[Federal Register Volume 73, Number 109 (Thursday, June 5, 2008)]
[Notices]
[Pages 32030-32031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12647]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 32031]]
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: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held July 22 and 23, 2008, from
8:30 a.m. to 5 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers
Lane, Rockville, MD.
Contact Person: Diem-Kieu Ngo, 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: [email protected], or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in
the Washington, DC area), code 3014512539. 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 July 22, 2008, the committee will do the following: (1)
Receive presentations from the Office of Pharmaceutical Science (OPS)
and discuss current thinking on issues pertaining to the use of
nanotechnology in drug manufacturing, drug delivery, or drug products,
and (2) receive an update from OPS, discuss, and make comments on
current strategies and directions for the testing of lead in
pharmaceutical products.
On July 23, 2008, the committee will do the following: (1) Receive
and discuss presentations from the Office of Generic Drugs (OGD) on the
bioequivalence methods for locally acting drugs that treat
gastrointestinal (GI) conditions, (2) receive and discuss presentations
from OGD on the use of inhaled corticosteroid dose-response as a means
to establish bioequivalence of inhalation drug products, and (3)
receive and discuss presentations from OPS on the drug classification
of orally disintegrating tablets (ODT) as a separate dosage form, and
the need for subsequent guidance on expectations and recommendations
that would be required for applications proposing the dosage form.
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 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 July
8, 2008. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. each day. 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 June 30, 2008. 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 July 1,
2008.
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 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/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: May 27, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-12647 Filed 6-4-08; 8:45 am]
BILLING CODE 4160-01-S