Daily Rules, Proposed Rules, and Notices of the Federal Government


Food and Drug Administration

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

Risk Communication Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.
ACTION: 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 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 theFederal Registerabout 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 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 ( To assist the private sector in meeting the year 2006 goal, FDA published a guidance on producing "Useful Written Consumer Medication Information (CMI)" (

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:

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, 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 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.