Medication Discovery Using Rat Models of Relapse
Presolicitation Notice: Solicitation Number: 75N95024R00011 Project Title: Medication Discovery Using Rat Models of Relapse Introduction: The National Institute on Drug Abuse (NIDA) intends to solicit... Presolicitation Notice: Solicitation Number: 75N95024R00011 Project Title: Medication Discovery Using Rat Models of Relapse Introduction: The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified organizations (NAICS Code 541715) having in-house capability to develop methodologies and to perform in vivo rodent behavioral pharmacology for other drug dependence disorders, using drug self-administration reinstatement models. The object of this contract is to determine the in vivo efficacy of novel compounds in animal models of relapse using cocaine, nicotine, methamphetamine, or opioids. This includes the following tests in animals trained to self-administer cocaine (for example): (1) the ability of test compound to block footshock or other stress-induced reinstatement of responding after a period of experimental extinction; (2) the ability of a test compound to block priming-induced reinstatement of responding after a period of extinction; and (3) the ability of a test compound to block the effects of a conditioned cue (previously paired with the training drug) to reinstate responding for the training drug (cocaine, nicotine, methamphetamine, or an opioid) after a period of extinction. An integral part of this work is to develop methods and to design and implement protocols for the evaluation of test compounds. A number of laboratories have used some of the methodologies described in the literature. While recognizing the need for methods development, NIDA anticipates that by Option Period 1, if Options are exercised, the majority of the Contractor’s efforts will be devoted to test compound evaluations. The Contractor shall identify and acquire standard compounds that merit the aforementioned types of evaluation. In addition, if NIDA exercises specific contract options, this contract shall support follow-up rodent pharmacology studies of compounds identified as promising potential drug-dependence treatment agents including through the use of drug self-administration studies. The details of these latter studies cannot be specified before contract award; they will depend upon specific successes in NIDA’s medication discovery efforts and scientific advances in the general field of drug abuse research. Written reports documenting the study findings are the anticipated end products of this contract. Mandatory Criteria: 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. 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. Notice: We anticipate the award of one cost-reimbursement, level of effort contract for a base period of one year with four one-year options to extend performance. The contract will include additional quantity options. RFP No. 75N95024R00011 will be available electronically on or about 15 days from the date of this posting. . You can access the RFP through the sam.gov (URL: http://sam.gov) or through the NIDA website: (URL: http://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 30 days from the release date. NIDA anticipates a July 2024 award date. 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.
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Medication Discovery Using Rat Models of Relapse
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 the availability and capabil... 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 the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies under the NAICS Code 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond. NOTE: SPECIAL REQUIREMENT: 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. Statement of Need and Purpose: Purchase Description: BACKGROUND, OBJECTIVES, AND REQUIREMENTS BACKGROUND INFORMATION This contract supports the NIDA Addiction Treatment Discovery Program, providing for the in vivo evaluation, in rodents, of potential pharmacotherapies that would specifically prevent relapse to cocaine and other drugs of abuse. It also provides support for the development of methods and protocols to be used for compound evaluation including drug self-administration. The Addiction Treatment Discovery Program was originally focused on the discovery and development of treatments that will produce two specific types of clinical effects. The first, agonist-type therapy, is based on the successful use of this type of treatment approach in the treatment of smokers (nicotine replacement) and heroin users (methadone and buprenorphine). The second, antagonist or blocking-type therapy, is based on successful use of this strategy for opiates (naltrexone). An existing set of other NIDA contracts support screening measures (locomotor activity, drug discrimination, and self-administration) that have been successful in identifying lead compounds for these two types of medications, some of which will be further evaluated for clinical efficacy. However, there exists another identified clinical need in addition to agonist and antagonist therapy, and