Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 5333-5334 [2010-2054]
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Federal Register / Vol. 75, No. 21 / Tuesday, February 2, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Safety and Occupational Health Study
Section (SOHSS), National Institute for
Occupational Safety and Health
(NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Times and Dates:
8 a.m.–5 p.m., February 17, 2010.
(Closed)
8 a.m.–5 p.m., February 18, 2010.
(Closed)
Place: Embassy Suites Hotel, 1900
Diagonal Road, Alexandria, Virginia
22314, Telephone (703) 684–5900, Fax
(703) 684–1403.
Status: These portions of the meeting
will be closed to the public in
accordance with provisions set forth in
Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the
Director, Management Analysis and
Services Office, Centers for Disease
Control and Prevention, pursuant to
Section 10(d) Public Law 92–463.
Purpose: The Safety and Occupational
Health Study Section will review,
discuss, and evaluate grant
application(s) received in response to
the Institute’s standard grants review
and funding cycles pertaining to
research issues in occupational safety
and health, and allied areas.
It is the intent of NIOSH to support
broad-based research endeavors in
keeping with the Institute’s program
goals. This will lead to improved
understanding and appreciation for the
magnitude of the aggregate health
burden associated with occupational
injuries and illnesses, as well as to
support more focused research projects,
which will lead to improvements in the
delivery of occupational safety and
health services, and the prevention of
work-related injury and illness. It is
anticipated that research funded will
promote these program goals.
Matters To Be Discussed: The meeting
will convene to address matters related
to the conduct of Study Section
business and for the study section to
consider safety and occupational healthrelated grant applications.
Agenda items are subject to change as
priorities dictate.
For More Information Contact: Price
Connor, PhD, NIOSH Health Scientist,
1600 Clifton Road, NE., Mailstop E–20,
VerDate Nov<24>2008
16:52 Feb 01, 2010
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Atlanta, Georgia 30333, Telephone (404)
498–2511, Fax (404) 498–2571.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Dated: January 25, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–2117 Filed 2–1–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The meeting of the
Endocrinologic and Metabolic Drugs
Advisory Committee scheduled for
February 24, 2010, is cancelled. This
meeting was announced in the Federal
Register of January 19, 2010 (75 FR
2875). This meeting has been cancelled
due to unexpected delays in the
preparation of materials for the meeting.
The agency will reschedule this meeting
and announce a future meeting date in
the Federal Register.
FOR FURTHER INFORMATION CONTACT: Paul
Tran, Center for Drug Evaluation and
Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
paul.tran@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512536. Please call the Information
Line for up-to-date information on this
meeting.
Dated: January 26, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–2096 Filed 2–1–10; 8:45 am]
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5333
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Pulmonary-Allergy Drugs 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: PulmonaryAllergy 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 March 9, 2010, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd, Silver Spring, MD, 301–
589–5200.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
Kristine.Khuc@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512545. 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 March 9, 2010, the
committee will discuss new drug
application (NDA) 22–535, pirfenidone,
by InterMune. The proposed indication
(purpose) of this drug is the treatment
of patients with idiopathic pulmonary
fibrosis (scarring of the lungs without a
known cause) to decrease the decline in
lung function associated with this
condition.
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
E:\FR\FM\02FEN1.SGM
02FEN1
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5334
Federal Register / Vol. 75, No. 21 / Tuesday, February 2, 2010 / Notices
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 February 23, 2010.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
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 February 12, 2010. 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
February 16, 2010.
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 Kristine T.
Khuc 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).
VerDate Nov<24>2008
16:52 Feb 01, 2010
Jkt 220001
Dated: January 25, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–2054 Filed 2–1–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Pulmonary-Allergy Drugs 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: PulmonaryAllergy 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 March 10 and 11, 2010, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel phone number is 301–589–5200.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
Kristine.Khuc@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512545. 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 March 10 and 11, 2010,
the committee will discuss the design of
medical research studies (known as
‘‘clinical trial design’’) to evaluate
serious asthma outcomes (such as
hospitalizations, a procedure using a
PO 00000
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Fmt 4703
Sfmt 4703
breathing tube known as intubation, or
death) with the use of the class of
asthma medications known as long
acting beta-2 adrenergic agonists in the
treatment of asthma in adults,
adolescents, and children.
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 February 23, 2010.
Oral presentations from the public will
be scheduled between approximately
8:30 a.m. and 9:30 a.m. on March 11,
2010. Those desiring to make 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 February 12, 2010. 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
February 16, 2010.
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 Kristine T.
Khuc 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/
E:\FR\FM\02FEN1.SGM
02FEN1
Agencies
[Federal Register Volume 75, Number 21 (Tuesday, February 2, 2010)]
[Notices]
[Pages 5333-5334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-2054]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Pulmonary-Allergy Drugs 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: Pulmonary-Allergy 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 March 9, 2010, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd, Silver Spring, MD, 301-589-5200.
Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: Kristine.Khuc@fda.hhs.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512545. 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 March 9, 2010, the committee will discuss new drug
application (NDA) 22-535, pirfenidone, by InterMune. The proposed
indication (purpose) of this drug is the treatment of patients with
idiopathic pulmonary fibrosis (scarring of the lungs without a known
cause) to decrease the decline in lung function associated with this
condition.
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
[[Page 5334]]
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
February 23, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make 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 February 12, 2010. 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 February
16, 2010.
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 Kristine T. Khuc 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: January 25, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-2054 Filed 2-1-10; 8:45 am]
BILLING CODE 4160-01-S