Inactive
Notice ID:75N95023R00071
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 avai...
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; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). 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 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. 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 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. Background: Dr. Leggio's NIDA Clinical Psychoneuroendocrinology (CPN) laboratory, jointly with NIAAA, conducts clinical and translational inpatient and outpatient studies to identify possible novel medications for addiction. His group uses a combination of state-of-the-art, innovative biobehavioral and pharmacological procedures performed under well-controlled human laboratory conditions. Dr. Leggio and his team are particularly interested in the role of neuroendocrine pathways in alcohol- and drug-seeking behaviors and identifying novel effective pharmacotherapies in this regard. Previous literature supports the overall hypothesis that both baclofen and spironolactone may have beneficial effects on HIV-related outcomes in PLWH and comorbid alcohol and substance use disorders (ASUDs) by decreasing HIV RNA levels, increasing CD4 count, improving retention on antiretroviral therapy (ART), and improving liver function. We aim to conduct pharmacoepidemiological studies using state-of-the-art methods leveraging longitudinal electronic health record data from the Veterans Aging Cohort Study (VACS). We will apply approaches consistent with the emerging role of data science in biomedical research and with cutting-edge pharmacoepidemiologic approaches, which have been used in other fields and recently gained traction in the addiction field. Robust pharmacoepidemiology analyses have the potential of expanding our real-world understanding about the relationship between ASUD and HIV-related outcomes and identifying early efficacy signals with medications that can then be tested in prospective randomized controlled trials. Purpose and Objectives: The National Institute on Drug Addiction (NIDA), Clinical Psychoneuroendocrinology (CPN) laboratory, is seeking consulting support to provide data extraction, management, analysis, and report of a propensity-score matched pharmacoepidemiological study of baclofen and spironolactone, prescribed for any indication, on HIV- and ASUD-related outcomes in a general patient population and a naturalistic setting, using the Veterans Aging Cohort Study (VACS). The contractor should abide by outlined standards of only sharing De-identified data if and when necessary. Sharing requires approval of the research proposal. Only aggregate information and data will be shared with the NIH research team. No personal identifiable information or raw data will be shared with the NIH research team. Project requirements: A Capable Offerors must demonstrate its ability to provide the following: Using electronic health record data from the VACS, the Contractor shall provide data analysis of the association between baclofen and spironolactone receipt (prescribed for any indication) and HIV- and ASUD-related outcomes in adults. Individuals exposed to baclofen and spironolactone shall be propensity-score matched to up to five unexposed individuals, based on parameters provided by the NIDA COR, and multivariable linear regression models shall be used to estimate changes in HIV- and ASUD-related outcomes before and after exposure. Per each study, pharmacy records shall be extracted to identify patients who did and did not receive the medication under investigation dispensed at VA pharmacies. Exposure to the medication is defined as receipt of two or more fills for a minimum number of continuous days (determined as part of the analysis), for any indication, from VA outpatient clinics. For unexposed comparators, patients who attended at least one of the same clinics, but never received the medication, should be selected, ensuring that unexposed patients came from the same source population, were exposed to an overall similar medical care, and had equal opportunities to receive the same medication. To balance the distribution of all potential confounders across treatment groups, the Contractor shall apply propensity score approaches (e.g., matching, weighting) in consultation with the NIDA research team. This shall be done by first modelling 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. To assess balance, absolute standardized mean differences (SMD) shall be calculated and interpreted in consultation with the research team. Variables included in the propensity score model should be guided by previous work in this field and using the same database. Therefore, given timeline restrictions and the important of research integrity/replication, it is required that the Contractor possess full access to the VACS data and other sources needed for these analyses, as well as an already built data analysis pipeline as a necessary requirement. 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 the analyses and reviewing aggregate results with the NIH research team, and drafting the methods use and detailed results. The NIH research team will lead the development of the manuscript for publication. Period of Performance: 12 months from date of award with four 12 month option periods. Other important considerations: Mandatory Criteria: Given timeline restrictions and the important of research integrity/replication, it is required that the Contractor possess full access to the VACS data and other sources needed for these analyses, as well as an already built data analysis pipeline. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products/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. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). 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 information submitted may 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. All responses to this notice must be submitted electronically to the Contracting Officer Identified below. The response must be received on or before August 10 at 2:00 p.m. 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).”
