pharmacology studies, and preclinical cardiovascular interaction safety studies that support the development of pharmacotherapies as medications to reduce substance abuse. The preclinical studies shall adhere to Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) guidelines as set forth by relevant Food and Drug Administration (FDA) guidance and regulations (Code of Federal Regulations Title 21, Chapter 1, Subchapter A, Part 58). B. Specific Requirements: Offerors must have access to in vivo toxicology (rodent, rabbit, guinea pig, canine and non-human primate) and in vivo cardiovascular safety testing facilities with telemetric recording capability in conscious, unrestrained animals (rat, dog, and non-human primate); Offerors must have access to state-of-the-art equipment for performing in vitro tests on cardiac muscle (hERG channel assays and action potential duration tests), access to state-of-the-art equipment for performing mutagenicity and genotoxicity tests, and access to state-of-the-art equipment for performing analytical testing of dosing solutions; Offerors must be able to verify the identity of the bulk substance through High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Nuclear Magnetic Resonance Spectroscopy (NMR); Offerors must possess experience conducting rodent, dog, and non-human primate GLP studies designed to evaluate the safety of test compounds in the presence of common drugs of abuse, including ethanol, cocaine, methamphetamine, and opioids; Preference will be given to offerors that can conduct GLP-compliant cardiovascular safety studies at their own facility at time of award over offerors that would employ subcontractors or vendors; After the Request for Proposals (RFP) is issued, and prior to award, each offeror must: Be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International). Demonstrate its understanding and compliance with the NIH Guide for the Care and Use of Laboratory Animals. Show that it has an Animal Welfare Assurance on file with the Office of Extramural Research, Office of Laboratory Animal Welfare (OLAW; see https://olaw.nih.gov). C. Mandatory Evaluation Criteria: To handle test substances under the Controlled Substances Act of 1970, and prior to award, each offeror must possess a U.S. Drug Enforcement Administration (DEA) Registration for Schedules II to V. In addition, each offeror must either possess, or demonstrate the ability to obtain prior to award, DEA Registration for Schedule I controlled substances. 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’s Animal Care and Use Committee (IACUC). The Assurance number shall be provided with the proposal. D. Additional Information: NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity (IDIQ), task order contract. NIDA may award either cost reimbursement and/or fixed price task orders under this contract. NIDA anticipates that at least one task order will be awarded with the contract. NIDA also anticipates the use of Options to Extend the Period of Performance negotiated and established at the individual task order level and Options for Increased Quantities negotiated and established at the Contract level. Each task order shall be individually negotiated at the time of evaluation, prior to award. RFP No. 75N95023R00019 will be available electronically after January 27, 2023. You will be able to access the RFP through SAM.gov. All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after we release the RFP. NIDA will consider proposals submitted by any responsible offeror. 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.
