[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66306-66307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 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 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.

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, [email protected].

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 https://healthpolicy.duke.edu/events/advancing-premarket-safety-analytics). 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


