Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints; Public Workshop, 44188-44189 [2017-20106]
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Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
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Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20105 Filed 9–20–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Drug Development in Pediatric Heart
Failure: Extrapolation, Clinical Trial
Design, and Endpoints; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘FDA-University of Maryland CERSI
Drug Development in Pediatric Heart
Failure: Extrapolation, Clinical Trial
Design, and Endpoints.’’ The purpose of
the public workshop is to address
challenges related to the evaluation of
products in pediatric heart failure
including population to study,
endpoints, and extrapolation of adult
efficacy data. The workshop will also
provide a forum for discussion on the
use of registry data, as well as
alternative trial designs and statistical
methods.
SUMMARY:
The public workshop will be
held on Friday, October 27, 2017, from
8 a.m. to 5 p.m.
DATES:
The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503A, Silver Spring, MD 20993–
0002. 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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jacquline Yancy, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6319,
Silver Spring, MD 20993–0002, 301–
796–7068, Jacquline.Yancy@
fda.hhs.gov.
E:\FR\FM\21SEN1.SGM
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Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of this public workshop
is to provide an opportunity for relevant
stakeholders, including clinicians,
academia, industry, and FDA, to discuss
alternative trial designs for product
development in pediatric heart failure.
II. Topics for Discussion at the Public
Workshop
Specifically, the workshop will
include application of pediatric
extrapolation in drug development for
pediatric heart failure and a discussion
of alternative approaches to establishing
effectiveness in pediatric heart failure,
including the use of Bayesian
approaches. Cases will be presented to
exemplify various approaches.
The agenda is located at https://
www.cersi.umd.edu/events/
index.php?mode=4&id=12500.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, visit the following Web site:
https://www.cersi.umd.edu/events/
index.php?mode=4&id=12500.
Registrants will receive confirmation
when they have been accepted. There
will be no onsite 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. The cost
to attend in person is as follows:
Category
asabaliauskas on DSKBBXCHB2PROD with NOTICES
$50
50
0
0
If you need special accommodations
due to a disability, please contact
Jacquline Yancy (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
Streaming Webcast of the Public
Workshop: This public workshop will
also be webcast. There is no registration
fee for attending the workshop via the
webcast, but registration is still
required. Information regarding access
to the webcast link is available at https://
www.cersi.umd.edu/events/
index.php?mode=4&id=12500.
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/
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17:52 Sep 20, 2017
Jkt 241001
Food and Drug Administration
systems. Attendance is free. Non-USDA
employees must enter through the Wing
3 entrance on Independence Avenue.
Attendees must be pre-registered for the
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You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before November 24, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 24, 2017. 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.
[Docket No. FDA–2017–N–5056]
Electronic Submissions
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20106 Filed 9–20–17; 8:45 a.m.]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
2017 Scientific Meeting of the National
Antimicrobial Resistance Monitoring
System; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we), together with the NARMS partner
agencies, is announcing a public
meeting entitled ‘‘2017 Scientific
Meeting of the National Antimicrobial
Resistance Monitoring System.’’ The
purpose of the public meeting is to
discuss the current status of the
National Antimicrobial Resistance
Monitoring System (NARMS) and
directions for the future.
DATES: The public meeting will be held
on October 24 and 25, 2017, from 8:30
a.m. to 5 p.m. Eastern Time. Submit
either electronic or written comments
on this public meeting by November 24,
2017. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at the Jefferson Auditorium in the
South Building, U.S. Department of
Agriculture (USDA), 14th and
Independence Avenue SW.,
Washington, DC 20250. The South
Building is a Federal facility, and
attendees should plan adequate time to
pass through the security screening
SUMMARY:
Cost
Industry Representative ................
Nonprofit Organization and Academic Other Than University of
Maryland ...................................
University of Maryland, College
Park and Baltimore ...................
Federal Government .....................
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff Office
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
44189
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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
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Submit written/paper submissions as
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written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44188-44189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20106]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
Drug Development in Pediatric Heart Failure: Extrapolation,
Clinical Trial Design, and Endpoints; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``FDA-University of Maryland CERSI
Drug Development in Pediatric Heart Failure: Extrapolation, Clinical
Trial Design, and Endpoints.'' The purpose of the public workshop is to
address challenges related to the evaluation of products in pediatric
heart failure including population to study, endpoints, and
extrapolation of adult efficacy data. The workshop will also provide a
forum for discussion on the use of registry data, as well as
alternative trial designs and statistical methods.
DATES: The public workshop will be held on Friday, October 27, 2017,
from 8 a.m. to 5 p.m.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503A, Silver Spring, MD 20993-
0002. 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: Jacquline Yancy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6319, Silver Spring, MD 20993-0002, 301-
796-7068, Jacquline.Yancy@fda.hhs.gov.
[[Page 44189]]
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of this public workshop is to provide an opportunity
for relevant stakeholders, including clinicians, academia, industry,
and FDA, to discuss alternative trial designs for product development
in pediatric heart failure.
II. Topics for Discussion at the Public Workshop
Specifically, the workshop will include application of pediatric
extrapolation in drug development for pediatric heart failure and a
discussion of alternative approaches to establishing effectiveness in
pediatric heart failure, including the use of Bayesian approaches.
Cases will be presented to exemplify various approaches.
The agenda is located at https://www.cersi.umd.edu/events/index.php?mode=4&id=12500.
III. Participating in the Public Workshop
Registration: To register for the public workshop, visit the
following Web site: https://www.cersi.umd.edu/events/index.php?mode=4&id=12500. Registrants will receive confirmation when
they have been accepted. There will be no onsite 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. The cost to attend in person is as follows:
------------------------------------------------------------------------
Category Cost
------------------------------------------------------------------------
Industry Representative...................................... $50
Nonprofit Organization and Academic Other Than University of 50
Maryland....................................................
University of Maryland, College Park and Baltimore........... 0
Federal Government........................................... 0
------------------------------------------------------------------------
If you need special accommodations due to a disability, please
contact Jacquline Yancy (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. There is no registration fee for attending the
workshop via the webcast, but registration is still required.
Information regarding access to the webcast link is available at https://www.cersi.umd.edu/events/index.php?mode=4&id=12500.
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, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
Office (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20106 Filed 9-20-17; 8:45 a.m.]
BILLING CODE 4164-01-P
