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A--Intent to Sole Source mRNA sequencing

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36C24219Q0983Federal

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The Department of Veterans Affairs (VA) Bronx VAMC intends to award a sole source contract to Novogene for bioinformatics services involving eukaryotic mRNA sequencing related to a research project on proneurogenic treatment for amyloid or tau-based neurodegeneration. Market research determined Novogene as the only capable vendor to provide the proprietary sequencing services needed, including library preparation, sequencing, and quantitative analysis at 30 million raw reads per sample. The project aims to assess the compound BCI-838’s ability to mimic or enhance the cognitive and neurogenic effects of physical exercise in mouse models of Alzheimer's and tauopathies, with subsequent behavioral testing and hippocampal analysis using RNA sequencing. The contract uses a firm fixed price type and the period of performance starts August 12, 2019, with the deliverables being submitted to the James J. Peters VA Medical Center in Bronx, NY. The scope includes standard bioinformatics processing of animal tissue samples without handling patient information, focusing on RNA extraction, sequence analysis, and data quantification. The government will oversee quality assurance and review deliverables but will not conduct meetings with the contractor. Confidentiality and data ownership clauses specify that all results and materials belong to the government, and the contractor must adhere to VA security and Section 508 compliance requirements. The contractor must maintain proper information security and follow all relevant VA policies. The VA reserves the right to terminate the task order at any time, with payment made only for services satisfactorily rendered up to termination.

General Info

VA awards sole source contract to Novogene for RNA sequencing on neurodegeneration research, fixed price.

