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, 9342-9344 [2019-04730]

Download as PDF 9342 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices Number of respondents Respondent/data collection activity Responses per respondent Hours per response Annual burden hours Title VI Part A, B and C ................................................................................... 274 1 2.5 685 Total .......................................................................................................... 274 1 2.5 685 Dated: March 5, 2019. Mary Lazare, Principal Deputy Administrator. [FR Doc. 2019–04734 Filed 3–13–19; 8:45 am] BILLING CODE 4154–01–P 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. Notice of public meetings; request for comments. ACTION: The Food and Drug Administration (FDA, the Agency, or we) is re-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) SUMMARY: VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 standards and relevant regional variations. DATES: The first public meeting is being rescheduled due to a previous lapse in appropriations. The rescheduled first public meeting will be held on March 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 April 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. The first public meeting will be held at the Silver Spring Civic Building at Veterans Plaza, The Buffalo Soldiers Great Hall, 1 Veterans Pl., Silver Spring, MD 20910. The second and third public meetings 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 April 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 April 25, 2019, August 16, 2019, and March 20, 2020, after the first, second, and the third meeting, respectively. Comments received by mail/hand ADDRESSES: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices 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/201523389.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: eprompt@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911, email: eprompt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 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 ICH E2B guideline 1 pertaining to the submission of adverse event reports across multiple regions: ‘‘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. 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. 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. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 9343 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 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 March 22, 2019, for the first meeting, June 14, 2019, for the second meeting, and January 17, 2020, for the third meeting. Persons who registered for the first public meeting date of January 25, 2019, should visit the website to register again for the rescheduled meeting date of March 25, 2019. 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 March 22, 2019, 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: Chenoa.Conley@fda.hhs.gov, 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 11:59 p.m. Eastern Time on March 19, 2019, 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 E:\FR\FM\14MRN1.SGM 14MRN1 9344 Federal Register / Vol. 84, No. 50 / Thursday, March 14, 2019 / Notices 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 March 20, 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 eprompt@fda.hhs.gov no later than 11:59 p.m. Eastern Time on March 22, 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: The second and third 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/ GuidanceCompliance RegulatoryInformation/Surveillance/ AdverseDrugEffects/ucm115894.htm. VerDate Sep<11>2014 17:22 Mar 13, 2019 Jkt 247001 Dated: March 11, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–04730 Filed 3–13–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1045] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. Consistent with FDA’s regulations, notice is being published with less than 15 days prior to the date of the meeting based on a determination that an immediate meeting of the Vaccines and Related Biological Products Advisory Committee is needed. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019– 2020 seasonal influenza vaccines. DATES: The meeting will be held on March 22, 2019, from 8:30 a.m. to 2:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. For those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://collaboration.fda.gov/ vrbpac032019. SUMMARY: FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 6338, Silver Spring, MD 20993–0002, 240–402–5771, serina.hunter-thomas@ fda.hhs.gov; or Monique Hill, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993–0002, 301–796–4620, monique.hill@ fda.hhs.gov; or the FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On March 22, 2019, in followup to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019– 2020 seasonal influenza vaccines, the Center for Biologics Evaluation and Research will reconvene the VRBPAC to discuss and make recommendations specifically on the H3N2 strain. The VRBPAC previously met on March 6, 2019, and made recommendations on the selection of all other strains to be included in seasonal influenza virus vaccines for the 2019–2020 influenza season. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at: https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On March 22, 2019, from 8:30 a.m. to 2:30 p.m. the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 15, 2019. On March 22, 2019, oral presentations from the public will be scheduled between E:\FR\FM\14MRN1.SGM 14MRN1

Agencies

[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9342-9344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04730]


-----------------------------------------------------------------------

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 
re-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 is being rescheduled due to a previous 
lapse in appropriations. The rescheduled first public meeting will be 
held on March 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 April 
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: The first public meeting will be held at the Silver Spring 
Civic Building at Veterans Plaza, The Buffalo Soldiers Great Hall, 1 
Veterans Pl., Silver Spring, MD 20910. The second and third public 
meetings 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 April 
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 April 25, 2019, 
August 16, 2019, and March 20, 2020, after the first, second, and the 
third meeting, respectively. 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

[[Page 9343]]

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: eprompt@fda.hhs.gov; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911, email: eprompt@fda.hhs.gov.

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 
ICH E2B guideline \1\ pertaining to the submission of adverse event 
reports across multiple regions: ``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 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 March 
22, 2019, for the first meeting, June 14, 2019, for the second meeting, 
and January 17, 2020, for the third meeting. Persons who registered for 
the first public meeting date of January 25, 2019, should visit the 
website to register again for the rescheduled meeting date of March 25, 
2019. 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 March 22, 2019, 
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: Chenoa.Conley@fda.hhs.gov, 
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 11:59 p.m. 
Eastern Time on March 19, 2019, 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

[[Page 9344]]

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 March 20, 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 eprompt@fda.hhs.gov no later 
than 11:59 p.m. Eastern Time on March 22, 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: The second and third 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: March 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04730 Filed 3-13-19; 8:45 am]
 BILLING CODE 4164-01-P