Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 25832 [05-9673]
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Federal Register / Vol. 70, No. 93 / Monday, May 16, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Food and Drug Administration
Statement of Organization, Functions
and Delegations of Authority
Notice is hereby given that under the
authority vested in the Assistant
Secretary for Children and Families by
the memorandum dated October 1, 2003
from the Assistant Secretary for
Administration and Management, I
hereby redelegate to the Deputy
Assistant Secretary for Administration,
the following authority:
Authority Delegated
The authority to issue formal
grievance decisions on matters under
the line of supervision where the
Assistant Secretary has the authority to
decide the matter being grieved, except
in cases where the Deputy Assistant
Secretary for Administration has issued
a prior decision.
Conditions and Limitations
This delegation excludes those
authorities specifically reserved to or by
the Secretary in the memorandum dated
October 11, 2001.
This authority is to be exercised in
accordance with the policies of the
Department and the Administration for
Children and Families.
Effective Date
This redelegation is effective on the
date of signature. I hereby ratify any
actions the Deputy Assistant Secretary
for Administration may have taken
pursuant to this authority prior to the
effective date of this delegation.
Effect on Existing Delegations
This redelegation supersedes the
redelegation to the Deputy Assistant
Secretary for Administration dated
February 10, 2005, relating to
grievances.
Dated: May 6, 2005.
Wade F. Horn,
Assistant Secretary for Children and Families.
[FR Doc. 05–9697 Filed 5–13–05; 8:45 am]
BILLING CODE 4184–01–P
VerDate jul<14>2003
16:37 May 13, 2005
Jkt 205001
Circulatory System 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: Circulatory System
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 22, 2005, from 8 a.m. to 4:30 p.m.,
and on June 23, 2005, from 8 a.m. to 4:30
p.m.
Location: Hilton Washington DC North/
Gaithersburg, The Ballrooms, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: Geretta Wood, Center for
Devices and Radiological Health (HFZ–450),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301–
443–8320, ext. 143, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 3014512625. Please call the
Information Line for up-to-date information
on this meeting.
Agenda: On June 22, 2005, the committee
will discuss, make recommendations, and
vote on a premarket approval application for
a cardiac device intended to treat patients
with heart failure. On June 23, 2005, the
committee will discuss, make
recommendations, and vote on a
humanitarian device exemption for an
artificial heart. Background information for
the topics, 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 8, 2005.
On both days, 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 committee
deliberations. Time allotted for each
presentation may be limited. Those desiring
to make formal oral presentations should
notify the contact person before June 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.
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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 Shirley
Meeks, Conference Management Staff, at
240–276–0450, ext. 105, 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 9, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–9673 Filed 5–13–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2002P–0312 and 2002P–0367
(formerly Docket Nos. 02P–0312 and 02P–
0367)]
CollaGenex Pharmaceuticals, Inc.;
Withdrawal of Approval of a New Drug
Application; Determination That
Doxycycline Hyclate 20-Milligram
Capsules Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of one new drug application
(NDA). CollaGenex Pharmaceuticals,
Inc., notified the agency in writing that
PERIOSTAT (doxycycline hyclate) 20milligram (mg) capsules were no longer
marketed and requested that approval of
NDA 50–774 be withdrawn. FDA has
determined that PERIOSTAT
(doxycycline hyclate) 20-mg capsules
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for doxycycline
hyclate 20-mg capsules.
DATES: The withdrawal of approval of
NDA 50–744 is effective June 15, 2005.
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION:
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16MYN1
]]>Agencies
[Federal Register Volume 70, Number 93 (Monday, May 16, 2005)]
[Notices]
[Page 25832]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9673]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Circulatory System 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: Circulatory System 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 22, 2005, from 8
a.m. to 4:30 p.m., and on June 23, 2005, from 8 a.m. to 4:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, The
Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Geretta Wood, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8320, ext. 143, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512625. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On June 22, 2005, the committee will discuss, make
recommendations, and vote on a premarket approval application for a
cardiac device intended to treat patients with heart failure. On
June 23, 2005, the committee will discuss, make recommendations, and
vote on a humanitarian device exemption for an artificial heart.
Background information for the topics, 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 8,
2005. On both days, 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
committee deliberations. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should
notify the contact person before June 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 Shirley Meeks,
Conference Management Staff, at 240-276-0450, ext. 105, 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 9, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9673 Filed 5-13-05; 8:45 am]
BILLING CODE 4160-01-S
