Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science; Notice of Meeting, 51198 [E6-14296]
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51198
Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Clinical Pharmacology Subcommittee
of the Advisory Committee for
Pharmaceutical Science; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 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: Clinical
Pharmacology Subcommittee of the
Advisory Committee for Pharmaceutical
Science.
General Function of the
Subcommittee: To provide advice and
recommendations to the Committee for
Pharmaceutical Science on FDA’s
regulatory issues.
Date and Time: The meeting will be
held on October 18, 2006, from 8:30
a.m. to 5:30 p.m. and on October 19,
2006, from 8:30 a.m. to 1 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Mimi Phan, 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–
827–6801, e-mail:
mimi.phan@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in
Washington, DC area), code
3014512539. Please call the Information
Line for up-to-date information on this
meeting. The background material will
become available no later than the day
before the meeting and will be posted
on FDA’s Web site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm under the heading
‘‘Advisory Committee for
Pharmaceutical Science (ACPS).’’ (Click
on the year 2006 and scroll down to
ACPS meetings.)
Agenda: On October 18, 2006, the
subcommittee will: (1) Receive an
update on previous Clinical
Pharmacology Subcommittee meeting
recommendations and an introduction
to three new topics of this meeting; (2)
discuss and provide comments on the
first new topic: The scope and strength
of evidence to support the inclusion of
VerDate Aug<31>2005
17:07 Aug 28, 2006
Jkt 208001
pharmacogenetic information on
Cytochrome P2D6 polymorphisms in a
revision of the label for tamoxifen to
improve the benefit/risk of the drug; and
(3) discuss and provide comments on
the second new topic: evaluation of
transporter-based drug interactions. On
October 19, 2006, the subcommittee will
consider the third new topic: The
impact of using prior knowledge on
drug development and regulatory
decisions. Prior knowledge of disease
change over time and covariates,
placebo variation and drug effects can
be used to make better decisions and
design more informative clinical trials.
Examples will be used to demonstrate
these principles.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the subcommittee. Written
submissions may be made to the contact
person on or before October 3, 2006.
Oral presentations from the public will
be scheduled between approximately
11:15 a.m. and 11:45 a.m. on both days.
Time allotted for each presentation may
be limited. Those desiring to make
formal oral presentation 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 3, 2006.
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 Mimi Phan at
least 7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–14296 Filed 8–28–06; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
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Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic Drugs Advisory
Committee; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The meeting of the
Psychopharmacologic Drugs Advisory
Committee scheduled for September 7,
2006, is cancelled. This amended
meeting was announced in the Federal
Register of August 17, 2006 (71 FR
47502).
FOR FURTHER INFORMATION CONTACT:
Cicely Reese, Center for Drug Evaluation
and Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7001,
FAX: 301–827–6776, e-mail:
cicely.reese@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. Please call the Information
Line for up-to-date information on this
meeting.
Dated: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–14293 Filed 8–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D–0331]
Draft Guidance for Institutional Review
Boards, Clinical Investigators, and
Sponsors; Exception from Informed
Consent Requirements for Emergency
Research
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Guidance for Institutional Review
Boards, Clinical Investigators, and
Sponsors; Exception from Informed
Consent Requirements for Emergency
Research.’’ This draft guidance, when
finalized, is intended to assist
Institutional Review Boards (IRBs),
clinical investigators, and sponsors in
the development and conduct of
emergency research.The draft guidance
E:\FR\FM\29AUN1.SGM
29AUN1
]]>Agencies
[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Page 51198]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14296]
[[Page 51198]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Clinical Pharmacology Subcommittee of the Advisory Committee for
Pharmaceutical Science; 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: Clinical Pharmacology Subcommittee of the
Advisory Committee for Pharmaceutical Science.
General Function of the Subcommittee: To provide advice and
recommendations to the Committee for Pharmaceutical Science on FDA's
regulatory issues.
Date and Time: The meeting will be held on October 18, 2006, from
8:30 a.m. to 5:30 p.m. and on October 19, 2006, from 8:30 a.m. to 1
p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers
Lane, Rockville, MD.
Contact Person: Mimi Phan, 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: 301-827-6801, e-mail: mimi.phan@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572) in
Washington, DC area), code 3014512539. Please call the Information Line
for up-to-date information on this meeting. The background material
will become available no later than the day before the meeting and will
be posted on FDA's Web site at https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm under the heading ``Advisory Committee for Pharmaceutical
Science (ACPS).'' (Click on the year 2006 and scroll down to ACPS
meetings.)
Agenda: On October 18, 2006, the subcommittee will: (1) Receive an
update on previous Clinical Pharmacology Subcommittee meeting
recommendations and an introduction to three new topics of this
meeting; (2) discuss and provide comments on the first new topic: The
scope and strength of evidence to support the inclusion of
pharmacogenetic information on Cytochrome P2D6 polymorphisms in a
revision of the label for tamoxifen to improve the benefit/risk of the
drug; and (3) discuss and provide comments on the second new topic:
evaluation of transporter-based drug interactions. On October 19, 2006,
the subcommittee will consider the third new topic: The impact of using
prior knowledge on drug development and regulatory decisions. Prior
knowledge of disease change over time and covariates, placebo variation
and drug effects can be used to make better decisions and design more
informative clinical trials. Examples will be used to demonstrate these
principles.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the subcommittee.
Written submissions may be made to the contact person on or before
October 3, 2006. Oral presentations from the public will be scheduled
between approximately 11:15 a.m. and 11:45 a.m. on both days. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentation 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 3, 2006.
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 Mimi Phan at least 7
days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-14296 Filed 8-28-06; 8:45 am]
BILLING CODE 4160-01-S
