[Federal Register: October 15, 2007 (Volume 72, Number 198)]
[Notices]
[Page 58311-58312]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15oc07-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 Committee: Pediatric Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues. The committee
also advises and makes recommendations to the Secretary of Health and
Human Services under 45 CFR 46.407 on research involving children as
subjects that is conducted or supported by the Department of Health and
Human Services , when that research is also regulated by FDA.
Date and Time: The meeting will be held on Thursday, November 29,
2007, from 8 a.m. to 4 p.m.
Location: Hilton, Washington DC North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Carlos Pe[ntilde]a, Office of Science and Health
Coordination, Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08),
Rockville, MD 20857, 301-827-3340, e-mail:
Carlos.Pe[ntilde]a@fda.hhs.gov, or 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.
Agenda: The Pediatric Advisory Committee will hear and discuss
issues related to FDA's draft guidance for Industry entitled ``Clinical
Lactation Studies--Study Design, Data Analysis, and Recommendations for
Labeling,'' that published in the Federal Register of Tuesday, February
8, 2005 (70 FR 6697). As part of the review and consideration of public
comments received by FDA in response to this draft guidance, the
Pediatric Advisory Committee will hear and discuss information on:
Labeling of drugs for use by lactating women; breastfeeding physiology,
benefits, and current research; the physiology and pharmacology of drug
transfer into breast milk; and ethical issues related to studying
breastfeeding mother/infant pairs.
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 will be
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
November 5, 2007. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. 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 October 26, 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
[[Page 58312]]
the speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by October 29, 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 Dr. Carlos
Pe[ntilde]a 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 athttp://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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 8, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20304 Filed 10-12-07; 8:45 am]
BILLING CODE 4160-01-S