
[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Pages 56590-56591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


First Annual Neonatal Scientific Workshop--Roadmap for Applying 
Regulatory Science to Neonates; Notice of 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 a public 
scientific workshop to discuss the roadmap for applying regulatory 
science to neonates. This public scientific workshop is being co-
sponsored with the FDA, the Critical Path Institute (C-Path) and the 
Burroughs Welcome Fund (BWF).
    The purpose of the public scientific workshop is to initiate 
constructive discussion among regulators, researchers, health care 
providers, representatives from the pharmaceutical industry and health 
care organizations, and the general public to determine whether there 
is sufficient interest on the part of stakeholders to develop a 
neonatal consortium and to discuss potential working groups dedicated 
to the regulatory science required to develop neonatal therapeutics.

DATES: The public scientific workshop will be held on October 28 and 
29, 2014, from 8 a.m. to 5 p.m. Section II provides attendance and 
registration information.

ADDRESSES: The public scientific workshop will be held at the FDA White 
Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, 
the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for 
the public scientific 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Indira Hills, Food and Drug 
Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4508, Silver Spring, MD 20993, 301-796-
9686, FAX: 301-796-9907, indira.hills@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    C-Path and BWF, in cooperation with FDA and various stakeholders, 
including industry, academia, professional organizations, patient 
advocacy groups, and other government Agencies, are proposing to 
establish the Neonatal Consortium in order to leverage resources and 
expertise toward mutually beneficial goals and in the interest of 
public health. Some of the potential priorities of the Neonatal 
Consortium to be discussed at the public scientific workshop would be 
the following:
    1. Developing and qualifying biomarkers, clinical outcome 
assessments, and other drug development tools. Valid and reliable 
endpoints are presently lacking in neonatal clinical trials.
    2. Developing physiologically-based pharmacokinetic modeling and 
simulation to predict on and off target responses to drugs.
    3. Optimizing clinical trial designs for the neonatal population. 
One aspect of clinical trial design in neonates is the need for long-
term studies to properly evaluate the effects of an intervention. There 
is also interest in examining bioethical questions related to neonatal 
care and their solutions.
    4. Maximizing the use of registry data. Such registries may be 
useful in long-term studies.
    5. Developing Clinical Data Interchange Standards Consortium data 
standards for registry data, electronic health record information, and 
clinical trial data.
    6. Building a neonatal database in which standardized data pooled 
from industry and academic neonatal trials could reside. Such a 
database would be an invaluable resource for the neonatal community.

II. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal 
facility with security procedures and limited seating. Individuals who 
wish to participate in the public scientific workshop (in person or via 
web) must register on or before October 20, 2014, by visiting http://www.cvent.com/d/34qr03 and contacting Indira Hills (see FOR FURTHER 
INFORMATION CONTACT) or Kerrie Bennymadho, Project Coordinator, 
Critical Path Institute, 520-382-1377, Cell: 760-636-3046, 
path.org">kbennymadho@c-path.org regarding registration. Early registration is 
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from 
each organization based on space limitations. Onsite registration on 
the day of the public scientific workshop will be based on space 
availability. The registration deadline is October 20, 2014.
    FDA will provide additional background information at the time the 
Federal Register notice is published and an agenda approximately 2 
weeks before the public scientific workshop at FDA Meeting Information 
page, which is available online at http://www.fda.gov/Drugs/NewsEvents/ucm410863.htm.
    If you need special accommodations because of disability, please 
contact Indira Hills (see FOR FURTHER INFORMATION CONTACT) at least 7 
days before the public scientific workshop.
    A live Webcast of this public scientific workshop will be viewable 
at Adobe Connect Link: https://collaboration.fda.gov/nsw2014/ on the 
day of the public scientific workshop. A video record of the public 
scientific workshop will be available at the same Web address for 1 
year.

III. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305). A transcript will also be 
available in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. Written requests are to be sent to the 
Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn

[[Page 56591]]

Dr., Element Bldg., Rockville, MD 20857.

    Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22460 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P


