[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7205-7206]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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 [email protected] 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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