[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58315-58316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology; 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: 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 October 31, 2013, from 8 
a.m. to 5 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White 
Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., 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: Kalyani Bhatt, 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, email: [email protected], or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCcommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: There will be two topics presented to the committee for 
their discussion and consideration. During the first session, the 
Office of New Drug Quality Assessment will lead a discussion on the 
challenges and opportunities of continuous manufacturing for 
pharmaceutical products. Speakers from the Agency, academia, and 
industry will provide their thoughts on scientific and regulatory 
challenges for implementing continuous processes for drug substance and 
drug product manufacturing.
    During the second session, the committee will receive an 
informational only update from the Office of Generic Drugs on what 
Agency actions/changes have taken place following previous discussions 
with the committee pertaining to quality and bioequivalence concerns 
for narrow therapeutic index drug products. This will be an awareness 
topic and there will not be formal committee discussion or 
recommendation.
    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

[[Page 58316]]

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 meeting 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 16, 2013. Oral presentations from the public will be scheduled 
between approximately 10:45 a.m. to 11:45 a.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 October 7, 2013. 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 October 8, 2013.
    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 Kalyani Bhatt 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 
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: September 16, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-23022 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P