Notice2023-20136
Food and Drug Administration Information Technology Strategy; Request for Comments
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Published
September 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
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<title>Federal Register, Volume 88 Issue 180 (Tuesday, September 19, 2023)</title>
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[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64435-64438]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<a href="http://www.FDA.gov">www.FDA.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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