Proteomic Analysis Services 75N95025R00048

SOURCES SOUGHT NOTICE Solicitation Number: 75N95025R00048 Title: Proteomic Analysis Services Classification Code: Q Medical Services NAICS Code: 621991 Blood and Organ Banks Size Standard: $40M 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 to perform this potential Research & Development (R&D) requirement; (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. Small Businesses are encouraged to respond. 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. Background: The NIH Intramural Center for Alzheimer s Disease and Related Dementias is an interdisciplinary initiative that is dedicated to advancing our understanding and treatment of Alzheimer s disease and related dementias (AD/ADRD). Biomarkers play a critical role in understanding, diagnosing, and monitoring disease progression and therapeutic efficacy. Purpose and Objectives: The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Institute on Agign (NIA), has a requirement for proteomic analysis services. This requirement for NULISA testing aims to identify biomarkers which will provide information about underlying molecular changes associated with Alzheimer s Disease and Related Dementias in well characterized samples from patients. Project requirements: Qualified sources independently and not an agent of the Government, qualified sources will be required to furnish all the necessary labor (qualified and experience personnel), services, material, equipment, supplies, and facilities, not otherwise provided by the Government, as needed to perform the requirements set forth below and shall use state -of-the-art methodologies and protocols to achieve all of the requirements. Qualified sources should have the ability to: Provide NuLISA CNS panel proteomic analysis per the specifications below: Vendor shall analyze cohorts independently, but all within the same batch of reagents to ensure consistency. Vendor shall run pooled Government samples with known analytes on each plate for normalization during quantification of proteins and library preparation. Vendor shall include a NuLISA (QC) bridging cohort to assess analytical performance over time and normalize datasets. Vendor s QC bridging cohort (n=30) shall be matched to the biofluid of interest whether cerebrospinal fluid (CSF) or EDTA plasma. Vendor s QC bridging cohort shall be used over multiple Government sample cohorts to ensure data set harmonization among cohorts. Vendor s QC bridging cohort shall control for changes in lots and between cohorts for batch correction. Vendor s quality control measures shall include a NuLISA plate for external controls, and internal vendor controls to control for individual plate variance. Vendor shall have the throughput capacity to prepare NuLISA libraries for up to 2,400 samples per week. Vendor shall perform whole-genome sequencing of libraries using Illumina NovaSeq 2000 platform, utilizing 150 bp paired-end sequencing Vendor shall perform raw sequencing data in FASTQ format via secure cloud server within two weeks of receiving the prepared libraries Vendor shall perform quality control checks on the data and communicate final results to the Government within an additional two weeks, provided all QC benchmarks are met. SEED AMPLIFICATION ASSAY (SAA): Vendor shall perform proteomic analysis using the Amprion platform. Vendor s reagents shall be tested and verified prior to running the SAA. They will be assessed across a set of standards with positive and negative controls. Vendor s run lengths shall be run long enough to obtain data for Alzheimer s Disease, Multiple System Atrophy, Parkinson s Disease and Dementia with Lewy Bodies. Vendor s SAA data shall be reported so that kinetic information is included, as well as positivity and negativity. Vendor shall run samples with enough replicates to eliminate ambiguity with the majority of samples. Vendor shall demonstrate proficiency with CSF and plasma samples from subjects with neurodegenerative disease and provide evidence of successful data analysis among several diseases and cohorts. Anticipated period of performance: The anticipated period of performance for this requirement is one (1) 12-month base period and two (2) 12-month option periods. Capability statement /information sought: Companies that believe they possess the capabilities to provide the required products or 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. Submission Instructions: 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 Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Robin Knightly, Contracting Officer, at e-mail address Robin.Knightly@nih.gov. The response must be received on or before September 4, 2025, at 9:00 a.m. Eastern Standard 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).

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE Solicitation: 75N95025R00048 Title: Proteomic Analysis Services INTRODUCTION PURSUANT TO FAR Subpart 5.2 Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), National Institute on Aging (NIA) intends to intends to solicit by a request for quotation from Banner Sun Health for award on or around September 15, 2025. The purpose of this purchase order will be to provide the National Institute on Aging (NIA) with proteomic analysis services. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 621991 Blood and Organ Banks with a Size Standard of $40M. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the current Federal Acquisition Circular (FAC). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 Simplified Acquisition Procedures. Contracts awarded using FAR Part 13 Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6 Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single Source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). DESCRIPTION OF REQUIREMENT Purpose and Objectives The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Institute on Agign (NIA), has a requirement for proteomic analysis services. The NIH Intramural Center for Alzheimer s Disease and Related Dementias is an interdisciplinary initiative that is dedicated to advancing our understanding and treatment of Alzheimer s disease and related dementias (AD/ADRD). Biomarkers play a critical role in understanding, diagnosing, and monitoring disease progression and therapeutic efficacy. This requirement for NULISA testing aims to identify biomarkers which will provide information about underlying molecular changes associated with Alzheimer s Disease and Related Dementias in well characterized samples from patients. Delivery or Deliverables Please see the attached Statement of Work for further details. CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.www.sam.gov. All responses must be received by Thursday, September 4, 2025 at 9:00 a.m., Eastern Standard Time, and reference number 75N95025R00048. Responses may be submitted electronically to Robin Knightly, Contract Specialist, at Robin.Knightly@nih.gov. Fax responses will not be accepted. Extensions to the deadline will not be granted. Please contact Robin Knightly, Contract Specialist, at Robin.Knightly@nih.gov or (301) 827-5302 with any questions.