83 FR 57732 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 222 (November 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 222 (November 16, 2018)
| Page Range | 57732-57734 | |
| FR Document | 2018-25063 |
[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)] [Notices] [Pages 57732-57734] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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
![57732 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT
SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM JANUARY 1, 2018, THROUGH SEPTEMBER 18, 2018—
Continued
PMA No., Docket No. Applicant Trade name Approval date
P160017/S031, FDA–2018–M– Medtronic MiniMed, Inc ....................... MiniMed 670G System ................................................................................ 6/21/2018
2461.
P160048, FDA–2018–M–2463 .. Senseonics, Inc ................................... Eversense Continuous Glucose Monitoring System ................................... 6/21/2018
P180008, FDA–2018–M–2462 .. Tandem Diabetes Care, Inc ................ t:slim X2 Insulin Pump with Basal-IQ Technology ...................................... 6/21/2018
P180002, FDA–2018–M–2571 .. Pulmonx Corp ..................................... Zephyr® Endobronchial Valve System ........................................................ 6/29/2018
P160026, FDA–2018–M–2883 .. Physio-Control, Inc .............................. LIFEPAK® 1000 Defibrillator, LIFEPAK® 1000 Defibrillator Lithium-Ion 7/2/2018
Rechargeable Battery, LIFEPAK® 1000 Defibrillator Non-Rechargeable
Battery, LIFEPAK® 20 Defibrillator/Monitor (Refurbished), LIFEPAK®
20e Defibrillator/Monitor, LIFEPAK® 15 Monitor/Defibrillator, LIFEPAK®
Lithium-ion Rechargeable Battery (for use with the LIFEPAK® 15 Mon-
itor/Defibrillator).
P170024, FDA–2018–M–2884 .. Stryker Neurovascular ........................ Surpass Streamline Flow Diverter ............................................................... 7/13/2018
P170041, FDA–2018–M–2885 .. Abbott Molecular, Inc .......................... Abbott RealTime IDH1 ................................................................................ 7/20/2018
P160030/S017, FDA–2018–M– Abbott Diabetes Care Inc ................... FreeStyle Libre 14 Day Flash Glucose Monitoring System ........................ 7/23/2018
2886.
P160053, FDA–2018–M–2887 .. Endomagnetics Ltd ............................. MagtraceTM and Sentimag® Magnetic Localization System ....................... 7/24/2018
P170042, FDA–2018–M–2983 .. C.R. Bard, Inc ..................................... COVERATM Vascular Covered Stent .......................................................... 7/30/2018
P150048/S012, FDA–2018–M– Edwards Lifesciences LLC ................. Edwards Pericardial Mitral Bioprosthesis, Model 11000M .......................... 8/9/2018
3131.
P170034, FDA–2018–M–3153 .. Ivantis, Inc ........................................... Hydrus® Microstent ..................................................................................... 8/10/2018
P150013/S011, FDA–2018–M– Dako North America, Inc .................... PD–L1 IHC 22C3 pharmDx ......................................................................... 8/16/2018
3212.
P030016/S001, FDA–2018–M– STAAR Surgical Co ............................ Visian® TORIC ICL (Implantable Collamer® Lens) ..................................... 9/13/2018
3503.
H170004, FDA–2018–M–3505 .. BIOTRONIK, Inc ................................. PK Papyrus Covered Coronary Stent System ............................................ 9/14/2018
P180011, FDA–2018–M–3548 .. Boston Scientific Corp ........................ ELUVIATM Drug-Eluting Vascular Stent System ......................................... 9/18/2018
II. Electronic Access International Council for Harmonisation for the second public meeting, and by
Persons with access to the internet (ICH) E2B(R3) Standards.’’ The purpose March 20, 2020, for the third public
may obtain the documents at https:// of these public meetings is to provide meeting. See the SUPPLEMENTARY
www.fda.gov/MedicalDevices/ the pharmaceutical industry and other INFORMATION section for registration
ProductsandMedicalProcedures/ interested parties with information on dates and information.
DeviceApprovalsandClearances/ the plans, progress, and technical ADDRESSES: Each public meeting will be
PMAApprovals/default.htm. specifications to upgrade electronic held at the FDA White Oak Campus,
submission standards for drug, 10903 New Hampshire Ave., Bldg. 31
Dated: November 13, 2018. biological, and drug/biologic-led Conference Center, the Great Room (Rm.
