Document ID: FDA-2014-N-0001-0036
Agency: fda
Document Type: Notice
Title: Advancing the Development of Pediatric Therapeutics: Pediatric Bone
Health; Public Workshop
Posted Date: 2014-04-16T04:00Z

[Federal Register Volume 79, Number 73 (Wednesday, April 16, 2014)]
[Notices]
[Page 21473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08592]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Advancing the Development of Pediatric Therapeutics: Pediatric 
Bone Health; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; rescheduling of public workshop.

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    The Food and Drug Administration's (FDA) Pediatric and Maternal 
Health Staff in the Center for Drug Evaluation and Research and the 
Office of Pediatric Therapeutics are announcing the rescheduling of a 
1-day public workshop entitled ``Advancing the Development of Pediatric 
Therapeutics (ADEPT): Pediatric Bone Health.'' The purpose of this 
initial workshop is to provide a forum to consider issues related to 
advancing pediatric regulatory science in the evaluation of bone health 
in pediatric patients. The workshop scheduled for March 4, 2014, was 
postponed due to unanticipated weather conditions and rescheduled for 
June 3, 2014.
    Date and Time: The public workshop will be held on June 3, 2014, 
from 8 a.m. to 5:30 p.m. This workshop is being rescheduled because of 
a postponed workshop announced in the Federal Register of February 6, 
2014 (79 FR 7205), originally scheduled for March 4, 2014.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 2, Rm. 2047, Silver Spring, MD 
20993. Entrance for the public workshop participants (non-FDA 
employees) is through Building 1 where routine security procedures will 
be performed. Please visit the following Web site for location, 
parking, security, and travel information: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Denise Pica-Branco, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-1732, FAX: 301-796-9858, email: 
denise.picabranco@fda.hhs.gov.
    Registration: There is no fee to attend the public workshop, but 
attendees should register in advance. Space is limited and registration 
will be on a first-come, first-served basis. Persons interested in 
attending this workshop must register online at 
PediatricBoneHealth@fda.hhs.gov before May 23, 2014. If you registered 
for the workshop before March 4, 2014, you must re-register for the 
workshop. For those without Internet access, please contact Denise 
Pica-Branco (see Contact Person) to register. Onsite registration will 
not be available.
    If you need special accommodations due to a disability, please 
contact Denise Pica-Branco (see Contact Person) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: FDA has engaged experts to address 
challenging issues related to the evaluation of effects on bone health 
for products used to treat pediatric patients. Identification of 
signals in animal studies and adult clinical trials that warrant 
further clinical investigation and identification of biomarkers that 
may be predictive of bone health in children will be discussed. 
Additionally, strategies and methods to address the challenges of 
assessing long-term bone health for products used to treat pediatric 
patients will be discussed.
    Information about this meeting is also available at http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm.

    Dated: April 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08592 Filed 4-15-14; 8:45 am]
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