Document ID: FDA-2009-N-0664-0097
Agency: fda
Document Type: Notice
Title: Meetings: Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
Posted Date: 2009-10-06T04:00Z

[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]               
[Page 51292-51293]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc09-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Joint Meeting of the Cardiovascular and Renal 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: Cardiovascular and Renal 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 December 8, 2009, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD. The hotel telephone number is 301-977-8900.
    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: 301-827-6778, 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), codes 3014512533 or 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 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

[[Page 51293]]

line/phone line to learn about possible modifications before coming to 
the meeting.
    Agenda: On December 8, 2009, the committee will discuss safety 
considerations related to FDA-approved gadolinium-based contrast agents 
used with magnetic resonance imaging (MRI) scans. An MRI is a medical 
imaging technique that does not require x-rays. These scans outline the 
internal body structures such as organs and other soft tissues. 
Contrast agents are substances injected into the body before MRI scans, 
helping doctors to better see and interpret MRI findings. FDA approved 
gadolinium-based contrast agents include: gadobenate dimeglumine 
(MULTIHANCE), gadodiamide (OMNISCAN), gadopentetate dimeglumine 
(MAGNEVIST), gadoteridol (PROHANCE), gadoversetamide (OPTIMARK), 
gadoxetate disodium (EOVIST), and gadofosveset (ABLAVAR, previously 
known as VASOVIST).
    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://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. 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 
November 23, 2009. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 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 November 13, 2009. 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 November 
16, 2009.
    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 http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 1, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24014 Filed 10-5-09; 8:45 am]

BILLING CODE 4160-01-S