Inactive Total Small Business Set-Aside (FAR 19.5)

The National Institute on Drug Abuse – Intramural Research Branch (NIDA-IRP) Clinical Program is seeking Capability Statements from Small Business organizations to provide the Government support for t... The National Institute on Drug Abuse – Intramural Research Branch (NIDA-IRP) Clinical Program is seeking Capability Statements from Small Business organizations to provide the Government support for technical consulting services and data analysis of Glucagon-like peptide-1 (GLP-1) analogues as a novel pharmacotherapeutic approach for alcohol use disorder (AUD). 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 541690 Other Scientific and Technical Consulting Services. The U.S. Small Business Administration establishes a size standard for 541690 at $16,500,000 or less. BACKGROUND INFORMATION AND OBJECTIVE: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) is part of the NIH who’s mission is to conduct state-of-the-art research on basic mechanisms that underlie substance use disorders (SUDs), and to develop new methods for the treatment of SUDs. Research is supported at the molecular, genetic, cellular, animal, and human clinical levels and conceptually integrates highly innovative strategies and techniques. The long-term goal of the research is to better understand the biological and behavioral factors contributing to initiation, maintenance, and elimination of SUDs (and associated diseases), and to translate this knowledge into improved strategies for prevention, treatment, and reduction of negative consequences for the individual and for society caused by substance use disorders. NIDA’s Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN) section, jointly with the National Institute on Alcohol Abuse and Alcoholism (NIAAA), conducts clinical and translational inpatient and outpatient studies to identify possible novel medications for addiction. This section uses a combination of state-of-the-art, innovative biobehavioral and pharmacological procedures performed under well-controlled human laboratory conditions. The CPN is particularly interested in the role of neuroendocrine pathways in alcohol and drug-seeking behaviors. Specifically, the CPN laboratory is currently investigating the potential role of feeding-related pathways, such as ghrelin, leptin, oxytocin, GLP-1, and aldosterone, as possible new neuropharmacological targets for the treatment of alcohol and substance use disorders. Both preclinical and human approaches are under development to shed light on the potential role of these pathways in alcohol and substance use disorders. Among the pharmacological targets listed above, a very promising one is GLP-1. GLP-1 is a 30 amino acid peptide primarily produced by endocrine cells of the intestinal mucosa. As an incretin, GLP-1 regulates food intake and glucose homeostasis via both central (e.g., hypothalamus) and peripheral (e.g., pancreas) receptors. In addition, GLP-1 acts as a neuropeptide and is synthesized by preproglucagon neurons of the nucleus of the solitary tract. The GLP-1 receptor (GLP-1R) is widely expressed in extrahypothalamic brain areas such as globus pallidus, ventral tegmental area and nucleus accumbens. Preclinical studies show that GLP-1R activation reduces operant self-administration of alcohol, conditioned place preference for alcohol, and accumbal dopamine release, suggesting that GLP-1R may represent a novel pharmacological target to treat AUD. A few years ago, the CPN section conducted a human study showing that genetic variation at the GLP-1R, leading to reduced expression of the receptor on the cell membrane, is associated with the risk of AUD, amount of intravenous alcohol self-administration, and brain activity in the globus pallidus (Suchankova, et. al., Translational Psychiatry, 2015). Recently, we conducted a more comprehensive imaging-genetics study and found that, for two uncommon single nucleotide polymorphisms (SNPs) that encode amino-acid substitutions with putative functional consequences on GLP-1R activity, high versus low alcohol use severity was associated with stronger within-network connectivity in the groups carrying the variant alleles (Farokhnia, Fede, et. al., Scientific Reports, 2022). We have also shown that alcohol administration in heavy-drinking individuals reduces peripheral GLP-1 concentrations and chronic exposure to alcohol is associated with increased GLP-1R gene expression in the brain (Farokhnia, et. al., Addiction Biology, 2022). In a set of preclinical experiments, in collaboration with UCLA, studies have shown that long-acting GLP-1 analogues, namely liraglutide and semaglutide, effectively reduce alcohol intake in different rodent models. The aforementioned evidence suggest that GLP-1 analogues may serve as novel pharmacotherapies for AUD. However, clinical data in this regard is very limited. Studying the effects of GLP-1 analogues on alcohol consumption in a large patient population is a cost-effective method to provide evidence on early efficacy signals with these drugs, which will also inform prospective randomized clinical trials. There are currently six GLP-1 analogues approved by the FDA for diabetes mellitus and/or obesity: (1) exenatide, (2) lixisenatide, (3) albiglutide, (4) dulaglutide, (5) liraglutide, and (6) semaglutide. Our goal is to start with the most commonly prescribed GLP-1 analogue. Pending feasibility, we also plan to expand our analyses to other GLP-1 analogues to better understand the potential role of these medications in AUD treatment. PERIOD OF PERFORMANCE Base Period – 12 months from the date of award Four (4) One-Year Option Periods PROJECT REQUIREMENTS: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the work below: Data extraction, management, analysis, and report of a propensity-score matched pharmacoepidemiological study of GLP-1 analogues, prescribed for any indication, on alcohol consumption in a general patient population and a naturalistic setting. The objective of the proposed project is to provide data analysis and consulting services to assist with NIDA IRP’s investigation of the impact of GLP-1 analogues on alcohol consumption in a general patient population. The contractor will be required to take de-identified data from individuals exposed to GLP-1 analogues to be propensity-score matched with up to five unexposed individuals. The contractor will provide multivariable linear regression models with estimated changes in Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) scores before and after exposure. Results will provide data for the NIDA IRP to evaluate the possible early efficacy signal with this drug, building the foundation for prospective randomized clinical trials. Contract staff will be responsible for pulling, organizing and cleaning the specific datasets. The contractor will provide personnel responsible for leading study data analyses and aid in resulting abstract and manuscript development (NIDA IRP will lead the development and preparation of the manuscript). The contractor will be required to provide data management and analysis for this project. CPN will regularly meet with the research team to brainstorm about and outline the specifics of the project. The contractor will run analyses and will send a final report of the methods and results, which will only include aggregate data (no raw data or personally identifiable information). Interested organizations must demonstrate and document in the submitted capability statement extensive experience in the areas listed above. INSTRUCTIONS: Capability statement /information sought. Companies 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. 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. The established NAICS code is 541690. Respondents must provide clear and convincing documentation of their capability of providing the products and support services specified in this notice. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) capability to perform the work; (c) prior completed projects of similar nature; and (d) compliance with requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. 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. 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, Rob Bailey at Rob.Bailey@nih.gov, NO LATER THAN 4:00 p.m. EST on August 1, 2023. 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 on 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).