Leslie Kux, combination products for the premarket 1503, Section A), Silver Spring, MD
Associate Commissioner for Policy. and postmarket safety surveillance 20993–0002. Entrance for the public
[FR Doc. 2018–25071 Filed 11–15–18; 8:45 am] programs managed by the Center for meeting participants (non-FDA
BILLING CODE 4164–01–P Drug Evaluation and Research (CDER) employees) is through Building 1, where
and the Center for Biologics Evaluation routine security check procedures will
and Research (CBER). These meetings be performed. For parking and security
DEPARTMENT OF HEALTH AND will focus on enhancements to information, please refer to https://
HUMAN SERVICES electronic submission of Individual www.fda.gov/AboutFDA/
Case Safety Reports (ICSRs) in FAERS WorkingatFDA/BuildingsandFacilities/
Food and Drug Administration using ICH E2B(R3) standards. WhiteOakCampusInformation/
[Docket No. FDA–2018–N–4002] FDA is seeking input from default.htm.
stakeholders as it fulfills its You may submit comments as
Electronic Submission of Adverse commitment to implement ICH E2B(R3) follows. Please note that late, untimely
Event Reports to the Food and Drug standards by holding three public filed comments will not be considered.
Administration Adverse Event meetings. FDA will use the information For timely consideration, we request
Reporting System Using International provided by the public to inform the that electronic comments be submitted
Council for Harmonisation E2B(R3) enhancements to FAERS required for before or within 30 days after each
Standards; Public Meetings; Request the implementation of ICH E2B(R3) public meeting (i.e., comments
for Comments standards and relevant regional submitted by or before February 25,
variations. 2019, for the first public meeting;
AGENCY: Food and Drug Administration,
HHS. DATES: The first public meeting will be August 16, 2019, for the second public
ACTION: Notice of public meetings; held on January 25, 2019, from 9 a.m. meeting; and March 20, 2020, for the
request for comments. to 4 p.m. The second public meeting third public meeting. The https://
amozie on DSK3GDR082PROD with NOTICES
will be held on July 17, 2019, from 9 www.regulations.gov electronic filing
SUMMARY: The Food and Drug a.m. to 4 p.m. The third public meeting system will accept comments until
Administration (FDA, the Agency, or will be held on February 19, 2020 from 11:59 p.m. Eastern Time at the end of
we) is announcing three public meetings 9 a.m. to 4 p.m. Submit either electronic February 25, 2019; August 16, 2019; and
entitled ‘‘Electronic Submission of or written comments on these public March 20, 2020, after the first, second,
Adverse Event Reports to FDA Adverse meetings by February 25, 2019, for the and the third meeting, respectively.
Event Reporting System (FAERS) Using first public meeting; by August 16, 2019, Comments received by mail/hand
VerDate Sep<11>2014 17:19 Nov 15, 2018 Jkt 247001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1](https://thefederalregister.org/doc/83_FR_57954/page/1.svg)
![57734 Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
above topics may be discussed in each selected for presentation, any DEPARTMENT OF HEALTH AND
meeting. FDA will consider all presentation materials must be emailed HUMAN SERVICES
comments made at these public to eprompt@fda.hhs.gov no later than
meetings or received through the docket 11:59 p.m. Eastern Time on January 18, Food and Drug Administration
(see ADDRESSES). 2019, for the first meeting, July 10, 2019, [Docket No. FDA–2018–N–3789]
III. Participating in the Public Meeting for the second meeting, and February
12, 2020, for the third meeting. Persons Request for Nominations for
Registration: To register for the public Individuals and Consumer
registered to speak should check in
meetings, please visit the following Organizations for Advisory
website to register: https:// before the meeting and are encouraged
to arrive early to ensure their designated Committees
fdae2br3.eventbrite.com by December
20, 2018, for the first meeting, June 14, order of presentation. Participants who AGENCY: Food and Drug Administration,
2019, for the second meeting, and are not present when called may not be HHS.
January 17, 2020, for the third meeting. permitted to speak at a later time. No ACTION: Notice.
