[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24261-24262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10024]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Risk Communications 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: Risk Communications 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 June 8, 2015, from 9
a.m. to 5 p.m. and June 9, 2015, from 9 a.m. to 12 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503) Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Luis G. Bravo, Office of Planning, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3367, 240-402-
5274, FAX: 301-847-3540, [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.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.
If you are unable to join us in person, we encourage you to watch
the free Webcast. Visit the Risk Communication Advisory Committee Web
site at http://www.fda.gov/AdvisoryCommittees/RiskCommunicationAdvisoryCommittee.htm. The link will become active
shortly before the open session begins at 9 a.m.
Agenda: On June 8 and 9, 2015, the 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 health care 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
[[Page 24262]]
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/RiskCommunicationAdvisoryCommittee.htm. Scroll down to the appropriate
advisory committee meeting 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 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
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 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 May 26, 2015. Interested
persons can also log on to http://www.fda.gov/AdvisoryCommittees/RiskCommunicationAdvisoryCommittee.htm to see and hear the proceedings.
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.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: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10024 Filed 4-29-15; 8:45 am]
BILLING CODE 4164-01-P