[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Pages 12972-12973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-5284]



Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Joint Meeting of the Nonprescription Drugs Advisory Committee and 
the Pediatric Advisory Committee; 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.

[[Page 12973]]

    Name of Committees: Nonprescription Drugs Advisory Committee and 
the Pediatric Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 17, 2011, from 8 
a.m. to 5 p.m. and on May 18, 2011, from 8 a.m. to 12 noon.

ADDRESSES: FDA is opening a docket for public comment on this meeting. 
The docket number is FDA-2011-N-0002. The docket will open for public 
comment on March 9, 2011. The docket will close on June 30, 2011. 
Interested persons may submit electronic or written comments regarding 
this meeting. Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management, Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
All comments received will be posted without change, including any 
personal information provided. Submit a single copy of electronic 
comments or a paper copy of any mailed comments, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in brackets in the heading of this meeting 
notice. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday. Comments 
received on or before May 3, 2011, will be provided to the committee 
before the meeting.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
    Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, e-
mail: diem.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow 
the prompts to the desired center or product 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 hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On May 17 and 18, 2011, the committees will review 
pertinent pharmacokinetic (how drugs are absorbed, distributed, used, 
and eliminated by the body), safety and efficacy data, and discuss 
whether new dosing information for oral over-the-counter (OTC) drug 
products containing acetaminophen should be added to the label for 
children less than 2 years of age. In addition, the committees will 
consider adding a weight-based dosing regimen to the existing age-based 
dosing regimen for children 2 to 12 years of age. Dosing for children 
12 years of age and older will not be discussed. Lastly, the committees 
will discuss ways that administration by caregivers can be improved so 
that medication errors can be minimized.
    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. 
All electronic and written submissions submitted to the Docket (see the 
ADDRESSES section of this document) on or before May 3, 2011, will be 
provided to the committees. Oral presentations from the public will be 
scheduled between approximately 3 p.m. and 5 p.m. on May 17, 2011. 
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 
April 25, 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 26, 2011.
    FDA will work with sponsors of acetaminophen products who wish to 
make presentations to ensure that adequate time, separate from the 3 
p.m. to 5 p.m. time slots for the general open public hearing, is 
provided. Sponsors interested in making formal presentations to the 
committees should notify the contact person on or before April 25, 
2011. Sponsors with common interest are urged to coordinate their oral 
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
    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 Diem-Kieu Ngo 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: March 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5284 Filed 3-8-11; 8:45 am]