[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Notices]
[Pages 57732-57734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25063]


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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 for Harmonisation E2B(R3) Standards; Public Meetings; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing three 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 information 
on the plans, progress, and technical specifications to upgrade 
electronic submission standards for drug, biological, and drug/
biologic-led combination products for 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 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) standards by holding three public 
meetings. FDA 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 January 25, 2019, from 
9 a.m. to 4 p.m. The second public meeting will be held on July 17, 
2019, from 9 a.m. to 4 p.m. The third public meeting will be held on 
February 19, 2020 from 9 a.m. to 4 p.m. Submit either electronic or 
written comments on these public meetings by February 25, 2019, for the 
first public meeting; by August 16, 2019, for the second public 
meeting, and by March 20, 2020, for the third public meeting. See the 
SUPPLEMENTARY INFORMATION section for registration dates and 
information.

ADDRESSES: Each public meeting will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for 
the public meeting participants (non-FDA employees) is through Building 
1, where routine security check procedures will be performed. For 
parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/default.htm.
    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 before or within 30 days 
after each public meeting (i.e., comments submitted by or before 
February 25, 2019, for the first public meeting; August 16, 2019, for 
the second public meeting; and March 20, 2020, for the third public 
meeting. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time at the end of February 
25, 2019; August 16, 2019; and March 20, 2020, after the first, second, 
and the third meeting, respectively. Comments received by mail/hand

[[Page 57733]]

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.
     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.gpo.gov/fdsys/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.

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: [email protected]; or Judith Richardson, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7309A, Silver Spring, MD 20993-0002, 
240-402-6473, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is committed to achieve 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 
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.'' FDA plans to incorporate ICH 
E2B(R3) recommended standards into the requirements for the electronic 
submission of adverse event reports to FAERS tentatively by April 2020. 
Consistent with the Prescription Drug User Fee Act (PDUFA) VI 
commitments, FDA is organizing several public meetings to allow 
industry the opportunity to provide feedback and/or participate in user 
acceptance testing in advance of the Agency's planned implementation of 
ICH E2B(R3) data standards. FDA's performance goals and procedures 
under the PDUFA program for the years 2018 to 2022 are outlined in the 
commitment letter available at: https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm.
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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 Meetings

    FDA will present its plan to incorporate ICH E2B(R3) recommended 
standards into the requirements for the electronic submission of 
adverse event reports to FAERS. The meetings will include a general 
discussion of CDER's and CBER's plans to revise the FDA Regional 
Implementation Specifications for premarketing and postmarketing 
adverse event reporting. The goal of this revision is to enhance the 
quality of adverse event reports received by the Agency by 
incorporating ICH E2B(R3) recommendations into FDA Regional 
Implementation Specifications. 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 inform CDER's and 
CBER's plans for the implementation of ICH E2B(R3) for drugs, 
biologics, and drug/biologic-led combination products.
    During the public meetings, FDA intends to discuss: (1) E2B(R3) 
Regional (U.S.) Data Elements; (2) Usage of Data Standards in E2B(R3); 
(3) Submission paths for premarket and postmarket ICSRs; (4) Data 
Migration Exceptions; and (5) FDA Regional Implementation 
Specifications for ICH E2B(R3) Implementation. One or more of the

[[Page 57734]]

above 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 the 
following website to register: https://fdae2br3.eventbrite.com by 
December 20, 2018, for the first meeting, June 14, 2019, for the second 
meeting, and January 17, 2020, for the third meeting. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, telephone, and method of attendance (in-
person or web conference).
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending the public 
meetings must register by 11:59 p.m. Eastern Time on December 20, 2018, 
for the first meeting, June 14, 2019, for the second meeting, and 
January 17, 2020, for the third meeting. Early registration is 
recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. Registrants will receive 
confirmation when they have been accepted. If time and space permit, 
onsite registration on the day of the public meeting/public workshop 
will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please 
contact Chenoa Conley, 301-796-0035, email: [email protected], 
at least 7 days before each meeting.
    Request for Oral Presentations: During online registration you may 
indicate if you wish to present during the public comment session. All 
requests to make oral presentations must be received by the close of 
registration at 11:59 p.m. Eastern Time on December 20, 2018, for the 
first meeting, June 14, 2019, for the second meeting, and January 17, 
2020, for the third meeting. We will do our best to accommodate 
requests to make public comments. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations and request time for a joint presentation. Following the 
close of registration, we will determine the amount of time allotted to 
each presenter and the approximate time each oral presentation is to 
begin and will select and notify participants by 11:59 p.m. Eastern 
Time on January 4, 2019, for the first meeting, June 26, 2019, for the 
second meeting, and January 30, 2020, for the third meeting. FDA will 
notify registered presenters of their scheduled presentation time. If 
selected for presentation, any presentation materials must be emailed 
to [email protected] no later than 11:59 p.m. Eastern Time on January 
18, 2019, for the first meeting, July 10, 2019, for the second meeting, 
and February 12, 2020, for the third meeting. Persons registered to 
speak should check in before the meeting and are encouraged to arrive 
early to ensure their designated order of presentation. Participants 
who are not present when called may not be permitted to speak at a 
later time. No commercial or promotional material will be permitted to 
be presented or distributed at the public meeting. An agenda will be 
made available at least 3 days before each public meeting at https://www.fda.gov/Drugs/NewsEvents/ucm621215.htm.
    Streaming Webcast of the Public Meetings and Video of the Public 
Meetings: These public meetings will also be webcast; the URL will be 
posted at https://www.fda.gov/Drugs/NewsEvents/ucm621215.htm at least 1 
day before each meeting. A video record of the public workshops will be 
available at the same website address for 1 year.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    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/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm.

    Dated: November 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25063 Filed 11-15-18; 8:45 am]
 BILLING CODE 4164-01-P