Inactive

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 regar... 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: Alzheimer's disease (AD) and related dementias affect >50 million people worldwide. Although people from all ethnicities are affected, most of our current understanding of the etiology, pathophysiology, phenotypic diversity, and progression of AD comes from research in European ancestry participants from the U.S. and Europe. This situation limits the generalizability of research findings and their potential translation to underrepresented groups, even within ethnically and culturally diverse countries such as the U.S., exacerbating existing health disparities. In Mexico, there are more than 15 million people aged 60 or older. Epidemiological studies estimate the prevalence of Alzheimer's disease in 7.3%, with an incidence of 27.3 per 1,000 people/year, with a higher prevalence among women and those with metabolic syndrome, cardiovascular disease, or depression. Current projections are that there will be >3.5 million AD patients in the country by 2050, having a significant impact on the healthcare system. Clinical, genetic, and biomarker studies of AD in the Mexican population are limited or inexistent and have been cross-sectional in small samples and focused mainly on the Mexico City Metropolitan Area population. Purpose and Objectives: The proposed research seeks to establish a multicentre cohort study in Mexico and characterize AD patients’ clinical, genetic, and phenotypic diversity in the admixed Mexican population, a group with unique genetic admixture and environmental exposures that is underrepresented in AD research. First, the Contractor shall determine the genetic substructure and familial contributions to AD in Mexico. This will advance efforts to treat AD in patients with rare mutations. Second, by assembling this large cohort, the Contractor shall work to establish a preliminary Mexican-specific polygenic risk score (PRS) for predicting AD risk in future samples. Project requirements: The Contractor shall be responsible for properly protecting all information used, gathered, or developed. The Contractor shall establish and implement appropriate administrative, technical, and physical safeguards to ensure the security and confidentiality of sensitive data, including personal protected identification. To achieve our aim, the Contractor shall: Provide standardized protocols for study implementation, volunteer recruitment, eligibility criteria, informed consent, volunteer tracking, neuropsychological testing, family history, phlebotomy, and specimen shipment across the four clinical sites. Coordinate collection of patient blood or DNA samples from the four clinical research sites in Mexico. Samples will be stored at the clinical sites after collection. The Contractor will then coordinate shipment of the stored patient samples from the sites to CARD. Monitor patient recruitment at each of the four clinical sites and provide patient recruitment numbers to the Government in quarterly reports. Identify case and control samples based on evidence of neurodegenerative diseases or lack thereof. A standardized diagnostic assessment shall be completed for each participant by the physician and entered directly into the REDCap database maintained by the Contractor. Coordinate shipment of patient DNA or blood samples to NIA/CARD for genetic analyses (whole genome sequencing and array genotyping, long-read sequencing on a subset of samples). Perform computational analyses on the raw genotyping and sequencing data for polygenic risk score (PRS), principal component analysis (PCA), case-control studies, genotype and sequence data calling, and basis quality control to ensure data quality and integrity, with consultation and oversight provided by the Government in bi-weekly virtual meetings and on an ad-hoc basis through email communications. The Government will also advise on platform-based results communication, visualization, and dissemination, once sequencing and genotyping results have been analyzed. Provide the analyzed data in electronic form and associated summary reports as specified under “Reporting Requirements and Deliverables”, in order to support derived analyses and publications. Anticipated period of performance: 8/1/2024 thru 7/31/2025 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. 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. 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 Hashim Dasti, Contract Specialist, at e-mail address hashim.dasti@nih.gov. The response must be received on or before August 21, 2023 at 11AM 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 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).