Please provide complete contact commercial or promotional material
information for each attendee, including will be permitted to be presented or SUMMARY: The Food and Drug
name, title, affiliation, address, email, distributed at the public meeting. An Administration (FDA or Agency) is
telephone, and method of attendance agenda will be made available at least 3 requesting that any consumer
(in-person or web conference). days before each public meeting at organizations interested in participating
Registration is free and based on https://www.fda.gov/Drugs/NewsEvents/ in the selection of voting and/or
space availability, with priority given to ucm621215.htm. nonvoting consumer representatives to
early registrants. Persons interested in serve on its advisory committees or
Streaming Webcast of the Public
attending the public meetings must panels notify FDA in writing. FDA is
register by 11:59 p.m. Eastern Time on Meetings and Video of the Public
also requesting nominations for voting
December 20, 2018, for the first meeting, Meetings: These public meetings will and/or nonvoting consumer
June 14, 2019, for the second meeting, also be webcast; the URL will be posted representatives to serve on advisory
and January 17, 2020, for the third at https://www.fda.gov/Drugs/ committees and/or panels for which
meeting. Early registration is NewsEvents/ucm621215.htm at least 1 vacancies currently exist or are expected
recommended because seating is day before each meeting. A video record to occur in the near future. Nominees
limited; therefore, FDA may limit the of the public workshops will be recommended to serve as a voting or
number of participants from each available at the same website address for nonvoting consumer representative may
organization. Registrants will receive 1 year. be self-nominated or may be nominated
confirmation when they have been If you have never attended a Connect by a consumer organization.
accepted. If time and space permit, Pro event before, test your connection at FDA seeks to include the views of
onsite registration on the day of the https://collaboration.fda.gov/common/ women and men, members of all racial
public meeting/public workshop will be and ethnic groups, and individuals with
help/en/support/meeting_test.htm. To
provided beginning at 8 a.m. and without disabilities on its advisory
If you need special accommodations get a quick overview of the Connect Pro
program, visit https://www.adobe.com/ committees and, therefore, encourages
due to a disability, please contact nominations of appropriately qualified
Chenoa Conley, 301–796–0035, email: go/connectpro_overview. FDA has
verified the website addresses in this candidates from these groups.
Chenoa.Conley@fda.hhs.gov, at least 7
document, as of the date this document DATES: Any consumer organization
days before each meeting.
Request for Oral Presentations: During publishes in the Federal Register, but interested in participating in the
online registration you may indicate if websites are subject to change over time. selection of an appropriate voting or
you wish to present during the public nonvoting member to represent
Transcripts: Please be advised that as consumer interests on an FDA advisory
comment session. All requests to make soon as a transcript of the public
oral presentations must be received by committee or panel may send a letter or
meeting is available, it will be accessible email stating that interest to FDA (see
the close of registration at 11:59 p.m. at https://www.regulations.gov. It may ADDRESSES) by December 17, 2018, for
Eastern Time on December 20, 2018, for be viewed at the Dockets Management
the first meeting, June 14, 2019, for the vacancies listed in this notice.
Staff (see ADDRESSES). A link to the Concurrently, nomination materials for
second meeting, and January 17, 2020,
transcript will also be available on the prospective candidates should be sent to
for the third meeting. We will do our
best to accommodate requests to make internet at https://www.fda.gov/Drugs/ FDA (see ADDRESSES) by December 17,
public comments. Individuals and GuidanceComplianceRegulatory 2018. Nominations will be accepted for
organizations with common interests are Information/Surveillance/AdverseDrug current vacancies and for those that will
urged to consolidate or coordinate their Effects/ucm115894.htm. or may occur through December 30,
presentations and request time for a Dated: November 8, 2018.
2018.
joint presentation. Following the close Leslie Kux, ADDRESSES: All statements of interest
of registration, we will determine the Associate Commissioner for Policy.
from consumer organizations interested
amount of time allotted to each in participating in the selection process
[FR Doc. 2018–25063 Filed 11–15–18; 8:45 am]
presenter and the approximate time should be submitted electronically to
each oral presentation is to begin and BILLING CODE 4164–01–P
ACOMSSubmissions@fda.hhs.gov, by
amozie on DSK3GDR082PROD with NOTICES
will select and notify participants by mail to Advisory Committee Oversight
11:59 p.m. Eastern Time on January 4, and Management Staff, 10903 New
2019, for the first meeting, June 26, Hampshire Ave., Bldg. 32, Rm. 5122,
2019, for the second meeting, and Silver Spring, MD 20993–0002, or by
January 30, 2020, for the third meeting. Fax: 301–847–8640.
FDA will notify registered presenters of Consumer representative nominations
their scheduled presentation time. If should be submitted electronically by
VerDate Sep<11>2014 17:19 Nov 15, 2018 Jkt 247001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1](https://thefederalregister.org/doc/83_FR_57954/page/3.svg)
Document Created: 2018-11-16 07:22:50
Document Modified: 2018-11-16 07:22:50
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meetings; request for comments. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 57732 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR