[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63131-63132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1617]
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). The meeting will
be open 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 December 2, 2014, from
8:30 a.m. to 4:30 p.m. and December 3, 2014, from 8:30 a.m. to 12:30
p.m.
ADDRESSES: FDA is opening a docket for person interested in presenting
data, information, or views, orally or in writing, on issues pending
before the committee. The docket number is FDA-2014-N-1617. Please see
the procedure section of the notice for further information.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
For those unable to attend in person, the meeting will also be Web
cast. The Web cast will be available at the following links:
December 2, 2014, Blood Products Advisory Committee Web link:
https://collaboration.fda.gov/bpac1214/
December 3, 2014, Blood Products Advisory Committee Web link:
https://collaboration.fda.gov/bpacdecember3/
Contact Person: Bryan Emery or Joanne Lipkind, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, Bldg. 71, Rm. 6132, 240-402-
8054 or 240-402-8106, 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 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
Advisory Committee on Blood and Tissue Safety and Availability where
the MSM blood donor deferral policy will be discussed. 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).
On December 3, 2014, the Blood Products Advisory Committee will be
seated as a device classification panel. In open session, the panel
will discuss
[[Page 63132]]
the appropriate device classification of 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.
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: 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
November 25, 2014. On December 2, 2014, oral presentations from the
public will be scheduled between approximately 1 p.m. to 2 p.m. On
December 3, 2014, oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.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 November 18, 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 November 19, 2014.
FDA has opened a docket for the public who are interested in
presenting data, information, or views, orally or in writing, on issues
pending before the committee. The docket number is FDA-2014-N-1617. The
docket will close November 25, 2014. Interested persons are encouraged
to use the docket to submit electronic or written comments regarding
this meeting. Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management, Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Comments are to be identified with the docket number found in
brackets in the heading of this document. Received comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday and will be posted to the docket at http://www.regulations.gov.
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 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: October 16, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-25067 Filed 10-21-14; 8:45 am]
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