that is the need for medications to prevent relapse. Whereas it is possible that agonist/antagonist type medications may prevent craving and subsequent relapse to cocaine use, there now exist more advanced behavioral screens, using reinstatement of extinguished drug self-administration in models of relapse, which may prove useful in identifying additional medications. Such a screen incorporates several clinically relevant aspects of relapse, including exposure to stressors, exposure to cues associated with the drug, and exposure to low doses of the drug itself. Use of these relapse models may permit the discovery of medications that differ from agonist/antagonist types of medications, and may include anxiolytics, antidepressants, and potential treatments with other non-dopaminergic mechanisms of action. As such, this project represents an important addition to the capabilities of the Addiction Treatment Discovery Program. In addition, NIDA wishes to continue its expansion of contract capabilities to enable use of models of relapse to other drugs of abuse (such as but not limited to methamphetamine, nicotine, opioids, and marijuana). This testing represents an essential component of the Division’s medication development efforts; the resulting data guide decisions regarding advancement of compounds to preclinical safety evaluations and eventual clinical trials. The NIDA Division of Therapeutics and Medical Consequences (DTMC) established a policy to encourage chemists and pharmaceutical companies to take part in NIDA’s preclinical medication discovery programs, including the Addiction Treatment Discovery Program. The policy provides that those who submit compounds to NIDA for evaluation in the programs have all rights to publish data generated on their compounds. NIDA sends the compounds, hereafter referred to as “test compounds,” to NIDA testing sites in a blinded fashion. NIDA does not provide the identity of test compounds to the testing sites, but instead, provides only essential compound information, such as storage, solubility, and doses. Because the selected Contractor will serve as a testing site for the NIDA Addiction Treatment Discovery Program, it is unlikely that NIDA will allow the Contractor to publish any test compound data created under this contract. However, the Contractor may publish data created during the course of evaluating “standard compounds.” Standard compounds are those compounds obtained directly by the Contractor for evaluation under the contract, with the resulting data available for immediate release to NIDA and the scientific community. B. OBJECTIVE In brief, the objectives of this contract are to determine the in vivo efficacy of novel compounds in animal models of relapse. This includes the following tests in animals trained to self-administer cocaine or other drugs of abuse; the ability of a test compound to block or reduce footshock- or other stressor-induced reinstatement of responding after a period of experimental extinction, the ability of a test compound to block or reduce drug-priming-induced reinstatement of responding after a period of extinction, and the ability of a test compound to block or reduce the effects of a conditioned cue (previously paired with drug) to reinstate responding for cocaine after a period of extinction. An integral part of this work is to develop methods and to design and implement protocols for the evaluation of test compounds. A number of laboratories have used some of the methodologies described in the literature. While recognizing the need for methods development, NIDA anticipates that by Option Period 1, if Options are exercised, the majority of the Contractor’s efforts will be devoted to test compound evaluations. The Contractor shall identify and acquire standard compounds that merit the aforementioned types of evaluation. In addition, if NIDA exercises specific contract options, this contract shall support follow-up rodent pharmacology studies of compounds identified as promising potential drug-dependence treatment agents including through the use of drug self-administration studies. The details of these latter studies cannot be specified before contract award; they will depend upon specific successes in NIDA’s medication discovery efforts and scientific advances in the general field of drug abuse research. Written reports documenting the study findings are the anticipated end products of this contract. C. GENERAL REQUIREMENTS Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below. The Contracting Officers Representative (COR) will monitor all work under this contract. D. SPECIFIC REQUIREMENTS During the effective period of this contract Years 1 through 5 (if Options are exercised), the Contractor shall perform the work described in Tasks 1 through 5. TASK 1. As directed by the NIDA COR, the Contractor shall devote up to 12,784-person hours per year to evaluating the efficacy of compounds in one or more models of relapse to drug self-administration. In these models, the Contractor shall train rats to self-administer cocaine (or another drug of abuse specified by the NIDA COR, for