Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 942 [E6-6]
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Federal Register / Vol. 71, No. 4 / Friday, January 6, 2006 / Notices
FDA is issuing this guidance as a level
1 guidance consistent with FDA’s good
guidance practices regulation § 10.115
(21 CFR 10.115). Consistent with FDA’s
good guidance practices regulation, the
agency will accept comment, but is
implementing the guidance document
immediately in accordance with
§ 10.115 (g)(2), because the agency has
determined that prior public
participation is not feasible or
appropriate. This document affects the
trans fat labeling effective date of
January 1, 2006, so it is urgent that FDA
explains its new enforcement policy
before that date. This guidance
represents the agency’s current thinking
on the subject. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. You may use an alternative
approach if such approach satisfies the
requirements of the applicable statutes
and regulations. If you want to discuss
an alternative approach, contact the
FDA staff responsible for implementing
this guidance (see FOR FURTHER
INFORMATION CONTACT).
II. Paperwork Reduction Act of 1995
This final guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in this guidance was
approved under OMB control number
0910–0571.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document at
any time. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. The guidance and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
cprice-sewell on PROD1PC66 with NOTICES
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance document at
https://www.cfsan.fda.gov/
guidance.html.
Dated: January 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–116 Filed 1–3–06; 3:14 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Drug Safety and Risk Management
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: Drug Safety and
Risk Management 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 9, 2006, from 8 a.m.
to 5 p.m. and February 10, 2006, from
8 a.m. to 3 p.m.
Location: Holiday Inn Gaithersburg,
Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Victoria FerrettiAceto, 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:
ferrettiv@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512535. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: Cases of sudden death and
serious adverse events including
hypertension, myocardial infarction,
and stroke have been reported to the
agency in association with therapeutic
doses of drugs used to treat Attention
Deficit Hyperactivity Disorder (ADHD)
in both pediatric and adult populations.
The few controlled clinical studies of
longer term drug treatment of ADHD
provided little information on
cardiovascular risks. On February 9,
2006, the committee will be asked to
discuss approaches that could be used
to study whether these products
increase the risk of adverse
cardiovascular outcomes. On February
10, 2006, the committee will be briefed
on developments in the Office of Drug
Safety and will receive updates on the
Drug Safety Oversight Board and agency
actions for the COX–2 selective
Nonsteroidal Anti-Inflammatory Drugs
(NSAIDs) and the risk management
program for the isotretinoin products.
Background materials for this meeting
will be posted 1 business day before the
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
meeting on FDA’s Web site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm (click on the year 2006 and
scroll down to Drug Safety and Risk
Management Advisory Committee).
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 by February 2, 2006. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. on February 9, 2006,
and between approximately 8:15 a.m.
and 9:15 a.m. on February 10, 2006.
Time allotted for each presentation may
be limited. Those desiring to make
formal oral presentations should notify
the contact person before February 2,
2006, 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.
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 Victoria
Ferretti-Aceto 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: December 27, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–6 Filed 1–5–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pediatric Oncology Subcommittee of
the 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.
E:\FR\FM\06JAN1.SGM
06JAN1
]]>Agencies
[Federal Register Volume 71, Number 4 (Friday, January 6, 2006)]
[Notices]
[Page 942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Drug Safety and Risk Management 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: Drug Safety and Risk Management 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 9, 2006, from 8
a.m. to 5 p.m. and February 10, 2006, from 8 a.m. to 3 p.m.
Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Victoria Ferretti-Aceto, 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:
ferrettiv@cder.fda.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512535. Please call the Information Line for up-to-date information
on this meeting.
Agenda: Cases of sudden death and serious adverse events including
hypertension, myocardial infarction, and stroke have been reported to
the agency in association with therapeutic doses of drugs used to treat
Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and
adult populations. The few controlled clinical studies of longer term
drug treatment of ADHD provided little information on cardiovascular
risks. On February 9, 2006, the committee will be asked to discuss
approaches that could be used to study whether these products increase
the risk of adverse cardiovascular outcomes. On February 10, 2006, the
committee will be briefed on developments in the Office of Drug Safety
and will receive updates on the Drug Safety Oversight Board and agency
actions for the COX-2 selective Nonsteroidal Anti-Inflammatory Drugs
(NSAIDs) and the risk management program for the isotretinoin products.
Background materials for this meeting will be posted 1 business day
before the meeting on FDA's Web site at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm (click on the year 2006 and scroll down to Drug
Safety and Risk Management Advisory Committee).
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 by February 2,
2006. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on February 9, 2006, and between
approximately 8:15 a.m. and 9:15 a.m. on February 10, 2006. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
February 2, 2006, 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.
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 Victoria Ferretti-
Aceto 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: December 27, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-6 Filed 1-5-06; 8:45 am]
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