[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63131-63132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25067]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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]
BILLING CODE 4164-01-P