RFI for Financial System Support Services (instruction and attachement).pdf

Request for Information (RFI) Instructions

1. Background:

This is Sources Sought Request for Information (RFI) to identify potential small businesses who are interested and capable to meet Food and Drug Administration’s requirements of seeking functional and technical services to maintain and support the day-to-day operations of FDA Financial Management systems, including all global and FDA business, financial, and budgetary interfaces in and out of the UFMS. Please review Attachment 1 – Statement of Work for detail information on the requirements.

2. General Instructions:

This RFI is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of FDA or its Centers.

FDA welcomes responses from all interested small businesses to submit a response to this RFI. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's

Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

A complete response to the RFI should include answers to all of the questions below. Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (e.g.: The response must go beyond the statement that, "XYZ company can provide Material characterization and Analysis Services.").

The RFI responses should be submitted via email to Min Jie Zeng at minjie.zeng@fda.hhs.gov by 4PM ET on July 30, 2024. E-Mail is the only acceptable method of delivery for this notice of sources sought.

3. Questions:

1) On the FACE PAGE of your response, please provide the following:

a. Organization name

b. DUNS number

c. Organization's website

d. Contact Name

e. Contact Telephone

f. Contact E-mail address

g. Size designation and type (i.e. Small Business, etc)

h. Number of employees in your organization

i. Your organization's current and gross revenue

j. Current GSA Federal Supply Schedule number

2) Identify your company’s size designation and type (i.e. Small Business, etc)

3) Provide the current GSA Federal Supply Schedule number.

4) Do any gaps exist in the Draft Statement of Works? If so, what are they? What changes, additions, updates, and clarifications would you suggest?

5) What is the NAICS code would you suggest use for this requirement?

6) Please state your organization’s expertise in implementing/maintaining Oracle E- Business suite (Oracle Federal Financials) in a cloud environment. Please describe your level of support in brief for these projects. If applicable, please provide evidence of performing the similar types of tasks, including but not limited to the contract number, period of performance, and the Government or private entity customer POC.

7) Please state your organization’s expertise in implementing/maintaining Oracle Business

Intelligence Enterprise Edition (OBIEE) or similar data warehousing or reporting tools.

Please describe your level of support in brief for these projects. If applicable, please provide evidence of performing the similar types of tasks, including but not limited to the contract number, period of performance, and the Government or private entity customer POC.

8) Please state your organization’s expertise in implementing/maintaining Oracle

Hyperion. Please describe your level of support in brief for these projects. If applicable, please provide evidence of performing the similar types of tasks, including but not limited to the contract number, period of performance, and the Government or private entity customer POC.

9) Please state your organization’s expertise in implementing/maintaining custom software with Angular JS or similar frameworks. Please describe your level of support in brief for these projects. If applicable, please provide evidence of performing the similar types of tasks, including but not limited to the contract number, period of performance, and the Government or private entity customer POC.

10) Please state your organization’s expertise in implementing/maintaining any data science tool. Please describe your level of support in brief for these projects. If applicable, please provide evidence of performing the similar types of tasks, including but not limited to the contract number, period of performance, and the Government or private entity customer POC.

11) Please state your organization’s expertise in implementing/maintaining any low code-no code tool. Please describe your level of support in brief for these projects. If applicable, please provide evidence of performing the similar types of tasks, including but not limited to the contract number, period of performance, and the Government or private entity customer POC.

12) Please state your organization’s certifications such as CMMI, ISO. If applicable, please provide evidence of performing the similar types of tasks, including but not limited to the contract number, period of performance, and the Government or private entity customer

POC.

4. Attachments:

Attachment 1 – Statement of Work

Food and Drug Administration (FDA)

OFFICE OF FINANCIAL MANAGEMENT (OFM)

FINANCIAL AND BUSINESS SYSTEMS SUPPORT SERVICES

STATEMENT OF WORK (SOW)

FDA Financial and Business Systems Support Services

1 Introduction

1.1 Background

The mission of the FDA Office of Finance, Budget, Acquisitions, and Planning (OFBAP), Financial System Support Staff (FSSS) is to coordinate the management of FDA’s financial systems of record in coordination with stakeholders within FDA and its centers, Health and Human Services (HHS) and the other HHS Operating Divisions (OpDivs). In this, OFBAP manages the Unified Financial Management System (UFMS), the User Fee System (UFS) which generates over one third of FDA’s budget, the Financial Data Analytics Systems (One Stop Shop), and Custom Budget formulation and Execution systems. In addition, FSSS in coordination with OFBAP and relevant business process owners also develops, operates, and maintains FDA’s other financial and business systems.

