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U.S. Department of Health and Human Services

Advisory Committees

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September 9, 2013: Pediatric Ethics Subcommittee Meeting Announcement

Center Date Time Location
OC Sept. 9, 2013
Sept. 10, 2013
8:00 a.m. - 5:30 p.m.
8:00 a.m. - 3:00 p.m.

Doubletree Hilton Hotel
8727 Colesville Rd.
Silver Spring, MD 20910 

Agenda

On Monday, September 9 and Tuesday September 10, 2013, the Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss ethical issues in pediatric product development, including medical counter measures, focusing on the concepts of minimal risk, disorder or condition, and exposure of pediatric subjects to risks under 21 CFR 50.54.

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 website prior to the meeting, the background material will be made publicly available at the location of the subcommittee meeting, and the background material will be posted on FDA's website 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 committee.  Written submissions may be made to the contact person on or before September 9, 2013.  Oral presentations from the public will be scheduled between approximately 2:00 p.m. and 3:00 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 August 30, 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 2, 2013.

Persons attending FDA's subcommittee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at this meeting 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, email walter.ellenberg@fda.hhs.gov, 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.

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

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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).