Inactive

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This annou... (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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 75N95024R00041 and the solicitation is issued as a request for proposal (RFP). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-03, with effective date 2/23/2024. (iv) The associated NAICS code 541380 and the small business size standard is $19 Million. This requirement is full and open with no set-aside restrictions. (v) This requirement is for the following services: See “Attachment 1 - HCR FISH Statement of Work” (vi) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance consists of a base year with one 12-month option period as follows: Base year: 4/29/2024 – 4/28/2025 Option Period 1: 4/29/2025 – 4/28/2026 (vii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders – Representation and Disclosures (Dec 2023) FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (Feb 2024) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached. FAR Clause 52.217-9, Option to Extend the Term of the Contract (Mar 2000). The Government may extend the term of this contract by written notice to the Contractor provided that the Government gives the Contractor a preliminary written notice of its intent to extend prior to the expiration of the contract. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended contract shall be considered to include this option clause. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 24 months. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions below and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Feb 2024) NIH Invoice and Payment Provisions (viii) The provision at FAR clause 52.212-2, Evaluation – Commercial Items (Nov 2021), applies to this acquisition. (a) 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. The following factors shall be used to evaluate offers: technical capability of the services offered to meet the Government requirement; (ii) price; (iii) past performance [see FAR 13.106-2(b)(3)] Technical and past performance, when combined, are significantly more important than cost or price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (ix) Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (Nov 2023), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (x) The following information security requirements apply to this acquisition and are included as an attachment: See “Attachment 2 - HCR FISH - Information Security Requirements” (xi) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xii) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), 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 offers must be received by 4:00 p.m., Eastern Standard Time, on April 18, 2024, and reference Solicitation Number 75N95024R00041. Responses must be submitted electronically to Eric McKay, Contracting Officer at eric.mckay@nih.gov. Fax responses will not be accepted.

Inactive

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 capabil... 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. 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: TDP-43 is an RNA-binding protein that plays a key regulatory role in amyotrophic lateral sclerosis (ALS) and frontotemporal degeneration (FTD) cases. The field is currently able to detect and quantify TDP-43 pathology only by assessing brains post-mortem and attempts to directly measure TDP-43 in biofluids have not yet been successful. The Inherited Neurodegenerative Disease Section (INDS) developed an ultra-sensitive modified smFISH technique to detect cryptic exons in proteins regulated by TDP-43 in fixed human mutated iPSC neurons. We hypothesize that brain-derived extracellular vesicles (EV) carry these cryptic exons and may serve as a reservoir of these biomarkers at distant body sites, such as within the cerebrospinal fluid (CSF) or the bloodstream. To this end, we plan to develop methods to detect EV-associated cryptic exons, first in iPSC neuron models and ultimately in CSF and blood samples. Purpose and Objectives: The contractor shall assist in applying the ultra-sensitive platform technology for capture and imaging of single extracellular vesicles (EVs), as well as optimize smFISH technology developed by INDS. Project requirements: To achieve our aim, the Contractor shall: Manage the receiving of (up to 200) CSF samples, and provide safe storage at vendor’s facility, including keeping all samples at -80C and preventing repeated freeze/thaw cycles. The contractor should provide a research fellow at 30% effort for 6 months per year and a research assistant at 100% effort for 12 months per year to perform the work associated with this contract. Provide relevant protocols and material lists associated with the Government’s samples to the Inherited Neurodegenerative Disease Section. Provide regular updates on processing of Government’s samples to ensure adequate progress is being made. Provide the analyzed data and associated summary reports in electronic form. Apply methods to fix and permeabilize EVs for RNA labeling and imaging inside programmable microchannels. Optimize fixative selection and duration of fixation to improve sensitivity of cryptic exon detection. Apply methods to detect EV-associated cryptic exons in STMN2 with fluorescent dye-conjugated RNA probes using iPS cell-derived neuron models with or without TDP-43 depletion via CRISPR inhibition. The primary modality for RNA detection is HCR FISH. Team will test combinations of single probes and multiple probes to identify parameters that result in the highest sensitivity of cryptic exon detection, ideally with co-detection of the native transcript for the CE gene. Additional parameters to optimize include temperature at different steps of the procedures, durations of individual steps, washing parameters, and imaging parameters. Apply these methods to detect the STMN2 cryptic exons in CSF samples from patients with ALS or FTD compared to age-matched control patients. These experiments will leverage methodological details that are defined in A and B, but will be adjusted as needed to improve sensitivity and specificity of CE detection in CSF. Initial optimizations will be performed on pooled samples from cases and controls. Apply these methods to detect the STMN2 cryptic exons in plasma samples from patients with ALS or FTD compared to age-matched control patients. These experiments will leverage methodological details that are defined in A and B, but will be adjusted as needed to improve sensitivity and specificity of CE detection in CSF. Additional variables to test include optimization of EV capture, including the use of antibodies that enrich/select for CNS-derived EVs. Initial optimizations will be performed on pooled samples from cases and controls. Based on the results of the initial 200 CSF samples, an additional 100 samples may need to be analyzed in the same fashion as the original 200. Anticipated period of performance: The anticipated period of performance consists of a base year with one 12-month option period as follows: Base year: 2/1/2024 – 1/31/2025 Option year 1: 2/1/2025 – 1/31/2026 Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition. In case domestic sources are available and capable of fulfilling the Government’s need, and a future solicitation is published, the Government will use evaluation preferences in accordance with FAR 25. 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 Eric McKay, at e-mail address eric.mckay@nih.gov The response must be received on or before January 19, 2024, at 4:00 pm, 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).