Notice2023-07766
Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments
Primary source
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Published
April 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing a request for information and comments on the development of an FDA Data and Technology Strategic Plan. 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 30, 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.
Full Text
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<title>Federal Register, Volume 88 Issue 71 (Thursday, April 13, 2023)</title>
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[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22453-22454]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1052]
Food and Drug Administration Data and Technology Strategic Plan;
Request for Information and Comments
AGENCY: Food and Drug Administration, Department of Health and Human
Services.
ACTION: Notice; request for information and comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a request for information and comments on the development of an FDA
Data and Technology Strategic Plan. 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 30, 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 request for
information and comments by May 15, 2023 to ensure that the Agency
considers your comments before it begins work on the final version of
the 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 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-1052 for ``FDA Data and Technology Strategic Plan.''
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.
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#88cbe9fbe1a6c9e4edf0e9e6ecedfac8eeece9a6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="226143514b0c634e475a434c464750624446430c4a4a510c454d54">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a request for information and
comments entitled ``FDA Data and Technology Strategic Plan; Request for
Information and Comments.''
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
[[Page 22454]]
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 the 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 as it
develops a comprehensive framework for guiding the Agency's work and
allocating annual technology budgets and resources. The FDA Data and
Technology Strategic Plan, covering Fiscal Years 2024-2027, will define
and shape the future course of FDA's data and technology capabilities
as FDA transitions to the next phase of its journey. FDA will take an
iterative approach to strategy development, starting with gathering
input, then, sharing a draft of the strategic plan for comment and
finally, considering inputs provided before publishing a final version
of the strategic plan. FDA will focus on the outcomes to empower the
Agency to meet its mission, building on the existing FDA Modernization
Framework and integrating Agency and center strategies. FDA will engage
internal and external stakeholders early and often throughout this
process. FDA plans to incorporate stakeholder input as the Agency
engages with internal and external stakeholders across the remainder of
this fiscal year including through two Federal Register notices for
information and comment (this one and a second one for comment on the
draft strategy). Stakeholder input is crucial for developing a
comprehensive plan that best meets the needs and goals of industry and
the Agency.
II. Requested Information and Comments
Interested persons are invited to provide detailed comments to ODT
(see ADDRESSES) on the following aspects of the development of FDA's
Agency-wide Data and Technology Strategic Plan. To facilitate input,
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.
This feedback will help inform the Agency's strategy development. FDA
encourages stakeholders to provide the specific rationale and basis for
their comments, including any available supporting data and
information. FDA will publish another notice in the Federal Register
requesting comments once the Data and Technology Modernization Strategy
is developed.
1. What are up to three outcomes the FDA Data and Technology
Strategic Plan can help you achieve, e.g., speed to market?
2. What are up to three challenges you are facing while trying to
achieve these outcomes?
3. What data and technical capabilities could FDA strengthen to
help support its public health mission?
4. What opportunities or risks do you foresee for the FDA Data and
Technology Strategic Plan?
5. What changes or trends in your industry could impact the FDA
Data and Technology Strategic Plan?
6. How might FDA best communicate and engage stakeholders in
developing and implementing the strategy?
Dated: April 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07766 Filed 4-12-23; 8:45 am]
BILLING CODE 4164-01-P
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