Document ID: FDA-2012-N-0001-0067
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee; Notice of Meeting
Posted Date: 2012-05-18T04:00Z

[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Page 29667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12164]

[[Page 29667]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Blood 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: Blood 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 June 12, 2012, from 12 
p.m. to 4:30 p.m.
    Location: National Institutes of Health (NIH), Bldg. 29, Conference 
Room 121, 9000 Rockville Pike, 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. 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.
    Contact Person: LCDR Bryan Emery or Rosanna Harvey, 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), to find out further information 
regarding FDA advisory committee information. 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 advisory committee information line, or 
visit our Web site at http://www.fda.gov/AdvisoryCommittees/default.htm 
to learn about possible modifications before coming to the meeting.
    Agenda: On June 12, 2012, the Committee will meet in open session 
to hear updates on the research programs of the Laboratory of Emerging 
Pathogens and the Laboratory of Bacterial and Transmissible Spongiform 
Encephalopathy Agents, Division of Emerging and Transfusion Transmitted 
Diseases, Office of Blood Research and Review, 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/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On June 12, 2012, from 12 p.m. to approximately 3:45 
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 June 1, 2012. 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 May 
24, 2012. 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 May 25, 2012.
    Closed Committee Deliberations: On June 12, 2012, from 
approximately 3:45 p.m. to 4:30 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 site visit report of the intramural research 
programs and make recommendations regarding personnel staffing 
decision.
    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 LCDR Bryan Emery or 
Rosanna Harvey 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: May 15, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-12164 Filed 5-17-12; 8:45 am]
BILLING CODE 4160-01-P