1.2 UFMS Overview

UFMS is the HHS department wide financial system of record. The HHS Financial Enterprise System Management (FESM) organization is responsible for managing the global UFMS. FSSS , ensures that the functionalities within UFMS meet FDA’s business needs and processes, any changes proposed by other OpDivs, or HHS are communicated to FDA UFMS end users and that a proposed change does not break our internal financial business processes. FSSS ensures reliability of financial information by providing accurate and timely solutions to stakeholders. The vision of FSSS is to provide FDA customers with a state-of-the-art FDA financial management systems, which includes UFMS, outbound and inbound interfacing financial transactions from other source systems (User Fee System (UFS), Property Management Information System (PMIS)) and reporting and analytical systems (Business Intelligence Reporting Solution (FBIS), and Hyperion) that enable timely decision-making and provide continued consistent support to approximately 1500 FDA financial system users.

As one of four OpDivs who share the HHS UFMS, FDA and its OFM FSSS component must communicate and coordinate daily with the HHS Division of Systems, Operations and Maintenance DSOM Project Management Office (PMO) for the effective operation and development of FDA financial systems. FSSS provides day-to-day management coordination of the UFMS which includes the Accounts Payable, Accounts Receivable, Budget Execution, General Ledger Purchase Order/iProcurement modules, Projects, Projects, User Provisioning (UPA), Governance, Risk and Compliance (GRC), PMIS, and Purchase Request Information System (PRISM) applications. FSSS also provides system analysis, design, development of extensions, migration instructions, testing, and systems oversight for FDA data held within the Global UFMS.

These efforts have enhanced the user experience and furthered the FDA OFM mission, vision, and strategic priorities. OFM and FSSS seek to continue financial system support through these requirements. An overview of the FDA financial management systems and interfaces is provided figure below.

Technical environment

The foundation for UFMS is Oracle Federal Financials, a modified commercial off-the-shelf (COTS) software package. This software is part of the Oracle E-Business Suite, an integrated set of applications. The current version in use is 12.2.9. In addition to Oracle Federal Financials, UFMS includes extension tables, reporting tools, and interfaces to other financial systems that are used globally by HHS and specifically by certain OPDIVs. UFMS is currently hosted in the Oracle Cloud Infrastructure (OCI). Further detail on the technical environment is provided in the task order.

1.3 User Fee Overview

The Food and Drug Administration (FDA), part of the Department of Health and Human Services (DHHS), currently regulates products that represent around 25 cents of every consumer dollar spent. Over one third of FDA’s budget is from user fee revenue. The user fee programs help FDA to fulfill its mission of protecting public health and accelerating innovation in the industry.

The Office of Financial Management (OFM) is responsible for the financial management of the user fee programs. OFM maintains an Accounts Receivable (AR) system used for user fee invoicing, collections, reporting, and data maintenance.

The fee collection role has become increasingly important with the addition of new user fee programs and a growing pool of domestic and international applicants. The FDA User Fee System (UFS) serves as the focal point in assessing and collecting the user fees that are projected to exceed $2 billion in FY 2024. The current user fee programs are as follows:

Prescription Drug User Fee Act (PDUFA) allows FDA to assess and collect fees for products, establishments, and applications related to human drugs and biologics.

Tropical Disease Priority Review Voucher authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher.

Rare Pediatric Disease Priority Review Voucher authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher.

Medical Device User Fee Amendments (MDUFA) allows FDA to assess and collect fees associated with medical device applications and facility registration fees. The facility registration interfaces with the FDA Unified Registration Listing System (FURLS).

Animal Drug User Fee Act (ADUFA) allows FDA to assess and collect fees for products, establishments, sponsors, and applications related to animal drugs.

Animal Generic Drug User Fee Act (AGDUFA) allows FDA to assess and collect fees for applications, products, and sponsors related to animal generic drugs.

Mammography Quality Standards Act (MQSA) authorizes FDA to collect inspection fees.

Export Reform and Enhancement Act (EREA) authorizes FDA to collect fees for export certificates.

Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to collect Color Certification fees.

Freedom of Information Act (FOIA) authorizes FDA to collect fees for information requests received from various stakeholders.

Family Smoking Prevention and Tobacco Control Act (FSPTCA) authorizes FDA to collect fees from domestic manufacturers and importers of tobacco products as well as civil money penalties from tobacco retailers.

Generic Drug User Fee Amendments (GDUFA) authorizes FDA to assess and collect fees for applications, drug master files and facilities related to human generic drugs.

Biosimilar User Fee Act (BsUFA) authorizes FDA to assess and collect fees for products, establishments and applications related to biosimilar biological products.

Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect fees for recalls, re-inspections, and other programs.

Compounding Quality Act (CQA) authorizes FDA to assess and collect facility registration and reinspection fees on outsourcing facilities.

Over-the-Counter Monograph User Fees Program (OMUFA) regulates over-the-counter monograph drugs.

