[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50885-50886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-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. The general function of the committee is to provide 
advice and recommendations to the Agency on FDA's regulatory issues. 
Members will participate via teleconference. At least one portion of 
the meeting will be closed to the public.

DATES: The meeting will be held on November 4, 2021, from 9:30 a.m. to 
5:20 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all meeting participants will be joining this advisory committee 
meeting via an online teleconferencing platform. The online web 
conference meeting will be available at the following link on the day 
of the meeting: https://youtu.be/2Xz4YzkwNDs.

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, <a href="/cdn-cgi/l/email-protection#63200b110a10170a0d024d35061117230507024d0b0b104d040c15"><span class="__cf_email__" data-cfemail="71321903180205181f105f27140305311715105f1919025f161e07">[email protected]</span></a>, or 
240-402-8106, <a href="/cdn-cgi/l/email-protection#a0eacfc1cecec58eecc9d0cbc9cec4e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="cc86a3ada2a2a9e280a5bca7a5a2a88caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a>, 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: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On November 
4, 2021, for Topic I, the committee will meet in open session to hear 
an overview of the research programs of the Plasma Derivatives Branch, 
Division of Plasma Protein Therapeutics, Office of Tissues and Advanced 
Therapies, Center for Biologics Evaluation and Research (CBER). For 
Topic II, the committee will meet in open session to hear an overview 
of the research programs of the Laboratory of Cellular Hematology, 
Division of Blood Components and Devices, Office of Blood Research and 
Review (OBRR), CBER. For Topic III, the committee will meet in open 
session to hear an overview of the research programs of the Laboratory 
of Emerging Pathogens, Division of Emerging & Transfusion Transmitted 
Diseases, OBRR, CBER. After the open sessions, the meeting will be 
closed to the public for committee deliberations.
    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

[[Page 50886]]

available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On November 4, 2021, the meeting is open to the public, 
from 9:30 a.m. to 11:30 a.m. for Topic I; 12:50 p.m. to 2:10 p.m. for 
Topic II; and 3:10 p.m. to 4:30 p.m. for Topic III. Interested persons 
may present data, information, or views, orally or in writing, on 
issues pending before the committee. Written submissions may be 
submitted to the contact person on or before October 28, 2021. Oral 
presentations from the public will be scheduled between approximately 
11:10 a.m. and 11:30 a.m. for Topic I; 1:50 p.m. and 2:10 p.m. for 
Topic II; and 4:10 p.m. and 4:30 p.m. for Topic III. 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 October 20, 2021. 
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 October 21, 2021.
    Closed Committee Deliberations: On November 4, 2021, from 11:30 
a.m. to 12:20 p.m. for Topic I; 2:10 p.m. to 3 p.m. for Topic II; and 
4:30 p.m. to 5:20 p.m. for Topic III, 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 
recommendations of the advisory committee regarding the progress of the 
individual investigator's research programs along with other 
information, will be discussed during this session. We believe that 
public discussion of these recommendations on individual scientists 
would constitute an unwarranted invasion of personal privacy.
    For press inquiries, please contact the Office of Media Affairs at 
<a href="/cdn-cgi/l/email-protection#a7c1c3c6c8cac6e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="325456535d5f53725456531c5a5a411c555d44">[email protected]</span></a> or 301-796-4540.
    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 (<a href="/cdn-cgi/l/email-protection#4406140507042220256a2c2c376a232b32"><span class="__cf_email__" data-cfemail="5d1f0d1c1e1d3b393c7335352e733a322b">[email protected]</span></a>) 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings 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 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19686 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P


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