Inactive

Amendment 1: Refer to the attachments: Document entitled Amendment 1 (questions and responses) and the revised Statement of Work. (i) This is a combined synopsis/solicitation for commercial items prep... Amendment 1: Refer to the attachments: Document entitled Amendment 1 (questions and responses) and the revised Statement of Work. (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 75N95021Q00414 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 2021-07, with effective date September 10, 2021. (iv) The associated NAICS code 541990 and the small business size standard is $16.5 million. No set-aside restriction is applicable. (v) Background and Objectives: The purpose of this requirement is to acquire the expertise of two epidemiologists/statisticians and one post-doc scholar who know the UK Biobank well to provide expertise and assistance for data usage and analysis. Motor slowing predicts mild cognitive impairment and Alzheimer’s disease (AD) up to 12 years later. Potential mechanisms for this relationship include brain oxidative stress related to mitochondrial dysfunction and iron deposition, but data that connect these factors with brain health in humans is scarce. The overall goal of the project is to determine the roles of two potentially important mechanisms that may be contributing to the development of dementia with or without motor impairment in a large and exceptionally risk UK Biobank (UKB) dataset. An advanced understanding of these mechanisms could lead to identifying prognostic biomarkers and new opportunities to intervene to prevent or slow dementia pathologies. (vi) Project Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform in the attached Statement of Work (SOW). The Contractor shall provide expertise and assistance for data usage and analysis in UK Biobank, generate analysis plan and results, and interpret results. Specifically, develop statistical analysis plans, perform statistical analyses, and interpret findings for three specific aims: (1) to examine whether copy number and heteroplasmy load predict incident Alzheimer’s disease (AD) dementia in UK Biobank, to identify genetic variants associated with mitochondrial copy number and heteroplasmy load, and to examine whether mitochondrial-related Genetic Risk Scores predict AD dementia. (2) to examine whether brain iron deposition predicts AD in UK Biobank, to identify genetic variants associated with brain iron deposition, and to examine whether brain iron deposition-related Genetic Risk Scores predict incident AD dementia. (3) to examine shared causal pathways between mitochondrial dysfunction, brain iron deposition and AD diagnoses. The proposed project utilizes several sources of data linked to the UK Biobank study to address the aims of the work; investigating the role of two potentially important mechanisms (iron accumulation and mitochondrial dysfunction) that may be contributing to the development of dementia associated with or without motor impairment. This shall require extensive linkage of genetic, anthropometric, cognitive, MRI, and electronic medical records data from primary care and from hospitals. To successfully meet the objectives of the project, reliable and meaningful analysis of UK Biobank data is critical. The Government seek experts in the analysis of UK Biobank data to provide a constructive service to the NIA IRP scientists who are leading this project. The contractor shall have a proven track record in the integrated analysis of iron accumulation (especially the iron-overload disease hemochromatosis), dementia, genetics, brain MRIs, and UK electronic medical records (both hospital episode statistics, and primary care) in UK Biobank itself. Familiarity with the UK health system, to support valid analysis of primary care and hospital data, is critical. Additionally, the contractor shall have expertise applying advanced causal analysis methods (Mendelian randomization, genetic correlation) in UK Biobank. Expertise for mitochondrial dysfunction exists at NIA as part of the applicant team. The contractor shall work closely with the NIA team to apply these methods to UK Biobank; a track record is essential to ensure the successful delivery of the project. Specific experience in the topics of brain iron accumulation with aging, dementia, aging, and genetics of chronic diseases and longevity shall be considered preferentially critical in the selection of the best offer. (vii) Level of Effort: Two epidemiologists/statisticians and one post-doc scholar who have extensive research experiences using UK Biobank data with a track record of publications in the integrated analysis of iron accumulation, dementia, genetics, brain MRIs, and UK electronic medical records. The contractor is required to provide expertise and assistance for data usage and analysis in UK Biobank. The contractor may indicate in their proposal the need of other personnel resources to accomplish the scope of the contract (for example a research fellow) and include the relative price. (viii) Government Responsibilities: The Government will provide scientific expertise in measurements of mitochondrial DNA copy number and heteroplasmy load. Delivery or Deliverables: The contractor shall provide written documentation to describe statistical analysis plans, results, and interpretation. The contractor shall also provide related table and figure results and abstract/manuscript drafts. (ix) Reporting Requirements: The contractor shall submit via e-mail as PDF or MS Word document progress report every month during the contract period. The progress report shall include tasks completed since submission of the last progress report and a list of tasks to be completed, inclusive of timeframe. This report shall also describe any problems that arose and state the resolution or provide an explanation if a solution was not identified. (x) Anticipated Period of Performance: The period of performance for this contract: Base period: 12 months from the date of award with two (2) Optional periods. Option period 1: End of Base period through 12 months. Option period 2: End of Option period 1 through 12 months. (xi) The Government anticipates award of a firm fixed-price purchase order for this acquisition. (xii) 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 (Jun 2020) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Aug 2020) FAR 52.225-4, Buy American-Free Trade Agreements-Israel Trade Act Certificate (May 2014) 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 (Oct 2018). Addendum to this FAR clause applies to this acquisition and is attached. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 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 quote. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) 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 2021) FAR 52.223-99 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors (Oct 2021) (Deviation) HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS NIH Invoice and Payment Provisions/Instructions for Submitting Electronic invoices (xiii) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (xiv) The Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. (xv) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xvi) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xvii) 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 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 from responsible sources must be submitted electronically (by email) to Fred Ettehadieh, Contracting Officer, at fred.ettehadieh@nih.gov by the closing date and time of this solicitation, and reference Solicitation number 75N95021Q00414. Fax responses will not be accepted. (xviii) All responses must be received by the specified closing date and time in order to be considered.