FSSS has automated a majority of the billing, collection and reporting of its user fees. UFS provides a web-based self-service registration, application and ordering capabilities to FDA customers using the Oracle iStore platform. In addition to iStore, UFS leverages other EBS modules including Configurator, Order Management, Inventory, Bills of Materials, Federal Administrator, General Ledger, Accounts Payable and Accounts Receivable. An AR-to-AR interface links UFS to UFMS. Additionally, interfaces link UFS to the various systems in place at the FDA centers to provide billing information and tracking capabilities. These centers and the corresponding user fee programs are listed below.

Center for Device and Radiological Health (CDRH) – MDUFA, FURLS, MQSA, and Exports

Center for Biologics Evaluation and Research (CBER) – MDUFA, PDUFA, BsUFA, GDUFA, PRV programs and Exports

Center for Drug Evaluation and Research (CDER) – PDUFA, GDUFA, BsUFA, CQA, OMUFA, PRV programs, and Exports

Center for Veterinary Medicine (CVM) – ADUFA, AGDUFA, FSMA and Exports

Center for Food Safety and Nutrition (CFSAN) – Color Certification and Exports

Division of Freedom of Information (DFOI) – FOIA

Center for Tobacco (CTP) – FSPTCA

Office of Regulatory Affairs (ORA) – PDUFA, GDUFA, MDUFA, ADUFA, AGDUFA and FSMA

UFS also interfaces with external systems including Dun and Bradstreet, U.S. Department of the Treasury (Treasury) Collections Information Repository, Pay.gov, and U.S. Bank.

The system has advanced reporting capabilities to support the user fee programs. The reporting tool is Oracle Business Intelligence Enterprise Edition (OBIEE).

Technical environment

The foundation for UFS is Oracle Federal Financials, a modified commercial off-the-shelf (COTS) software package. This software is part of the Oracle E-Business Suite, an integrated set of applications. The current version in use is 12.2.9.

All UFS environments including Development, Test, Pre-Production and Production are hosted in AWS GovCloud. The contractor shall use all these environments in the performance of its support. The contractor is expected to provide infrastructure support (e.g., Virtual Private Cloud (VPC), Elastic Cloud 2 (EC2), storage, firewalls, etc.) for UFS in AWS GovCloud. This is a crucial area of support for UFS.

Further detail on the technical environment is provided in the task order.

User Fee System Overview

1.4 Financial Data Analytics Systems (One Stop Shop) Overview

In order to meet increasing demand both internally and externally to the FDA for comprehensive reporting, transformation, and data-minded decision making, FSSS designed and implemented a comprehensive data suite. FSSS has implemented the following Data Analytics Systems “One stop shop” and the overview diagram is given below.

The one stop shop is a portal that will contain multiple applications. The applications are noted here:

Fully Loaded Cost (FLC) Model Dashboard – Live Five Year Plan – Live Financial Reports – Live Federal Notices – Live Business Case Management – Live UDO/OR – go live soon

FLC Model Dashboard The Full time Equivalent (FTE) Cost Model is intended to serve as the basis for: negotiating funding requirements for new FTE for UFA negotiations, cost of a new FTE in the Capacity Planning Adjustment (CPA) which is currently used in PDUFA & BsUFA, and cost of a new FTE for internal business cases

Model is designed to be updated each year based on actuals – thus helping to ensure the most accurate data is available for adjustment purposes.

Five Year Plan Ability to formulate User Fee five-year plan with appropriate allocations to operating and planning expenses.

Ability to formulate User Fee All-purpose tables (APTs) provided to the Division of Budget

Formulation (DBF) for review and validation via a provision of a web service Ability to view consolidated statements that contain previous year actuals and targeted revenue based on the forecast for future years.

Ability to view the consolidated statements by allocation type (e.g. Payroll, Operating, Rent

& WCF) broken out by service provider Ability to create Five years plan with consideration for variable factors such as Inflation, Full time equivalents (FTE) increase and new business cases (automate creation of the tables published in the BsUFA, GDUFA, and PDUFA external 5 year plans)

Ability to allocate funds to the Working Capital Fund (WCF) business managers and be able to accommodate other expenses like GSA Rent

To pull information from Unified Financial Management Systems (UFMS) and The User Fees System (UFS) to interface revenue, collections, and carry over funding amounts. This will continue to follow the current process of getting data through spreadsheets.

Supports 5-year user fee planning functions and assists users towards the user fee analysis and informed decision making

Assist to finalize the Tobacco Program UF plan as CTP is funded entirely by Industry. The system should be flexible to provide this special treatment to Tobacco Program and be flexible to meet CTP’s business needs.

