[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8299-8300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]


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 or Agency) announces a 
forthcoming public advisory committee meeting of the Blood Products 
Advisory Committee (BPAC). The general function of the committee is to 
provide advice and recommendations to the Agency on FDA's regulatory 
issues related to blood and products derived from blood.

[[Page 8300]]

Matters considered at the meeting will include current strategies to 
reduce the risk of Zika virus (ZIKV) transmission by blood and blood 
components, an update on the Transfusion Transmissible Infections 
Monitoring System (TTIMS), and testing blood donations for hepatitis B 
surface antigen. The meeting will be open to the public.

DATES: The meeting will be held on April 2, 2020, from 8:30 a.m. to 
3:45 p.m. and April 3, 2020, from 8:30 a.m. to 12:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Entrance for the public meeting participants (non-FDA employees) 
is through Building 1 where routine security check procedures will be 
performed. For security information, please refer to https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus. Answers to commonly asked questions including 
information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    For those unable to attend in person, the meeting will also be 
webcast and will be available at the following link: https://collaboration.fda.gov/bpacapril20/.

FOR FURTHER INFORMATION CONTACT: Christina Vert or Joanne Lipkind, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver 
Spring, MD 20993-0002, 240-402-8054, christina.vert@fda.hhs.gov, or 
240-402-8106, joanne.lipkind@fda.hhs.gov, respectively, 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 website 
at https://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: https://collaboration.fda.gov/bpacapril20/.

SUPPLEMENTARY INFORMATION: 
    Agenda: On April 2, 2020, in the morning, the BPAC will meet in 
open session to discuss and make recommendations on strategies to 
reduce the risk of ZIKV transmission by blood and blood components. The 
committee will discuss whether universal testing of blood donations for 
ZIKV is an appropriate strategy considering the decline of ZIKV cases 
in the United States and worldwide. In the afternoon, the committee 
will meet in open session to hear an update on the TTIMS. Sponsored by 
the FDA, the National Institutes of Health National Heart, Lung and 
Blood Institute, and the Department of Health and Human Services Office 
of the Assistant Secretary for Health, TTIMS collects incidence, 
prevalence and risk factor data for certain transfusion-transmitted 
infections, including human immunodeficiency virus, in U.S. blood 
donations. On April 3, 2020, the committee will meet in open session to 
discuss and make recommendations on testing for hepatitis B surface 
antigen (HBsAg) in blood donations. The committee will discuss whether 
testing for HBsAg can be discontinued considering the sensitivity of 
hepatitis B virus nucleic acid testing and hepatitis B anti-core 
testing of blood donations in the United States.
    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 website 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 website after the meeting. Background material is 
available at https://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 25, 2020. On April 2, 2020, oral presentations from the public 
will be scheduled between approximately 10:50 a.m. to 11:20 a.m. and 
3:15 p.m. to 3:45 p.m. On April 3, 2020, oral presentations from the 
public will be scheduled between approximately 11 a.m. to 11:30 a.m. 
Those individuals interested in making 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 16, 2020. 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 March 17, 2020.
    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 Christina Vert (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at: https://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 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02873 Filed 2-12-20; 8:45 am]
BILLING CODE 4164-01-P


