[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10353-10354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 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

[[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: 
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: 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, [email protected]; 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, [email protected].

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 https://www.fda.gov/media/99140/download). 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 (http://estri.ich.org/e2br3/index.htm) 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 https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions). 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 
https://fdae2br3.eventbrite.com 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 https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using.
    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 https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using 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 https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using.

    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