
[Federal Register: December 8, 2008 (Volume 73, Number 236)]
[Notices]               
[Page 74505-74506]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de08-59]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
Risk Communication 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 Communication 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 February 26, 2009, from 
8 a.m. to 5 p.m. and February 27, 2009, from 8 a.m. to 2 p.m.
    Addresses: Submit electronic comments and information to http://
www.regulations.gov. Comments are to be identified with the docket 
number found in brackets in the heading of this document. Written 
comments should be submitted to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, by close of business on March 31, 2009. All 
comments received will be posted without change, including any personal 
information provided. Comments received on or before February 12, 2009, 
will be provided to the committee before or at the meeting; comments 
received after that time will still be considered by FDA.
    Location: National Transportation Safety Board (NTSB) Conference 
Center, 429 L'Enfant Plaza SW., Washington, DC 20594 (at Metro's 
L'Enfant Plaza station; parking is limited and public transportation is 
recommended.)
    Contact Person: Lee L. Zwanziger, Office of the Commissioner, 
Office of Policy, Planning and Preparedness, Office of Planning (HFP-
60), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery: rm. 15-22), Rockville, MD, 20857, 301-827-2895, FAX: 301-827-
3285, Food and Drug Administration, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 8732112560. Please call the Information Line for up-to-date 
information on this meeting. A notice in the Federal Register about 
last minute modifications

[[Page 74506]]

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 February 26 and 27, 2009, there will be a discussion of 
different types of prescription drug information currently available to 
patients in the form of Medication Guides, Patient Package Inserts 
(PPIs), and Consumer Medication Information (CMI).
    CMI is information developed by the private sector and distributed 
with each prescription at the pharmacy, as provided by law. On August 
6, 1996, Public Law 104-180 was enacted and adopted the following goals 
with regard to CMI: 75 percent of people receiving new prescriptions 
would receive ``useful'' written patient information with their 
prescriptions by 2000, and 95 percent of people receiving new 
prescriptions would receive ``useful'' written patient information with 
their prescriptions by 2006. The committee will review and discuss a 
recently completed survey designed to assess whether the year 2006 goal 
was achieved (for results, see committee background, to be posted as 
described in this document). The committee will also discuss possible 
next steps for assuring that consumers receive useful written 
information with their prescriptions.
    The survey is a followup to the year 2001 evaluation of the quality 
of consumer medication information dispensed in community pharmacies 
(http://www.fda.gov/cder/reports/prescriptionInfo/default.htm). To 
assist the private sector in meeting the year 2006 goal, FDA published 
a guidance on producing ``Useful Written Consumer Medication 
Information (CMI)'' (http://www.fda.gov/cder/guidance/7139fnl.htm).
    In 1998, FDA published a final rule that required the development 
of a Medication Guide for a small number of drugs that the agency 
considered posed a serious and significant health concern (63 FR 66378, 
December 1, 1998). A Medication Guide is produced by the drug sponsor, 
reviewed and approved by FDA and is a component of the approved 
professional product labeling. An FDA public meeting was held in June 
2007 to obtain feedback on the development, distribution, 
comprehensibility and accessibility of Medication Guides. At that 
meeting, stakeholders voiced a concern that for prescription drugs with 
both a Medication Guide and CMI, patients would be getting 
unnecessarily duplicative information (meeting summary: http://
www.fda.gov/cder/meeting/SummaryPublicHearingMedicationGuides.htm).
    Finally, PPIs are also required for some drugs and are considered 
part of the approved product labeling, for example, for estrogens and 
oral contraceptives.
    FDA will seek the advice of the advisory committee, and commentary 
from stakeholders and from the public, for consideration as it 
considers appropriate next steps to improve the communication of 
information about prescription drugs to patients.
    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 or 
will be available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, 
click on the year 2009 and 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 
February 19, 2009. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 3 p.m. on February 26 and between 
approximately 10:30 a.m. and 11:30 a.m. on February 27. Those 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 February 19, 2009. 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 February 20, 2009.
    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 Lee L. Zwanziger 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/oc/advisory/
default.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: November 26, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-28887 Filed 12-5-08; 8:45 am]

BILLING CODE 4160-01-S