Agency

N/A

NAICS

541380 - Testing Laboratories and Services

Place of Performance

Not specified

Set-Aside

NONE

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Full Description

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TITLE: A- NOTICE OF INTENT TO AWARD SOLE SOURCE SOL: 36C24219Q0983 DUE: 26 July 2019 at 10:00am EST SET ASIDE: N/A NAICS: 541380 POP START: 8/12/2019 AGENCY: Department of Veterans Affairs - Bronx VAMC POC: Carlton Lunsford, email: contact@example.gov DESCRIPTION: NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT TO Novogene. Market research was conducted and determined that Novogene is the only vendor capable of providing the Novogene service necessary that meet the requirements. All items are proprietary to Novogene and not able to be sourced out to another. This Notice of Intent is not a request for Proposals or Quotations. No solicitation document exists and no telephone or email inquiries will be accepted. No contract award will be made on the basis of proposals, or quotations received in response to this notice. The government MAY consider all Expressions of Interest (EOI) received prior to 26 July 2019. 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. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses to this notice must be emailed to contact@example.gov and received by 10:00AM EST on 26 July 2019. Submitters are responsible for ensuring their EOI reaches the designated contracting officer on-time. Department of Veterans Affairs Proneurogenic Treatment for Amyloid or Tau-Based Neurodegeneration Statement of Work (SOW) A. GENERAL INFORMATION Title of Project: Proneurogenic Treatment for Amyloid or Tau-Based Neurodegeneration Background: Recent studies indicate that physical exercise exerts benefits on cognitive health, at least in part, through effects on hippocampal neurogenesis. Other lines of investigation indicate that physical exercise is essential for the optimum health, differentiation, and tissue integration of therapeutic stem cell implants. The current proposal is focused on assessing the potential ability of this compound, BCI-838, to mimic and/or potentiate the proneurogenic and procognitive effects of physical exercise when studied in either the " A oligomer only" model and a MAPTP301L model of tauopathy. Developing effective treatments for both cerebral amyloidosis and cerebral tauopathy are considered to be within the mission of the RRD section of VA ORD. Scope of Work: The current proposal is focused on assessing the potential ability of the compound BCI-838, to mimic and/or potentiate the proneurogenic and procognitive effects of physical exercise when studied in either the " A oligomer only" model and a MAPT P301L model of tauopathy. In order to assess the potential ability of a Group II mGluR antagonist (BCI-838) to mimic and/or potentiate the proneurogenic and procognitive effects of physical exercise, Borchelt mutant APP KM670/671NL A oligomer only" mice and MAPTP301L tauopathy mice will be undergo 3 mo treatment with either (i) voluntary exercise only, (ii) proneurogenic drug treatment only (Group II mGluR antagonist, BC l-838), or (iii) both. The treated mice will undergo behavioral tests to assess their cognitive performance and anxiety levels. After finishing behavioral tests, their hippocampi will be used for an assay of neurogenesis and RNA seq assay of transcriptome. Because of the implication of brain derived neurotrophic factor (BDNF) in exercise-stimulated neurogenesis, we will also analyze each type of mouse (wild type, A oligomer, tauopathy) for drug or exercise response after crossing with either (i) 616 a floxed/conditional Ntrk2(also known as trkB)-1- mouse or (iii) a floxed/conditional Ntrk2F A. The mouse is engineered such that all trkB signaling is acutely abolished following oral treatment with the drug MPP l. Together, the floxed trkB-/- and the tloxed Ntrk2F 616 A provide scenarios of chronic and acute deficiencies, respectively, of trkB signaling. Period of Performance: The period of performance (POP) shall be as soon as possible: In august 2019. Type of Contract: Firm Fixed Price, Standard bioinformatics analysis, quantification of Eukaryotic mRNA-seq (lib prep & seq & quantitative analysis) (30M raw reads/sample) Place of Performance: The Contractor shall deliver the bioinformatics analysis to the Department of Veterans Affairs, James J. Peters VA Medical Center at 130 W Kingbridge Rd Bronx 10468 B. GENERAL REQUIREMENTS The contractor will provide Eukaryotic mRNA-seq (lib prep & seq & quantitative analysis)(30M raw reads/sample). This service will include the standard bioinformatics analysis, quantification the library preparation from animal tissue samples for the project of Proneurogenic Treatment for Amyloid or Tau-Based Neurodegeneration. C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES See quote Task 1: Regular Communication/Meetings and Recording Decisions No meetings and record decisions will be done with the vendor. Task 2: Project Plan and Procedures RNA extraction from animal tissue samples will be performed for the project of Proneurogenic Treatment for Amyloid or Tau-Based Neurodegeneration. Then, the contractor will perform the Eukaryotic mRNA-seq Include the lib prep & seq & quantitative analysis. Post analysis will be assessed by Researchers. Task 3: Quality Assurance The control plan of the performance will be supervised by Researchers. Task 4: Submit a Confidentiality Plan and Data Security Procedures Not apply Storage and Access to Data Not apply Data Security Patient information will be not handling or storage in this project. D. SCHEDULE OF DELIVERABLES See Attachment A E. INSPECTION AND ACCEPTANCE CRITERIA Final inspection and acceptance of all work performed, reports and deliverables will occur at the place of delivery designated by the COR. Final approval and acceptance of documentation required herein shall be by letter of approval and acceptance by COR. The Contractor shall not construe any letter of acknowledgment of receipt of material as a waiver of review, or as an acknowledgment that the material is in conformance with this SOW. This section will be a part of the Quality Assurance Surveillance Plan (QASP). Note that the table below is directly related to the tasks and deliverables in Section C, Specific Mandatory Tasks & Deliverables above, and Attachment A, Schedule of Deliverables. TASKS Deliverable Standard AQL Method(s) of Surveillance Task 1: Select Personnel Deliverable 1 - Notify VA with justifications and details of essential personnel NA NA NA Task 1: Select Personnel Deliverable 2 Designate an administrative contact NA NA NA Task 2: Regular Communication/Meetings and Recording Decisions Deliverable 3 Attend weekly meetings with the COR and VA study team and keep minutes of discussions NA NA NA Task 3: Project Plan and Procedures Deliverable 4 Develop a project plan and procedures and update to within 15 months of contract award NA NA NA Task 4: Quality Assurance Deliverable 5 Develop a quality control plan and update to within 15 months of contract award NA NA NA Task 4: Quality Assurance Deliverable 6 Develop a data management system to track progress of mailings and to facilitate routine reporting NA NA NA Task 5: Submit a Confidentiality Plan and Data Security Procedures Deliverable 7 Submit a confidentiality plan and data security procedures NA NA NA NA=Not Apply The Government will monitor performance and review deliverables utilizing solicited and unsolicited feedback from all applicable resources as follows: Not apply Months 1-5: Not apply Months 6-13: Not apply Months 6-15: Only in case software needs update F. CHANGES TO STATEMENT OF WORK No changes are allowed G. GOVERNMENT RESPONSIBILITIES Tel/Fax: +1 (555) 000-0000 / +1 (555) 000-0000 TOLL FREE [US Only]: +1 (555) 000-0000 PERSONNEL QUALIFICATIONS: Curriculum Vitae (CVs) or detailed bios are provided for each proposed staff member (see documents attach) Georgina Perez Garcia PhD will performance the animal work and harvest. Georgina Perez Garcia PhD had 12-years experience in animal research demonstrate the appropriate mix and balance of education, academic excellence, training and experience in research. J. SECURITY Information System Security The contractor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The contractor s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA project manager and the VHA Headquarters Information Security Officer as soon as possible. The contractor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation. M. SECTION 508 The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998. In December 2000, the Architectural and Transportation Barriers Compliance Board (Access Board), pursuant to Section 508(2) (A) of the Rehabilitation Act Amendments of 1998, established Information Technology accessibility standards for the Federal Government. Section 508(a)(1) requires that when Federal departments or agencies develop, procure, maintain, or use Electronic and Information Technology (EIT), they shall ensure that the EIT allows Federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by other Federal employees. The Section 508 requirement also applies to members of the public seeking information or services from a Federal department or agency. Section 508 text is available at: http://www.opm.gov/HTML/508-textOfLaw.htm http://www.section508.gov/index.cfm?FuseAction=Content&ID=14 N. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables and all associated working papers, application source code, and other materials deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 2. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted in writing to the CO for response. 3. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. 4. The Contractor will sign a National Business Associate Agreement with the VA, in accordance with the mandated guidelines. O. RIGHTS IN DATA Performance of this effort may require the contractor to access and use data and information proprietary to a Government agency or Government contractor which is of such a nature that its dissemination or use, other than in performance of this effort, would be adverse to the interests of the Government and/or others. Contractor and/or contractor personnel shall not divulge or release data or information developed or obtained in performance of this effort, until made public by the Government, except to authorize Government personnel or upon written approval of the Contracting Officer (CO). The contractor shall not use, disclose, or reproduce proprietary data that bears a restrictive legend, other than as required in the performance of this effort. Nothing herein shall preclude the use of any data independently acquired by the contractor without such limitations or prohibit an agreement at no cost to the Government between the contractor and the data owner which provides for greater rights to the contractor. The Department of Veterans Affairs shall have unlimited rights to and ownership of all deliverables provided under this effort, including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic award as well as and any optional task deliverables that are exercised by the Contracting Officer. The definition of unlimited rights is contained in Federal Acquisition Regulation (FAR) 27.401, Definitions. P. TASK ORDER TERMINATION VA has the right to terminate (in whole or in part) this task order at any time in accordance with the termination clauses of the governing GSA Schedule Contract. The Contractor will be paid only for the services rendered up to the point of receiving the termination notice, and then only to the extent that those services meet the requirements of this SOW.

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