[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]


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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.

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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, [email protected].

[[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 http://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: http://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:

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                           Category                               Cost
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Industry Representative......................................        $50
Nonprofit Organization and Academic Other Than University of          50
 Maryland....................................................
University of Maryland, College Park and Baltimore...........          0
Federal Government...........................................          0
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    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 http://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