[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68280-68281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26969]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1617]
Blood Products Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of the meeting of the Blood Products Advisory
Committee. This meeting was announced in the Federal Register of
October 22, 2014. The amendment is being made to reflect a change in
the Agenda portion of the document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993,
240-402-8054 or 240-402-8129, 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 22, 2014
(79 FR 63131), FDA announced that a meeting of the Blood Products
Advisory Committee would be held on December 2 and 3, 2014. On page
63131, in the third column, the Agenda portion of the document is
changed to read as follows:
Agenda: On December 2, 2014, the Committee will meet in open
session to hear scientific data related to reconsideration of the
current blood donor deferral policy for men who have had sex with
another man (MSM) even one time since 1977. The Committee will be
presented with an update on the November 13, 2014, meeting of the U.S.
Department of Health and Human Services Advisory Committee on Blood and
Tissue Safety and Availability where the MSM blood donor deferral
policy will be discussed. In the afternoon, the Committee will hear an
informational presentation on Ebola virus, the potential implications
for blood safety in the United States and FDA's considerations on the
collection of convalescent plasma for investigational use.
On December 3, 2014, the Blood Products Advisory Committee will be
seated as a device classification panel. In open session, the panel
will discuss the appropriate device classification of
[[Page 68281]]
blood establishment computer software (BECS) and accessories to BECS.
Blood establishment computer software is currently subject to the
premarket notification (510(k)) provisions of the Federal Food, Drug,
and Cosmetic Act. In the afternoon, an informational presentation will
be made regarding the emergence of chikungunya virus infections in the
Western Hemisphere and potential implications for blood transfusion
safety. The Committee will also hear an informational presentation on
the first survey of the Rapid Donor Surveillance (RapidDOS) project on
Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV)
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: November 10, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-26969 Filed 11-13-14; 8:45 am]
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