Notice2023-09169
Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments; Extension of Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 1, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing a request for information and comments that appeared in the Federal Register of April 13, 2023. In that notice, FDA requested information and comments on the FDA Data and Technology Strategic Plan. The Agency is taking this action to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 88 Issue 83 (Monday, May 1, 2023)</title>
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[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26566-26567]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09169]
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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; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information and comments; extension of
comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice announcing a request for
information and comments that appeared in the Federal Register of April
13, 2023. In that notice, FDA requested information and comments on the
FDA Data and Technology Strategic Plan. The Agency is taking this
action to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the notice published
April 13, 2023 (88 FR 22453). Either electronic or written comments
must be submitted by June 12, 2023, to ensure that the Agency considers
your comment on this request for information and comments before it
begins work on the strategic plan.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 12, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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
[[Page 26567]]
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, those filed in a timely manner (see ADDRESSES), 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,
<a href="/cdn-cgi/l/email-protection#c281a3b1abec83aea7baa3aca6a7b082a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="226143514b0c634e475a434c464750624446430c4a4a510c454d54">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 13, 2023,
FDA published a notice announcing a request for information and
comments entitled ``FDA Data and Technology Strategic Plan; Request for
Information and Comments.'' Interested persons were originally given
until May 15, 2023, to comment on the document. The Agency has elected
to extend the comment period so that all interested parties are able to
more thoroughly consider the request for input. FDA is extending the
comment period for 30 days, until June 12, 2023. The Agency believes
that this 30-day extension allows adequate time for interested persons
to submit comments.
Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09169 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P
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