Ability to generate event-based emails and workflow notifications Ability to achieve version control of data, data versions (scenarios), reviews, and approvals Archive and maintain the historical data for Financial Reports Comply with FDA’s security guidelines Provide role-based access control for Users of 5-year plan and financial reports User registration and management

Business Case Management Ability to add and maintain Business Cases approved by the User Fee Financial

Management Committee. Each Business case should have additional details including dollar amount, duration (Number of Years), FTEs, and purpose.

Ability to create, update, track, and approve new business cases and provide a workflow approval for centers/programs (should be integrated with the UFFMC tool, currently gathering requirements)

Financial Reports, Federal Notices Automation of User Fees (UF) eight (8) Financial Reports in two phases ADUFA Financial Report AGDUFA Financial Report BSUFA Financial Report CQA Annual Report GDUFA Financial Report MDUFMA Financial Report OMUFA Financial Report PDUFA Financial Report Automation of User Fees (UF) fourteen (14) FR notices in phase 2 Replace multiple disparate MS Excel files management and ability to upload files from specified directories Automate formulae and macros used in the Fee setting tool and related spreadsheet Template development in MS Word format and update the stats as per the Fiscal Year

UDO/OR

UDO/OR provides the ability to annotate entries in undelivered obligations reconciliation reports that need to be de-obligated Provide UDO/OR quarterly reporting Provide UDO/OR data analytics

One-Stop-Shop (OSO) is a custom developed system on the Angular.JS framework, Oracle database, Micro front-end, CI/CD, KNIME server, and Linux operation system. All One-Stop-Shop (OSO) environments including Development, Test and Production are hosted in AWS GovCloud.

The contractor shall use all these environments in the performance of its support. The contractor is expected to provide infrastructure support (e.g., Virtual Private Cloud (VPC), Elastic Cloud 2 (EC2), storage, firewalls, etc.) for OSO in AWS GovCloud. This is a crucial area of support for the program.

Further detail on the technical environment is provided in the task order.

1.5 Budget, Acquisition and Planning Systems Overview

The Food and Drug Administration (FDA), OFBAP staff performs all duties involved with the formulation and presentation of FDA’s budget requests, as well as the execution of the annual budget; and provides advice and guidance on budgetary matters.

FDA’s Office of Finance, Budget, Acquisitions, and Planning (OFBAP) successfully implemented an end-to-end Integrated Budget and Acquisition Planning System (IBAPS).

IBAPS Overview – Current State

IBAPS Application Integrations

Currently FDA is modernizing IBAPS to a new modernized enterprise-wide budget planning and execution application leveraging a low-code application platform. This new enterprise-wide application will be implemented to support the FDA centers and offices that currently use the Parent IBAPS Planning and Execution Application (ORA, NCTR, OO, OC, and WCF Group) and the new Human Foods Program. The new IBAPS application will allow users to plan the acquisition budget requests for contracts, grants, IAA, P-Card, travel, and miscellaneous transactions. The new application will also allow the above Centers and Offices, including the new HFP organization, to plan for the payroll budget for FY2025 and beyond. The Centers with the center-specific child IBAPS applications (CDER, CBER, CDRH, CFSAN, and CVM) will be onboarding to the new enterprise-wide budget planning and execution application. The new modernized enterprise-wide application will have all the core functionality implemented across the current IBAPS parent and center-specific child applications and will have one enterprise-wide budget planning and execution system.

Budget formulation, Budget execution and control includes includes:

Producing three major budget submissions a year to: 1) the Department of Health and

Human Services (HHS) in June; 2) Office of Management and Budget (OMB) in September;

and 3) Congress in February.

Developing and presenting required background exhibits, MAX input, and supplemental budget requests as necessary; coordinating graphic material for presentations; and coordinating budget pass back appeals at each level.

Tracking resources supporting major and crosscutting activities, including supplemental funding, in coordination with DBEC, Centers, and Offices.

Planning, organizing, and carrying out annual and multi-year budgeting in support of FDA's public health mission and programs.

Allocating funds appropriated by Congress and apportioned by OMB among FDA components and overseas transfers between components.

Hyperion Planning Solution – provides financial data related to Budget Formulation, Budget Execution and Payroll Planning for the Agency

K2/SharePoint Solution – used to develop the narratives for the Agency’s budget submissions in Budget Formulation.

Oracle Business Intelligence Enterprise Edition (OBIEE) Interim Reporting Solution – provides enhanced reporting with drill down capabilities and dashboard reports for Agency’s Payroll Planning, Budget Execution, and AAP.

Advanced Acquisition Planning (AAP) application:

Provides the Agency wide data for the Advanced Acquisition Plan (AAP).

OFBAP supports and maintains both custom and COTS business systems. These systems support formulation and presentation of FDA’s budget requests, as well as the execution of the annual budget; and provides advice and guidance on budgetary matters.

