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U.S. Department of Health and Human Services

Advisory Committees

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May 11, 2011: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee Meeting Announcement

Center Date Time Location
OC May 11, 2011 8:00 a.m. - 3:00 p.m. North Marriott Hotel & Conference Center
5701 Marinelli Rd.
Bethesda, MD 20852
 

Agenda

The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the general topic of the ethics of administering subtherapeutic doses of investigational products to children for the purpose of determining, for example, drug metabolism, disposition, and targeting (e.g., exploratory investigational new drug (IND) studies). In this context, the subcommittee will also discuss the referral of such protocols by an Institutional Review Board for review by a Federal panel under 21 CFR 50.54.

The subcommittee's recommendations will then be presented to the FDA Pediatric Advisory Committee on Monday, May 16, 2011.

Meeting Materials

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.

Public Participation and Sponsor Information 

Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee.

  • Written submissions may be made to the contact person on or before April 28, 2011.
  • Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon on May 11, 2011.  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 April 20, 2011. 

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 April 21, 2011.

Comments

FDA is opening a docket to allow for additional public comments to be submitted to the Agency on issues before the Pediatric Ethics Subcommittee beginning April 15, 2011, and closing May 5, 2011.  All comments received on or before May 5, 2011, will be provided to the committee members.  All comments received after May 5, 2011, will be taken into consideration by the Agency.  Interested persons are encouraged to use the docket to submit either electronic or written comments regarding this meeting (see ADDRESSES). Submit electronic comments to Regulations.gov. Submit written comments  to Division of Dockets Management (see ADDRESSES).  It is necessary to submit only one set of comments.  It is no longer necessary to send two copies of mailed comments.  Identify comments with the docket number found in brackets in the heading of this document.  Received comments may be seen in the Division of Dockets management between 9 a.m. and 4 p.m. Monday through Friday.

Contact Information

Walter Ellenberg, Ph.D.
Office of Pediatric Therapeutics
Office of the Commissioner
Food and Drug Administration
Bldg. 32, Room 5154
10903 New Hampshire Ave.
Silver Spring, Maryland 20993-0002
Phone: 301–796-0885
Fax: 301-847-8640
E-mail: walter.ellenberg@fda.hhs.gov

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Code: 8732310001
    Please call the Information Line for up-to-date information on this meeting.

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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

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.

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 Walter Ellenberg at (301) 796-0885 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 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).