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60022 Federal Register / Vol. 72, No.

204 / Tuesday, October 23, 2007 / Notices

V. Responsiveness Criteria (HFD–21), Food and Drug public hearing session. The contact
Each application submitted will be Administration, 5600 Fishers Lane (for person will notify interested persons
screened to determine whether it was express delivery, 5630 Fishers Lane, rm. regarding their request to speak by
received by the closing date and time. 1093), Rockville, MD 20857, 301–827– November 16, 2007.
Applications received by the closing 7001, FAX: 301–827–6776, e-mail: Persons attending FDA’s advisory
date and time will be screened for diem.ngo@fda.hhs.gov, or FDA committee meetings are advised that the
completeness and conformity with the Advisory Committee Information Line, agency is not responsible for providing
requirements outlined in Sections III 1–800–741–8138 (301–443–0572 in the access to electrical outlets.
and IV of this Notice and the Program Washington, DC area), codes FDA welcomes the attendance of the
Announcement. Only complete 3014512541 and 3014512536. Please public at its advisory committee
applications that meet these call the Information Line for up-to-date meetings and will make every effort to
information on this meeting. A notice in accommodate persons with physical
requirements will be considered for
the Federal Register about last minute disabilities or special needs. If you
funding.
modifications that impact a previously require special accommodations due to
VI. Application Review Information announced advisory committee meeting a disability, please contact Diem-Kieu
Not Applicable. cannot always be published quickly Ngo at least 7 days in advance of the
enough to provide timely notice. meeting.
VII. Agency Contacts Therefore, you should always check the FDA is committed to the orderly
Direct inquiries regarding agency’s Web site and call the conduct of its advisory committee
programmatic issues to U.S. Department appropriate advisory committee hot meetings. Please visit our Web site at
of Health and Human Services, line/phone line to learn about possible http://www.fda.gov/oc/advisory/
Administration on Aging, Office for modifications before coming to the default.htm for procedures on public
American Indian, Alaskan Native and meeting. conduct during advisory committee
Native Hawaiian Programs, Washington, Agenda: The committees will evaluate meetings.
DC 20201, telephone: (202) 357–3501. data submitted by Merck & Co., Inc., to Notice of this meeting is given under
support the over-the-counter use of the Federal Advisory Committee Act (5
Dated: October 18, 2007. MEVACOR (lovastatin) 20 milligrams U.S.C. app. 2).
Josefina G. Carbonell, (mg) a day to help lower cholesterol
Dated: October 17, 2007.
Assistant Secretary for Aging. which may prevent a first heart attack.
FDA intends to make background Randall W. Lutter,
[FR Doc. E7–20837 Filed 10–22–07; 8:45 am]
BILLING CODE 4154–01–P material available to the public no later Deputy Commissioner for Policy.
than 2 business days before the meeting. [FR Doc. E7–20855 Filed 10–22–07; 8:45 am]
If FDA is unable to post the background BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND material on its Web site prior to the
HUMAN SERVICES meeting, the background material will
be made publicly available at the DEPARTMENT OF HEALTH AND
Food and Drug Administration location of the advisory committee HUMAN SERVICES
meeting, and the background material
Joint Meeting of the Nonprescription will be posted on FDA’s Web site after Food and Drug Administration
Drugs Advisory Committee and the the meeting. Background material is
Endocrinologic and Metabolic Drugs Vaccines and Related Biological
available at http://www.fda.gov/ohrms/
Advisory Committee; Notice of Meeting Products Advisory Committee; Notice
dockets/ac/acmenu.htm, click on the
of Meeting
AGENCY: Food and Drug Administration, year 2007 and scroll down to the
HHS. appropriate advisory committee link. AGENCY: Food and Drug Administration,
Procedure: Interested persons may HHS.
ACTION: Notice.
present data, information, or views, ACTION: Notice.
This notice announces a forthcoming orally or in writing, on issues pending
meeting of a public advisory committee before the committee. Written This notice announces a forthcoming
of the Food and Drug Administration submissions may be made to the contact meeting of a public advisory committee
(FDA). The meeting will be open to the person on or before November 29, 2007. of the Food and Drug Administration
public. Oral presentations from the public will (FDA). At least one portion of the
Name of Committees: be scheduled between approximately 1 meeting will be closed to the public.
Nonprescription Drugs Advisory p.m. and 2 p.m. Those desiring to make Name of Committee: Vaccines and
Committee and the Endocrinologic and formal oral presentations should notify Related Biological Products Advisory
Metabolic Drugs Advisory Committee. the contact person and submit a brief Committee.
General Function of the Committees: statement of the general nature of the General Function of the Committee:
To provide advice and evidence or arguments they wish to To provide advice and
recommendations to the agency on present, the names and addresses of recommendations to the agency on
FDA’s regulatory issues. proposed participants, and an FDA’s regulatory issues.
Date and Time: The meeting will be indication of the approximate time Date and Time: The meeting will be
held on December 13, 2007, from 8 a.m. requested to make their presentation on held by teleconference on November 14,
to 5 p.m. or before November 15, 2007. Time 2007, from 1 p.m. to approximately 4:30
Location: Hilton Washington DC/ allotted for each presentation may be p.m.
rfrederick on PROD1PC67 with NOTICES

Silver Spring, The Ballrooms, 8727 limited. If the number of registrants Location: National Institutes of
Colesville Rd., Silver Spring, MD. The requesting to speak is greater than can Health, Building 29B, Conference
hotel telephone number is 301–589– be reasonably accommodated during the Rooms A/B, Bethesda, MD. This
5200. scheduled open public hearing session, meeting will be held by teleconference.
Contact Person: Diem-Kieu Ngo, FDA may conduct a lottery to determine The public is welcome to attend the
Center for Drug Evaluation and Research the speakers for the scheduled open meeting at the specified location where

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