Hyperion/ESSBASE/Oracle RDMBS Oracle Database 19c

Oracle ADF Oracle Data Integrator (ODI) Oracle Business Intelligence Enterprise Edition (OBIEE)

Oracle Internet Directory (OID) Salesforce MuleSoft K2/SharePoint Solution UI-Path

Python/R (Predictive Analytics)

New Technology after Modernization in addition to above

Appian

Maria DB

Enhanced Data Pipeline

2 Objective

In summary, the objective is for functional, technical, infrastructure, and advisory services to maintain and support and enhance the day-to-day operations of FDA’s off-the-shelf or custom financial and business systems on behalf of FSSS.

3 Task Area Descriptions

3.1 Order Management

For the future Blanket Purchasing Agreement (BPA) Orders issued under this contract, the Contractor shall provide Order level project management to establish control management, monitoring, and notification mechanisms, while ensuring contracted tasks stay on track and important milestones and performance measures are met. For each order, the Contractor shall prepare a Management Plan describing the technical approach, organizational resources, risk management and other management controls to be employed to meet the cost, performance, and schedule requirements throughout order execution.

The Contractor shall provide monthly status reports on all awarded Orders and their progress to FSSS. Within the first 30 days after contract award, the contractor shall meet with the Government to design and agree upon a standard reporting format that includes, at a minimum, the following information:

Status and progress of tasks.

Cost and schedule variances.

Earned Value Management (EVM): the Contractor shall provide (as specified in Orders issued) Budgeted Cost of Work Scheduled (BCWS) and Budgeted Cost of Work Performed (BCWP) and other information monthly as required.

Significant risks to scheduled deliverables and plans to mitigate them.

Progress against service level metrics.

Recommendations for changes or additional activities to support the overall future BPA objectives.

Work accomplished in the reporting period.

Problems and difficulties encountered Previous problems and difficulties solved.

Any staffing changes or issues and provide mitigation plans.

Breakdown of actual labor hours expended per individual on task (including Firm-Fixed-

Price Orders).

Monthly Financial Reports: Monthly Financial Report is part of the monthly status report and shall cover the period beginning with the first of the month and continuing through the end of the month, except for the partial period of the months the order begins and ends. The financial report shall include, at a minimum, monthly expenditures and expenditures to date.

The Contractor shall collaborate with the FSSS in the drafting of a charter for the Consortium that describes the protocol for working together. The charter will establish roles, responsibilities, accountability, identify specific performance objectives, and describe the framework and platform for monitoring performance and continually identifying areas for improvement for both parties. The charter shall be established no later than 45 days after Order award (or as specified in individual orders) and will be reviewed by FSSS for approval. The Consortium will meet quarterly.

In addition to progress reporting, the Contractor shall be proactive in informing the designated government Project Managers and Contracting Officer Representatives of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of order goals. Recommendations for actions that need to be taken by FDA staff, or other Contractors, shall be clearly defined and communicated to the responsible party and the FDA, and have identified dates for completion.

3.2 Consortium

The purpose of the Consortium is to foster collaboration, uniformity, and standardization across all FDA financial systems. To foster this collaboration, the Contractor shall participate in a Consortium composed of the respective Program Managers from private industry and other government entities.

The Consortium coordinates efforts for technical changes in all FDA financial systems in the most effective and cost-beneficial way possible. Specific goals of the Consortium include sharing industry best practice to make for an effective and efficient transition to the new financial system environment and minimize overall cost to the FDA. FDA’s financial systems are supported by multiple contract vendors. All participants involved in the FDA financial system support will work collaboratively with each other. This collaboration includes the sharing of information during and after the Consortium meetings.

All deliverables, artifacts, processes, and procedures developed by the Consortium:

Are Government properties and can be reused on other Federal programs and projects.

Can be shared with other Contractors in cooperation with FDA for government reuse.

That similar deliverables, artifacts, processes, and procedures from other Contractors in cooperation with DHHS will be used when appropriate.

3.3 Transition-In Support

The Contractor shall provide Transition-In support in order to provide an orderly transition from the incumbent Contractor to the successor Contractor. The successor Contractor shall work toward the Government’s goal of minimizing disruption to the current system and operational activities.

Working with the incumbent Contractor and the COR, the successor Contractor shall develop a transition plan to take over ongoing work from the incumbent Contractor as required in the Orders released under the future BPA. Representative activities may include, but are not limited to:

Development of a Transition-In plan.

Participate in Transition-In meetings.

Conduct and coordinate all on-boarding activities with the Government and obtain secure badging for team personnel.

Ensure staff identified as key personnel are available to work with Subject Matter Experts

(SME) from the Government and the incumbent Contractor immediately after Order award.

Engage in regularly scheduled meetings.

