Inactive

Title: iNDI ALFAtag cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format i... Title: iNDI ALFAtag cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project (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 75N95025Q00078 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2025-03, with effective date January 17, 2025. (iv) The associated NAICS code 621511 and the small business size standard is $41.5 dollars. (v) This requirement is for the following: iNDI ALFAtag cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project See Statement of Work attached. (vi) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 months. The place of delivery and acceptance will be 9000 Rockville Pike,Bethesda, MD 20892 (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 https://www.acquisition.gov/caac-letters (End of provision) The following provisions apply to this acquisition and are incorporated by reference: • FAR 52.204-7, System for Award Management (Nov 2024) • FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) • FAR 52.212-1, Instructions to Offerors-Commercial Items (Sep 2023) • FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2024) (DEVIATION Feb 2025) CAAC_Letter_2025-01_Supplement-1.pdf and CAAC_Letter_2025-02_Supplement-1.pdf 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 https://www.acquisition.gov/caac-letters (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 Items (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached. The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 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 (Jan 2025) (DEVIATION Feb 2025) Per CAAC Letters 2025-01 and 2025-02, FAR 52.222-21, Prohibition of Segregated Facilities and FAR 52.222-26 - Equal Opportunity will not be considered when making award decisions or enforce requirements. • HHSAR 352.239-78, Information and Communication Technology Accessibility Notice (Feb 2024) (DEVIATION) • HHSAR 352.239-79, Information and Communication Technology Accessibility Notice (Feb 2024) (DEVIATION). FAR DEVIATION STATEMENT: The CAAC Letter 2025-01-Supplement 1 and CAAC Letter 2025-02-Supplement 1 are applicable to this acquisition. System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM. The mentioned CAAC Letters may be accessed electronically at this address: CAAC Letters | Acquisition.GOV. • NIH Invoice and Payment Provisions (Mar 2023) (viii) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, 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: (i) technical capability of the item offered to meet the Government requirement; (ii) past performance [see FAR 13.106-2(b)(3)]; (iii) price. Technical and past performance, when combined, are significantly more important than price. (b) 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) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2024) (DEVIATION Feb 2025), 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. See DEVIATION STATEMENT above regarding applicable CAAC Letters. (x) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2023), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include past performance, special features required for effective program performance, trade-in considerations, probable life of the product selected as compared with that of a comparable product, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a subcontracting plan by other than small business offeror(s) is a requirement as a part of the proposal submission process and is to be submitted separately from the technical and cost proposals. An offeror's subcontracting plan must be determined to be acceptable, by the Contracting Officer, prior to the contract award. Offerors are required to submit a subcontracting plan electronically using the US Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system via the link below: https://osdbu.hhs.gov/subcontracting/92f6fa1a-655a-4ffc-9c77-5fe7c8697fb4 The official point of receipt for determining timely submission of an offeror’s subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted in the SBCX system the offeror should receive an email notification and confirmation message of completion upon submission. If an offeror's subcontracting plan is not confirmed as received within the SBCX system by the proposal submission date specified in the solicitation, it will be considered late. Disposition of late submittals of a subcontracting plan by an offeror via the SBCX system is at the discretion of the Contracting Officer. See attached document “SBCX Industry Subcontracting Guide” for additional information. The Dun & Bradstreet Number (DUNS), 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 quotations must be received by Tuesday April 15, 2025 at 12:00 pm Eastern Time and must reference solicitation number 7N95025Q00078. Responses must be submitted electronically to Andrea Clay, Contract Specialist, at amcgee@nida.nih.gov Fax responses will not be accepted. (xiv) The name and of the individual to contact for information regarding the solicitation: Andrea Clay Contract Specialist amcgee@nida.nih.gov

Inactive

• Solicitation Number: 75N95025Q00078 • Title: iNDI ALFAtag cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project • NAICS Code: 325414 • PSC: 6550 Description: This is a Small Busi... • Solicitation Number: 75N95025Q00078 • Title: iNDI ALFAtag cell lines for the iPSC Neurodegenetive Disease Initiative (iNDI) project • NAICS Code: 325414 • PSC: 6550 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; (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; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. 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: Purpose and Objectives: The purpose of this acquisition is to generate a collection of up to 230 isogenic Alzheimer's disease and related dementias (ADRD) iPSC cell lines harboring a WT-ALFAtag or SNV-ALFAtag in the KOLF2.1J cell line. Description: The Contractor shall provide genetically engineered iPSCs for the purpose of creating a national cell repository as an open resource for the scientific community and as a tool to characterize how mutations change fundamental biological properties of disease-relevant cell types. These lines will harbor a fluorescent ALFAtag to visualize the tag and single nucleotide alleles through microscopy approaches. The cell line development and QC reporting should be consistent with other project data that has been collected from the iNDI project. Specific Requirements: 3-6 independent heterozygous clones will be recovered for each project and screened to identify the candidate lead clone. The Contractor should target the below numbers for each cell type: - 70 WT-ALFAtag projects - 160 SNV-ALFAtag projects Platforms used by vendor must include: Amaxa4D nucleofection system to facilitate editing human iPSCs. The vendor shall also provide QC results on all engineered clones that will include Sanger sequencing, imaging validation via antibody staining and imaging on an OperaPhoenix system, mycoplasma testing, long read sequencing, and array-based genotyping using a high-density Illumina SNP arrays in a CLIA-certified laboratory. Where appropriate, on-target analysis by PCR and sequencing should be performed and results reported. All data must be compatible with existing iNDI cell line data. To accomplish these requirements, the Contractor will provide dedicated laboratory staff to develop cell lines and also a computational scientist to analyze the data. LEVEL OF EFFORT: Vendor staff shall provide clones after engineering and QC/QA information that includes the description of genetic modification and associated IDs, primer sequences for genotyping, quality control data (Sanger sequence traces of the edited allele and results of karyotype and array analysis). GOVERNMENT RESPONSIBILITIES The government will provide a list of selected mutations to vendor for cell line engineering. DELIVERY OR DELIVERABLES Each clone will be expanded and archived in quadruplicate 96-well Matrix™ storage plates each containing 8 vials of the heterozygous clone. One lead clone will be identified that is verified by the below QC measures. REPORTING REQUIREMENTS The vendor is to provide documentation regarding: a. General method of engineering employed for each line, including information about the nuclease used and protein/plasmid based delivery (e.g. WT spCas9 RNP, TALENs, plasmid-based CRISPR, etc) b. Sanger sequencing for each iPSC line c. Next Generation sequencing results for each line d. cDNA genotyping for each line e. Imaging validation on an OperaPheonix system for each iPSC line f. SNP Array results from a CLIA-certified laboratory for each iPSC line OTHER CONSIDERATIONS The principal place of performance is the vendor’s work site. Travel for contractor employees will not be necessary. KEY PERSONNEL Vendor will provide a dedicated project manager to the government as a point of contact for the services. Period of Performance: 12 months Capability statement /information sought. Contractors that believe they possess the ability to provide the requirement should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The response should directly and specifically state in the, capabilities statement, which project requirements you can supply. Contractors must also provide their Company Name, DUNS Number, Physical Address, Point of Contact, and Size and Type of Business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. 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 an 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. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses (capability statements) sent in response to this Small Business Sources Sought Notice must be submitted electronically (via e-mail) to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Andrea Clay, Contract Specialist at e-mail address amcgee@mail.nih.gov and Karen Mahon, Contracting Officer at karen.mahon@nih.gov. The response must be received on or before December 27, 2024 at 12:00PM, 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 Federal Business Opportunities. 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).”