This PDF is the current document as it appeared on Public Inspection on 07/17/2013 at 08:45 am.
Food and Drug Administration, HHS.
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: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology.
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 September 25, 2013, from 8 a.m. to 5 p.m.
Location: Bethesda North Marriott Hotel and Conference Center, White Oak Room, 5701 Marinelli Rd., Bethesda, MD. The hotel phone number is 301-822-9200.
Contact Person: Yvette Waples, 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, email: ACPS-CP@fda.hhs.gov, 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 Start Printed Page 42967announced 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.
Agenda: On September 25, 2013, the committee will discuss optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information. FDA will seek input on: (1) Best practices in DDI communication through prescription drug product labels (i.e., “package inserts”), namely: (a) Appropriate format for presentation (e.g. tables, graphs, text) of DDI information; (b) level of detail of DDI study results; and (c) appropriate wording for clinical recommendations based on empirical data versus anticipated interactions; (2) appropriate criteria for determining whether or not to describe DDI information derived from the literature in product labels; and (3) how package insert information on DDIs is used by various end-users (e.g., prescribers, dispensers, DDI database curators) in decision making and/or communication.
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 September 11, 2013. Oral presentations from the public will be scheduled between approximately 12:45 p.m. and 1:45 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 September 3, 2013. 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 September 4, 2013.
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 Yvette Waples 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).Start Signature
Dated: July 12, 2013.
Assistant Commissioner for Policy.
[FR Doc. 2013-17212 Filed 7-17-13; 8:45 am]
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