[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Pages 38351-38352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15239]



Food and Drug Administration

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

Blood Products Advisory Committee; 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). 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 August 2, 2013, from 10 
a.m. to approximately 1:30 p.m.
    Location: National Institutes of Health, Building 29, Conference 
Room A/B, 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.
    Contact Person: Bryan Emery or Pearline Muckelvene, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, HFM-71, Rockville, MD 20852, 301-827-0314, email: 
Bryan.Emery@fda.hhs.gov or Pearline.Muckelvene@fda.hhs.gov 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 
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 August 2, 2013, the Committee will meet in open session 
to hear updates on the research programs of the Laboratory of Molecular 
Virology, 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

[[Page 38352]]

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 August 2, 2013, from 10 a.m. to approximately 1 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 July 26, 2013. Oral presentations from the public will be 
scheduled between approximately 12 noon and 1 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 18, 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 July 19, 2013.
    Closed Committee Deliberations: On August 2, 2013, from 
approximately 1 p.m. to 1:30 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 decisions.
    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 Bryan Emery or Pearl 
Muckelvene 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: June 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-15239 Filed 6-25-13; 8:45 am]