FDA-RFI-75F40124Q00156.pdf

REQUEST FOR INFORMATION NOTICE FROM THE FDA

Request for Information (RFI) Request # FDA-RFI-75F40124Q00156

FOR: The Food and Drug Administration Enterprise IT Application Development (EAD) BPA

DEPT/AGENCY INFORMATION: Department of Health and Human Services

U.S. Food and Drug Administration

Requiring Offices: Office of Digital Transformation (ODT)

GENERAL INFORMATION

The U.S. Food and Drug Administration (FDA) is issuing this RFI as a means of conducting market research, pursuant to Federal Acquisition Regulation (FAR) Part 10 Market Research, to identify potential stakeholders from the marketplace capable of providing professional Information Technology (IT) services for the FDA Enterprise IT Application Development (EAD) Blanket Purchase Agreement (BPA). The Department of Health and Human Services (HHS) U.S. Food and Drug Administration (FDA) is looking to enter into Multiple-Award Blanket Purchase Agreements (BPAs) against General Services Administration (GSA) MAS Schedule 54151S and/or 54151HEAL Information Technology Professional Services and/or Health Information Technology Services and Order-Level Materials (OLM) with Contractors to obtain Information Technology Application development professional services. The FDA intends to use NAICS codes 541512.

This is a REQUEST FOR INFORMATION ONLY, not a Request for Quote (RFQ). The RFI does not commit the Government to award a contract now or in the future for any supply or services whatsoever.

Furthermore, the FDA will not accept unsolicited proposals.

The Government is not responsible for any cost incurred by stakeholders in furnishing information. All costs (time/material/services) associated with responding to this RFI will be solely at the interested stakeholder's expense. Not responding to this RFI does not preclude participation in any future RFI, Vendor Day, or Request for Proposal (RFP), if any are issued. Any information submitted by stakeholders to this RFI is strictly voluntary. All submissions will become Government property and will not be returned. The Government reserves the right to request clarifying remarks from RFI submissions.

Proprietary, classified, confidential, or sensitive information should not be included in your response.

The Federal Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

The FDA will use the results of the market research to determine if small business sources are capable of satisfying the Agency's and the Administrations contracting goals based on responses to the RFI. The FDA does not intend to make a selection decision or award a contract on the basis of responses.

Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested stakeholders. However, FDA reserves the right to contact stakeholders if additional information is required.

INSTRUCTIONS

Please review and provide objective and comprehensive responses to the questions listed in the Excel file, Attachment A - FDA RFI Response Template. All stakeholders must provide their responses in Attachment A, as emailed responses submitted external to the RFI Response template or outside the designated limitations will not be considered. We will not accept any other documents except for Attachment A. Please note that fields have limitations on how many characters can be entered in certain fields and fields with drop down selection capabilities. Please review the template instructions prior to completing the RFI. Multiple submissions by the same company or same company in teaming or joint ventures will not be considered. Please ensure you are objective and specific with experience in your responses while addressing the questions. A complete response should include answers to all the questions in Attachment A. Please note that a stakeholder's failure to provide a complete response to a question will be interpreted to mean that the stakeholder is unable to demonstrate stakeholder capability to provide the required services. Responses should demonstrate capability, not merely affirm the respondent's capability (i.e., the response must go beyond the statement that, "XYZ company can provide technical support").

Stakeholders will not receive individualized or group feedback on any suggestions provided in the RFI.

No basis for claims against the Government shall arise as a result of a response to this RFI or from the Government's use of such information.

While the Government anticipates establishing a BPA for the EAD which requires contractual support, A SOLICITATION IS NOT CURRENTLY AVAILABLE. The Government is not obligated and will not pay for any information received from potential sources as a result of this RFI.

Response Due Date/Time: 4:00 PM EST on Friday, May 24, 2024.

Email responses to: Sephora Calderon, Sephora.Calderon@fda.hhs.gov

Please include the RFI number FDA-RFI-75F40124Q00156 EAD BPA in the subject line. No phone calls will be accepted for this notice.

