Inactive

(i) This is a combined synopsis/solicitation for a commercial service in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information inc... (i) This is a combined synopsis/solicitation for a commercial service in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95023Q00552 and the solicitation is issued as a Request for Quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Products and Commercial Services, and is not expected to exceed the Simplified Acquisition Threshold (SAT). A fixed-price type of purchase order is contemplated for this requirement. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-05, dated August 8, 2023. (iv) The North American Industry Classification System (NAICS) code for this procurement is 541690 – Other Scientific and Technical Consulting Services, and the small business size standard is $16,500,000 in revenue or less. This requirement shall be solicited using full and open competitive procedures. (v) DESCRIPTION The government requires the following commercial service – 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 commercial service shall include at a minimum the following General Requirements: Extract pharmacy records to identify patients who did and did not receive the FDA-approved medications (identified above) at VA pharmacies.’ Apply propensity score approaches (e.g., matching, weighting) in consultation with the NIDA research team to balance the distribution of all potential confounders across treatment groups. Variables included in the propensity score model shall be guided by previous work in this field and using the same database. Model the probability (i.e., propensity) of receiving the medication as a function of measured covariates associated with the exposure and outcome using a multivariable logistic regression model. These covariates must be already created and ready for analysis. Covariates shall be summarized, using descriptive statistics and shall be stratified by treatment group. Absolute standardized mean differences (SMD) shall be calculated and interpreted in consultation with the research team. Due to timeline restrictions and the importance of research integrity/replication, it is required that the contractor possess full access to the Veteran Aging Cohort Study (VACS) data and other sources needed for these analyses, as well as an already built data analysis pipeline. The contractor will be responsible for pulling, organizing, and cleaning the data needed for this project. Formulating a data analysis plan in consultation with the NIH research team Running analyses and reviewing aggregate results with the NIH research team Drafting the methods used and detailing the results. Organize data management and analysis to support CPN with their study. Meet regularly with the NIDA IRP research team to brainstorm about and outline the specifics of the project. Prepare and deliver a final report of the methods used and aggregated data results. (vi) Please refer to Attachment 1 – Statement of Work for details and information describing the specific requirements. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the contractor shall provide the technical consulting service and data analysis for a period of twelve (12) months from the date of award Four (4) one-year option periods shall also be provided. (viii) The provision at FAR Clause 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (MAR 2023) is applicable and incorporated by reference into this solicitation. (ix) The provision at FAR Clause 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021) is applicable and incorporated by reference into this solicitation. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Each quote will be evaluated in strict conformity with the evaluation factors. The evaluation will be based upon the demonstrated capabilities of the prospective Contractor in relation to the needs of the project as set forth in the solicitation. The quote will also be evaluated taking into consideration any price reductions for the requirement being ordered. A price reasonableness determination will be made and a best value analysis will be performed. The best value analysis will take into consideration the results of the technical evaluation, price evaluation, and the ability to complete the work within the Government's required schedule. The analysis will document that the award represents the best value to the Government (considering technical evaluation factors, past performance, and price) to meet the Government’s needs. The Government reserves the right to issue an order to the best advantage of the Government, technical merit, price, and other factors considered. All aspects of a quote are subject to discussion, including price, technical approach and terms and conditions. At the completion of discussions, the Contractor will ensure the technical and price quote reflects the mutual understandings of the requirement and if requested, submit a revised technical and price quote to the Contracting Officer. The Government may request clarifying information from the Contractor, as it relates to its quote. If an award will be made without conducting discussions, Contractors may be given the opportunity to clarify certain aspects of their quote (e.g., the relevance of the contract, the Contractor's past performance information, and adverse past performance information to which the Contractor has not previously had an opportunity to respond) or to resolve minor or clerical errors. Discussions will not be held with any Offeror determined to be technically unacceptable. The Government reserves the right to make a single award, multiple awards, or no award at all as a result of the solicitation. In addition, the solicitation may be amended or canceled as necessary to meet the Government’s requirements. A tradeoff process shall be used for this acquisition because it has been determined to be in the best interest of the Government to consider award to other than the lowest priced Offeror or other than the highest technically rated offeror. All evaluation factors other than cost or price, when combined, are more important than cost or price. For this acquisition, the following considerations will be part of the trade-off process: Technical Evaluation Factors including Past Performance, and Price. The evaluation factors are used by the technical evaluation committee when reviewing the technical quotes. The factors below are listed in order of its relative importance for evaluation purposes. 