[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64435-64438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20136]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3636]


Food and Drug Administration Information Technology Strategy; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of an information technology (IT) strategic plan 
entitled the ``FDA Information Technology Strategy'' and a request for 
comment on this IT Strategy. As part of our User Fee Program 
commitments and Omnibus Bill requirements, FDA will develop and publish 
an FDA Data and Technology Strategic Plan by September 29, 2023. This 
plan will define and shape the future course of FDA's data and 
technology capabilities, building on the existing FDA Modernization 
Framework. The plan will also integrate Agency and center strategies.

DATES: Submit either electronic or written comments on the Strategy by 
October 30, 2023, to ensure that the Agency considers your comments on 
this Strategy for future iterations of the IT Strategy.

ADDRESSES: You may submit comments as follows:

[[Page 64436]]

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-3636 for ``FDA IT Strategy.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    Submit written requests for single copies of this IT strategy to 
the Office of Digital Transformation, Food and Drug Administration, FDA 
Library, 5630 Fishers Lane, Rm. 1087, Rockville, MD 20857. Send one 
self-addressed adhesive label to assist that office in processing your 
request or include a Fax number to which the strategy may be sent. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the draft strategy.

FOR FURTHER INFORMATION CONTACT: Casi Alexander, Office of Digital 
Transformation, Food and Drug Administration, FDA Library, 5630 Fishers 
Lane, Rm. 1087, Rockville, MD 20857, 240-402-5171, email: 
<a href="/cdn-cgi/l/email-protection#2d6e4c5e44036c4148554c4349485f6d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="b0f3d1c3d99ef1dcd5c8d1ded4d5c2f0d6d4d19ed8d8c39ed7dfc6">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a request for comment on its 
draft strategy, entitled ``FDA Information Technology Strategy''.
    The Office of Digital Transformation (ODT) was established in 
September 2021 and reports directly to the Office of the Commissioner. 
ODT provides the vision and leadership in information technology, data, 
and cybersecurity needed to advance FDA's mission and strategic 
priorities. ODT has published a series of strategy documents known as 
the FDA Modernization Framework. The framework includes the Technology 
Modernization Action Plan, Data Modernization Action Plan, Enterprise 
Modernization Action Plan, Cybersecurity Modernization Action Plan, and 
the Leadership Modernization Action Plan. The FDA Modernization 
Framework aims to develop an integrated technology, data, 
cybersecurity, business, and leadership approach to advancing FDA's 
public health mission in collaboration with industry.
    As part of FDA's fulfillment of requirements in section 3627 of the 
Consolidated Appropriations Act, 2023 (Pub. L. 117-328), and 
commitments described in section IV.A.2. of the ``PDUFA Reauthorization 
Performance Goals and Program Enhancements Fiscal Years 2023-2027'' 
(PDUFA VI commitment letter), FDA will work with industry while 
developing a comprehensive framework for guiding the Agency's work and 
allocating annual technology budgets and resources. The FDA IT 
Strategy, covering Fiscal Years 2024-2026, defines and shapes the 
future course of FDA's data and technology capabilities as FDA 
transitions to the next phase of its journey. The Agency took a 
collaborative approach to strategy development by gathering input from 
numerous internal and external stakeholders that resulted in the draft 
FDA IT Strategy. Stakeholder input is crucial for developing a 
comprehensive plan that best meets the needs and goals of industry and 
the Agency. Comments on the strategy will be considered for future 
iterations of the FDA IT Strategy. Once adopted, this strategy will 
serve as the basis for developing an internal operational plan with 
objectives, tactics, and performance measures.
    As part of this effort, FDA will hold an FDA Digital Transformation 
Symposium on December 4 to 7, 2023, to discuss this groundbreaking IT 
Strategy and encourage further collaboration, innovation, and 
transformation. On December 4 and 5, the Symposium will be shaped 
around the six new strategic goals, highlighting supporting objectives 
and initiatives. The FDA Digital Transformation Symposium will extend 
to December 6 and 7 to engage IT vendors in a Reverse Industry Day and 
other vendor-focused events. Registration information will be found on 
www.FDA.gov for this event.

[[Page 64437]]

II. Requested Feedback

    Interested persons are invited to provide detailed comments to ODT 
(see ADDRESSES) on the specific IT Strategy Goals and Objectives within 
FDA's Agency-wide IT Strategy. To facilitate comment, FDA has developed 
a series of questions in this section. The questions are not meant to 
be exhaustive, and FDA is also interested in any other pertinent 
information stakeholders would like to share on this topic. FDA 
encourages stakeholders to provide the specific rationale and basis for 
their comments, including any available supporting data and 
information.
    1. Which goals and objectives are most important to you? Why?
    2. Describe up to five ways the FDA IT Strategy will impact your 
industry?
    3. What gaps do you see in the FDA IT Strategy's goals or 
objectives?
    4. What challenges or risks do you foresee in executing the FDA IT 
Strategy?

