Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting, 32586-32587 [E8-12868]
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32586
Federal Register / Vol. 73, No. 111 / Monday, June 9, 2008 / Notices
Analysis and Services Office, CDC pursuant
to Public Law 92–463. Agenda items are
subject to change as priorities dictate.
Contact Person for More Information: Ms.
Amy Harris, Executive Secretary, ACIPC,
NCIPC, CDC, 4770 Buford Highway, NE., M/
S F–63, Atlanta, Georgia 30341–3724,
telephone (770) 488–4936.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: June 3, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–12892 Filed 6–6–08; 8:45 am]
Services Office, Centers for Disease Control
and Prevention, pursuant to Section 10(d)
Public Law 92–463.
Matters To Be Discussed: The meeting will
convene to address matters related to the
conduct of Study Section business and to
consider Safety and Occupational HealthRelated Grant Applications.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Price
Connor, PhD, NIOSH Health Scientist, 1600
Clifton Road, NE., Mailstop E–20, Atlanta,
Georgia 30333, Telephone (404) 498–2511,
Fax (404) 498–2571.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: May 30, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–12793 Filed 6–6–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Safety and Occupational Health Study
Section (SOHSS), National Institute for
Occupational Safety and Health,
(NIOSH)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on PROD1PC66 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
Times and Dates:
8 a.m.–5 p.m., June 26, 2008 (Closed);
8 a.m.–5 p.m., June 27, 2008 (Closed).
Place: Embassy Suites Hotel, 1900
Diagonal Road, Alexandria, Virginia 22314,
Telephone (703) 684–5900, Fax (703) 684–
1403.
Purpose: The Safety and Occupational
Health Study Section will review, discuss,
and evaluate grant application(s) received in
response to the Institute’s standard grants
review and funding cycles pertaining to
research issues in occupational safety and
health, and allied areas.
It is the intent of NIOSH to support broadbased research endeavors in keeping with the
Institute’s program goals. This will lead to
improved understanding and appreciation for
the magnitude of the aggregate health burden
associated with occupational injuries and
illnesses, as well as to support more focused
research projects, which will lead to
improvements in the delivery of occupational
safety and health services, and the
prevention of work-related injury and illness.
It is anticipated that research funded will
promote these program goals.
These portions of the meeting will be
closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and
(6), Title 5 U.S.C., and the Determination of
the Director, Management Analysis and
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Food and Drug Administration
Notice of Approval of Supplemental
New Animal Drug Application;
Moxidectin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Dated: June 2, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 08–1329 Filed 6–5–08; 12:00 pm]
BILLING CODE 4160–01–S
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice that it has approved a
supplemental new animal drug
application (NADA) filed by Fort Dodge
Animal Health, Division of Wyeth. The
approved NADA provides for the
veterinary prescription use of a
sustained-release injectable moxidectin
formulation for prevention of
heartworm disease and treatment of
existing hookworm infections in dogs.
The supplemental NADA adds animal
safety information to product labeling.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth, 800 Fifth St. NW., Fort Dodge,
IA 50501, filed a supplement to NADA
141–189 that provides for veterinary
prescription use of PROHEART 6
(moxidectin) Sustained Release
PO 00000
Injectable for Dogs, used for prevention
of heartworm disease and treatment of
existing hookworm infections. The
supplemental NADA updates the
warning, precaution, adverse reactions,
and post-approval experience sections
of product labeling. In accordance with
section 512(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360b(i))
and 21 CFR 514.105(a) and 514.106(a),
the Center for Veterinary Medicine is
providing notice that this supplemental
NADA is approved as of May 23, 2008.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33(d)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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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 June 25, 2008, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC/
Silver Spring, Maryland Ballroom, 8727
E:\FR\FM\09JNN1.SGM
09JNN1
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 73, No. 111 / Monday, June 9, 2008 / Notices
Colesville Rd., Silver Spring, MD, 301–
589–5200.
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) 22–275,
tolvaptan (proposed trade name
SAMSKA), Otsuka Pharmaceutical
Development & Commercialization, Inc.,
for the proposed indication of treatment
of hypervolemic and euvolemic,
hyponatremia. The committee will hear
presentations from FDA and the
sponsors specifically regarding change
in sodium level as basis for drug
approval.
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 June 20, 2008. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 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
VerDate Aug<31>2005
18:05 Jun 06, 2008
Jkt 214001
requested to make their presentation on
or before June 13, 2008. 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 June 16, 2008.
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.
FDA regrets that it was unable to
publish this notice 15 days prior to the
June 25, 2008, Cardiovascular and Renal
Drugs Advisory Committee meeting.
Because the agency believes there is
some urgency to bring this issue to
public discussion and qualified
members of the Cardiovascular and
Renal Drugs Advisory Committee were
available at this time, the Commissioner
of Food and Drugs concluded that it was
in the public interest to hold this
meeting even if there was not sufficient
time for the customary 15-day public
notice.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 2, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–12868 Filed 6–6–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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Fmt 4703
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ACTION:
32587
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: Orthopaedic and
Rehabilitation 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 July 15, 2008, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Ronald P. Jean,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–3676, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512521. 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,
make recommendations, and vote on a
premarket approval application for
Oxiplex/SP Gel, sponsored by FzioMed,
Inc. This device is intended to be used
as a surgical adjuvant during posterior
lumbar laminectomy, laminotomy, or
discectomy to improve patient outcomes
by reducing postoperative leg pain, back
pain, and neurological symptoms.
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
E:\FR\FM\09JNN1.SGM
09JNN1
]]>Agencies
[Federal Register Volume 73, Number 111 (Monday, June 9, 2008)]
[Notices]
[Pages 32586-32587]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12868]
-----------------------------------------------------------------------
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 June 25, 2008, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, Maryland Ballroom,
8727
[[Page 32587]]
Colesville Rd., Silver Spring, MD, 301-589-5200.
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-
275, tolvaptan (proposed trade name SAMSKA), Otsuka Pharmaceutical
Development & Commercialization, Inc., for the proposed indication of
treatment of hypervolemic and euvolemic, hyponatremia. The committee
will hear presentations from FDA and the sponsors specifically
regarding change in sodium level as basis for drug approval.
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 June
20, 2008. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 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 June 13, 2008. 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 June 16,
2008.
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.
FDA regrets that it was unable to publish this notice 15 days prior
to the June 25, 2008, Cardiovascular and Renal Drugs Advisory Committee
meeting. Because the agency believes there is some urgency to bring
this issue to public discussion and qualified members of the
Cardiovascular and Renal Drugs Advisory Committee were available at
this time, the Commissioner of Food and Drugs concluded that it was in
the public interest to hold this meeting even if there was not
sufficient time for the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 2, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-12868 Filed 6-6-08; 8:45 am]
BILLING CODE 4160-01-S