3.4 Operation and Maintenance (O&M)

The purpose of this effort is to provide all functional and technical services to maintain and support the day-to-day operations of any off-the-shelf or custom, financial, collections, data analytics, or business systems and provide minor enhancements as needed (under 100 hours level of effort per minor enhancement). Representative activities for this task area include, but are not limited to:

Provide daily O&M support to internal and external users as required Provide support to FSSS for all HHS and FDA required routine system activities, such as, but not limited to, error resolution, address end-user inquiries, background concurrent programs, interface transaction monitoring.

Provide functional and technical systems support and implement changes required per federal mandates such as, but not limited to, Digital Accountability and Transparency Act (Data Act), E-invoicing, Time and Reporting System, Working Capital Fund, G-Invoicing.

Provide functional and technical systems support when the system is upgraded.

Provide functional and technical systems support when software patches are applied.

Provide functional support to identify reporting needs and data elements required to create these reports.

Provide Help Desk level 1, 2 and 3, break fix identification and tracking to resolution, Provide financial system analysis and system expertise for data calls, activity-based costing, and advanced reporting.

Promote daily communication with all stakeholders.

Provide fiscal close functional and technical system support (monthly, quarterly, yearly), Provide financial audit and reporting support.

Perform minor site-specific enhancements to the system.

Collaborate with users to perform the user acceptance testing.

Provide system validation, testing co-ordination, and both technical and functional support during the system patches, upgrades and point releases.

Participate in train-the-trainer sessions and provide ad hoc end user training and knowledge transfer session.

Identify opportunities for systemic efficiency, requirements analysis, end user and stakeholder communications, and resolution of daily system and accounting issues with federally complaint system enhancements.

Maintaining written Standard Operating Procedures (SOP) Addressing end-user inquiries, such as system access, scheduling reports to run, and performing ad-hoc queries Support built in reporting, dashboards and analytics Manage database programs providing highly technical expertise in the use of Database

Management Systems (DBMS) and infrastructure concepts.

Provide system administration to include managing end users and group permissions within user account administration.

Performing system administration activities such as provisioning users to access Conduct release execution and deployment activities.

Maintain the integrity and accuracy of the data stream between connected systems. These activities should include timely reconciliation, reporting, and exception handling.

Collaborate with FDA database administrators to maintain Development, Test, Pre-

Production, and Production technical environments.

Collaborate with database administrative staff to ensure availability of technical environments for O&M testing and releases.

Provide software configuration updates to address configuration fixes and product capabilities.

For the future BPA O&M tasks, the technology stack includes but not limited to below:

Oracle eBusiness Suite R12 Financial Suite Oracle eBusiness Suite R12 modules – Configurator (CZ), iStore UI Framework - Angular.js, Oracle ADF AWS Cloud Environment Data analytics tools – KNIME, Hyperion, OBIEE Databases – Oracle, Essbase, PostgreSQL

3.5 Development, Modernization and Enhancements (DME)

The purpose of this effort is to implement modernization and enhancements identified by FSSS and its stakeholders in order to improve the effectiveness and efficiency of FDA’s financial and business systems.

Application Upgrades and Major Enhancements

The contractor shall develop and implement application upgrades and major enhancements.

Major enhancements and application upgrades are defined as all development tasks that require more than 100 hours of development time. Minor enhancements are considered part of the O&M task. A Call Order will be awarded for each major enhancement and will specify the type of development to be used. On average, between 1-2 major enhancements were implemented in a year.

Once these new system development efforts under this component are deployed (go-live), the ongoing O&M support shall be performed under O&M components. Sample major enhancements tasks include, but are not limited to:

New legislative mandates Software upgrades of Oracle Federal Financial software, Hyperion, KNIME, and other commercial-off-the-shelf solutions supported by FSSS.

Changes in core IT infrastructure needed for application support Evolving design to meet the changing needs of the stakeholder requirements and new regulations.

Configuring existing tools and / or implementing new COTS solutions to assist with data mining, data integrity, data reporting, and data management.

Modifying to be compliant with FDA policies, such as the Working Fund Capital, Congressional mandates, Government standards, and HHS related regulatory and security policies.

Requirements Gathering, Development and Analysis

The contractor shall perform requirements gathering, development, and analysis. Representative activities may include:

Facilitate requirements gathering and definition activities per call order designated methodology such as waterfall, agile or iterative Analyze, decompose and translate FDA business requirements (e.g. current business rules and workflow processes) into detailed functional and non-functional system requirements for major enhancements

Work with the project team, including business representatives, to review and validate the system requirements

Update or develop the System Requirements Specifications, user stories, or use cases Establish and maintain the Requirements Traceability Matrix Communicate and work with the relevant FDA system owners regarding design changes which impact other FDA systems such as UFMS, FDA Center applications and other external systems.

Conduct feasibility analysis of proposed new user fee programs and determine the high-level gap-fit between new legislative requirements and existing system capabilities.

Participate in work groups related to the addition to or expansion of user fee programs per the direction of the COR.

