[Federal Register Volume 79, Number 136 (Wednesday, July 16, 2014)]
[Notices]
[Pages 41583-41584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Food and Drug Administration Third Annual Patient Network 
Meeting; Under the Microscope: Pediatric Drug Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration (FDA), Office of Health and 
Constituent Affairs (OHCA) is announcing a 1-day meeting to explore 
challenges related to pediatric product development. The meeting will 
serve as a forum for FDA's stakeholders (patients, caregivers, patient 
advocates, healthcare professional groups, the general public, 
academia, and industry) to learn about regulations that encourage 
pediatric product development; to discuss ways to advance pediatric 
product development, how health disparities impact pediatric product 
development, the importance of transparency in pediatric clinical 
trials, and how analysis of information from failed pediatric clinical 
trials might improve future designs for pediatric trials; and to 
identify ways patient input can benefit clinical trial design for 
pediatric trials.
    The 1-day meeting will also provide an opportunity to participate 
in panel discussions on the challenges related to development of 
products used to treat pediatric patients, including pediatric patients 
with rare diseases and explore ways that patients/caregivers, FDA, and 
industry may work together to incorporate patient input in future 
pediatric product development and regulatory decisionmaking.

DATES: The public meeting will be held on September 10, 2014, from 8 
a.m. to 4:30 p.m. If you wish to attend the 1-day meeting, visit the 
Patient Network at http://patientnetwork.fda.gov/3rd-annual-patient-network. Please register before September 5, 2014. Those who are unable 
to attend the meeting in person can register to view a live webcast of 
the meeting. You will be asked to indicate in your registration whether 
you plan to attend the meeting in person or via the webcast. 
Registrants will receive confirmation once they have been accepted. 
Onsite registration on the day of the meeting will be based on space 
availability. There is no registration fee for this meeting and early 
registration is suggested because space is limited. We request that 
non-patient organizations limit the number of representatives to three. 
For further registration information or problems with the Web site call 
Steve Morin (see FOR FURTHER INFORMATION CONTACT) at 301-796-0161 or 
email at [email protected].
    If you need special accommodations due to a disability, please 
specify those accommodations when registering for this 1-day meeting.

ADDRESSES: The meeting will be held at the Washington Marriott at Metro 
Center, 775 12th St. NW., Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT: Steve Morin, Office of Health and 
Constituent Affairs, 10903 New Hampshire Ave., Silver Spring, MD 20993, 
301-796-0161, FAX: 301-847-8623, [email protected].

SUPPLEMENTARY INFORMATION: 

I. The FDA Patient Network

    This is the third FDA Patient Network Annual Meeting hosted by 
OHCA, the Agency's primary liaison with patient and health professional 
communities. This annual meeting is being hosted as part of the larger 
FDA Patient Network program. The FDA Patient Network is a resource that 
seeks to:
     Educate and inform patients and patient advocacy 
organizations about FDA's:
    [cir] Regulatory authorities and processes;
    [cir] Initiatives;
    [cir] Public meetings;
    [cir] Ways to comment on FDA draft guidances; and
     Provide a venue for patient advocacy involvement within 
the FDA.
    In addition to an annual meeting, the FDA Patient Network consists 
of:

[[Page 41584]]

     The FDA Patient Network Web site 
(www.patientnetwork.fda.gov)--a patient-centered Web site that 
contains:
    [cir] Educational modules and FDA webinars;
    [cir] Centralized agency information for patients;
    [cir] Periodic LiveChat and listening discussions between patient 
advocates and FDA staff; and
     The biweekly FDA Patient Network News email newsletter 
informs the community on current FDA-related information on medical 
product:
    [cir] Medical approvals;
    [cir] Safety labeling changes;
    [cir] Safety warnings;
    [cir] Ways to participate on upcoming public meetings;
    [cir] Ways to comment on proposed regulatory guidances;
    [cir] Information on food safety; and
    [cir] Other information of interest to patient and patient 
advocates.
    To sign up for the FDA Patient Network News, visit http://www.patientnetwork.fda.gov/get-involved/get-newsletter.
    FDA will post the agenda 5 days before the meeting at http://patientnetwork.fda.gov/3rd-annual-patient-network.

    Dated: July 11, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-16714 Filed 7-15-14; 8:45 am]
BILLING CODE 4164-01-P