example, methamphetamine, nicotine, opioids, or THC) at stable levels. Following training, the contractor will extinguish, and then reinstate the behavior using a stimulus that reliably reinstates the self-administration behavior. The Contractor shall develop standard protocols and characterize them with standard compounds. The Contractor will then utilize the standard protocols for evaluating the effects of test compounds on the ability of three types of stimuli to produce reinstatement. These stimuli are 1) a priming dose of the training drug, 2) exposure to a laboratory stressor, and 3) exposure to a drug-associated cue. The Contractor shall devote at least 24 chambers to this work if rats have additional “home” cages, or at least 36 chambers if rats will dwell in the test chambers. For those compounds specified by the NIDA COR, the Contractor shall also evaluate effects of test compounds on rats trained to respond for an alternative reinforcer (for example, food) under a procedure similar to that utilized for drug self-administration. NIDA anticipates that this latter testing will be required only for a limited number of compounds because this work is currently being conducted under another contract. The Contractor shall compare each dose of a compound to its vehicle with regard to its ability to prevent or reduce reinstatement of responding for drug or its ability to impair responding on the non-active lever. Unless otherwise directed by the NIDA COR, the Contractor shall use a minimum of 12 rats to evaluate the effects of each dose of compound under study. The specific details of each protocol, the specific compounds to be evaluated (standard compounds as well as test compounds), and the doses of each compound that the Contractor utilizes are subject to the approval of the NIDA COR. The NIDA COR shall specify the route of administration that the Contractor shall use for each test compound. Occasionally, the Contractor shall administer a test compound by oral gavage, if so directed by the NIDA COR. Although it is probable that the contract will require reinstatement studies involving cocaine, it is also possible that the Contract will require the development and utilization of similar reinstatement protocols for self-administration of another drug of abuse, such as but not limited to methamphetamine, nicotine, opioids, or THC. The Contractor shall utilize protocols using drugs of abuse other than cocaine if directed by the NIDA COR. The Contractor shall blind the identity of all standard compounds under evaluation to those who are conducting the assays. NIDA recognizes the specific details of the reinstatement protocols adopted for this contract will influence the maximum number of compounds that the Contractor can evaluate using the operant chambers specified in this Task. Depending on the type(s) of reinstatement models in which the Contractor evaluates each compound and the final details of each protocol, NIDA anticipates that the contractor will evaluate 15 to 30 compounds per year. For each standard compound or test compound evaluated, the contractor shall prepare a Compound Evaluation Report. TASK 2. Approximately every twelve months, the Contractor shall attend a meeting (up to two days) with NIDA staff and possibly as many as six consultants to review past, current, and future work under this contract. Prior to each meeting, the Contractor shall prepare and organize “pre-meeting packets” in 4 sections. Section 1 shall have a summary of all data presented and a description of relevant methods. Section 2 shall provide a summary of all problems encountered when implementing the tasks required by the contract, as well as suggested solutions for those problems. Section 3 shall include proposals for improving or expanding protocols utilized for Task 1 evaluations. Section 4 shall suggest compounds for potential evaluation under the contract and suggested doses to be evaluated for each compound. If so requested by the NIDA COR, methods included in Section 1 shall be in a research protocol format, with a description of each testing type. The Contractor shall provide this information (the pre-meeting packets) to the consultants and the NIDA COR at least two weeks in advance of the meeting. The Contractor shall present this information at the meeting and subsequently prepare a “meeting report” to summarize and synthesize the results of the meeting, including specific consultant recommendations. During the meeting, the Contractor shall obtain consultant suggestions regarding additional compounds that may merit evaluation under the contract and, by a method approved by the NIDA COR, use the consultants to prioritize the compounds suggested for each task. The Contractor shall include the resulting prioritized compound lists in the meeting report. In most cases, the meeting site is in the Washington, D.C. area. However, in some special circumstances the NIDA COR may designate another meeting site, such as at a professional meeting (e.g., a College on Problems of Drug Dependence meeting, a Society for Neuroscience meeting, etc.). NIDA will reimburse the Contractor’s travel