82 FR 12229 - Blood Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 39 (March 1, 2017)

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Notices]
[Pages 12229-12230]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Blood Products Advisory 
Committee. The general function of the committee is to provide advice 
and recommendations to the Agency on FDA's regulatory issues. At least 
one portion of the meeting will be closed to the public.

DATES: The meeting will be held on April 4, 2017, from 8:30 a.m. to 
3:45 p.m. and on April 5, 2017, from 8:30 a.m. to 12 p.m.

ADDRESSES: The meeting will be held at Tommy Douglas Conference Center, 
10000 New Hampshire Ave., Silver Spring, MD 20903. The conference 
center's telephone number is 240-645-4000. Answers to commonly asked 
questions including information regarding special accommodations due to 
a disability, visitor parking, and transportation may be accessed at: 
http://www.tommydouglascenter.com.

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-
0002, 240-402-8054, 240-402-8106, [email protected], 
[email protected]; 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. For those unable to attend in person, the meeting will 
also be available via Webcast. The Webcast will be available at the 
following link for both days: April 4, 2017, 115th Meeting of the Blood 
Products Advisory Committee--Day 1 at: http://fda.yorkcast.com/webcast/Play/bb044b891a7b48ff82cc30b18ece526e1d; April 5, 2017, 115th Meeting 
of the Blood Products Advisory Committee--Day 2 at: http://fda.yorkcast.com/webcast/Play/b4068ead1c874966860584b421dcfd231d.

SUPPLEMENTARY INFORMATION:
    Agenda: On April 4, 2017, in open session, the Committee will 
discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the 
afternoon, in open session, the Committee will hear an update 
presentation on a summary of responses to Docket FDA-2016-N-1502: Blood 
Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency 
Virus Transmission by Blood and Blood Products.
    On April 5, 2017, in open session, the committee will hear overview 
presentations on the research programs in the Laboratory of Emerging 
Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, 
Office of Blood Research and Review, Center for Biologics Evaluation 
and Research, FDA. At the conclusion of the open session, the meeting 
will be closed to permit discussion where disclosure would constitute 
an unwarranted invasion of personal privacy in accordance with 5 U.S.C 
552b(c)(6). During the closed session, the Committee will discuss the 
research progress made by staff involved in the intramural research 
programs and make recommendations regarding their personnel actions and 
staffing decisions.
    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 
March 28, 2017. Oral presentations from the public will be scheduled 
between approximately 10:50 a.m. to 11:20 a.m. and will be scheduled 
between approximately 3:15 p.m. to 3:45 p.m. on April 4, 2017. Oral 
presentations from the public will be scheduled between approximately 
10:15 a.m. and 11:15 a.m. on April 5, 2017. 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 March 20, 2017. 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

[[Page 12230]]

speakers for the scheduled open public hearing session. The contact 
person will notify interested persons regarding their request to speak 
by March 21, 2017.
    Closed Committee Deliberations: On April 5, 2017, from 11:15 a.m. 
to 12:00 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 report of 
the intramural research program 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 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require 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: February 24, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-03944 Filed 2-28-17; 8:45 am]
BILLING CODE 4164-01-P