[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Pages 65000-65001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2012-N-0001]


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 Committee: Drug Safety and Risk Management 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 December 12, 2012, from 
8 a.m. to 5:30 p.m. and on December 13, 2012, from 8 a.m. to 3:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503), 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

[[Page 65001]]

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). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee link, or call the advisory committee information 
line to learn about possible modifications before coming to the 
meeting.
    Agenda: The Food and Drug Administration Amendments Act of 2007 
requires FDA to bring, at least annually, one or more drugs with Risk 
Evaluation and Mitigation Strategies (REMS) with Elements to Assure 
Safe Use (ETASU) before CDER's Drug Safety and Risk Management Advisory 
Committee (DSaRM). The Agency plans to present information on the risk 
management of teratogens, some of which have REMS with ETASU.
    On December 12, 2012, the committee will meet to discuss the 
various strategies used by the Agency to define and address teratogenic 
risk, including requiring REMS with ETASU. The discussion will include 
an evaluation of the different strategies and the decision framework 
for selecting risk management strategies for teratogens. The committee 
will discuss whether the risk management strategies, including REMS 
with ETASU, assure safe use, are not unduly burdensome to patient 
access to the drug, and to the extent practicable, minimize the burden 
to the health care delivery system.
    On December 13, 2012, the committee will discuss two common risk 
management tools used to minimize the risk of teratogens--contraception 
and pregnancy testing. The committee will discuss considerations for 
standardizing recommendations for use of these two tools.
    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 28, 2012. Oral presentations from the public will be scheduled 
between approximately 1:40 p.m. to 2:10 p.m. on December 12, 2012, and 
between approximately 12:45 p.m. to 1:15 p.m. on December 13, 2012. 
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 
November 19, 2012. 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 20, 
2012.
    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: October 16, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-26162 Filed 10-23-12; 8:45 am]
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