Food and Drug Administration Rare Disease Patient Advocacy Day; Notice of Meeting, 78931 [2011-32436]
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Policy for Premarket Notification
Requirements for Certain In Vitro
Diagnostic and Radiology Devices.’’ It
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to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
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V. Comments
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Dated: December 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–32437 Filed 12–19–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0885]
Food and Drug Administration Rare
Disease Patient Advocacy Day; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration’s
(FDA) Office of Orphan Products
Development is announcing the
following meeting: FDA Rare Disease
Patient Advocacy Day. This meeting is
intended to enhance the awareness of
the rare disease community as to FDA’s
roles and responsibilities in the
development of products (drugs,
biological products, and devices)
intended for the diagnosis, prevention,
and/or treatment of rare diseases or
conditions. The goal of this meeting is
to engage and educate the rare disease
community on the FDA regulatory
processes.
This educational meeting will consist
of a live and interactive simultaneous
Web cast of presentations provided by
FDA experts from various Centers and
Offices, as well as from outside experts.
The interactive meeting will include
two general panel discussion sessions,
as well as afternoon breakout sessions
for more indepth information on the
roles of FDA. In addition, onsite
attendees will have an opportunity
during lunch to engage with FDA and
outside experts in a small group setting.
Date and Time: The meeting will be
held on March 1, 2012, from 8:30 a.m.
to 5 p.m.
PO 00000
Frm 00050
Fmt 4703
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78931
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
For participants who cannot attend the
live meeting, a live interactive Web cast
will be made available. Participants may
access this live Web cast by visiting the
following site: https://www.fda.gov/For
Industry/DevelopingProductsforRare
DiseasesConditions/OOPDNews
Archive/ucm277194.htm.
Contact: Soumya Patel, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm.5279,
Silver Spring, MD 20993–0002, (301)
796–8660, FAX: (301) 847–8621, email:
FDAadvocacy@fda.hhs.gov.
Registration: Interested participants
may register for this meeting at the
following Web site: https://www.teamshare.net/FDA_Rare_Disease_Patient_
Advocacy_Day_Registration.
If you need sign language
interpretation during this meeting,
please contact Megan McNamee at
mmcnamee@icfi.com by February 15,
2012.
The FDA Rare Disease Patient
Advocacy Day is supported by FDA, the
National Institutes of Health (NIH), the
National Organization for Rare
Disorders, and the Genetic Alliance.
FDA encourages all attendees to also
plan on attending the NIH Rare Disease
Day day-long celebration on February
29, 2011. Please refer to the following
Web site for more information regarding
the NIH Rare Disease Day event:
https://rarediseases.info.nih.gov/Rare
DiseaseDay.aspx. (FDA has verified the
Web site addresses throughout this
document, but we are not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Dated: December 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–32436 Filed 12–19–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Advisory Committees; Tentative
Schedule of Meetings for 2012
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
SUMMARY:
E:\FR\FM\20DEN1.SGM
20DEN1
Agencies
[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Notices]
[Page 78931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32436]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0885]
Food and Drug Administration Rare Disease Patient Advocacy Day;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration's (FDA) Office of Orphan Products
Development is announcing the following meeting: FDA Rare Disease
Patient Advocacy Day. This meeting is intended to enhance the awareness
of the rare disease community as to FDA's roles and responsibilities in
the development of products (drugs, biological products, and devices)
intended for the diagnosis, prevention, and/or treatment of rare
diseases or conditions. The goal of this meeting is to engage and
educate the rare disease community on the FDA regulatory processes.
This educational meeting will consist of a live and interactive
simultaneous Web cast of presentations provided by FDA experts from
various Centers and Offices, as well as from outside experts. The
interactive meeting will include two general panel discussion sessions,
as well as afternoon breakout sessions for more indepth information on
the roles of FDA. In addition, onsite attendees will have an
opportunity during lunch to engage with FDA and outside experts in a
small group setting.
Date and Time: The meeting will be held on March 1, 2012, from 8:30
a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. For participants who cannot attend the live meeting, a live
interactive Web cast will be made available. Participants may access
this live Web cast by visiting the following site: https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/ucm277194.htm.
Contact: Soumya Patel, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm.5279, Silver Spring, MD 20993-0002, (301)
796-8660, FAX: (301) 847-8621, email: FDAadvocacy@fda.hhs.gov.
Registration: Interested participants may register for this meeting
at the following Web site: https://www.team-share.net/FDA_Rare_Disease_Patient_Advocacy_Day_Registration.
If you need sign language interpretation during this meeting,
please contact Megan McNamee at mmcnamee@icfi.com by February 15, 2012.
The FDA Rare Disease Patient Advocacy Day is supported by FDA, the
National Institutes of Health (NIH), the National Organization for Rare
Disorders, and the Genetic Alliance.
FDA encourages all attendees to also plan on attending the NIH Rare
Disease Day day-long celebration on February 29, 2011. Please refer to
the following Web site for more information regarding the NIH Rare
Disease Day event: https://rarediseases.info.nih.gov/RareDiseaseDay.aspx. (FDA has verified the Web site addresses
throughout this document, but we are not responsible for any subsequent
changes to the Web sites after this document publishes in the Federal
Register.)
Dated: December 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32436 Filed 12-19-11; 8:45 am]
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