Pediatric Master Protocols; Public Workshop, 51918 [2016-18555]
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Federal Register / Vol. 81, No. 151 / Friday, August 5, 2016 / Notices
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 1, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–18560 Filed 8–4–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Pediatric Master Protocols; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in collaboration
with the University of Maryland Center
of Excellence in Regulatory Science and
Innovation, is announcing a public
workshop titled, ‘‘Pediatric Master
Protocols’’. The objective of the
workshop is to discuss regulatory and
scientific concerns related to pediatric
master protocols and clinical trial
design considerations for these
protocols. In addition, applications of
pediatric master protocols to specific
pediatric therapeutic areas will be
presented.
SUMMARY:
The public workshop will be
held on September 23, 2016, from 8:30
a.m. to 4:30 p.m.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), 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
mstockstill on DSK3G9T082PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:42 Aug 04, 2016
Jkt 238001
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Audrey Thomas, Office of Regulatory
Science and Innovation, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4220, Silver Spring,
MD 20993–0002, 301–796–3520,
Audrey.Thomas@fda.hhs.gov.
The
purpose of this public workshop is to
provide an opportunity for relevant
stakeholders including: Clinicians and
scientists from FDA and other
government Agencies, academia, nonprofit organizations, and industry to
discuss use of pediatric master protocols
for development of medical products for
children. Specifically, the workshop
will present the current status of
pediatric protocol development in the
United States, considerations for
pediatric protocol development
internationally, and development of
international consortia in this area.
Clinical trial design considerations and
the preliminary steps needed for
development of pediatric master
protocols, including the role of in vitro
diagnostic tests, will also be discussed.
Finally, examples of pediatric master
protocol development for medical
products with no, partial, and full
extrapolation of data from adults to
children will be presented. The
workshop will include two panel
sessions for interaction and discussion
among the speakers and attendees.
Agenda: The agenda is available at
https://www.fda.gov/ScienceResearch/
SpecialTopics/RegulatoryScience/
ucm507079.htm (FDA has verified the
Web site address, but FDA is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register).
Registration: There is a registration fee
to attend this public workshop inperson. Seats are limited and
registration will be on a first-come, firstserved basis. To register, please
complete registration online at https://
www.fda.gov/ScienceResearch/Special
Topics/RegulatoryScience/
ucm507079.htm (FDA has verified the
Web site address, but FDA is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register).
There will be no onsite registration. The
costs of registration, to attend in-person,
for different categories of attendees are
as follows:
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
Category
Cost
Industry Representative ........
Nonprofit Organization and
Academic Other Than University of Maryland ............
University of Maryland, College Park and Baltimore ...
Federal Government .............
$50
50
0
0
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. There is no registration
fee for access to the workshop via the
Webcast, but registration is still
required. Information regarding
registration and access to the Webcast
link is available at https://www.fda.gov/
ScienceResearch/SpecialTopics/
RegulatoryScience/ucm507079.htm. 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 Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Accommodations: Attendees are
responsible for their own hotel
accommodations. If you need special
accommodations while at FDA’s White
Oak Campus due to a disability, please
contact Shari Solomon at
Shari.Solomon@fda.hhs.gov at least 7
days in advance.
Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18555 Filed 8–4–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
National Mammography Quality
Assurance 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 National Mammography
Quality Assurance Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
SUMMARY:
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 81, Number 151 (Friday, August 5, 2016)]
[Notices]
[Page 51918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18555]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Pediatric Master Protocols; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), in collaboration with
the University of Maryland Center of Excellence in Regulatory Science
and Innovation, is announcing a public workshop titled, ``Pediatric
Master Protocols''. The objective of the workshop is to discuss
regulatory and scientific concerns related to pediatric master
protocols and clinical trial design considerations for these protocols.
In addition, applications of pediatric master protocols to specific
pediatric therapeutic areas will be presented.
DATES: The public workshop will be held on September 23, 2016, from
8:30 a.m. to 4:30 p.m.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503), 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/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Audrey Thomas, Office of Regulatory
Science and Innovation, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993-0002, 301-
796-3520, Audrey.Thomas@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to
provide an opportunity for relevant stakeholders including: Clinicians
and scientists from FDA and other government Agencies, academia, non-
profit organizations, and industry to discuss use of pediatric master
protocols for development of medical products for children.
Specifically, the workshop will present the current status of pediatric
protocol development in the United States, considerations for pediatric
protocol development internationally, and development of international
consortia in this area. Clinical trial design considerations and the
preliminary steps needed for development of pediatric master protocols,
including the role of in vitro diagnostic tests, will also be
discussed. Finally, examples of pediatric master protocol development
for medical products with no, partial, and full extrapolation of data
from adults to children will be presented. The workshop will include
two panel sessions for interaction and discussion among the speakers
and attendees.
Agenda: The agenda is available at https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm507079.htm (FDA has
verified the Web site address, but FDA is not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register).
Registration: There is a registration fee to attend this public
workshop in-person. Seats are limited and registration will be on a
first-come, first-served basis. To register, please complete
registration online at https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm507079.htm (FDA has verified the Web
site address, but FDA is not responsible for subsequent changes to the
Web site after this document publishes in the Federal Register). There
will be no onsite registration. The costs of registration, to attend
in-person, for different categories of attendees are as follows:
------------------------------------------------------------------------
Category Cost
------------------------------------------------------------------------
Industry Representative................................. $50
Nonprofit Organization and Academic Other Than 50
University of Maryland.................................
University of Maryland, College Park and Baltimore...... 0
Federal Government...................................... 0
------------------------------------------------------------------------
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. There is no registration fee for access to the
workshop via the Webcast, but registration is still required.
Information regarding registration and access to the Webcast link is
available at https://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm507079.htm. 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 Web site addresses in
this document, but FDA is not responsible for any subsequent changes to
the Web sites after this document publishes in the Federal Register.)
Accommodations: Attendees are responsible for their own hotel
accommodations. If you need special accommodations while at FDA's White
Oak Campus due to a disability, please contact Shari Solomon at
Shari.Solomon@fda.hhs.gov at least 7 days in advance.
Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18555 Filed 8-4-16; 8:45 am]
BILLING CODE 4164-01-P