expenses (up to four people) to all consultant meetings in accordance with federal travel regulations. Following each meeting, the NIDA COR shall approve a specific list of compounds for the Contractor to acquire. The Contractor shall attempt to obtain and evaluate those compounds. The Contractor shall not attempt to obtain any compounds for evaluation under this contract without approval of the NIDA COR. Throughout the life of the contract, the NIDA COR shall arrange for blinded test compounds to be sent to the Contractor for evaluation. Test compounds and standard compounds were differentiated above (see Background Information). Information generated on standard compounds must be immediately available for distribution to the scientific community (e.g., through presentation at a consultant meeting or through publication). Therefore, the Contractor, in the course of acquiring standard compounds, shall not enter into any agreement that would limit the availability of data generated on the compounds. In many cases, the Contractor will purchase standard compounds from a commercial source or obtain them free of charge from the NIDA Drug Supply Program. In all other cases, the Contractor shall request standard compounds through letters that include the following statement: “The contractor will evaluate the compound as a standard, and will make available to the scientific community the data that the contractor generates on the compound. Data on standard compounds will not be confidential.” In the event that the contract cannot obtain a standard compound, the NIDA COR may provide the compound to the contractor as a test compound. In some cases, NIDA may be able to arrange for (under a separate contract) the synthesis of an interesting compound for evaluation as either a standard compound or a test compound, depending upon the specific compound. TASK 3. Throughout the life of the contract, the Contractor shall maintain a chronological log of compound receipt. When the Contractor receives compounds (standards compound or test compounds) sent by the COR for evaluation, then the Contractor shall make several log entries: (1) the test compound name or Addiction Treatment Discovery Program identification number and (2) tests authorized (3) the doses authorized (4) the vehicle (5) the pretreatment time, (6) the date of receipt. TASK 4. Throughout the life of the contract, the Contractor shall maintain a log of compound evaluation. This log shall contain five columns. In Column 1, date of study initiation (date laboratory testing begins). In Column 2 identify the compound under study (compound name or Addiction Treatment Discovery Program code number). In Column 3 describe the study description. In Column 4 enter the study completion date (date that Contractor completes laboratory testing). In Column 5 enter the date that resulting Compound Evaluation Report is sent to the NIDA Project Officer. The Contractor shall maintain this table chronologically, by date of study initiation. The Contractor shall update this table at least once each month. TASK 5. If appropriate contract options are exercised, the Contractor shall, as directed by the NIDA COR, utilize a specified number of person hours for several purposes. These person hours shall be used (1) for supplemental protocol development for Task 1; (2) for designated “follow-up studies for compounds identified as promising potential treatment agents which could include drug self-administration; (3) for additional testing of compounds in Task 1; and, (4) for the preparation of corresponding data reports. The details of these Task 5 studies cannot be specified in advance of contract award; rather, the NIDA COR shall specify the details as the decision is made to exercise contract options. The Contractor and the NIDA COR will jointly determine study designs, which possibly could involve chronic test compound administration, cocaine reinstatement tests using female rats, or reinstatement protocols for methamphetamine self-administration or self-administration of other drugs of abuse. Data reports shall adhere to a format determined by the NIDA COR. Capability Statement /Information Sought: Companies that believe they possess the capabilities to provide the required products or services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. Submission Instructions: The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contracting Officer Identified below. The response must be received on or before November 16, 2023, at 3:00 pm EST. Facsimile responses are NOT accepted. Disclaimer and Important Notes: 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 presolicitation synopsis and solicitation may be published in www.sam.gov. 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).” Closing Statement: THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95024R00011. Responses must be submitted electronically to Llakim Dubroff, Contract Specialist, at Llakim.Dubroff@nih.gov U.S. Mail and Fax responses will not be accepted. Primary Point of Contact: Llakim Dubroff, Contract Specialist
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