Notice2022-23925
Advancing Premarket Safety Analytics Workshop; Request for Comments
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
November 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is requesting comments on the topics discussed at a public workshop entitled "Advancing Premarket Safety Analytics Workshop" held on September 14, 2022. The purpose of the public workshop was to present FDA's work and perspective on premarket review of safety data.
Full Text
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<title>Federal Register, Volume 87 Issue 212 (Thursday, November 3, 2022)</title>
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[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66306-66307]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23925]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1961]
Advancing Premarket Safety Analytics Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
requesting comments on the topics discussed at a public workshop
entitled ``Advancing Premarket Safety Analytics Workshop'' held on
September 14, 2022. The purpose of the public workshop was to present
FDA's work and perspective on premarket review of safety data.
DATES: Either electronic or written comments on this public workshop
must be submitted by December 5, 2022. See the SUPPLEMENTARY
INFORMATION section for information.
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 December 5, 2022. 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 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-2022-N-1961 for ``Advancing Premarket Safety Analytics Workshop.''
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: Christopher Smith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6230, Silver Spring, MD 20993, 301-796-
4851, <a href="/cdn-cgi/l/email-protection#395a514b504a4d5649515c4b174a54504d510b795f5d581751514a175e564f"><span class="__cf_email__" data-cfemail="73101b011a00071c031b16015d001e1a071b41331517125d1b1b005d141c05">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Because of a lack of standardization of safety data analysis and
visualization, inconsistencies have been noted in how adverse events
are defined, categorized, analyzed, and presented in marketing
applications. The FDA Center for Drug Evaluation and Research's
(CDER's)
[[Page 66307]]
Office of New Drugs (OND) led the development of two documents to
facilitate internal review of safety data. The first document, ``FDA
Medical Queries,'' provides a standardized approach to group preferred
terms of adverse events using ``Medical Dictionary for Regulatory
Activities'' (MedDRA) terminology. The second document, ``Standard
Safety Tables and Figures Integrated Guide,'' provides standardized
methods for visualization of clinical trial safety data into tables and
figures. FDA values transparency and collaboration with external
stakeholders; therefore, both documents are available for public
comment through the docket.
II. Topics Discussed at the Public Workshop
At the public workshop entitled ``Advancing Premarket Safety
Analytics Workshop,'' CDER's OND presented its work and perspective
related to safety analytics. The workshop provided presentations from
FDA staff on the two documents ``FDA Medical Queries'' and ``Standard
Safety Tables and Figures Integrated Guide '' (meeting materials
available at <a href="https://healthpolicy.duke.edu/events/advancing-premarket-safety-analytics">https://healthpolicy.duke.edu/events/advancing-premarket-safety-analytics</a>). The workshop also included panel discussions with
industry representatives on ``Stakeholder Perspectives Exploring
Premarket Adverse Event Grouping'' and ``Examining Strategies for
Adverse Event Analysis.'' FDA documents were intended as a starting
point for broader discussions on best practices and innovative
approaches for advancing premarket safety signal analytics. We are also
seeking comment on the topics discussed at the workshop.
Dated: October 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23925 Filed 11-2-22; 8:45 am]
BILLING CODE 4164-01-P
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