Assessment of Potential Treatments to Treat Drug-induced Respiratory Depression and Overdose Toxicity   4

PLEASE NOTE THIS SOLICITATION HAS BEEN AMENDED.

The purpose of Amendment No. 01 is to provide additional clarification to formal questions submitted in response to the solicitation. This amendment shall also extend the solicitation due date to February 25, 2022 at 03:00 pm EST. Please see the Attachment RFP_75N95022R00012_Amendment 01 - Response to Questions for details.

The purpose of Amendment No. 02 is to provide additional clarification to formal questions submitted in response to the solicitation. Please see the Attachment RFP_75N95022R00012_Amendment 02 - Response to Questions for details.

Please refer to Attachment below containing the RFP Cover Letter, RFP and all accompanying RFP Attachments for complete details and submission instructions.

The National Institute on Drug Abuse (NIDA) Division of Therapeutics and Medical Consequences (DTMC) and National Institutes of Health (NIH) plans to solicit proposals from Offerors that can demonstrate the capability to provide service to support NIDA DTMC with determining the effects of experimental compounds on respiratory parameters in rodents or other species in models relevant to the opioid overdose crisis.

The objectives of this project are to determine the effects of experimental compounds on respiratory parameters in rodents or other species in models relevant to the opioid overdose crisis. Compounds may be tested alone for effects on respiration (stimulation or depression), or for their ability to modulate respiratory depressant effects of opioids and possibly other drugs of abuse.

The objectives of this project are to determine the in vivo efficacy of novel compounds in animal models of respiration such as, but not limited to, plethysmography. This includes the following types of evaluations:

1. the ability of a test compound to stimulate respiration when administered alone, using standard measures such as tidal volume, respiration rate, minute volume, and/or blood gas analysis
2. the ability of a test compound as a pretreatment to reduce or enhance the respiratory depressant effects of opioids alone, in combination with naloxone, or possibly in combination with alcohol, benzodiazepines, or methamphetamine.
3. the ability of a test compound, when administered as rescue medication, to reduce the respiratory depressant effects of opioids alone, with naloxone, or possibly in combination with alcohol, benzodiazepines, or methamphetamine.

An integral part of this work is to validate established methods and to design and implement protocols for the evaluation of test compounds.

GENERAL REQUIREMENTS:

Independently, and not as an agent of the Government, the Contractor shall furnish the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise furnished by the Government under the terms of the contract.

Task 1: The Contractor shall conduct studies on the acute effects of a drug on respiratory parameters in rodents. The objective of these studies shall be to determine the degree to which a compound, tested over a range of doses and/or pretreatment times, will affect respiration using standard measurements. Protocol development for a particular compound is considered part of this task.

Task 2: The Contractor shall conduct respiratory interaction studies, or specifically, the ability of a test compound to reduce or enhance the respiratory depressant effects of opioids, alone or possibly in combination with naloxone or other drugs of abuse such as alcohol, benzodiazepines, or stimulants such as methamphetamine. Protocol development for a particular experiment will be considered part of this task.

Task 3: The Contractor shall conduct studies to evaluate the ability of a test compound, when administered as rescue medication, to reduce the respiratory depressant effects of opioids, alone or possibly in combination with naloxone and/or drugs of abuse such as alcohol, benzodiazepines, or methamphetamine. Protocol development for a particular experiment will be considered part of this task.

Task 4: The Contractor shall collect plasma samples at specified intervals for bioanalysis. The Contractor shall process and store these samples for shipment to another laboratory, as specified by NIDA, for analysis.

Task 5: The Contractor shall conduct, as directed by NIDA, special in vivo or in vitro pharmacology studies, the details of which cannot be specified in advance of the contract award. These studies may necessitate the development and characterization of a model that is amenable to the evaluation of potential pharmacotherapeutic agents.

Task 6: This task covers general administrative activities of maintaining the contract to include recordkeeping and accounting. In addition to these maintenance tasks, Contractor shall maintain a chronological log of compounds received, priority status, study type authorized, doses, vehicle, route, and pretreatment time, as well as dates of study initiation and completion.

MANDATORY CRITERIA:

Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess, at the time of proposal submission, a DEA Research Registration for Schedules II to V to handle substances under the Controlled Substances Act of 1970. In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule I controlled substances prior to Award. 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.

ADDITIONAL INFORMATION:

NIDA anticipates that one (1) indefinite delivery, indefinite quantity (IDIQ), task order contract will be awarded for a period of performance of five (5) years. NIDA intends to award cost reimbursement task orders under this contract. These individual task orders may include options periods and/or options quantities. If options or option quantities are utilized for an individual task order the will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. All funding will be made through the issuance of task orders and will be dependent on program needs and availability of funds.

The attached RFP No. 75N95022R00012 has proposal DUE DATE of February 25th, 2022 at 3:00 p.m.. You can access the RFP through the link below. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.