[Federal Register: August 16, 2007 (Volume 72, Number 158)]
[Notices]
[Page 46091-46092]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au07-101]
[[Page 46091]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007P-0074]
Joint Meeting of the Nonprescription Drugs Advisory Committee and
the Pediatric Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 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 October 18 and 19, 2007,
from 8 a.m. to 5 p.m.
Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Select ``2007P-0074--Final Monongraph
for Cough, Cold, Allergy, Brochodilator, Antiasthmatic Drug Products
for Over-the-Counter Human Use'' and follow the prompts to submit your
statement. Written comments should be submitted to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, by close of business on
August 28, 2007.
Location: The National Labor College, Lane Kirkland Center,
Solidarity Hall, 10000 New Hampshire Ave., Silver Spring, MD. The phone
number is 301-431-6400.
Contact Person: Darrell Lyons, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: darrell.lyons@fda.hhs.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), codes 3014512541 and 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.
Agenda: The committees will meet in joint session to discuss the
safety and efficacy of over-the-counter (OTC) cough and cold products
marketed for pediatric use. A citizen petition was submitted to FDA on
March 1, 2007, that raised concerns about the safety and efficacy of
cough and cold products in children under 6 years of age. The petition
requested among other things that FDA amend the OTC drug monograph for
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products
(CCABADP) in 21 CFR Part 341 to require that labeling for OTC
antitussive, expectorant, nasal decongestant, antihistamine, and
combination cough and cold products state that these products have not
been found to be safe or effective in children under 6 years of age for
the treatment of cough and cold, and that these products should not be
used for the treatment of cough and cold in children under 6 years of
age. In addition, the petitioner requested the agency to notify
manufacturers of these products whose labeling either uses such terms
as ``infant'' or ``baby'' or displays images of children under the age
of 6, that such marketing is not supported by scientific evidence and
that manufacturers will be subject to enforcement action at any time.
The petition and additional information can be found at the following
Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/dockets/07p0074/07p0074.htm.
The committee's discussion will focus on several areas of interest
which include: The extrapolation of efficacy data from adults to
children of any age for cough and cold products; the safety profile of
these products in children; the basis for dosing recommendations in the
CCABADP monograph and the use of extrapolation of pharmacokinetic data
to determine appropriate dosing in children; the basis of dosing
recommendations for various age intervals of less than 2 years, 2 to 5
years of age, and 6 to 11 years of age; the use of the products in
children less than 2 years of age; the potential for misuse,
unintentional overdose, and excessive dosing; the ability of parents or
caregivers to correctly dose and administer cough and cold products to
their children; and the potential labeling changes recommended by the
petitioner and the effects they will have on the use of these products
in children and the recommendations of health providers.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm; click on
the year 2007 and 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
October 3, 2007. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 3 p.m. on October 18, 2007. 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 September 25, 2007.
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 26, 2007.
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 Darrell Lyons 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
for procedures on public conduct during advisory committee
meetings.
[[Page 46092]]
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 9, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-16169 Filed 8-15-07; 8:45 am]
BILLING CODE 4160-01-S