Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting, 54559 [05-18365]
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Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices
Dated: September 9, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–18321 Filed 9–14–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
ACTION:
Food and Drug Administration
[Docket No. 2004N–0486]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Experimental Study of Health Claims
on Food Packages
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Experimental Study of Health Claims
on Food Packages’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
In the
Federal Register of April 20, 2005 (70
FR 20568), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0565. The
approval expires on August 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
SUPPLEMENTARY INFORMATION:
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18283 Filed 9–14–05; 8:45 am]
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15:03 Sep 14, 2005
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Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 November 16, 2005, from 8 a.m.
to 5 p.m.
Location: Food and Drug
Administration, CDER Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Cathy Groupe, 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:
GroupeC@cder.fda.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.
Agenda: The committee will discuss
new drug application (NDA) 21–628,
proposed trade name CERTICAN
(everolimus) Tablets (0.25 milligrams
(mg), 0.50 mg, 0.75 mg, and 1.0 mg),
Novartis Pharmaceuticals Corporation,
for the proposed indication of
prophylaxis of rejection in heart
transplantation. 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. (Click on the year 2005
and scroll down to the heading
Cardiovascular and Renal Drugs
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 November 8, 2005. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Time allotted for each
PO 00000
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54559
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before November 8, 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 Beverly
O’Neil 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: September 6, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05–18365 Filed 9–14–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dental Products 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: Dental Products
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 October 11, 2005, from 9:15
a.m. to 5:45 p.m., and on October 12,
2005, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Ballroom Salons A
and B, 620 Perry Pkwy., Gaithersburg,
MD.
Contact Person: Michael E. Adjodha,
Center for Devices and Radiological
Health (HFZ–480), Food and Drug
E:\FR\FM\15SEN1.SGM
15SEN1
]]>Agencies
[Federal Register Volume 70, Number 178 (Thursday, September 15, 2005)]
[Notices]
[Page 54559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18365]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 November 16, 2005, from
8 a.m. to 5 p.m.
Location: Food and Drug Administration, CDER Advisory Committee
Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Cathy Groupe, 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: GroupeC@cder.fda.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.
Agenda: The committee will discuss new drug application (NDA) 21-
628, proposed trade name CERTICAN (everolimus) Tablets (0.25 milligrams
(mg), 0.50 mg, 0.75 mg, and 1.0 mg), Novartis Pharmaceuticals
Corporation, for the proposed indication of prophylaxis of rejection in
heart transplantation. 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. (Click on the
year 2005 and scroll down to the heading Cardiovascular and Renal Drugs
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 November 8,
2005. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before November 8, 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 Beverly O'Neil 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: September 6, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-18365 Filed 9-14-05; 8:45 am]
BILLING CODE 4160-01-S
