Advancing the Development of Pediatric Therapeutics 5: Advancing Pediatric Pharmacovigilance; Public Workshop, 37816-37817 [2018-16524]
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37816
Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
[FR Doc. 2018–16537 Filed 8–1–18; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2657]
Advancing the Development of
Pediatric Therapeutics 5: Advancing
Pediatric Pharmacovigilance; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Division of Pediatric and
Maternal Health, Office of Surveillance
and Epidemiology, and Office of
Pediatric Therapeutics, Food and Drug
Administration (FDA or the Agency) are
announcing a public workshop entitled
‘‘Advancing the Development of
Pediatric Therapeutics 5: Advancing
Pediatric Pharmacovigilance.’’ The
purpose of this 1-day workshop is to
provide a forum to gather information
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:06 Aug 01, 2018
Jkt 244001
on the latest developments in pediatric
pharmacovigilance from the perspective
of various stakeholders and to expand
the conversation to include the utility
and challenges of emerging
pharmacovigilance tools, including
specific challenges associated with
pediatric data tools.
DATES: The public workshop will be
held on Friday, September 14, 2018,
from 8 a.m. to 5 p.m. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDAWhite Oak Campus,
10903 New Hampshire Ave. Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993.
Entrance for the public workshop
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/
ucm241740.htm.
For
questions regarding the workshop,
contact Denise Pica-Branco, Center for
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00034
Fmt 4703
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Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–1732,
denise.picabranco@fda.hhs.gov; or
Meshaun Payne, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–6668,
meshaun.payne@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Drugs and biologics (products) receive
marketing approval only after
undergoing premarket review and upon
establishment of safety and efficacy
through adequate and well-controlled
clinical trials. Because all safety issues
related to a product may not be detected
in the premarket phase, FDA receives
and analyzes postmarket safety
information to determine if events
reported in the postmarketing period are
likely to be related to exposure to a
product. When FDA determines that
reported postmarketing events are likely
related to a product, FDA can introduce
labeling changes and other activities to
inform the professional and lay public.
E:\FR\FM\02AUN1.SGM
02AUN1
EN02AU18.007</GPH>
Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Federal Register / Vol. 83, No. 149 / Thursday, August 2, 2018 / Notices
FDA receives reports through the
MedWatch website (https://
www.fda.gov/Safety/MedWatch/
HowToReport/default.htm), which are
then entered into the FDA Adverse
Event Reporting System for subsequent
analysis. Because the volume of reports
is large and because reporting entities
(product manufacturers and the
professional or lay public) need only
suspect a possible link between product
exposure and an adverse event, FDA
employs specific tools and strategies to
assess postmarket safety reports and
potential signals that arise from review
of these reports. The process for receipt
and assessment of such postmarket
safety information is referred to as
pharmacovigilance.
FDA has a specific regulatory
mandate to perform pediatric
pharmacovigilance and to present or
make available the results of such
pediatric pharmacovigilance to the
Pediatric Advisory Committee.
II. Topics for Discussion at the Public
Workshop
daltland on DSKBBV9HB2PROD with NOTICES
III. Participation in the Public
Workshop
Jkt 244001
[FR Doc. 2018–16524 Filed 8–1–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2015–N–2126]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration’s Research and
Evaluation Survey for the Public
Education Campaign on Tobacco
Among the Lesbian Gay Bisexual
Transgender Community
AGENCY:
Food and Drug Administration,
HHS.
Registration: Persons interested in
attending this public workshop must
register online at https://
www.eventbrite.com/e/advancing-thedevelopment-of-pediatric-therapeutics5-adept5-tickets-46654530958 by
Thursday, September 6, 2018, midnight
Eastern Time. Please provide complete
contact information for each attendee,
including name, title, affiliation,
address, email, and telephone. Onsite
registration will not be available.
Registration for onsite participation or
via webcast is free and based on space
availability, with priority given to early
registrants. 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 you need special accommodations
due to a disability, please contact
Denise Pica-Branco (denise.picabranco@
fda.hhs.gov) or Meshaun Payne
(meshaun.payne@fda.hhs.gov) no later
than Thursday, September 6, 2018.
