[Federal Register Volume 89, Number 123 (Wednesday, June 26, 2024)]
[Notices]
[Pages 53425-53427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2886]


Food and Drug Administration Information Technology Strategy and 
Customer Experience 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 requesting 
comments on its ``Information Technology (IT) Strategy'' and ``Customer 
Experience (CX) Strategy.'' In accordance with the Agency's User Fee 
Program commitments and Omnibus Bill requirements, FDA must annually 
update and publish its IT Strategy by September 30. The initial 
strategy, released in September 2023, outlines the future direction of 
FDA's data and technology capabilities. A key objective of FDA's IT 
Strategy is to modernize enterprise services and capabilities to 
improve customer experience. The FDA CX Strategy was created to guide 
this effort. This comprehensive enterprise plan introduces the Agency's 
CX framework and considers the perspective of interested parties such 
as the public, employees, and industry.

DATES: Submit either electronic or written comments on the IT Strategy 
by July 31, 2024, to ensure that the Agency considers your comments for 
future iterations of the IT Strategy.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     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.
     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:
     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.
     For written/paper comments submitted to the Dockets 
Management

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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-2024-N-2886 for ``FDA IT Strategy and CX 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.
     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 & CX 
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 IT 
Strategy or CX Strategy may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the IT Strategy or CX 
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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a request for comment on its 
strategies entitled ``FDA Information Technology Strategy'' and 
``Customer Experience Strategy.''
    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 VII commitment letter), FDA is developing a comprehensive 
framework for guiding the Agency's work and allocating annual 
technology budgets and resources. The announcement of the availability 
of the first Agency-wide IT Strategy was published in the Federal 
Register on September 13, 2023 (88 FR 64435). As part of an annual 
strategic planning process, FDA reviewed the strategy and made minor 
updates to align with internal and external changes. FDA's 2024 refresh 
of the IT Strategy required no change to its IT goals and minimal 
changes listed below:
     Updated 14 objectives to increase clarity;
     Highlighted our commitment to working with global public 
health partners and advocating for global standards;
     Clarified mission outcomes the IT Strategy aims to drive; 
and
     Promoted alignment to relevant strategies, e.g., those of 
the Department of Health and Human Services.
    For additional context on how the IT Strategy will be executed, FDA 
suggests reading the IT Operating Plan, a companion document to the IT 
Strategy. The IT Operating Plan, published in February 2024, is a 
blueprint designed to guide FDA's technological growth and development 
in accordance with the IT strategic goals. It encompasses an IT 
strategic roadmap, governance, and organization construct as well as a 
performance measurement process designed to advance public health 
outcomes.
    One of FDA's IT strategic goals is to ``Modernize Enterprise 
Services and Capabilities'' which includes an objective to improve 
customer experience. This objective is focused on creating customer-
centric solutions that enhance satisfaction by improving accessibility 
to IT solutions, streamlining processes, and easing adoption. The CX 
Strategy was developed to outline FDA's approach to make progress 
against this objective. The CX Strategy introduces the Agency's CX 
framework and is written with the perspective of interested parties 
from the public, employees, and industry in mind.
    The Agency continues to take a collaborative approach to strategy 
development by gathering input from numerous internal and external 
interested parties. This input is crucial for developing an updated 
comprehensive plan that best meets the needs and goals of industry and 
the Agency. Comments on the IT Strategy as well as the CX Strategy will 
be considered for future iterations.

II. Requested Feedback

    Interested persons are invited to provide detailed comments to the 
Office of Digital Transformation (see ADDRESSES) on the specific IT 
Strategy Goals and Objectives within FDA's Agency-wide IT Strategy as 
well as the CX 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 interested parties would like to share on this topic. FDA 
encourages interested parties to provide the specific rationale and 
basis for their comments, including any available supporting data and 
information.

A. IT Strategy and Operating Plan

    This annual update to the IT Strategy contains minimal changes per 
the summary above. If you previously responded to the Agency's Federal 
Register notice published on September 13, 2023 (88 FR 64435), 
soliciting feedback, you will see some similar questions. You may 
choose to refer to your prior response or to provide additional 
feedback based on your experience since the first IT Strategy 
publication as well as context provided in our IT Operating Plan, a 
companion guide to the IT Strategy.
    1. Which goals and objectives are most important to you? Why?

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    2. What are up to three outcomes the IT Strategy has helped or will 
help you achieve? Please provide examples.
    3. What gaps do you see in the IT Strategy?
    4. What challenges or risks do you foresee in executing the IT 
Strategy beyond those captured in the IT Operating Plan?
    5. How have you leveraged the IT Strategy and/or IT Operating Plan 
since they were published in 2023?
    6. How might FDA continue to communicate and engage interested 
parties in developing and implementing the strategy?

B. Customer Experience Strategy

    1. Which goals and objectives are most important to you? Why?
    2. What gaps do you see in the CX Strategy's goals or objectives?
    3. What has been your customer experience when interacting with 
FDA?
    4. What is one thing FDA can do to improve your customer 
experience?

III. Electronic Access

    Persons with access to the internet may obtain electronic versions 
of the IT Strategy and CX Strategy at https://www.regulations.gov and 
the IT Operating Plan at https://www.fda.gov/about-fda/office-digital-transformation/odt-reports.

    Dated: June 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13941 Filed 6-25-24; 8:45 am]
BILLING CODE 4164-01-P