Food and Drug Administration, HHS.
Notice; rescheduling of public workshop.
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: firstname.lastname@example.org.
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.
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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.
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Dated: April 10, 2014.
Assistant Commissioner for Policy.
[FR Doc. 2014-08592 Filed 4-15-14; 8:45 am]
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