III. FDA IT Strategy Goals and Objectives

    Goal 1: Create a Shared OneFDA Ecosystem: Establish greater access 
to trusted data and shared resources across Centers, Offices, and 
external stakeholders. Encourage and facilitate cross-functional 
investment in technology to support enterprise business objectives for 
speed, scale, and value through robust Agency level governance 
processes, enhanced collaboration channels, and technology products and 
services. Shift FDA's culture to make sharing across Centers and 
Offices and with external stakeholders (where appropriate) the norm--
where prioritizing Agency-level public health outcomes improves results 
for everyone.
Objectives
    <bullet> Enhance Communication and Collaboration: Foster 
information and resource sharing with internal and external 
stakeholders to achieve both Agency and specific stakeholder outcomes, 
using a variety of communication channels to reach broader audiences. 
Enable collaboration and develop strong partnerships across Centers and 
Offices through integrated technologies and platforms.
    <bullet> Promote Transparency: Actively involve impacted 
stakeholders in IT solution planning, development, and execution to 
drive expected outcomes.
    <bullet> Optimize Investments: Align the diverse needs across FDA 
to the overarching strategy through stronger financial fidelity, 
enhanced budget coordination, and improved financial planning. Ensure 
effective IT resource utilization, transparency in IT budget 
allocation, and measurement of results achieved.
    <bullet> Strengthen Governance: Ensure the effective and efficient 
use of IT in enabling FDA to achieve mission outcomes through 
established standards, responsible procurement, and more robust 
decision-making and accountability mechanisms.
    Goal 2: Strengthen IT Infrastructure: Continue to modernize and 
secure the foundational IT infrastructure for all IT services and 
solutions. Proactively provide the ability to adapt to changes in 
workload demand, detect issues before they impact stakeholders, and 
quickly resolve technology issues to avoid disruptions to day-to-day 
operations.
Objectives
    <bullet> Provide Flexible Infrastructure Offerings: Provide a 
marketplace with usage-based models for users to identify and implement 
the infrastructure solutions based on their business requirements with 
an appropriate chargeback model.
    <bullet> Accelerate Cloud Adoption: Empower users with cloud 
offerings to meet their mission needs, e.g., scalability and agility. 
Provide best practice guidance on cloud models, e.g., hybrid and 
transition strategies based on the unique needs across Centers and 
Offices.
    <bullet> Ensure Service Availability: Provide stable access to IT 
services through proactive, continuous monitoring of IT infrastructure 
service performance (e.g., Service Level Agreements, Operating Level 
Agreements) and feedback from FDA users to identify potential problems 
and implement targeted improvements.
    <bullet> Implement Zero Trust Approach: Establish a comprehensive 
zero trust and risk-based approach to obtain optimal maturity level by 
upgrading, modernizing, and enhancing FDA's security and cyber 
defenses.
    Goal 3: Modernize Enterprise Services and Capabilities: Optimize 
the IT services portfolio to support everyday needs with cross-cutting, 
mission-critical offerings and benefit from economies of scale. Ensure 
enterprise IT services are stable, resilient, and adaptive, with 
opportunities for stakeholders to tailor solutions, where appropriate, 
and feedback loops to drive continuous improvement.
Objectives
    <bullet> Increase Business Alignment: Lead with a business-first 
approach to modernizing enterprise services and capabilities to ensure 
technology enables the capabilities defined in FDA's Business 
Capability Model and supporting business processes.
    <bullet> Scale Operations: Develop and drive adoption of enterprise 
solutions for standard capabilities, e.g., Finance/Budget, Human 
Resources, Acquisitions, Inspections, Freedom of Information Act 
requests, and Complaints Management with continuous user testing, while 
providing flexibility for customization where relevant. Manage the 
lifecycle of applications within the enterprise portfolio.
    <bullet> Increase Digital Maturity: Maximize the use of technology 
(e.g., data, automation) in core business areas and enable processes to 
improve their ability to adapt to changes and scale.
    <bullet> Improve Customer Experience: Create customer-centric 
solutions that enhance satisfaction by improving accessibility to IT 
solutions, including external-facing systems (e.g., Electronic 
Submission Gateway Next Generation), streamlining processes, and easing 
adoption. Increase stakeholder engagement with FDA IT services by 
prioritizing customer and employee feedback and establishing formal 
feedback loops.
    <bullet> Modernize FDA Cybersecurity Defenses: Upgrade, enhance, 
and modernize FDA's critical cyber defenses and practices to address 
the evolving threat landscape where risks to FDA's critical assets, 
industry, and sensitive data exist.
    <bullet> Reduce Technology Debt: Decommission legacy systems, 
applications, and End-of-Life devices and reinvest in enterprise 
solutions and business process improvements to minimize technical debt 
and enterprise risk.
    Goal 4: Share Data for Mission Outcomes: Identify common data 
assets critical to stakeholders across FDA and make them widely 
available and consumable to drive operational efficiencies and 
excellence. Leverage valuable data assets and insights to develop new 
capabilities and services and enable public health innovation.
Objectives
    <bullet> Enhance Data Governance: Implement Artificial Intelligence 
(AI)-powered best practices for governance and data management that 
improve data quality, security, and the speed and accuracy of insights 
and decisions.
    <bullet> Foster OneFDA Data Literacy: Educate the workforce on best 
practices and the benefits of consuming, analyzing, and making data-
based decisions.

