Notice2023-03372
Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council of Harmonisation E2B(R3) Standards; Public Meeting; Request for Comments
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Published
February 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a series of two public meetings entitled "Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonisation (ICH) E2B(R3) Standards." The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with updated information on the plans, progress, and technical specifications to upgrade electronic submission standards for drug, biological product, and drug- or biologic-led combination products in the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings are part of a public meeting series initiated by FDA in 2019 to communicate FDA's implementation plan and regional requirements for ICH E2B(R3). The 2023 meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. FDA is seeking input from stakeholders as it fulfills its commitment to implement ICH E2B(R3) and will use the information provided by the public to inform the enhancements to FAERS required for the implementation of ICH E2B(R3) standards and relevant regional variations.
Full Text
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<title>Federal Register, Volume 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10353-10354]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03372]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4002]
Electronic Submission of Adverse Event Reports to the Food and
Drug Administration Adverse Event Reporting System Using International
Council of Harmonisation E2B(R3) Standards; Public Meeting; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a series of two public meetings entitled ``Electronic
Submission of Adverse Event Reports to FDA Adverse Event Reporting
System (FAERS) Using International Council for Harmonisation (ICH)
E2B(R3) Standards.'' The purpose of these public meetings is to provide
the pharmaceutical industry and other interested parties with updated
information on the plans, progress, and technical specifications to
upgrade electronic submission standards for drug, biological product,
and drug- or biologic-led combination products in the premarket and
postmarket safety surveillance programs managed by the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research (CBER). These meetings are part of a public meeting series
initiated by FDA in 2019 to communicate FDA's implementation plan and
regional requirements for ICH E2B(R3). The 2023 meetings will focus on
enhancements to electronic submission of Individual Case Safety Reports
(ICSRs) in FAERS using ICH E2B(R3) standards. FDA is seeking input from
stakeholders as it fulfills its commitment to implement ICH E2B(R3) and
will use the information provided by the public to inform the
enhancements to FAERS required for the implementation of ICH E2B(R3)
standards and relevant regional variations.
DATES: The first public meeting will be held on April 4, 2023, from 9
a.m. to 3 p.m. The second public meeting will be held on November 7,
2023, from 9 a.m. to 12 p.m. Submit either electronic or written
comments on these public meetings by May 3, 2023, for the first public
meeting, and by December 6, 2023, for the second public meeting. See
the SUPPLEMENTARY INFORMATION section for registration dates and
information.
ADDRESSES: The public meeting will be held virtually, by webcast only.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. For timely consideration, we
request that electronic comments be submitted no later than 30 days
after each public meeting (i.e., comments submitted by or before May 3,
2023, for the first public meeting; and December 6, 2023, for the
second public meeting. 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 6, 2023). Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is 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-2018-N-4002 for ``Electronic Submission of Adverse Event Reports to
FAERS using ICH E2B(R3) Standards.'' 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
[[Page 10354]]
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: Suranjan De, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993-0002, 240-
402-0498, <a href="/cdn-cgi/l/email-protection#b3d6c3c1dcdec3c7f3d5d7d29ddbdbc09dd4dcc5"><span class="__cf_email__" data-cfemail="e98c999b8684999da98f8d88c781819ac78e869f">[email protected]</span></a>; or Katie Rivers, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7336, Silver Spring, MD 20993-0002, 301-
796-1818, <a href="/cdn-cgi/l/email-protection#3c594c4e53514c487c5a585d1254544f125b534a"><span class="__cf_email__" data-cfemail="87e2f7f5e8eaf7f3c7e1e3e6a9efeff4a9e0e8f1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is committed to achieving the long-term goal of improving the
predictability and consistency of the electronic submission process and
enhancing transparency and accountability of FDA information
technology-related activities. FDA participated in the development of
an ICH E2B guideline \1\ pertaining to the submission of adverse event
reports to the FAERS system: ``Implementation Guide for Electronic
Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) Data
Elements and Message Specification.'' In the Prescription Drug User Fee
Act VI commitment letter, FDA committed to the goal of allowing
industry to participate in user acceptance testing and/or organizing a
meeting to provide industry an opportunity to provide feedback in
advance of the Agency's implementation of ICH E2B(R3) data standards
for electronic submission of adverse event reports. The commitment
letter outlines FDA's performance goals and procedures under the
Prescription Drug User Fee Act VI program for the years 2018-2022
(available at <a href="https://www.fda.gov/media/99140/download">https://www.fda.gov/media/99140/download</a>). In 2019 and
2020 FDA had conducted a series of three public meetings to communicate
FDA's implementation plan and regional requirements for ICH E2B(R3).
FDA incorporated the recommendations received in the comments from the
2019 and 2020 public meetings as ICH E2B(R3) regional technical
specifications.
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\1\ The ICH E2B(R3) IG guideline (<a href="http://estri.ich.org/e2br3/index.htm">http://estri.ich.org/e2br3/index.htm</a>) provides technical and business specifications for the
harmonized, core set of ICH data elements.
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II. Topics for Discussion at the Public Meeting
The public meetings will include a general discussion of the
updated specifications for premarketing and postmarketing ICSRs listed
in the FDA Regional Implementation Guide for E2B(R3) Electronic
Submission of Individual Case Safety Reports for Drug and Biological
Products that published in April 2022 (available at <a href="https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions">https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions</a>). The goal of this discussion is to communicate the updated
specific regional requirements that will enhance the quality of adverse
event reports received by the Agency. The information exchange at the
meetings will enhance the pharmaceutical industry's knowledge of the
processes needed to implement ICH E2B(R3) into their systems. In
addition, the comments provided by participating stakeholders will
continue to inform CDER and CBER's plans for the implementation of ICH
E2B(R3) for drugs, biological products, and drug- or biologic-led
combination products.
During the public meetings, FDA intends to discuss: (1) E2B(R3)
Regional (U.S.) data elements and business rules; (2) usage of data
standards in E2B(R3); (3) submission paths for premarket and postmarket
ICSRs; (4) forward compatible rules; (5) review of FDA Regional
Implementation Specifications for ICH E2B(R3) Implementation; and (6)
FDA ICSR XML Instances. One or more topics may be discussed in each
meeting. FDA will consider all comments made at these public meetings
or received through the docket (see ADDRESSES).
III. Participating in the Public Meeting
Registration: To register for the public meetings, please visit
<a href="https://fdae2br3.eventbrite.com">https://fdae2br3.eventbrite.com</a> by March 31, 2023, for the first
meeting and November 3, 2023, for the second meeting. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
An agenda will be made available at least 3 days before each public
meeting at <a href="https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using">https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using</a>.
Streaming Webcast of the Public Meetings and Video of the Public
Meetings: These public meetings will only be webcast; the URL will be
posted at <a href="https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using">https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using</a> at least 1 day before each meeting. A recording of the
public workshops will be available at the same website address for 1
year.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at <a href="https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using">https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using</a>.
Dated: February 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03372 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P
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