Tolerability studies of candidate AD drugs and efficacy of Poly(L-lysine succinylated)-hydroxychloroquine (PLS-HCQ) in a transgenic AD mouse model

(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 75N95022Q00316 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; FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items; and FAR Part 12'Acquisition of Commercial Items, and is not 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 2022-06, with effective date May 26, 2022. (iv) The associated NAICS code 541380 and the small business size standard is $16.5 million. This requirement has no set-aside restrictions. (v) This requirement is for the following services: Tolerability studies of candidate AD drugs and efficacy of Poly(L-lysine succinylated)-hydroxychloroquine (PLS-HCQ) in a transgenic AD mouse model. (vi) There is currently a pressing need to identify effective treatments for Alzheimer's disease (AD). With the repeated failures of multiple pivotal phase-III clinical trials in patients with AD, it is critical to test novel methods of discovering disease-modifying AD treatments. As part of two ongoing studies called the Drug Repurposing for Effective Alzheimer's Medicines (DREAM) study and the Experimental Validation of candidate Alzheimer's disease treatments identified by multi-omics analyses (PREVENT-AD) study, in addition to two ongoing contracts, the National Institute on Aging (NIA) Intramural Research Program (IRP) is testing the utility of commonly prescribed, FDA-approved drugs that may be repurposed as - candidate AD treatments. The proposed acquisition will build on this work to test 1) tolerability of candidate AD drugs in the 5x-FAD transgenic mouse model of AD to determine their optimal dosing in efficacy studies; and 2) the in vivo efficacy of Poly(L-lysine succinylated)-hydroxychloroquine (PLS-HCQ) in a transgenic AD mouse model. Please see the attached Statement of Work (SOW) for detailed requirements. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is: 9/30/2022 - 9/29/2025 (viii) 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 52.212-1, Instructions to Offerors-Commercial Items (NOV 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (NOV 2021) FAR 52.222-22 Previous Contracts and Compliance Reports (FEB 1999) 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 Items (NOV 2021). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.227-14, Rights in Data - General (MAY 2014) 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 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 (MAY 2022) The following are also attached, however only one will be incorporated in the final award: Invoicing Instructions With IPP 4-21-22 Invoicing Instructions Without IPP 4-21-22 (ix) 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: (i) technical capability to meet the Government's requirements; (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. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (NOV 2021), 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. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (NOV 2021), 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 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 questions must be received by 2:00 pm Eastern Time, on Friday, July 22, 2022, and reference Solicitation Number 75N95022Q00316. Questions may be submitted electronically to contact@example.gov All quotations must be received by 2:00 pm Eastern Time, on Thursday, August 11, 2022, and reference Solicitation Number 75N95022Q00316. Responses must be submitted electronically to contact@example.gov. Fax responses will not be accepted.