2011-9149. Pediatric Ethics Subcommittee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Pediatric Advisory Committee on FDA and certain Department of Health and Human Services regulatory issues.

DATES:

The meeting will be held on Wednesday, May 11, 2011, from 8 a.m. to 3 p.m.

FDA is opening a docket to allow for additional public comments to be submitted to the Agency on the issues before the Pediatric Ethics Subcommittee. Submit either electronic or written comments by May 5, 2011.

ADDRESSES:

The meeting will be held at the North Marriott Hotel & Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852.

Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Contact Person: Walter Ellenberg, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154, Silver Spring, MD 20993-0002, 301-796-0885, or by e-mail: Walter.Ellenberg @fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 hotline/phone line to learn about possible modifications before coming to the meeting.

Agenda: On May 11, 2011, 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. The announcement of the May 16, 2011, Pediatric Advisory Committee meeting can be found elsewhere in this issue of the Federal Register.

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 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 http://www.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.

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 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).

Dated: April 11, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.