Document ID: FDA-2014-N-0001-0013
Agency: fda
Document Type: Notice
Title: Advancing the Development of Pediatric Therapeutics: Pediatric Bone
Health; Public Workshop
Posted Date: 2014-02-06T05:00Z

[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7205-7206]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02552]

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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 of public workshop.

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SUMMARY: 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 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.
    Date and Time: The public workshop will be held on March 4, 2014, 
from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held in the Pooks Hill 
Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814. The hotel's 
telephone number is 301-897-9400.
    Contact: 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.

SUPPLEMENTARY INFORMATION: FDA has engaged experts in pediatrics 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.

I. Participation in the Public Workshop

    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 
February 28, 2014.

[[Page 7206]]

For those without Internet access, please contact Denise Pica-Branco 
(see Contact) to register. Onsite registration will not be available.
    If you need special accommodations due to a disability, please 
contact Denise Pica-Branco (see Contact) at least 7 days in advance.

II. Transcripts

    Transcripts of the workshop will be available for review at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and at http://www.regulations.gov approximately 30 days after the workshop. A 
transcript will also be available in either hard copy or on CD-ROM, 
after submission of a Freedom of Information request. Send written 
requests to the Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857. Send faxed requests to 301-827-9267.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02552 Filed 2-5-14; 8:45 am]
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