Allergenic Products Advisory Committee; Notice of Meeting, 59406-59407 [2011-24597]
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59406
Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Notices
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Minh Doan
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 20, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–24601 Filed 9–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Anti-Infective Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSK4TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anti-Infective
Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 3, 2011, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel telephone number is 301–589–
5200.
Contact Person: Minh Doan, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
VerDate Mar<15>2010
17:37 Sep 23, 2011
Jkt 223001
796–9001, FAX: 301–847–8533, e-mail:
AIDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On November 3, 2011, the
committee will discuss clinical trial
design issues for the development of
antibacterials for the treatment of
community-acquired bacterial
pneumonia and the draft document
entitled ‘‘Guidance for Industry:
Community-Acquired Bacterial
Pneumonia: Developing Drugs for
Treatment,’’ published March 2009 (see
FDA Web site at https://www.fda.gov/
Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
ucm064980.htm).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 20, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before October
12, 2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
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speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 13, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Minh Doan
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 20, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–24600 Filed 9–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Allergenic Products Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Allergenic
Products Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 25, 2011, from 8:30
a.m. to approximately 1:30 p.m.
E:\FR\FM\26SEN1.SGM
26SEN1
jlentini on DSK4TPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 186 / Monday, September 26, 2011 / Notices
Location: Hilton Washington DC/
Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD 20910, 301–589–
5200. For those unable to attend in
person, the meeting will also be Web
cast. The link for the Web cast is
available at https://fda.yorkcast.com/
webcast/Viewer/?peid=ca9ce867
368c410999cde1d63208e9ef1d.
Contact Person: Donald W. Jehn or
Joanne Lipkind, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On October 25, 2011, the
committee will meet in open session to
hear and discuss CBER’s review of
scientific and medical literature
concerning the use of non-standardized
allergen extracts in the diagnosis and
treatment of allergic disease. FDA is
announcing the availability of this
report entitled ‘‘CBER’s Report of
Scientific and Medical Literature and
Information on Non-Standardized
Allergen Extracts in the Diagnosis and
Treatment of Allergic Disease’’
elsewhere in this issue of the Federal
Register.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 18, 2011.
Oral presentations from the public will
VerDate Mar<15>2010
17:37 Sep 23, 2011
Jkt 223001
be scheduled between approximately
11:30 a.m. and 12:30 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 11, 2011. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 11, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Joanne Lipkind at least 7 days
in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–24597 Filed 9–23–11; 8:45 am]
BILLING CODE 4160–01–P
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59407
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0599]
Center for Biologics Evaluation and
Research Report of Scientific and
Medical Literature and Information on
Non-Standardized Allergenic Extracts
in the Diagnosis and Treatment of
Allergic Disease; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of its report of scientific and
medical literature and information
concerning the use of non-standardized
allergenic extracts in the diagnosis and
treatment of allergic disease. The report
is provided in a data file entitled
‘‘Center for Biologics Evaluation and
Research Report of Scientific and
Medical Literature and Information on
Non-Standardized Allergenic Extracts in
the Diagnosis and Treatment of Allergic
Disease.’’ FDA is making this report
available to provide information and
obtain comments from public and
private stakeholders. FDA will also seek
input on the report from the Allergenic
Products Advisory Committee (APAC)
at a meeting to be held on October 25,
2011. FDA has not made any regulatory
decisions concerning the report or the
products discussed in the scientific
literature and information cited. FDA
will review comments and other
information it receives, as part of its
continued oversight of regulated
products.
SUMMARY:
Submit either electronic or
written comments on the report by
November 25, 2011.
ADDRESSES: Submit written requests for
single copies of the report to the Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The data file may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the data file
document.
Submit electronic comments on the
report to https://www.regulations.gov.
Submit written comments on the report
to the Division of Dockets Management
DATES:
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59406-59407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24597]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Allergenic Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Allergenic Products Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on October 25, 2011, from
8:30 a.m. to approximately 1:30 p.m.
[[Page 59407]]
Location: Hilton Washington DC/Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD 20910, 301-589-5200. For those unable to attend in
person, the meeting will also be Web cast. The link for the Web cast is
available at https://fda.yorkcast.com/webcast/Viewer/?peid=ca9ce867368c410999cde1d63208e9ef1d.
Contact Person: Donald W. Jehn or Joanne Lipkind, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), and follow the prompts to the desired
center or product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On October 25, 2011, the committee will meet in open
session to hear and discuss CBER's review of scientific and medical
literature concerning the use of non-standardized allergen extracts in
the diagnosis and treatment of allergic disease. FDA is announcing the
availability of this report entitled ``CBER's Report of Scientific and
Medical Literature and Information on Non-Standardized Allergen
Extracts in the Diagnosis and Treatment of Allergic Disease'' elsewhere
in this issue of the Federal Register.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 18, 2011. Oral presentations from the public will be scheduled
between approximately 11:30 a.m. and 12:30 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 11, 2011.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 11, 2011.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donald W. Jehn or
Joanne Lipkind at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24597 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P