1. Technical Approach We will evaluate a vendor’s technical approach for soundness, practicality, and feasibility to accomplish the tasks and requirements in all Performance Areas of the Statement of Work. We will evaluate the vendor’s technical approach for their ability to meet performance/delivery schedules under the required tasks. Also, we will evaluate their technical proposal on how well it shows a comprehensive understanding of the project’s goals, objectives, and tasks as called for in the Statement of Work (SOW). We will evaluate their understanding of the tasks to be performed, their interrelation and complexity. We will evaluate the vendor’s discussion of anticipated problems and constraints likely to be encountered in performing the work, and their plans, solutions, and approaches to resolving them. 2. Contract Management and Customer Support NIDA shall evaluate the offeror’s ability to provide a high level of customer service, particularly in the area of initial responsiveness and resolution of problems. Specifically, the Government will evaluate the Offeror’s capability to effectively conduct, manage and coordinate the resources to ensure successful performance of the tasks outlined in the Statement of Work. 3. Speed of Service NIDA shall evaluate the offeror’s technical approach for completeness, feasibility, soundness and practicality of the proposed approach and work plan for accomplishing the requirements of the Statement of Work. PAST PERFORMANCE The Offeror should provide past performance information. Past performance information should cover a minimum of one (1) year in relevant services and deliveries of comparable systems. The Offeror should provide at least one reference for any project identified under the experience factor that has a performance period within the past three (3) years. For each reference, the offeror should provide the following: (1) Organization or contracting partner's name; (2) Point of contact's (POCs) name and contact information (i.e., current phone numbers and valid email addresses); and (3) a description that precisely explains the general scope and specific requirements of the contract. Offerors will be evaluated based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. Furthermore, the Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an offeror's performance on a list of contracts but rather the product of subjective judgment by the Government after it considers all available and relevant information. PRICE EVALUATION Offerors price quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques. Price evaluation will not be conducted on any Offeror determined to be technically unacceptable. EVALUATION OF OPTIONS It is anticipated that any contract(s) awarded from this solicitation will contain option provision(s) and period(s). In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s). (x) The provision at FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Products and Commercial Services (DEC 2022), is applicable and incorporated by reference into this solicitation. (xi) The provision at FAR Clause 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (DEC 2022), applies to this acquisition. See Attachment 2. (xii) The provision of FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (JUN 2023), applies to this acquisition. See Attachment 3. (xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement. (xv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses to this solicitation must include clear and convincing evidence of the Offeror’s capability of fulfilling the requirement as it relates to the government requirements stated in this solicitation. Basic cost and price information in the Offeror’s proposal must contain sufficient information to allow the Government to perform a basic analysis of the reasonableness of the Offeror to supply the required goods/services. Any other information or factors that may be considered in the award decision may include such factors as: past performance; special features required for effective service coverage; and prompt payment discount terms. The Contractor shall submit its quote electronically. Offerors MUST verify the valid certifications, registrations, and Representation and Certifications from the System of Award Management (SAM) applications at www.SAM.gov, which may be indicated on the Offeror’s cover sheet. In addition the vendor Unique Entity Identifier (UEI) and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received no later than August 23, 2023, 11:00 AM EST. Late responses may not be accepted. All responses must reference solicitation number 75N95023Q00552. Responses must be submitted electronically to the Contract Specialist, Rob Bailey, at rob.bailey@nih.gov with a copy also to the Contracting Officer, Josh Lazarus, at josh.lazarus@nih.gov. For information regarding this solicitation, please contact Rob Bailey by email at rob.bailey@nih.gov or by phone at 301-451-7586. (xvi) DATE QUESTIONS DUE: Questions and requests for clarification must be submitted electronically to the Contract Specialist, Rob Bailey, at rob.bailey@nih.gov on or before 11:00 AM EST, August 21, 2023. Fax responses will NOT be accepted. ATTACHMENTS Attachment 1 – Statement of Work (SOW) Attachment 2 - FAR 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services (DEC 2022) Attachment 3 - FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services (JUN 2023) Attachment 4 – Invoice and Payment Instructions

Inactive

The National Institute on Drug Abuse – Intramural Research Branch (NIDA-IRP) Clinical Program is seeking Capability Statements from Other Than Small Business organizations to provide the Government su... The National Institute on Drug Abuse – Intramural Research Branch (NIDA-IRP) Clinical Program is seeking Capability Statements from Other Than 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; and (2) 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).