[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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