[Federal Register Volume 84, Number 191 (Wednesday, October 2, 2019)]
[Notices]
[Pages 52513-52514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0573]


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. The committee 
will discuss scientific considerations for cold stored platelet 
products intended for transfusion. The meeting will be open to the 
public.

DATES: The meeting will be held on November 22, 2019, from 8:30 a.m. to 
4:45 p.m.

ADDRESSES: Tommy Douglas Conference Center, 10000 New Hampshire Ave., 
Silver Spring, MD 20993. Answers to commonly asked questions about FDA 
advisory committee meetings, including information regarding special 
accommodations due to a disability, may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. 
Information about the Tommy Douglas Conference Center may be accessed 
at: https://www.tommydouglascenter.com/.
    For those unable to attend in person, the meeting will also be 
webcast; please see the following link for webcast and other meeting 
information: https://www.fda.gov/advisory-committees/blood-products-advisory-committee/2019-meeting-materials-blood-products-advisory-committee.

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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On November 22, 2019, the BPAC will meet in open session to 
discuss scientific considerations for cold stored platelet products 
intended for transfusion, including product characterization, duration 
of storage and clinical indications for use. The committee will hear 
presentations on available characterization and

[[Page 52514]]

functional studies of cold stored platelets, clinical studies, and the 
potential role of cold stored platelets in clinical care in military 
and civilian patient populations. The committee will also discuss the 
clinical studies needed to support the indications for use of cold 
stored platelet products stored beyond 3 days.
    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. For those unable to attend in person, the meeting will also be 
webcast; please see the following link for webcast and other meeting 
information: https://www.fda.gov/advisory-committees/blood-products-advisory-committee/2019-meeting-materials-blood-products-advisory-committee.
    Procedure: On November 22, 2019, from 8:30 a.m. to 4:45 p.m., the 
meeting is open to the public. 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 13, 2019. Oral presentations from the public will be 
scheduled between approximately 2:35 p.m. and 3:35 p.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 4, 2019. 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 5, 
2019.
    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: September 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21399 Filed 10-1-19; 8:45 am]
BILLING CODE 4164-01-P


