[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Pages 38668-38669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16576]



Food and Drug Administration

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

Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology; 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.
    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 on July 26, 2011, from 8 
a.m. to 5:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You'', click on ``Public Meetings at the FDA White Oak 
Campus''. Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Yvette Waples, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, e-mail: [email protected], 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 July 26, 2011, the committee will discuss presentations 
by the Office of Generic Drugs (OGD) on bioequivalence issues and 
quality standards relative to narrow therapeutic index (NTI) drug 
products as a class. In response to feedback during the April 13, 2010, 
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology 
(ACPS-CP) meeting, the committee will further discuss the definition 
and list of NTI drugs, as well as proposed bioequivalence standards for 
these products. The committee will also receive awareness presentations 
relevant to OGD's ongoing focus on quality and safety of generic drug 
products. Presentations will outline current activities seeking to 
better understand the impact of formulation and quality on the 
performance of generic drug products and current thinking related to 
potential regulatory pathways for these issues.
    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. 
Written submissions may be made to the contact person on or before July 
19, 2011. Oral presentations from the public will be scheduled between 
approximately 11 a.m. to 12 noon, and 4:30 p.m. to 5 p.m. 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 July 
12, 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 July 13, 2011.
    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 Yvette Waples 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 

[[Page 38669]]

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: June 27, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-16576 Filed 6-30-11; 8:45 am]