Background The FDA, an agency within the U.S. Department of Health and Human Services, is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The FDA is responsible for the oversight of more than $2.8 trillion in consumption of food, medical products, and tobacco. The FDA-regulated products account for about 20 cents of every dollar spent by U.S. consumers and regulates about 78 percent of the U.S. food supply.

In recent years, due to the dramatically accelerating pace of innovation and adoption of new digital health technologies and complex scientific advances across industries regulated by the FDA, there are opportunities and challenges for FDA operations to transform IT ecosystems and capabilities. Across all these areas, regulations are also evolving to keep pace for improved safety and efficacy of food and drugs. To meet these challenges and opportunities, the FDA is streamlining processes to accelerate the digital transformation journey. The FDA is investing in emerging technologies to better support FDA’s business, technology, and regulatory flexibility while proactively enhancing and developing new IT mailto:Sephora.Calderon@fda.hhs.gov capabilities to drive FDA’s public health mission forward.

The FDA Chief Information Officer (CIO) established the new Office of Digital Transformation (ODT) in 2021. The FDA CIO’s strategic investment goal is to revolutionize technologies to improve the FDA’s regulatory process and improve public health outcomes while eliminating unnecessary redundancies.

The FDA CIO reports directly to the FDA Commissioner providing the vision and leadership enhancing the FDA-wide IT, data, and cybersecurity and enabling data driven decision making needed to advance FDA's mission and strategic priorities. The FDA CIO directs enterprise strategic planning, policy, and resource management to ensure that Agency IT, data, and cybersecurity investments and activities across the FDA provide maximum value to the FDA. The FDA CIO's mission is to provide high quality, secure, and efficient IT solutions that enable the FDA to promote and protect the public health.

Since 2021, the FDA CIO’s published strategic action plans such as the Technology Modernization Action Plan (TMAP), the Data Modernization Action Plan (DMAP), the Enterprise Modernization Action Plan (EMAP), the Cybersecurity Modernization Action Plan (CMAP), and the Leadership Modernization Action Plan (LMAP). These strategic plans align and enhance IT technology, data, and cybersecurity with the FDA IT vision and mission. Recently, the FDA CIO released the FDA IT Strategic Plan for FY2024-FY2027 which is being used to guide and strengthen FDA's digital transformation journey to meet 21st century opportunities and challenges.

The FDA CIO established the following goals and objectives through the IT Strategic Plan to streamline the FDA’s digital modernization:

1) Create a shared OneFDA ecosystem

2) Strengthen IT Infrastructure

3) Modernize Enterprise Services and Capabilities

4) Share Data for Mission Outcome

5) Adopt AI and Mission-Driven Innovations

6) Cultivate Talent and Leadership

In order to achieve the above goals and objectives, the FDA is performing market research to establish a multivendor enterprise strategic acquisition vehicle. This vehicle will be used for IT application development utilizing Lean-Agile software development best practices and DevSecOps principles to deliver quality, secure, and cost-effective digital solutions. To ensure robust support and success of the IT Strategic Plan, the FDA is performing market research to review/gauge stakeholder’s capabilities in the following critical areas:

• Governance

• Program Management

• Risk Management

• Financial

• Technical

• Resource Management

• Supply Chain

• Change Management

• Innovation

Stakeholder replies to this RFI will be reviewed from the above capability viewpoints. Please incorporate these capabilities into stakeholder responses to effectively address the questions in this RFI.

https://www.fda.gov/about-fda/office-digital-transformation/fda-information-technology-strategy-fy-2024-fy-2027

Scope:

The FDA CIO’s office is performing market research for an EAD BPA strategic acquisition vehicle to centralize, streamline, and rationalize acquisition vehicles for all the IT solutions development across FDA to implement governance, standardization, monitoring, tracking, reporting, and managing of all FDA IT investments to support the mission and functions of the organization.

Overall, the EAD Strategic Acquisition vehicle goals are:

• Expand sharing of FDA-wide buying data, leading to better-informed business decisions.