[[Page 64438]]

    <bullet> Improve Data Visibility and Accessibility: Prioritize 
which data assets to make widely available first based on value to the 
mission and the most significant number of stakeholders.
    <bullet> Enable Advanced Data Analytics: Ensure experts can easily 
combine and analyze information from various internal and external 
sources to gain comprehensive insights.
    <bullet> Enhance Secure Data Exchange: Improve interoperable and 
secure data exchange and collaboration across FDA and its public health 
partners.
    Goal 5: Adopt AI and Mission-Driven Innovations: Drive exploration 
and address impacts of emerging technologies and trends, such as AI and 
virtual reality, on FDA's IT portfolio and regulatory operations. 
Proactively identify opportunities and risks to FDA's mission and 
inform responsible use of technology. Enhance partnerships with 
external experts to leverage these technologies and promptly respond to 
their impact.
Objectives
    <bullet> Balance Policy and Technology Value: Develop ethical 
guidance for technology use while maximizing business value, such as 
Guidance on AI Strategy. Ensure responsible actions by conducting 
comprehensive research and analysis to fully understand technological 
advancements' potential impacts and implications on society.
    <bullet> Ensure Responsible Use of Innovations: Deploy 
technological innovations, such as AI/Machine Learning, responsibly 
with an understanding of regulatory impacts and effective risk response 
strategies. Establish appropriate guardrails where necessary.
    <bullet> Provide Proactive Thought Leadership: Lead as a partner in 
creating novel use cases for emerging technologies through a deep 
understanding of business processes, industry, and technology. Stay at 
the forefront of technological advancements by harnessing industry 
expertise and fostering collaboration.
    <bullet> Foster Innovation: Create an environment where innovative 
approaches are encouraged, identified, shared, and evaluated for use in 
driving operational efficiency and developing new capabilities. Apply a 
structured process to manage the innovation lifecycle from ideation to 
investment to adoption (or project shutdown) to produce usable 
innovations.
    Goal 6: Cultivate Talent and Leadership: Mature Agency-wide IT 
competencies to deepen technology expertise and keep pace with the 
accelerated rate of change in FDA's regulated industries and 
technology. Develop holistic leaders equipped to lead through change 
and drive FDA's digital transformation journey forward. Deliver 
enterprise IT services with an Agency-first mindset. Given the 
continued competition for talent, proactively build a robust talent 
pipeline for targeted roles leveraging a combination of recruitment, 
retention, and talent development strategies.
Objectives
    <bullet> Instill OneFDA Mindset: Cultivate an Agency-first approach 
to IT so that decisions promote and protect the health of the American 
people first and foremost.
    <bullet> Attract and Retain Talent: Build a diverse talent pipeline 
through a compelling employee value proposition and total compensation 
approach, talent acquisition, employee engagement, and talent 
development strategies. Drive improvements across the employee 
lifecycle from recruitment to retirement.
    <bullet> Hire and Develop Resilient Leaders: Strengthen leadership 
competencies required to drive holistic transformational IT initiatives 
in a dynamic environment successfully.
    <bullet> Develop Skills for the Future of Work: Develop IT skills 
and competencies required to deliver current and future IT services 
through upskilling, reskilling, and continuous learning.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the IT Strategy at https://www.regulations.gov.

    Dated: September 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20136 Filed 9-18-23; 8:45 am]
BILLING CODE 4164-01-P


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