Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting, 24605-24606 [05-9229]
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24605
Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
Number of
Respondents
Activity
Pretest
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
30
30
0.167
5
4,000
Experiment
1
1
4,000
0.167
668
Total
893
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here.
Dated: May 4, 2005.
Jeffery Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–9328 Filed 5–9–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Neurological Devices Panel of the
Medical Devices 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: Neurological
Devices Panel of the Medical Devices
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 June 17, 2005, from 8:30 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Janet L. Scudiero,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–594–1184, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512513. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will hear a
presentation on the FDA Critical Path
Initiative and a presentation by the
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Office of Surveillance and Biometrics in
the Center for Devices and Radiological
Health outlining their responsibility for
the review of postmarket study design.
The committee will also hear an update
on the status of recent devices brought
before the committee. Subsequently, the
committee will discuss, make
recommendations, and vote on a
premarket approval application for a
selective head cooling system intended
for use in infants 36 weeks of gestation
or older at risk for moderate to severe
hypoxic-ischemic encephalopathy (HIE)
to prevent or reduce the severity of HIE.
Background information for the topic,
including the agenda and questions for
the committee, will be available to the
public 1 business day before the
meeting on the Internet at https://
www.fda.gov/cdrh/panelmtg.html.
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 June 3, 2005. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person by June 3, 2005, 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 AnnMarie
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Williams at 240–276–0450, ext. 113 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: May 3, 2005.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 05–9296 Filed 5–9–05; 8:45am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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 July 13 and 14, 2005, from 8
a.m. to 5:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Teresa A. Watkins,
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, e-mail: watkinst@cder.fda.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.
Agenda: On July 13, 2005, the
committee will discuss the implications
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24606
Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
of recently available data related to the
safety of long-acting beta-agonist
bronchodilators. On July 14, 2005, the
committee will discuss the continued
need for the essential use designations
of prescription drugs for the treatment
of asthma and chronic obstructive
pulmonary disease under 21 CFR 2.125.
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 July 1, 2005. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. on July 13, 2005, and
between approximately 11 a.m. and 12
noon on July 14, 2005. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before July 1, 2005, 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 La’Nise Giles
at 301–827–7001 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: April 29, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–9229 Filed 5–9–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0062]
Draft Guidance for Industry on the
Food and Drug Administration’s ‘‘Drug
Watch’’ for Emerging Drug Safety
Information; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘FDA’s ‘Drug Watch’
for Emerging Drug Safety Information.’’
This document provides guidance about
how FDA intends to develop and
disseminate important emerging drug
safety information concerning marketed
drug products to healthcare
professionals and patients. This
information will appear on an FDA Web
page to be called the ‘‘Drug Watch.’’
DATES: Submit written or electronic
comments on the draft guidance by
August 8, 2005. General comments on
agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Deborah J. Henderson, Center for Drug
Evaluation and Research (HFD–6), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20855, 301–594–
5400.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘FDA’s ‘Drug Watch’ for Emerging Drug
Safety Information.’’ This document
provides guidance about how FDA
intends to develop and disseminate
important emerging drug safety
information concerning marketed drug
products to healthcare professionals and
patients.
In the last several months, members of
patient groups, the medical community,
and Congress have raised concerns
regarding the way in which FDA has
handled certain drug safety issues, most
recently in connection with the
withdrawal of Vioxx from the market
and with the management of the risks of
suicide associated with pediatric use of
antidepressants. As a result, FDA is
carefully evaluating its institutional
approach to drug safety issues, focusing
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especially on the ways in which the
agency responds to new safety concerns
and resolves scientific disagreements
about product safety between agency
components. As part of this process,
FDA is also reexamining its risk
communication program, including how
and when we communicate significant
emerging safety information to
healthcare professionals and patients.1
FDA has long provided information
on drug risks and benefits to healthcare
professionals and patients. In the past,
we provided that information when we
were certain of its significance or it
prompted a regulatory action, such as a
labeling change. We have now decided
to make important drug safety
information available to healthcare
professionals and patients in a new
format and earlier than we have in the
past. This information will appear on an
FDA Web page called the ‘‘Drug
Watch.’’
II. The Drug Watch Program
The goal of the Drug Watch program
is to ensure that patients and healthcare
professionals have quick access to the
most up-to-date and accurate product
information available in an easily
accessible form. The Drug Watch Web
page will post significant emerging
safety information that FDA has
received about certain drugs (or classes
of drugs) while the agency continues to
actively evaluate the information. The
Drug Watch page is not intended to be
a list of drugs that are particularly risky
or dangerous for use; listing of a drug on
the Drug Watch should not be construed
as a statement by FDA that the drug is
dangerous or that it is inappropriate for
use. All drugs have risks, and
prescribers must balance the risks and
benefits of a drug when making
judgments about an individual patient’s
therapy. However, sometimes after a
drug is approved, rare but serious new
side effects emerge as the drug is more
widely used or is prescribed for off-label
uses. Sometimes these emerging risks
appear to be life-threatening, while in
other cases they may appear to be less
serious. In most instances, however,
there is a period of uncertainty while
FDA and the drug’s sponsor evaluate
new, emerging safety information to
determine whether the safety concern in
fact relates to the drug, and whether
regulatory or other action is appropriate.
The purpose of the Drug Watch is to
provide a forum from which FDA can
communicate emerging safety
information to the public while we
1 For information about the other steps FDA is
taking see https://www.fda.gov/bbs/topics/news/
2004/NEW01131.html.
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]]>Agencies
[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24605-24606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9229]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 July 13 and 14, 2005,
from 8 a.m. to 5:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Teresa A. Watkins, 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, e-mail: watkinst@cder.fda.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.
Agenda: On July 13, 2005, the committee will discuss the
implications
[[Page 24606]]
of recently available data related to the safety of long-acting beta-
agonist bronchodilators. On July 14, 2005, the committee will discuss
the continued need for the essential use designations of prescription
drugs for the treatment of asthma and chronic obstructive pulmonary
disease under 21 CFR 2.125.
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 July 1, 2005.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on July 13, 2005, and between
approximately 11 a.m. and 12 noon on July 14, 2005. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 1, 2005, 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 La'Nise Giles at
301-827-7001 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: April 29, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9229 Filed 5-9-05; 8:45 am]
BILLING CODE 4160-01-S
