[Federal Register: June 6, 2007 (Volume 72, Number 108)]
[Notices]
[Page 31332-31333]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jn07-100]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0215]
Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 Committees: Endocrinologic and Metabolic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 30, 2007, from 8
a.m. to 5 p.m.
Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Select ``2007N-0215--Thiazolidinedione''
and follow the prompts to submit your statement. Written comments
should be submitted to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, by close of business on July 23, 2007. All comments will be
posted without change, including any personal information provided.
Comments received on or before July 23, 2007, will be provided to the
committee before the meeting.
Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel telephone number is 301-948-8900.
Contact Person: Cathy A. Miller, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1099), Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: Cathy.Miller1@fda.hhs.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), codes 3014512536 and 3014512535. 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
[[Page 31333]]
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 Endocrinologic and Metabolic Drugs and the Drug Safety
and Risk Management Advisory Committees will meet in joint session to
discuss the cardiovascular ischemic/thrombotic risks of the
thiazolidinediones, with focus on rosiglitazone, as presented by FDA
and GlaxoSmithKline.
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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 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 July
6, 2007. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2:30 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 28, 2007. 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 29,
2007.
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 John Lauttman, 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: May 31, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-10850 Filed 6-5-07; 8:45 am]
BILLING CODE 4160-01-S