Notice2024-13941
Food and Drug Administration Information Technology Strategy and Customer Experience Strategy; Request for Comments
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Published
June 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 123 (Wednesday, June 26, 2024)</title>
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[Federal Register Volume 89, Number 123 (Wednesday, June 26, 2024)]
[Notices]
[Pages 53425-53427]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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
[[Page 53426]]
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 <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 & 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:
<a href="/cdn-cgi/l/email-protection#10537163793e517c7568717e747562507674713e7878633e777f66"><span class="__cf_email__" data-cfemail="71321002185f301d1409101f151403311715105f1919025f161e07">[email protected]</span></a>.
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:
<bullet> Updated 14 objectives to increase clarity;
<bullet> Highlighted our commitment to working with global public
health partners and advocating for global standards;
<bullet> Clarified mission outcomes the IT Strategy aims to drive;
and
<bullet> 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?
[[Page 53427]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> and
the IT Operating Plan at <a href="https://www.fda.gov/about-fda/office-digital-transformation/odt-reports">https://www.fda.gov/about-fda/office-digital-transformation/odt-reports</a>.
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
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