Assessment of Potential Treatments to Treat Drug-induced Respiratory Depression and Overdose Toxicity
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:
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
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.
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 may award either cost reimbursement and/or fixed price task orders under this contract. These individual task orders may include options 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. NIDA anticipates that at least one task order will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds. Various task orders will be issued to support distinct tasks and studies.
The attached RFP No. 75N95022R00012 has proposal DUE DATE of February 18th, 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.
75N95022R00012 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
12/22/21, 4:35 PM Assessment of Potential Treatments to Treat Drug-induced Respiratory Depression and Overdose Toxicity
The National Institute on Drug Abuse (NIDA) Division of Therapeutics and Medical Consequences (DTMC) and National Institutes of Health (NIH) is seeking Capability Statements from BOTH Other than Small Business and Small Business organizations with the demonstrated capability of providing 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.
This is a Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; (2) the availability of capable Small Businesses; HUBZone Small Businesses; Service-Disabled, Veteran-Owned Small Businesses; 8(a) Small Businesses; Veteran-Owned Small Businesses; Woman-Owned Small Businesses; or Small Disadvantaged Businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The established NAICS code is 541715, Research and Development in the Physical, Engineering and Life Sciences (Except Nanotechnology and Biotechnology). The U.S. Small Business Administration establishes a size standard for 541715 as 1,000 employees or less.
BACKGROUND AND OBJECTIVES:
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:
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
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.
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. While recognizing the need for methods development/validation, NIDA anticipates that by Year 2, the majority of the Contractor’s efforts will be devoted to test compound evaluations.
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.
SPECIFIC REQUIREMENTS:
Specifically, the Contractor shall perform the following tasks.
Task 1: The Contractor shall conduct studies on the acute effects of a drug on respiratory parameters in rodents. Specific methods to be used in these studies shall be subject to the approval of the NIDA. 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. The route of administration, pretreatment time, dose range, and drug vehicle will the specified by NIDA. 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. In this case, the test drug would be administered at a specified time prior to the opioid (pretreatment) to insure its maximum effect. Specific methods including doses, routes of administration, and pretreatment times to be used in the study shall be specified by and otherwise subject to the approval of NIDA. 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. In this case, the test drug would be administered at a specified time after the opioid to insure its maximum effect. Specific methods including doses, routes of administration, and pretreatment times to be used in the study shall be specified by and otherwise subject to the approval of NIDA. Protocol development for a particular experiment will be considered part of this task.
The findings generated in Tasks 1-3 shall each be presented in a comprehensive report that shall include tabulations and graphical presentations of the collected individual and averaged data. Appropriate statistical methods shall be used to determine treatment-related effects for all the data that are collected. NIDA requires a complete report for each study, and the requirements for report content and format shall be similar to GLP guidelines, and are subject to the approval of NIDA.
Typically, the Contractor shall use a sufficient number of animals to show significant effects on measured parameters based on predicted or known effect sizes in the particular model being used. Animals may be used for multiple doses of single test compounds within the same experiments assuming appropriate washout intervals. Control groups subjected to the same experimental conditions should always be used rather than relying solely on within-subject designs to ensure data integrity and reproducibility.
Task 4: If requested, 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. Another NIH contract shall cover the cost of this analysis. This task would typically be requested in combination with Tasks 1-3.
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. Examples of such studies include, but are not limited to:
Modifications of the specified protocols in Tasks 1-3 to allow for a more specialized evaluation of test compounds
Development of a protocol and pharmacology studies with features similar to a clinical situation
Development of a protocol and pharmacology studies using neuroanatomical, neuroendocrine, neurochemical, metabolic and/or physiological endpoints relevant to a specific test compound
Protocol development and pharmacology studies to assess other drug toxicity or overdose, the details of which cannot be specified at this time, but that shall be agreed upon by NIDA and the Contractor.
Protocols for which the details cannot be specified at this time, the details of which shall be agreed upon by NIDA and the Contractor.
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. An annual report of contract activities shall be required at the end of each contract year to include the chronological log described above as well as a description of the key elements of the protocols used. It is expected that this task order will be issued annually.
MANDATORY 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 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.
INSTRUCTIONS:
Respondents must provide clear and convincing documentation of their capability and experience with providing the personnel and services as specified in the tasks above. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) current capability to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and other management capability; and (e) examples of prior completed Government contracts, references, and other related information.
Each capability statement must include the respondent’s DUNS number, organization name, and address. Each response should include the technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses. The capability statement should clearly identify the size and type of business (e.g., 8(a), HubZone, Non-Profit, Other Than Small Business, etc.), pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.
One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.
The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement paragraphs stated herein. A cover page and an executive summary may be included but is not required.
The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, resumes, or references, if requested.
Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Shaun Rostad at Shaun.Rostad@nih.gov, NO LATER THAN 1:00 p.m. EST on September 23, 2021. The Subject line for the submission should include this Sources Sought Number and organization name. NIDA will not accept paper or faxed capability statements.
THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
75N95021R00066 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
9/7/21, 9:10 AM Assessment of Potential Treatments to Treat Drug-induced Respiratory Depression and Overdose Toxicity
DESCRIPTION:
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:
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
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.
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 may award either cost reimbursement and/or fixed price task orders under this contract. These individual task orders may include options 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. NIDA anticipates that at least one task order will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds. Various task orders will be issued to support distinct tasks and studies.
RFP No. 75N95022R00012 will be available electronically on or about December 1, 2021. You can access the RFP through the www.SAM.gov or through the NIDA website: (URL: https://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). 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 45 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.
75N95022R00012 Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse
11/16/21, 4:29 PM