17:06 Aug 01, 2018
Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
In this workshop, FDA will gather
information on the latest developments
in pediatric pharmacovigilance from the
perspective of various stakeholders and
expand the conversation to include the
utility and challenges of emerging
pharmacovigilance tools, including
specific challenges associated with
pediatric data tools.
VerDate Sep<11>2014
Streaming Webcast of the Public
Workshop: Webcast information will be
provided after participants have
registered for the workshop. 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.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on FDA’s Research
and Evaluation Survey for the Public
Education Campaign on Tobacco
(RESPECT) among the Lesbian Gay
Bisexual Transgender (LGBT).
DATES: Submit either electronic or
written comments on the collection of
information by October 1, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
SUMMARY:
PO 00000
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37817
be submitted on or before October 1,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 1, 2018. 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–
2015–N–2126 for ‘‘Food and Drug
Administration’s (FDA’s) Research and
Evaluation Survey for the Public
Education Campaign on Tobacco
(RESPECT) among LGBT.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37816-37817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16524]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2657]
Advancing the Development of Pediatric Therapeutics 5: Advancing
Pediatric Pharmacovigilance; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Division of Pediatric and Maternal Health, Office of
Surveillance and Epidemiology, and Office of Pediatric Therapeutics,
Food and Drug Administration (FDA or the Agency) are announcing a
public workshop entitled ``Advancing the Development of Pediatric
Therapeutics 5: Advancing Pediatric Pharmacovigilance.'' The purpose of
this 1-day workshop is to provide a forum to gather information on the
latest developments in pediatric pharmacovigilance from the perspective
of various stakeholders and to expand the conversation to include the
utility and challenges of emerging pharmacovigilance tools, including
specific challenges associated with pediatric data tools.
DATES: The public workshop will be held on Friday, September 14, 2018,
from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at FDAWhite Oak Campus,
10903 New Hampshire Ave. Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993. Entrance for the public workshop
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/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: For questions regarding the workshop,
contact Denise Pica-Branco, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002, 301-796-1732, [email protected]; or Meshaun
Payne, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-6668, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Drugs and biologics (products) receive marketing approval only
after undergoing premarket review and upon establishment of safety and
efficacy through adequate and well-controlled clinical trials. Because
all safety issues related to a product may not be detected in the
premarket phase, FDA receives and analyzes postmarket safety
information to determine if events reported in the postmarketing period
are likely to be related to exposure to a product. When FDA determines
that reported postmarketing events are likely related to a product, FDA
can introduce labeling changes and other activities to inform the
professional and lay public.
[[Page 37817]]
FDA receives reports through the MedWatch website (https://www.fda.gov/Safety/MedWatch/HowToReport/default.htm), which are then
entered into the FDA Adverse Event Reporting System for subsequent
analysis. Because the volume of reports is large and because reporting
entities (product manufacturers and the professional or lay public)
need only suspect a possible link between product exposure and an
adverse event, FDA employs specific tools and strategies to assess
postmarket safety reports and potential signals that arise from review
of these reports. The process for receipt and assessment of such
postmarket safety information is referred to as pharmacovigilance.
FDA has a specific regulatory mandate to perform pediatric
pharmacovigilance and to present or make available the results of such
pediatric pharmacovigilance to the Pediatric Advisory Committee.
II. Topics for Discussion at the Public Workshop
In this workshop, FDA will gather information on the latest
developments in pediatric pharmacovigilance from the perspective of
various stakeholders and expand the conversation to include the utility
and challenges of emerging pharmacovigilance tools, including specific
challenges associated with pediatric data tools.
III. Participation in the Public Workshop
Registration: Persons interested in attending this public workshop
must register online at https://www.eventbrite.com/e/advancing-the-development-of-pediatric-therapeutics-5-adept5-tickets-46654530958 by
Thursday, September 6, 2018, midnight Eastern Time. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone. Onsite registration will
not be available.
Registration for onsite participation or via webcast is free and
based on space availability, with priority given to early registrants.
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 you need special accommodations due to a disability, please
contact Denise Pica-Branco ([email protected]) or Meshaun
Payne ([email protected]) no later than Thursday, September 6,
2018.
Streaming Webcast of the Public Workshop: Webcast information will
be provided after participants have registered for the workshop. 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.
Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16524 Filed 8-1-18; 8:45 am]
BILLING CODE 4164-01-P
