Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting, 6903-6904 [E9-2862]
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Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices
After publication of the January 15
notice, FDA received comments and has
determined it would be beneficial to
have more time to deliberate further on
the policy issues presented by this
action. Consequently, FDA is revising
the guidance to announce that it intends
to stop issuing EU Export Certificates on
June 17, 2009.
FDA is issuing this guidance
document as a level 2 guidance
consistent with FDA’s good guidance
practices regulation (21 CFR
10.115(c)(2)). The guidance represents
FDA’s current thinking on this topic. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA, NOAA SIP, or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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 maybe seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance document at
https://www.cfsan.fda.gov/
guidance.html.
Dated: February 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–2802 Filed 2–6–09; 12:00 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on PROD1PC66 with NOTICES
[Docket No. FDA–2009–N–0664]
Improving Endpoints, Improving Care:
Alpha-1 Antitrypsin Augmentation
Therapy and Clinical Trials; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
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17:58 Feb 10, 2009
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The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: Improving Endpoints,
Improving Care: Alpha-1 Antitrypsin
Augmentation Therapy and Clinical
Trials. The purpose of the public
workshop is to identify the most useful
clinical trial endpoints and surrogate
markers for Alpha-1 antitrypsin (AAT)
augmentation therapy. FDA, Alpha-1
Foundation, and the Department of
Health and Human Services, Office of
Public Health and Science are
convening this workshop to facilitate
the design of future clinical trials
intended to establish clinical efficacy of
AAT products. The public workshop
will feature presentations and panel
discussions led by experts from
academic institutions, government, and
industry.
Date and Time: The public workshop
will be held on March 23, 2009, from
8:30 a.m. to 5:30 p.m. and March 24,
2009, from 8:30 a.m. to 5 p.m.
Location: The public workshop will
be held at the Lister Hill Center
Auditorium, Bldg. 38A, National
Institutes of Health, 8800 Rockville
Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to the
contact person by March 6, 2009. There
is no registration fee for the public
workshop. Early registration is
recommended because seating is limited
to 175 attendees. Registration on the day
of the public workshop will be provided
on a space available basis beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: AAT
deficiency is a genetic condition that
leads to decreased levels of alpha-1
antitrypsin in the blood and
significantly increases the risk of serious
lung disease in adults and liver disease
in infants, children, and adults.
Intravenous augmentation therapy with
FDA-licensed, plasma-derived AAT
products has become the standard of
care for treatment in the subset of
patients with AAT deficiency who have
moderate pulmonary disease. Since the
original product approvals, additional
data collection and advances in
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understanding of AAT deficiency
suggest the need to revisit and improve
clinical trial efficacy endpoints.
The public workshop will facilitate
scientific discussions to identify the
most relevant and feasible, currently
available and future clinical trial
efficacy endpoints for AAT
augmentation therapy and further
evaluate its usefulness to a broader
patient population. Topics to be
discussed include: (1) AAT deficiency
disease characteristics, progression and
pulmonary pathophysiology; (2) patient
selection for clinical trials; (3) current
challenges to the development of
endpoints for clinical trials; and (4)
currently available and future clinical
trial endpoints, including functional
markers of disease progression, and
radiological and biochemical endpoints.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/cber/
minutes/workshop-min.htm.
Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–2905 Filed 2–10–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Cardiovascular and Renal 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: Cardiovascular
and Renal 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 March 18, 2009, from 8 a.m. to
5 p.m.
E:\FR\FM\11FEN1.SGM
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6904
Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Notices
Location: Marriott Conference
Centers, UMUC Inn and Conference
Center, 3501 University Blvd. East,
Adelphi, MD. The hotel telephone
number is 301–985–7385.
Contact Person: Elaine Ferguson,
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:
elaine.ferguson@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. 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) 22–425,
dronedarone 400 milligrams oral tablets,
Sanofi Aventis, for the proposed
indication in patients with a history of,
or current atrial fibrillation or atrial
flutter, for the reduction of the risk of
cardiovascular hospitalization or death.
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 March 4, 2009. Oral
presentations from the public will be
scheduled approximately between 1
p.m. to 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 February 24, 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
February 25, 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 Elaine
Ferguson 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: February 4, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–2862 Filed 2–10–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Request for Nominations for Voting
and Nonvoting Consumer
Representative Members on Public
Advisory Committee and Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting and nonvoting
consumer representatives to serve on
the National Mammography Quality
Assurance Advisory Committee
(NMQAAC) and certain devices panels
of the Medical Devices Advisory
Committee in the Center for Devices and
Radiological Health (CDRH).
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: Nominations will be accepted for
current vacancies and for those that will
or may occur through October 31, 2009.
Because vacancies occur on various
dates throughout the year, there is no
cutoff date for the receipt of
nominations.
ADDRESSES: All nominations for
membership should be sent
electronically to CV@OC.FDA.GOV or
by mail to Advisory Committee
Oversight and Management Staff (HF–
4), 5600 Fishers Lane, Rockville, MD
20857. Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Web site at https://www.fda.gov/oc/
advisory/default.htm.
FOR FURTHER INFORMATION CONTACT: For
specific committee questions, contact
the following persons listed in table 1 of
this document:
TABLE 1
mstockstill on PROD1PC66 with NOTICES
Contact Person
Committee/Panel
Geretta P. Wood, Center for Devices and Radiological Health (HFZ–
400), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3993, e-mail: Geretta.Wood@fda.hhs.gov
Certain Device Panels of the Medical Devices Advisory Committee
Nancy M. Wynne, Center for Devices and Radiological Health (HFZ–
240), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850, e-mail: Nancy.Wynne@fda.hhs.gov
National Mammography Quality Assurance Advisory Committee
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]]>Agencies
[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6903-6904]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2862]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Cardiovascular and Renal 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: Cardiovascular and Renal 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 March 18, 2009, from 8
a.m. to 5 p.m.
[[Page 6904]]
Location: Marriott Conference Centers, UMUC Inn and Conference
Center, 3501 University Blvd. East, Adelphi, MD. The hotel telephone
number is 301-985-7385.
Contact Person: Elaine Ferguson, 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:
elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512533. 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) 22-
425, dronedarone 400 milligrams oral tablets, Sanofi Aventis, for the
proposed indication in patients with a history of, or current atrial
fibrillation or atrial flutter, for the reduction of the risk of
cardiovascular hospitalization or death. 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
March 4, 2009. Oral presentations from the public will be scheduled
approximately between 1 p.m. to 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 February 24, 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 February
25, 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 Elaine Ferguson 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: February 4, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-2862 Filed 2-10-09; 8:45 am]
BILLING CODE 4160-01-S
