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This statement of work outlines services required to characterize SARS-CoV-2 infection in brain organoids through neurohistological analysis. The contractor shall embed 25 organoids in a single block, uniformly section them, and stain every sixth slide for the SARS-CoV-2 N protein and nucleic acids. Digital images of the stained slides will be delivered along with unused sections. The contractor will also provide infected and fixed organoid samples for analysis. The period of performance is approximately one month following sample delivery. This supports the federal contract opportunity to characterize SARS-CoV-2 infection in organoids under Solicitation Number 75N95023Q00635 issued by the National Institutes of Health National Institute on Drug Abuse.

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9.0.0.2.20101008.1.734229 Statement of Work for Services (SOW) General Information:

Title of Project:

Statement of Need and Purpose:

Background Information and Objective:

Period of Performance:

Scope of Work:

General 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 the Statement of Work below:

Specific Requirements:

Level of Effort:

Government Responsibilities:

Delivery or Deliverables:

Reporting Requirements:

Other Considerations:

Travel:

Key Personnel:

Information System Security Plan:

Data Rights:

Section 508:

Publications and Publicity:

Confidentiality of Information:

Neurohistology of SARS-CoV-2 infected and compound treated brain organoids COVID-19 is a current global pandemic that has resulted in millions of deaths and sickened many more worldwide. It has been thoroughly established that SARS-CoV-2 infection leads to a variety of short and long-term neurological symptoms that present a significant challenge for the healthcare system. TDB aims to use previously established human relevant models that can be used to study SARS-CoV-2 neurotropism to accelerate development of therapeutics. The goal of this project aims to characterize the rate of infection of different SARS-CoV-2 strains in the brain by using neurohistology to quantify the presence of SARS-CoV-2 N protein in brain organoids.

NeuroScience Associates (NSA) a high-throughput neurohistology company which produces unsurpassed quality of stained sections and accelerated image analysis. Their proprietary MultiBrain® technology allows for up to 25 brain samples to be positioned in a single MultiBrain® block which allows all of the brains to be freeze-sectioned at uniform thickness and subsequently stained uniformly. This exclusive embedding process also allows for large format brains, including entire human brain hemispheres, to be embedded, sectioned, stained and mounted, fully-intact. This process preserves local architecture and allows for the most reproducible and reliable quantification of protein markers. In this project, TDB will generate cortical brain organoids infected with different SARS-CoV-2 strains and treated with different compound inhibitors of SARS-CoV-2 infection, which after fixation and sterilization will be delivered to NSA for MultiBrain® block embedding, sectioning and co-staining for one neuronal marker, SARS-CoV-2 N protein and a nucleic acid counter stain. Sections will then be fluorescence digitally imaged and images and remaining unstained sections will be delivered back to TDB for further analysis or additional staining.

The work will take approximately 1 month after sample delivery.

1) Embedding 25 brain organoids into a single block

2) Uniform cryosectioning of brain organoids at 30 um of thickness

3) Preservation, cataloging and organization of slides

4) Staining of every 6th slide with two antibodies, one of which recognizes the SARS-CoV-2 N protein, plus a nuclei acid counter stain

5) Digital imaging of all tissue on each slide at 20x magnification with 3 wavelengths Delivery of 25 infected, fixed and steralized brain organoid samples.

1) Digital images of immunofluorescence stained slides of the 25 organoid samples at 20x with 3 wavelengths.

2) Unused sections of the 25 orgnaoid samples in antigen preserve solution, approximately 30 days after the shipment of the stained slides.

3) Stained slides of the 25 organoid samples.

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Enter the title of your project.:
Include a general narrative of the need of the project and the desired results.:
Include a brief history of the project, the importance of the project, and the overall program objectives.:
Specify base period of performance. If applicable, specify option periods (not to exceed sixty (60) months,) or options for additional quantities.:
Include a detailed description of the technical requirements. Provide sufficient detail to accurately reflect the Government’s requirement. State what is to be accomplished without prescribing the method the contractor is to use, and include performance standards, if applicable. See 307.104(b)(2) and FAR 37.602 for guidance on preparation of a PWS. You may include tasks and subtasks. The degree of breakout depends on the size and complexity of the project. Indicate whether the tasks are sequential or concurrent. Specify requirements clearly so all readers can understand them. Reference only the absolute minimum applicable specifications and standards needed. Tailor specifications and other documents. Separate general information from direction.:
Specify labor category, e.g., scientific writer, editor, senior researcher, etc., and estimated number of labor hours for each period of performance.:
List any government-furnished data, property or facilities; describe the government‘s responsibility for reviewing and approving reports and final products generated under the contract. Specify if the government will provide workspace, desktop computers and telephones for contractor personnel. Specify if the contractor will require access to government facilities and identify the facility location and specific area. Identify any federal holidays or other times when access may be restricted.:
Specify all deliverable requirements. Specify a completion time for the government’s review of the draft deliverable, e.g. within ___ calendar days from date of receipt. Specify the number of business days the contractor has to deliver the final deliverable from date of receipt of the government’s comments. Specify that the timely submission of deliverables is essential to successfully completing this requirement. Specify if deliverables are to be submitted in “hard copy” or “electronic copy.” :
Specify as applicable if the contractor is required to provide written progress reports. Specify the frequency of the reports, e.g. monthly, annually, etc. Specify the reporting periods. Specify what the reports will cover, e.g. accomplishments, problems encountered, problem resolution, unresolved problems, etc. Specify the number of copies required.:
Identify if contractor travel is required in the performance of the SOW. Specify locations involved, number of trips, and duration of anticipated travel. Specify responsibility for travel reimbursement, e.g., the contractor or the Government. If the travel will be reimbursed by the Government, discuss the method of reimbursement, e.g., in accordance with Federal/agency travel regulations. If applicable, state the Government official authorized to approve contractor travel, e.g., the Contracting Officer’s Representative (COR).:
Specify any contractor key personnel by labor category that are considered essential to successful performance of the requirement. :
Specify if the statement of work requires the contractor to (1) develop, (2) access, or (3) host and/or maintain a federal information system(s), the information security policies and procedures that are applicable to the requirement. A "federal information system" is defined as an information system used or operated by an executive agency, by a contractor of an executive agency, or by another organization on behalf of an executive agency. [40 U.S.C., Sec. 11331]:
Specify if data is to be produced, furnished, acquired, or used in meeting the requirement of the SOW. Specify the respective rights and obligations of the government and the contractor regarding the use, production, and disclosure of that data. Specify who will have limited or unlimited rights. :
Specify if the contractor is required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW. Specify if the EIT will be used by 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. Specify if the public will have access to the EIT. :
Specify if the government will provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential. Specify if the contract is expected to generate information or data which is confidential. Specify how the contractor should handle information or data prior to any release, disclosure, dissemination, or publication.:

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