Minor software upgrades will be handled under O&M. Major software upgrades will be separately tasked.

Design and Development

The contractor shall perform design and development activities. Representative activities include:

Execute major enhancement design and development utilizing techniques compatible with

Call Order designated SDLC’s such as waterfall, agile, or iterative methods Complete the design of the new application/module based on the detail requirements identified, verified, documented and approved in the requirements analysis phase.

Develop/update the System Design Document Create/Update Interface Control Document(s) to be used when interfacing with other systems such as UFMS, and FDA center systems.

Test the design against the Requirements Traceability Matrix Work with the FSSS in the verification and approval of the design at designated milestones and update project artifacts accordingly Develop/update all application/system code required to build the system according to the

System Design Document Construct/Update Software Application Modules Develop all application/system code in compliance with 508 requirements, FDA defined IT standards and approved software on FDA approved hardware.

Use an iterative development approach supporting prototypes and demos throughout the development process Develop system/application code level documentation in compliance with FDA EPLC methodology (see Attachment) with particular emphasis on source code documentation Conduct and document unit testing Identify and resolve all defects before completion of development phase (HPALM to be used for tracking defects.)

Initiate defect identification starting with unit testing and continuing throughout the lifecycle of the task Prepare Unit Test Report for review and approval by the COR Resolve all requests for new requirements that have been processed and approved for the production release through change control and update all project artifacts as required Create/update SOP Complete design/development EPLC artifacts as required in the Call Order. Coordinate review meetings, preparation of materials, and resolution of any issues.

Work with OFM and Data Center teams to deploy final code to Test environment

Testing and Integration

The contractor shall perform Testing and Integration activities following EPLC guidelines. The testing requirements are comprehensive and require extensive formal testing to support major enhancements. Testing is conducted in each of the four environments, development, test, pre-production, and production. Representative activities include:

Design and develop major enhancement test strategies and plans aligned with Call Order designated EPLC processes Develop Master/Release Test Plan, Test Case Specifications Develop and stage the Test Data Conduct and document Functional Testing

Conduct and document System Test Conduct and document Performance Testing Conduct and document Section 508 Compliance Testing Conduct and document Interface Testing Conduct and document Integration Testing Conduct and document Regression Testing as needed Create the System Test Report Create the Section 508 Compliance Test Report Create the Performance Test Report Record and track all issues discovered during each testing phase Complete successful Test Readiness Review in preparation for moving into the UAT phase Deploy final code to Pre-Production environment Coordinate and document UAT Create the UAT Report Provide technical support to users as issues and questions arise during UAT Migrate any failed component back to the Development Phase for rework Repeat all development and test activities as needed until code passes test with no critical or high defects Complete a successful test stage gate review including coordination of review meeting, preparation of materials, and resolution of any issues identified The Government may waive/defer the resolution of minor defects discovered during the testing and integration phase. The contractor shall track, report and resolve the waived/deferred defects once the application/module is in production. The contractor shall follow the EPLC process when fixing the defects

Implementation

The contractor shall perform the following representative activities:

Coordinate implementation activities with OFM and Data Center teams, deploy final code to Production environment Validate system enhancements in Production environment Prepare for and perform Post-Implementation Review to document lessons learned

Release Deployment and Management

The contractor shall deploy changes for major enhancements following the release and change management process. The contractor shall work with OFM and ODT to support the development and deployment of system releases to the appropriate Data Center environments.

Representative tasks include:

Develop release plans aligned with designated Call Order development methodologies which may include waterfall, agile, or iterative approaches Prepare and present level of effort estimates and technical evaluation for enhancements as requested by the CRB and CCB. The technical evaluation should include analysis of related impacts) to systems that interface with the one that is being modified. Support the CRB and CCB to obtain approvals for each defect and enhancement to be included in a release, and to determine the overall content of each release

Plan, develop, test, and implement all enhancement releases Plan, coordinate and support UAT and obtain user approval for each enhancement per the requirements in the Call Order. Submit and track release requests for Development, Test, Pre- Production, and Production environments following FDA procedures for submission of infrastructure change requests

Coordinate and prepare input to stakeholder notifications. Ensure timely advance notice within the specifications in the Call Order of scheduled maintenance detailing planned downtime to relevant internal stakeholders via email and industry/external customers via notification on the FDA UFS web site. The Government provides the contractor the information or the tools to gather the information

Create all required deployment artifacts including release notes, software builds, scripts, VDDs, and deployment plans, as required in by EPLC guidelines. Maintain system documentation in a central repository as designated by the COR, currently SharePoint. All system changes shall be updated per the specifications in the Call Order and shall be provided to the COR for review and approval and uploaded to the central repository in a Microsoft Word, PowerPoint, Visio or other mutually agreed upon electronic format

Support production releases, which are normally scheduled outside of normal business hours as, needed. Production releases may be required to continue into the weekend.

