SOURCES SOUGHT
A -- Assessment of potential substance abuse treatment medications in nonhuman primate models
- Notice Date
- 3/29/2023 6:04:08 AM
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023R00047
- Response Due
- 4/13/2023 11:00:00 AM
- Point of Contact
- Tracy Cain, Phone: 3014436677, Josh Lazarus, Phone: 3014436677
- E-Mail Address
-
tracy.cain@nih.gov, josh.lazarus@nih.gov
(tracy.cain@nih.gov, josh.lazarus@nih.gov)
- Description
- This is a Small Business 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 small business sources; (2) whether they are 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This is a Research and Development (R & D) 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 R & D requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition.� 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. Background:� There is a need for new therapeutic agents that diminish the reinforcing effects of drugs of abuse, curtail the subjective effects, decrease addictive properties, and decrease the self-administration of abused substances.� There is also a need for compounds that moderate and/or eliminate the dysphoria, anhedonia, and in the case of opiates, physical symptoms associated with withdrawal, and ultimately reduce the likelihood of subsequent relapse to renewed use. 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 Addiction Treatment Discovery Program (ATDP) is a compound screening and profiling program that is modeled after similar efforts in the pharmaceutical industry.� The program utilizes preclinical (animal) models to predict clinical efficacy.� A testing hierarchy and a decision tree to study candidate chemical entities has been developed by the ATDP.� The screens currently in use are conducted by laboratories under contract to NIDA and consist of several in vitro and in vivo assays.� The in vitro tests allow for pharmacological characterization of a compound�s mechanism of action.� A series of rodent in vivo tests are used to provide an initial behavioral profile of test compounds, and include the mouse locomotor activity test, the rat drug discrimination test, and the rat reinstatement of self-administration (using stress, cues, and prime) tests.� Compounds of particular promise are evaluated either rodent relapse models or in nonhuman primate drug-discrimination and self-administration tests as a preclinical assessment of potential clinical for the treatment of either relapse or to facilitate decreased use and abstinence.� Purpose and Objectives: In brief, the objectives of this contract are to determine the effects of compounds in the following paradigms: (1) drug discrimination test in nonhuman primates when tested alone or in combination with cocaine, (2) self-administration test in nonhuman primates when tested for ability to reduce cocaine, methamphetamine, or heroin self-administration or to be directly self-administered, and (3) ability to attenuate signs of opioid withdrawal in opioid dependent nonhuman primates.� Insofar as the Addiction Treatment Discovery Program (ATDP) is a screening and evaluation program that utilizes standardized protocols, the Contractor shall be willing to adopt the ATDP protocols in order to accommodate the needs of the program. However, NIDA recognizes that advances in the field of substance abuse research during the course of the Contract may require modification of the testing paradigms as specified in the Statement of Work. Project requirements: This project will be utilized by the Division of Therapeutics and Medical Consequences, Addiction Treatment Discovery Program (ATDP), for the purpose of evaluating the efficacy of potential drug abuse treatment medications in non-human primates. Specifically, Rhesus monkeys will be trained in either drug discrimination or self-administration procedures using cocaine, methamphetamine, or heroin. Test compounds will be provided for testing under blinded conditions with information regarding dose, vehicle, and pretreatment time supplied by NIDA. The requirement is to evaluate the effects of the test compound to either substitute or antagonize the discriminative stimulus effects of the training drug, or for its effects on the self-administration dose-effect curve of the training compound using standard protocols to be agreed upon in advance. Standardized, detailed reports with graphs will be prepared and submitted promptly to the program for each compound tested. It is estimated that approximately five to twelve compounds per year will be tested using drug discrimination procedures, and another five to twelve compounds will be tested using self-administration procedures, as specified by NIDA. The project will provide the Government with a resource to assist in the management of a research portfolio in substance abuse. Information sent should be relevant and specific in the area under consideration, on each of the following qualifications/capabilities: Have the capability to obtain and maintain a Drug Enforcement Administration (DEA) drug research registration to work with scheduled drugs. Have the capability to 1) to determine the efficacy (i.e., dose response evaluation) of Addiction Treatment Discovery Program (ATDP) compounds to substitute for the discriminative stimulus effects of cocaine, and/or 2) to inhibit or antagonize the discriminative stimulus effects of cocaine. Have the capability to determine the efficacy (i.e., dose-response evaluation) of ATDP test compounds to alter cocaine-, methamphetamine-, and/or heroin-maintained responding (i.e., drug self-administration) as compared to food-maintained responding in nonhuman primates (pretreatment protocol), and/or to evaluate the efficacy of ATDP compounds to replace cocaine, methamphetamine, and/or heroin as the drug available for intravenous self-administration (substitution protocol). Have the capability to determine the effectiveness of ATDP compounds to attenuate the expression of opioid withdrawal in opioid dependent nonhuman primates. Following repeated administration of an opioid (e.g., morphine), the Contractor shall assess the efficacy of ATDP compounds in reducing spontaneous and/or naloxone-precipitated withdrawal by assessment of observable opioid-withdrawal signs and potentially other measures of opioid withdrawal (e.g., disruption of food-maintained responding, physiological measurements). Have the capability to attend yearly project meetings. Have the capability to maintain a chronological list of compound authorization, receipt, usage, and evaluation, with separate logs for compounds authorized for drug discrimination and self-administration testing. Have the capability to retain, for the duration of this project, all laboratory notebooks (which shall include hard copies of raw data) and any electronic data files generated under this project, as well as all coded ATDP compounds received for evaluation under this project. Have the capability to conduct follow-up studies on compounds with particular promise as clinical candidates for treatment of drug dependence. These studies may necessitate the development and pharmacological characterization of a nonhuman primate model of drug dependence that is amenable to the evaluation of potential pharmacotherapeutic agents. Anticipated period of performance: It is anticipated that this requirement shall have a base period of 12 months, with four 12-month option periods. Other important considerations: Capability statements must indicate your current DEA registration for working with Schedules II-V controlled substances.� All work performed must comply with the NIH guidelines on the care and use of laboratory animals, and the laboratory must be operated according to the FDA�s Good Laboratory Practices Program. Capability statement /information sought. Small business concerns that believe they possess the capabilities to provide the required 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. Small businesses must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested small businesses 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. The respondent must also provide their UEI number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, 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 and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. 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. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.� Facsimile responses are NOT accepted. The response must be submitted to Tracy Cain, Contracting Officer, at e-mail address tracy.cain@nih.gov. The response must be received on or before April 12, 2023, 2:00 PM Eastern Time. 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 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).
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/5f5eb12441714549ad781e653dec5313/view)
- Record
- SN06634363-F 20230331/230329230111 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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