[Federal Register: June 5, 2008 (Volume 73, Number 109)]
[Page 32030-32031]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


[[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: Diem.Ngo@fda.hhs.gov, 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 
    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, 
    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/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
    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]