PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE Solicitation: 75N95024R00082 Title: National Institutes of Health (NIH) NeuroBioBank (NBB) Tissue Toxicology Testing Services INTRODUCTION PURSUANT TO... PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE Solicitation: 75N95024R00082 Title: National Institutes of Health (NIH) NeuroBioBank (NBB) Tissue Toxicology Testing 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 of Mental Health (NIMH) intends to intends to solicit by a request for quotation from National Medical Service (NMS) for award on or around August 15, 2024. The purpose of this purchase order will be to provide the National Institute of Mental Health (NIMH) with tissue toxicology testing services. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 621511 – Medical Laboratories with a Size Standard of $32.5M. 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 of Mental Health (NIMH), NeuroBioBank (NBB), has a requirement for tissue toxicology testing services. The National Institutes of Health (NIH) NeuroBioBank (NBB), supported by the National Institute of Mental Health (NIMH), National Institute of Neurological Diseases and Stroke (NINDS), National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), is composed of six (6) Brain and Tissue Repositories (BTRs) that are federated through an IT Portal (www.neurobiobank.nih.gov) to increase coordination and sharing of valuable tissue and data resources. Since its inception in 2013, the NIH NBB has sought to identify ways to centralize services to enhance standardization thereby limiting the variability of specimens obtained by different BTRs. One way is to provide centralized toxicology services for all brains acquired by the NBB BTRs. 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 Monday, July 1, 2024 at 9:00 a.m., Eastern Standard Time, and reference number 75N95024R00082. 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.
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SOURCES SOUGHT NOTICE Solicitation Number: 75N95024R00082 Title: National Institutes of Health (NIH) NeuroBioBank (NBB) Tissue Toxicology Testing Services Classification Code: Q – Medical Services NAI... SOURCES SOUGHT NOTICE Solicitation Number: 75N95024R00082 Title: National Institutes of Health (NIH) NeuroBioBank (NBB) Tissue Toxicology Testing Services Classification Code: Q – Medical Services NAICS Code: 621511 Medical Laboratories Size Standard: $41.5M 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 NBB, supported by the National Institute of Mental Health (NIMH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Neurological Diseases and Stroke (NINDS), the National Institute on Aging (NIA) and the Blueprint for Neuroscience (https://neuroscienceblueprint.nih.gov), National Institutes of Health (NIH) is a network of Brain and Tissue Repositories (BTRs) that are federated through and IT Portal (www.neurobiobank.nih.gov). NBB’s mission is to increase coordination and sharing of valuable tissue and data resources to support biomedical and translational neuroscience research. Since its inception in 2013, the NBB has sought to identify ways to centralize services to enhance standardization thereby limiting the variability of specimens obtained from different BTRs. One way is to provide a centralized tissue toxicology testing services for all subjects acquired by network BTRs. Purpose and Objectives: The purpose of this acquisition is to acquire toxicology screening services to detect the presence and abundance of drugs of abuse, therapeutic drugs, and environmental toxins in human postmortem tissues, including brain, and blood. These data will be provided back to the NIH NBB contractor and will constitute a component of the phenotypic characterization of these tissues which will accompany the donor’s demographic, clinical and pathological data. More importantly this information will inform the design of the scientific investigations undertaken by researchers receiving tissues from the NIH NBB. 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. Additionally and as directed by the COR, the qualified source will be required to work cooperatively with each BTR to receive regular shipments of biospecimens (e.g., tissue, blood, hair) and to provide toxicological analysis and quantitative read-outs on an as-needed basis throughout the contract. Finally, qualified sources will perform toxicology screens, approved by the COR, on a case-by-case basis such that not all tests will be done on all tissues or donors. Qualified sources should have the ability to: Receipt of Samples (Shipping and Receiving and Process/Procedures) The process for receiving samples and return of data to BTR, Neurobiobank, and the NIMH COR is summarized as follows: The Contractor shall receive anonymized samples shipped from the NBB BTRs on a schedule that will be agreed on with the Contractor after the award. The Contractor shall use a chain of custody tracking process to assure that assay results are ascribed to the correct sample. The Contractor shall employ the appropriate assays for specified analyses as directed by the NBB BTR and the COR. The Contractor shall return the assay results to the NBB BTR and to the COR or the COR’s designee on a monthly basis. Toxicological Assays of Human Biospecimens The Contractor shall assay human tissues (primarily post-mortem brain tissue, but also blood and hair) for different drugs (therapeutic and drugs of abuse), (see Appendix One). The Contractor shall be expected to perform a combination of assays on a given tissue, or to assess a particular drug in multiple tissue types (e.g., blood, brain, and hair) according to the needs of the BTRs requesting services and NIH Neurobiobank programmatic priorities, as directed by the COR. The majority of agents to be tested under this program will be therapeutic agents, psychotropic drugs, or drugs of abuse. The Contractor shall be expected to perform confirmatory assays to verify inconclusive findings. Depending on assay complexity, the Contractor shall complete testing within 14 to 28 business days after receiving samples. The Contractor shall destroy all samples following their assay as directed by the COR in accordance with Industry standards. The Contractor shall use state of the art operating procedures for tissue tracking, storage, analysis, and biohazard disposal. Data Management On a monthly basis, the contractor shall provide quantitative results of all toxicological testing performed to the NBB BTR and to the COR or to the COR’s designee(s). These results should be provided electronically on a monthly basis, using a file format and transfer protocol to be determined by the COR. The contractor shall ensure the security and confidentiality of all specimen data throughout its lifecycle (e.g. receipt of the specimens through delivery of quantitative results). The Contractor shall maintain a secure, cumulative electronic database of toxicology test results for no more than one month after data has been returned to the COR or their designee. After one month, results must be archived in a secure database and only made available with permission from the COR until COR directs the results be deleted permanently, or the termination of this contract. Other Important Considerations Protocols and standards at a minimum should meet those set forth in the NCI Best Practices for Biospecimen Resources established by the Office of Biorepository and Biospecimen Research. Section 508 compliance is applicable for all systems housing data. Compliance with the NIH/Office for Human Research Protections (OHRP) guidelines and 45 CFR Part 46, to ensure that the Bank has undergone annual review by the Institutional Review Board (IRB). Information Technology (IT) Security that is compliant with the Federal Information Security Modernization Act of 2014 (FISMA) to ensure security of all data generated over the life of the contract. Appropriate shipping licenses and permits from local, state, federal and international authorities for the safe import, storage and distribution of biological specimens, according to current regulatory guidelines, will be required, as applicable. Procedures and protocols for safe handling of potentially hazardous and infectious materials will be required. Anticipated period of performance: The anticipated period of performance for this requirement is one (1) 12-month base period and three (3) 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 May 20, 2024, 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).”
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