Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 2081-2082 [E9-686]
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Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Filing Objections and Requests for a
Hearing on a Regulation or Order—21
CFR Part 12 (OMB Control Number
0910–0184)—Extension
The regulations in 21 CFR 12.22,
issued under section 701(e)(2) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 371(e)(2)), set forth
the instructions for filing objections and
requests for a hearing on a regulation or
order under § 12.20(d) (21CFR 12.20(d)).
Objections and requests must be
submitted within the time specified in
§ 12.20(e). Each objection, for which a
hearing has been requested, must be
separately numbered and specify the
provision of the regulation or the
proposed order. In addition, each
objection must include a detailed
description and analysis of the factual
information and any other document,
with some exceptions, supporting the
objection. Failure to include this
information constitutes a waiver of the
right to a hearing on that objection. FDA
uses the description and analysis to
determine whether a hearing request is
justified. The description and analysis
may be used only for the purpose of
determining whether a hearing has been
justified under 21 CFR 12.24 and do not
limit the evidence that may be
presented if a hearing is granted.
Respondents to this information
collection are those parties that may be
adversely affected by an order or
regulation.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
12.22
1There
5
Total Annual
Responses
1
Hours per
Response
5
Total Hours
20
100
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
collection of information is based on
past filings. Agency personnel,
responsible for processing the filing of
objections and requests for a public
hearing on a specific regulation or order,
estimate approximately five requests are
received by the agency annually, with
each requiring approximately 20 hours
of preparation time.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: January 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–574 Filed 1–13–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
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 February 4, 2009, from 8:30 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/ Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD. The
hotel telephone number is 301–977–
8900.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5630 Fishers Lane (for
express delivery, 5630 Fishers Lane,rm.
1093), Rockville, MD 20857, 301–827–
PO 00000
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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: The committee will discuss
biologics license application (BLA) No.
125277, KALBITOR, for ecallantide
injection by Dyax Corp., for the
proposed indication of treatment of
acute attacks of hereditary angioedema.
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/ohrms/
dockets/ac/acmenu.htm, click on the
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14JAN1
2082
Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 8, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–686 Filed 1–13–09; 8:45 am]
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year 2009 and 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 January 23, 2009.
Oral presentations from the public will
be scheduled approximately between 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 January 21, 2009. 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
January 22, 2009.
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/oc/advisory/
default.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).
Name of Committee: NIH Advisory Board
for Clinical Research.
Date: January 26, 2009.
Open: 10 a.m. to 1:15 p.m.
Agenda: To review the strategic and
operational issues of the NIH Intramural
Research Program, including the Clinical
Center.
Place: National Institutes of Health,
Building 10, 10 Center Drive, CRC Medical
Board Room 4–2551, Bethesda, MD 20892,
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National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, January
26, 2009, 2 p.m. to January 26, 2009, 4
p.m., National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD, 20892
which was published in the Federal
Register on December 31, 2008, 73 FR
80417–80418.
The meeting has been changed to an
AED meeting starting January 26, 2009,
8 a.m. to January 27, 2009, 5 p.m. The
meeting title has been changed to
‘‘Coagulation and Thrombosis’’. The
meeting is closed to the public.
Dated: January 6, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–403 Filed 1–13–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Clinical Center; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the NIH
Advisory Board for Clinical Research.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended to
discuss personnel matters, the
disclosure of which would constitute a
clearly unwarranted invasion of privacy.
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Dated: January 7, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–515 Filed 1–13–09; 8:45 am]
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National Institutes of Health
PO 00000
Closed: 1:15 p.m. to 2 p.m.
Agenda: To discuss personnel matters.
Place: National Institutes of Health,
Building 10, 10 Center Drive, CRC Medical
Board Room 4–2551, Bethesda, MD 20892.
Contact Person: Maureen E. Gormley,
Executive Secretary, Mark O. Hatfield
Clinical Research Center, National Institutes
of Health, Building 10, Room 6–2551,
Bethesda, MD 20892, 301/496–2897.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Cancer Institute Board of
Scientific Advisors.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: National Cancer
Institute Board of Scientific Advisors.
Date: March 2–3, 2009.
Time: March 2, 2009, 8 a.m. to 6 p.m.
Agenda: Director’s Report: Ongoing and
New Business; Reports of Program Review
Group(s); and Budget Presentations; Reports
of Special Initiatives; RFA and RFP Concept
Reviews; and Scientific Presentations.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6th Floor,
Conference Room 10, Bethesda, MD 20892.
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]]>Agencies
[Federal Register Volume 74, Number 9 (Wednesday, January 14, 2009)]
[Notices]
[Pages 2081-2082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-686]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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 February 4, 2009, from
8:30 a.m. to 5 p.m.
Location: Hilton Washington DC North/ Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5630 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: The committee will discuss biologics license application
(BLA) No. 125277, KALBITOR, for ecallantide injection by Dyax Corp.,
for the proposed indication of treatment of acute attacks of hereditary
angioedema.
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/ohrms/dockets/ac/acmenu.htm, click on
the
[[Page 2082]]
year 2009 and 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
January 23, 2009. Oral presentations from the public will be scheduled
approximately between 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 January 21, 2009. 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 January
22, 2009.
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/oc/advisory/
default.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 8, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-686 Filed 1-13-09; 8:45 am]
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