[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52668-52669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Vaccines and Related Biological Products Advisory Committee; 
Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Vaccines and Related Biological 
Products Advisory Committee. This meeting was announced in the Federal 
Register of July 22, 2011 (76 FR 44016). The amendment is being made to 
reflect a change in the Date and Time, Location, Agenda, Procedure, and 
Closed Committee Deliberations portions of the document. There are no 
other changes.

FOR FURTHER INFORMATION CONTACT: Donald W. Jehn 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), and follow the prompts to the desired 
center or product area. Please call the Information Line for up-to-date 
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 22, 2011, 
FDA announced that a meeting of the Vaccines and Related Biological 
Products Advisory Committee would be held on September 20, 2011. On 
page 44016, in the 2nd and 3rd column and on page 44017, in the 1st 
column, the Date and Time, Location, Agenda, Procedure, and Closed 
Committee Deliberations portions of the document are changed to read as 
follows:

[[Page 52669]]

    Date and Time: The meeting will be held on September 20, 2011, from 
1 p.m. to approximately 4 p.m.
    Location: National Institutes of Health (NIH), 9000 Rockville Pike, 
Building 29B, Conference Room C, Bethesda, MD 20892. 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. 
Important information about transportation and directions to the NIH 
campus, parking, and security procedures is available on the Internet 
at http://www.nih.gov/about/visitor/index.htm. (FDA has verified the 
Web site address, but FDA is not responsible for any subsequent changes 
to the Web site after this document publishes in the Federal Register.) 
Visitors must show two forms of identification, one of which must be a 
government-issued photo identification such as a Federal employee 
badge, driver's license, passport, green card, etc. Detailed 
information about security procedures is located at http://www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking 
visitors are encouraged to use public transportation.
    Agenda: On September 20, 2011, the committee will meet in open 
session to hear updates of the research programs in the Laboratory of 
Enteric and Sexually Transmitted Diseases, Division of Bacterial, 
Parasitic, and Allergenic Products, Office of Vaccines Research and 
Review, Center for Biologics Evaluation and Research, FDA.
    Procedure: On September 20, 2011, from 1 p.m. to approximately 3:30 
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 September 13, 2011. Oral presentations from the 
public will be scheduled between approximately 2:30 p.m. and 3:30 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 
September 9, 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 September 10, 
2011.
    Closed Committee Deliberations: On September 20, 2011, from 
approximately 3:30 p.m. to approximately 4 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.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: August 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-21535 Filed 8-22-11; 8:45 am]
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