[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Notices]
[Pages 12062-12063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4669]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Cardiovascular and Renal Drugs 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Cardiovascular and Renal Drugs 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 March 27, 2012, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, Building 31 Conference Center, the
Great Room (rm. 1503), 10903 New Hampshire Ave., Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
Contact Person: Kristina Toliver, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, email: [email protected], or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and
follow the prompts to the desired center or product area. 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 line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On March 27, 2012, the committee will begin with a closed
session from 8 a.m. to 10:45 a.m. Following the closed session, from 11
a.m. to 5 p.m., the meeting will be open to the public. The committee
will discuss biologics license application 125410, proposed tradename
REPLAGAL (agalsidase alfa), submitted by Shire Human Genetics
Therapies, for an enzyme replacement therapy for patients with Fabry
disease.
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: On March 27, 2012, from 11 a.m. to 5 p.m., the meeting
is open to the public. 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 March 13, 2012. Oral presentations from the public will be
scheduled between approximately 2:10 p.m. and 3:10 p.m. Those
individuals interested in making 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
March 5, 2012. Time allotted
[[Page 12063]]
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 March 6, 2012.
Closed Presentation of Data: On March 27, 2012, from 8 a.m. to
10:45 a.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential information (5 U.S.C. 552b(c) (4)).
During this session, the committee will discuss confidential
manufacturing information.
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 Kristina Toliver 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: February 23, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-4669 Filed 2-27-12; 8:45 am]
BILLING CODE 4160-01-P