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25832 Federal Register / Vol. 70, No.

93 / Monday, May 16, 2005 / Notices

DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Persons attending FDA’s advisory
HUMAN SERVICES HUMAN SERVICES committee meetings are advised that the
agency is not responsible for providing
Food and Drug Administration access to electrical outlets.
Administration for Children and FDA welcomes the attendance of the
Families public at its advisory committee meetings
Circulatory System Devices Panel of
and will make every effort to accommodate
Statement of Organization, Functions the Medical Devices Advisory persons with physical disabilities or special
and Delegations of Authority Committee; Notice of Meeting needs. If you require special accommodations
AGENCY: Food and Drug Administration, due to a disability, please contact Shirley
Notice is hereby given that under the Meeks, Conference Management Staff, at
HHS. 240–276–0450, ext. 105, at least 7 days in
authority vested in the Assistant ACTION: Notice. advance of the meeting.
Secretary for Children and Families by Notice of this meeting is given under the
the memorandum dated October 1, 2003 This notice announces a forthcoming Federal Advisory Committee Act (5 U.S.C.
from the Assistant Secretary for meeting of a public advisory committee app. 2).
Administration and Management, I of the Food and Drug Administration
hereby redelegate to the Deputy (FDA). The meeting will be open to the Dated: May 9, 2005.
Assistant Secretary for Administration, public. Sheila Dearybury Walcoff,
the following authority: Name of Committee: Circulatory System Associate Commissioner for External
Devices Panel of the Medical Devices Relations.
Authority Delegated Advisory Committee. [FR Doc. 05–9673 Filed 5–13–05; 8:45 am]
General Function of the Committee: To BILLING CODE 4160–01–S
The authority to issue formal provide advice and recommendations to the
grievance decisions on matters under agency on FDA’s regulatory issues.
the line of supervision where the Date and Time: The meeting will be held DEPARTMENT OF HEALTH AND
Assistant Secretary has the authority to on June 22, 2005, from 8 a.m. to 4:30 p.m., HUMAN SERVICES
decide the matter being grieved, except and on June 23, 2005, from 8 a.m. to 4:30
p.m. Food and Drug Administration
in cases where the Deputy Assistant Location: Hilton Washington DC North/
Secretary for Administration has issued Gaithersburg, The Ballrooms, 620 Perry [Docket Nos. 2002P–0312 and 2002P–0367
a prior decision. Pkwy., Gaithersburg, MD. (formerly Docket Nos. 02P–0312 and 02P–
Contact Person: Geretta Wood, Center for 0367)]
Conditions and Limitations Devices and Radiological Health (HFZ–450),
Food and Drug Administration, 9200 CollaGenex Pharmaceuticals, Inc.;
This delegation excludes those Corporate Blvd., Rockville, MD 20850, 301– Withdrawal of Approval of a New Drug
authorities specifically reserved to or by 443–8320, ext. 143, or FDA Advisory Application; Determination That
the Secretary in the memorandum dated Committee Information Line, 1–800–741– Doxycycline Hyclate 20-Milligram
October 11, 2001. 8138 (301–443–0572 in the Washington, DC Capsules Were Not Withdrawn From
area), code 3014512625. Please call the
This authority is to be exercised in Information Line for up-to-date information
Sale for Reasons of Safety or
accordance with the policies of the on this meeting. Effectiveness
Department and the Administration for Agenda: On June 22, 2005, the committee AGENCY: Food and Drug Administration,
Children and Families. will discuss, make recommendations, and
HHS.
vote on a premarket approval application for
Effective Date a cardiac device intended to treat patients ACTION: Notice.
with heart failure. On June 23, 2005, the
This redelegation is effective on the SUMMARY: The Food and Drug
committee will discuss, make
date of signature. I hereby ratify any recommendations, and vote on a Administration (FDA) is withdrawing
actions the Deputy Assistant Secretary humanitarian device exemption for an approval of one new drug application
for Administration may have taken artificial heart. Background information for (NDA). CollaGenex Pharmaceuticals,
pursuant to this authority prior to the the topics, including the agenda and Inc., notified the agency in writing that
questions for the committee, will be available PERIOSTAT (doxycycline hyclate) 20-
effective date of this delegation. to the public 1 business day before the milligram (mg) capsules were no longer
Effect on Existing Delegations meeting on the Internet at http:// marketed and requested that approval of
www.fda.gov/cdrh/panelmtg.html. NDA 50–774 be withdrawn. FDA has
This redelegation supersedes the Procedure: Interested persons may present
data, information, or views, orally or in determined that PERIOSTAT
redelegation to the Deputy Assistant (doxycycline hyclate) 20-mg capsules
writing, on issues pending before the
Secretary for Administration dated committee. Written submissions may be were not withdrawn from sale for
February 10, 2005, relating to made to the contact person by June 8, 2005. reasons of safety or effectiveness. This
grievances. On both days, oral presentations from the determination will allow FDA to
public will be scheduled for approximately approve abbreviated new drug
Dated: May 6, 2005.
30 minutes at the beginning of committee applications (ANDAs) for doxycycline
Wade F. Horn, deliberations and for approximately 30 hyclate 20-mg capsules.
Assistant Secretary for Children and Families. minutes near the end of the committee
deliberations. Time allotted for each DATES: The withdrawal of approval of
[FR Doc. 05–9697 Filed 5–13–05; 8:45 am] NDA 50–744 is effective June 15, 2005.
presentation may be limited. Those desiring
BILLING CODE 4184–01–P to make formal oral presentations should FOR FURTHER INFORMATION CONTACT:
notify the contact person before June 8, 2005, Mary Catchings, Center for Drug
and submit a brief statement of the general Evaluation and Research (HFD–7), Food
nature of the evidence or arguments they and Drug Administration, 5600 Fishers
wish to present, the names and addresses of Lane, Rockville, MD 20857, 301–594–
proposed participants, and an indication of
the approximate time requested to make their
2041.
presentation. SUPPLEMENTARY INFORMATION:

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