• Maximize FDA’s shared purchasing power, allowing FDA to leverage volume discounts.

• Maximize FDA’s purchasing efficiencies by reducing administrative costs and contract duplications.

The EAD acquisition vehicle will bring the following advantages:

1. Centralized governance and oversight to meet the HHS and FDA CIOs and FITARA objectives;

2. Meet the objectives of the FDA enterprise IT Strategic plan of OneFDA Shared environment;

3. Strategic acquisition vehicle for agile acquisition processing;

4. Compliance with OMB directive of category management and Spend Under Management initiatives;

5. Streamlining of the FDA IT acquisition vehicles and investments;

6. Alignment with OMB directive of enterprise architecture;

7. Contributing to socio-economic goals related to technological advancement and prosperity; and

8. Cost reduction through economies of scale and savings through reduction of purchasing redundancies.

Task Areas: Please refer to the Attachment B for Task Areas (1 –19) covered under the EAD BPA

Additional background information for question 2

FDA has 350 to 400 complex and integrated IT systems. Please refer to the attachments to the RFI for further information on FDA’s IT Portfolio. FDA wants to transform and modernize its enterprise business processes using the guidance from FDA’s Enterprise Modernization Action Plan. The EAD BPA will be a strategic vehicle to address business transformation initiatives of FDA to consolidate, optimize, and simplify business processes and IT systems while moving towards a hybrid cloud environment. The Contractor shall mention their experience achieving enterprise business transformation in the RFI response.

FDA prefers to leverage Cloud migration acceleration programs benefits/credits while migrating to the cloud and is looking for the AWS (or equivalent) Cloud Migration Acceleration Program (MAP) Competency Partner to leverage MAP benefits for FDA. The Contractor shall mention in their RFI response if they are an AWS (or equivalent) Cloud Migration Acceleration Program (MAP) Competency Partner and have previous experiences utilizing/transferring the incentives/credits to their clients.

It is the intent of the BPA to develop technology strategies and roadmaps for a variety of IT priority areas for the FDA and provide recommendations for technology modernization based on business and IT

Strategies. The BPA will require development of roadmaps for multi-year strategic plans and authoring whitepapers with salient characteristics and considerations for recommended/preferred solutions. The FDA expects implementation and support for FDA Enterprise architecture support tools to include deployment and configuration of the tools, integration with other applications such as ServiceNow, and provide administration, operations and maintenance of the new tools. The FDA will review RFI responses for information on experience in developing an enterprise architecture for a federal agency.

Also, FDA requires implementation and use of fully automated DevSecOps CI/CD pipelines with agile development in a hybrid cloud environment for application deployment while using Containers as a Service (CaaS) and Application Programming Interfaces (APIs). This includes developing automated testing scripts and perform automated testing of multiple applications (50 Plus/year). The FDA requires support of Zero Trust implementation and cybersecurity task areas as outlined in the SOW, Attachment B. The FDA will review RFI responses for information on experience in developing fully automated DevSecOps pipelines, automated testing, and Zero Trust implementations.

Referring to Attachment B and the nineteen (19) Task Areas, please answer question 2 (a) to (f) for each Task Area in the Attachment A.

Attachments Attachment A - FDA RFI Response Template Attachment B - FDA Enterprise IT Application Development (EAD) BPA SOW Excerpt Attachment 1 - FDA TBM Layers and Diagrams Attachment 2 - Application Development Technology and Process Standards Attachment 3 - EPLC Agile Methodology Overview for Contractors Attachment 4 - Contractor Personnel Security Clearance Standards and Residency Requirements Attachment 5 - FDA List of Technologies Attachment 6 - FDA Cloud Technologies Attachment 7 - Utilization of Cloud Service Provider (CSP) Migration Rebates Attachment 8 - FDA Application Development Constraints and Assumptions Attachment 9 - FDA Security and Privacy Language for Contracts Attachment 10 - FDA Standard Language for IT Procurements Attachment 11 - FDA EAD SOW Acronym List