Final SOW.pdf

Statement of Work (SOW)

Title: BayesiaLab Professional Edition, Continental Token

(Brand Name or Equal)

INTRODUCTION

Background

The primary function of the Food and Drug Administration (FDA) is to promote public health associated with the use of foods, dietary supplements, cosmetics, drugs, tobacco, and other products under its jurisdiction. FDA's Center for Tobacco Products (CTP) implements PL 111-31, the Family Smoking Prevention and Tobacco Control Act that was signed into law on June 22, 2009. The Tobacco Control Act grants FDA authority to regulate the manufacturing, marketing, and distribution of tobacco products to protect the public health.

• Several research projects being conducted by the Statistics Branch in the Office of Science (OS) of the Center for Tobacco Products (CTP) require access to software that allows the development and generation of structural network models through Bayesian Network Analysis.

The software is required to estimate dependencies between variables in a system without distinguishing between dependent and independent variables. The software provides a comprehensive machine environment which allows integration of external code and interactive sharing of models and presentations with external researchers. The software allows models developed by CTP to be transferred to the World Wide Web for user-friendly public use.

This software will be used for the following future projects:

• Population health modeling for tobacco-related mortality and disease rates in the U.S. population as a function of either population-level tobacco-use rates or networks between individuals

• Development of disease risk assessment models from toxicological data.

• Development of models to estimates and predict tobacco use rates in the U.S. population.

• Convert programs previously developed in BayesiaLab to SAS and R code to facilitate sharing with internal and external researchers.

Objectives

The software will be utilized to explore, model, analyze, simulate, and optimize subgroup identification and selection algorithms for precision medicine. Software must be approved on the FDA Master Approved Technologies (MAT) List.

SCOPE

Contractor shall provide the following:

Software salient characteristics: BayesiaLab Professional Edition, 2 single-user/single-machine licenses (Brand Name or Equal):

Note: A Single-User/Single-Machine (SUSM) License is tied to one user and one physical computer. You may transfer a SUSM License between computers, e.g., due to a hardware upgrade, if you follow the specified uninstall/reinstall protocol. A SUSM License can run entirely offline, i.e., it can operate in environments without an Internet connection.

Technical Specifications:

• The software shall provide a desktop application (Windows/Unix) with a modern graphical user interface for Bayesian networks construction and modeling.

• The software shall provide subject matter experts with ability to express their causal understanding of a domain in the form of diagrams, using nodes and edges in the graphical interface.

• The software shall support discrete, nonlinear, and nonparametric modeling.

• The software shall support supervised learning, unsupervised learning, and clustering.

• The software shall provide capacity for diagnosis, prediction, and simulation.

TASKS

The provider shall provide access and installation of the software within one month of the award date. The provider shall provide Technical Support and Software Maintenance for the period of access

DELIVERABLES

Product Description Qty Unit of Issue Delivery Software meeting the salient characteristics:

single-user/single-machine licenses ea

Within 1 month of award

Technical Support and Software Maintenance ea

Continuous through period of access

Inspection and Acceptance

FDA will load the software and licensing to verify that the media is functioning properly. The Government will inspect and verify that the software is operational, functional and compatible with FDA server and software. The Government will provide written notification of acceptance or rejection within 10 working days of receipt. The Contractor shall correct any deficiencies within thirty (30) days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR or technical POC of the reason for the delay and provide a proposed corrective action plan within ten (10) business days.

Delivery & Performance

Delivery Contractor shall deliver software products within 10 calendar days after receipt of order.

Period of Performance The contractor shall provide maintenance services for 12 months after start of the Period of Performance.

Contracting Officer Representative:

Lacinda Welch

(870) 543-7664 Lacinda. Welch@fda.hhs.gov

Authorized Reseller/Services Agent

The Contractor shall be an authorized reseller and/or servicing agent of the software manufacturer while performing on this contract.

Information Technology Investment Management/Master Approved Technology List

The item acquired may require approval by the Food and Drug Administration (FDA) Office of Information Management (OIM) for operation in FDA’s Information Technology environment (IT Investment Management Process/Master Approved Technologies List). Any item proposed not previously tested and approved for IT environment operations may require testing by OIM before award.

508 Requirements The following standards are apply for this contract:

• Must meet WCAG 2.0 A and AA

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Appropriate Scoping Requirement from Appendix A

• E207 Software (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

Appropriate Technical Performance and Technical Requirement from Appendix C

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

Per 339.203-70 Contract Clauses for Electronic and Information Technology (EIT) Acquisitions

(a) The contracting officer shall insert the provision at 352.239-73, Electronic and Information Technology Accessibility Notice, in all solicitations.

(b) The contracting officer shall insert the clause at 353.239-74, Electronic and Information Technology Accessibility, in all contracts and orders.

Specification of a Directed Acyclic Graph is inherently visual in nature. While it is possible to provide accommodations for employees with moderately impaired vision, employees with highly impaired vision may not be able to use the software without the aid of an interpreter or coworker.

The same restrictions also apply to sharing of models with outside researcher through BayesiaLab- API, but would it not apply to sharing with researchers through BayesiaLab Export.