Deployment of production releases includes, but is not limited to validation that the implementation was completed, and the software is working as intended in the production environment

Ensure that the code and other configuration items are labeled and tagged with the software release version and all required information is packaged together per implementation documentation

Support system release deployment activities to ensure that the designated change is released into the planned environments

Document, track, and schedule releases using FDA established tools and processes.

For software defects introduced during the release, perform planning, requirements analysis, design, development, testing and implementation during the execution of these releases. The contractor shall identify in writing the root cause of any such defects and shall propose a plan to promptly resolve those defects. The contractor shall obtain approval from the COR for approval of the plan and steps for curing defects

Share information and provide full access to code, constructs, databases, and documentation to the Government while delivering integrated, cohesive business and technology services. The contractor shall properly label all artifacts in a manner that does not restrict the Government’s access and clearly indicates that the Government owns the intellectual property

Configuration Management

The contractor shall conduct configuration management in accordance with the OFM and FDA change management and testing policy in the OFM Business Process Change Control procedures (See Attachment). The contractor shall accurately label version of all critical project documents, application and database components. The contractor shall document any changes in code, test scripts and test results.

Additionally, the contractor shall perform the following:

Follow OFM CRB process (See Attachment) Provide technical information for proposed change requests (e.g., technical feasibility, technical alternatives, LOE required to complete the change Participate in OFM CRB and ODT CCB meetings Support configuration management activities aligned with the designated Call Order’s software development methodologies which may include waterfall, agile or iterative approaches

Training and Knowledge Transfer Support

The contractor shall work collaboratively with FSSS to assess the training/job aid needs associated with major enhancements. The contractor shall assist OFM to develop training materials in accordance with the training medium/requirements directed by the COR. These training materials shall include, but are not limited to the following:

Appropriate training documentation (e.g. job-aids, user guides) Workflow aids and diagrams “Tools” and “tips” for the end-user community

The contractor shall transfer application functionality knowledge to Federal users especially for new releases and at the time of new hires as per the direction of the COR. The contractor shall provide training workshops to new and current users regarding system configuration and procedures with supporting documentation. The contractor shall be required to provide workshops to FDA information technology (IT) personnel (on COR’s request) to optimize processes and procedures for running and troubleshooting the applications.

3.6 Software, Subscriptions, and Tools

As tasked, the Contractor shall purchase software, subscriptions and tools for use in the financial and budgetary systems detailed in the overview section on behalf of the government. The Government will maintain ownership.

3.7 Business Transformation Activities

The contractor may be tasked to provided business transformation activities. Representative Business Transformation Activities include:

Conduct Functional/Technical Design Reviews to confirm business requirements and minimize customization.

Evaluate, redesign and re-engineer current business processes to ensure effective and efficient use of business information technology and resources and improve process performance.

Recommend cost-effective solutions to meet financial management goals. Understanding of process steps and the capabilities provided by computer software.

Provide broad context and understanding of business functions as they cross boundaries between functional areas and organizational boundaries. This activity includes transactions within the organization and transactions that flow outside to customers and suppliers.

Survey and analyze existing systems including software elements and the relationship between them.

Develop views of the system components and relationships among them.

Provide a detailed inventory of business processes, data applications and databases.

Develop an architecture plan that can optimize system performance by including, where necessary, distributed architecture.

3.8 Transition Out

As tasked, the Contractor shall facilitate the transition of contracted activities and services to the Federal Government or to a follow-on Contractor at the end of the contract period of performance. Representative activities under this task area may include, but are not limited to:

Providing the FDA with current versions of all system and user documentation.

Providing FDA all licensing and renewal information, asset management records, software documentation, and training materials.

Providing FDA with a current inventory of all Government-owned assets used by the

Contractor along with full support in the reconciliation of this inventory.

Providing FDA with current versions of all CONOPS, operational procedures, standard operating procedures, guidelines, performance reports, specifications for hardware and software, and other pertinent information needed to continue the services being performed by the Contractor.

Providing “shadowing” and other knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

Providing SQL queries and similar tools used for regular O&M along with configuration management information.

Providing up-to-date Enterprise Performance Lifecycle (EPLC) and program/project management document.

Ensure submission of open help desk tickets/reports and latest communication trail with customers around ‘in process’ issues.

Maintain ability to answer any system or business process related question from new contractor (if applicable) via emails routed through the COR.

Provide FDA with current versions of all system and user documentation.

Provide FDA all licensing and renewal information, asset management records, software documentation, and training materials.

Provide FDA with a current inventory of all Government-owned assets used by the contractor along with full support in the reconciliation of this inventory.

Provide FDA with current versions of, operational procedures, standard operating procedures, guidelines, performance reports, specifications for…