Anti-Infective Drugs Advisory Committee; Notice of Meeting, 26119-26120 [E8-10307]
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26119
Federal Register / Vol. 73, No. 90 / Thursday, May 8, 2008 / Notices
Dated: April 30, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–10215 Filed 5–7–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0063] (formerly
Docket No. 2008N–0016)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exports:
Notification and Recordkeeping
Requirements
AGENCY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0482. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
Food and Drug Administration,
HHS.
ACTION:
Fax written comments on the
collection of information by June 9,
2008.
DATES:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Exports: Notification and
Recordkeeping Requirements—(OMB
Control Number 0910–0482)—Extension
The respondents to this information
collection are exporters who have
notified FDA of their intent to export
unapproved products that may not be
sold or marketed in the United States as
allowed under section 801(e) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 381(e)). In general,
the notification identifies the product
being exported (e.g. name, description,
and in some cases, country of
destination) and specifies where the
notification should be sent. These
notifications are sent only for an initial
export; subsequent exports of the same
product to the same destination (or, in
the case of certain countries identified
in section 802(b) of the act (21 U.S.C.
382(b)), to any of those countries would
not result in a notification to FDA.
The recordkeepers to this information
collection are exporters who export
human drugs, biologics, devices, animal
drugs, foods and cosmetics that may not
be sold in the United States to maintain
records demonstrating their compliance
with the requirements in section
801(e)(1) of the act.
The total burden estimate of 39,120 is
based on the number of notifications
received by the relevant FDA centers in
fiscal year 2007, or the last year the
figures were available.
In the Federal Register of January 28,
2008 (73 FR 4874), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
1.101(d) and (e)
1 There
Annual Frequency
per Response
400
Total Annual
Responses
3
Hours per
Response
1,200
Total Hours
15
18,000
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
1.101(b) and (c)
1 There
Annual Frequency
per
Recordkeeping
No. of
Recordkeepers
21 CFR Section
320
3
Hours per
Record
960
Total Hours
22
21,120
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–10204 Filed 5–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Anti-Infective Drugs Advisory
Committee; Notice of Meeting
AGENCY:
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Total Annual
Records
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
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17:22 May 07, 2008
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(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 July 16, 2008, from 8 a.m. to 5
p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
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26120
Federal Register / Vol. 73, No. 90 / Thursday, May 8, 2008 / Notices
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Sohail Mosaddegh,
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:
sohail.mosaddegh@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512530. 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
new drug application (NDA) 022–171,
doripenem powder for reconstitution
and intravenous administration,
Johnson and Johnson Pharmaceutical
Research and Development, LLC,
proposed for the treatment of
nosocomial pneumonia, including
ventilator-associated pneumonia.
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
year 2008 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 July 1, 2008. Oral
presentations from the public will be
scheduled between approximately 11
a.m. and 12 noon. 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 June 23, 2008. Time allotted
VerDate Aug<31>2005
17:22 May 07, 2008
Jkt 214001
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 June 24, 2008.
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 Sohail
Mosaddegh 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: April 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–10307 Filed 5–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic 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: Oncologic 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 May 30, 2008, from 8 a.m. to
12:30 p.m.
Location: Hyatt Regency McCormick
Place, Regency Ballroom, 2233 South
Martin L. King Dr. , Chicago, IL. The
hotel phone number is 312–567–1234.
PO 00000
Frm 00047
Fmt 4703
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Contact Person: Nicole Vesely, 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, 301–827–6793, fax: 301–
827–6776, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. 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
the new drug application (NDA) 022–
291, proposed trade name PROMACTA
(eltrombopag olamine), by
GlaxoSmithKline, proposed indication
for the short-term treatment of
previously-treated patients with chronic
idiopathic thrombocytopenic purpura
(ITP) to increase platelet counts and
reduce or prevent bleeding.
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
year 2008 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 May 21, 2008. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. and 11:30 a.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 May 15, 2008. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 73, Number 90 (Thursday, May 8, 2008)]
[Notices]
[Pages 26119-26120]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10307]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Anti-Infective 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: 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 July 16, 2008, from 8
a.m. to 5 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory
[[Page 26120]]
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Sohail Mosaddegh, 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: sohail.mosaddegh@fda.hhs.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512530. 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 new drug application (NDA) 022-
171, doripenem powder for reconstitution and intravenous
administration, Johnson and Johnson Pharmaceutical Research and
Development, LLC, proposed for the treatment of nosocomial pneumonia,
including ventilator-associated pneumonia.
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 year 2008 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 July
1, 2008. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 noon. 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 June 23, 2008. 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 June 24,
2008.
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 Sohail Mosaddegh 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: April 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-10307 Filed 5-7-08; 8:45 am]
BILLING CODE 4160-01-S
