June 8, 2015: Risk Communication Advisory Committee Meeting Announcement
|OC||June 8, 2015||9:00 a.m. - 5:00 p.m.||
Food and Drug Administration
On June 8 and 9, 2015, the FDA Risk Communication Advisory Committee will discuss approaches to communicating information about fetal effects in product labeling for methadone or buprenorphine maintenance therapy for opioid addiction, and about the maternal benefits and risks of treatment, to best enable patients and healthcare providers to make informed decisions about the use of these drugs during pregnancy.
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 on the RCAC meeting materials page.
Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at "Public Meetings on the FDA White Oak Campus" on the FDA website. Please note that visitors to the White Oak Campus must enter through Building 1.
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 meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Public Participation Information
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 June 1, 2015.
- Oral presentations from the public will be scheduled between approximately 2 p.m. and 3:30 p.m. on June 8, 2015
- Those individuals 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 May 22, 2015. 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 26, 2015.
Interested persons can also log on to https://collaboration.fda.gov/rcac/ to hear and see the proceedings.
Luis G. Bravo, Designated Federal Official
10903 New Hampshire Ave., Building 32, Room 3367
Silver Spring, Maryland 20993
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.
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 Luis G. Bravo 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). Official FR Notice