[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Page 40735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-17271]



Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Joint Meeting of the Advisory Committee for Reproductive Health 
Drugs and the Drug Safety and Risk Management Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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: Advisory Committee for Reproductive Health 
Drugs 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 September 9, 2011, from 
8 a.m. to 4:30 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College (UMUC), The Ballroom, 3501 University 
Boulevard East, Adelphi, MD. The conference center telephone number is: 
301 985-7300.
    Contact Person: Kalyani Bhatt, 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, e-mail: [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 September 9, 2011, the committees will discuss the 
benefits and risks of long-term bisphosphonate use for the treatment 
and prevention of osteoporosis (thinning and weakening of bones that 
increases the chance of having a broken bone) in light of the emergence 
of the safety concerns of osteonecrosis of the jaw (jawbone death) and 
atypical femur fractures (unusual broken thigh bone) that may be 
associated with the long-term use of bisphosphonates. Bisphosphonates 
for the treatment and prevention of osteoporosis include: FOSAMAX 
(alendronate sodium) tablets and solution and FOSAMAX PLUS D 
(alendronate sodium/cholecalciferol) tablets, Merck & Co., Inc.; 
ACTONEL (risedronate sodium) tablets, ATELVIA (risedronate sodium) 
delayed release tablets, and ACTONEL WITH CALCIUM (Copackaged) 
(risedronate sodium with calcium carbonate) tablets, Warner Chilcott, 
LLC; BONIVA (ibandronate sodium) tablets and injection, Roche 
Therapeutics, Inc.; RECLAST (zoledronic acid) injection, Novartis 
Pharmaceuticals Corp.; and the generic equivalents for these products, 
if any.
    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 
August 25, 2011. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 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 August 17, 2011. 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 August 18, 2011.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
    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 Kalyani Bhatt 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: June 27, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-17271 Filed 7-8-11; 8:45 am]