Advancing the Development of Pediatric Therapeutics: Pediatric Bone Health; Public Workshop, 21473 [2014-08592]
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Federal Register / Vol. 79, No. 73 / Wednesday, April 16, 2014 / Notices
Dated: April 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08589 Filed 4–15–14; 8:45 am]
BILLING CODE 4160–01–P
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.
Notice; rescheduling of public
workshop.
pmangrum on DSK3VPTVN1PROD with NOTICES
ACTION:
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: https://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,
VerDate Mar<15>2010
15:20 Apr 15, 2014
Jkt 232001
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 https://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]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0406]
Proposed Strategy and
Recommendations for a Risk-Based
Framework for Food and Drug
Administration Safety and Innovation
Act Health Information Technology;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing the following
public workshop entitled ‘‘Proposed
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
21473
Strategy and Recommendations for a
Risk-Based Framework for Food and
Drug Administration Safety and
Innovation Act Health Information
Technology.’’ FDA, the Office of the
National Coordinator for Health
Information Technology (ONC), and the
Federal Communication Commission
(FCC) (collectively referred for the
purpose of this notice as ‘‘the
Agencies’’ 1) seek broad input from
stakeholders and experts on the
proposed strategy and recommendations
for a risk-based framework for the Food
and Drug Administration Safety and
Innovation Act (FDASIA) Health
Information Technology (IT). The topic
to be discussed is the FDASIA Health IT
report that contains a proposed strategy
and recommendations on an
appropriate, risk-based framework for
health IT that promotes innovation,
protects patient safety, and avoids
regulatory duplication.
DATES: Dates and Times: The public
workshop will be held on May 13–15,
2014, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at National Institute of
Standards and Technology, 100 Bureau
Dr., Building 101, Red Auditorium,
Gaithersburg, MD 20899–1070.
Contact Person: Bakul Patel, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
5456, Silver Spring, MD 20993, 301–
796–5528, email: Bakul.patel@
fda.hhs.gov.
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
this public workshop must register
online by 4 p.m. on May 2, 2014. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. Onsite
registration on the day of the public
workshop will not be available.
If you need special accommodations
due to a disability, please contact Susan
Monahan, Food and Drug
Administration, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4321,
Silver Spring MD 20993, 301–796–5661,
email: susan.monahan@fda.hhs.gov no
later than April 29, 2014.
To register for the public workshop,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
1 ONC is not an agency, but an office, within the
Department of Health and Human Services.
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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]
BILLING CODE 4160-01-P
