Document ID: FDA-2014-N-0001-0015
Agency: fda
Document Type: Notice
Title: Vaccines and Related Biological Products Advisory Committee; Notice
of Meeting
Posted Date: 2014-02-12T05:00Z

[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Notices]
[Pages 8463-8464]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02943]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Vaccines and Related Biological Products 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Vaccines and Related Biological Products 
Advisory Committee.
    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 March 20, 2014, from 
11:30 a.m. to approximately 3:20 p.m.
    Location: Rockwall II, Conference Room 1033, 5515 Security Lane, 
Rockville, MD 20852. The public is welcome to attend the meeting at the 
specified location where a speakerphone will be provided. Public 
participation in the meeting is limited to the use of the speakerphone 
in the conference room.
    Contact Person: Prabha Atreya or Denise Royster, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, 
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/AdvisoryCommittees/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: On March 20, 2014, the committee will meet in open session 
to hear updates of the research programs in the Laboratory of 
Respiratory and Special Pathogens, Division of Bacterial, Parasitic and 
Allergenic Products, and in the Laboratory of Hepatitis Viruses, 
Division of Viral Products, Center for Biologics Evaluation and 
Research, FDA.
    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/

[[Page 8464]]

default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On March 20, 2014, from 11:30 a.m. to approximately 2:10 
p.m., the meeting is open to the public. 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 March 13, 2014. Oral presentations from the public 
will be scheduled between approximately 1:10 p.m. and 2:10 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 
March 4, 2014. 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 March 5, 2014.
    Closed Committee Deliberations: On March 20, 2014, from 
approximately 2:10 p.m. to approximately 3:20 p.m., the meeting will be 
closed to permit discussion where disclosure would constitute a clearly 
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The 
committee will discuss the report of the intramural research programs 
and make recommendations regarding personnel staffing decisions.
    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 Prabha Atreya or 
Denise Royster 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: February 6, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-02943 Filed 2-11-14; 8:45 am]
BILLING CODE 4160-01-P