[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Page 9066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03476]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0008]


Device Good Manufacturing Practice 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 Device Good 
Manufacturing Practice Advisory Committee. The committee reviews 
regulations proposed for promulgation regarding good manufacturing 
practices governing the methods used in, and the facilities and 
controls used for, the manufacture, packing, storage, and installation 
of devices, and makes recommendations to the Commissioner of Food and 
Drugs regarding the feasibility and reasonableness of those proposed 
regulations. The meeting will be open to the public.

DATES: The meeting will take place virtually on March 2, 2022, from 9 
a.m. to 6 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19 
pandemic, all meeting participants will be joining this advisory 
committee meeting via an online teleconferencing platform. Answers to 
commonly asked questions including information regarding special 
accommodations due to a disability may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.

FOR FURTHER INFORMATION CONTACT: Jarrod Collier, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 
<a href="/cdn-cgi/l/email-protection#074d66757568632944686b6b6e627547616366296f6f7429606871"><span class="__cf_email__" data-cfemail="aae0cbd8d8c5ce84e9c5c6c6c3cfd8eacccecb84c2c2d984cdc5dc">[email protected]</span></a>, 240-672-5763, 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 the 
meeting. The meeting will be webcast and will be available at the 
following links: YouTube (primary): https://youtu.be/SPrNfVb2Yv8 and 
TEAMS (captions): https://teams.microsoft.com/. Please log on 20 
minutes before the webcast to test your signal. You may have to refresh 
your browser before logging on.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. As required 
by section 520(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 360j(f)(1)(B)), on March 2, 2022, the committee 
will discuss and make recommendations on the current good manufacturing 
practice requirements for medical devices under 21 CFR part 820, the 
Quality System Regulation, to align more closely with an international 
consensus standard for medical devices used by other regulatory 
authorities.
    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 on FDA's website at 
the time of the advisory committee meeting, and the background material 
will be posted on FDA's website after the meeting. Background material 
and the link to the online teleconference meeting room will be 
available at https://www.fda.gov/advisory-committees/medical-devices/device-good-manufacturing-practice-advisory-committee. Select the link 
for the 2022 Meeting Materials. The meeting will include slide 
presentations with audio components to allow the presentation of 
materials in a manner that most closely resembles an in-person advisory 
committee meeting.
    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 
February 24, 2022. Oral presentations from the public will be scheduled 
on March 2, 2022, between approximately 1:30 p.m. to 2:30 p.m. Eastern 
Time. Those individuals interested in making formal oral presentations 
should notify the contact person (see FOR FURTHER INFORMATION CONTACT). 
The notification should include 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 
February 21, 2022. 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 February 22, 
2022.
    For press inquiries, please contact the Office of Media Affairs at 
<a href="/cdn-cgi/l/email-protection#7a1c1e1b15171b3a1c1e1b54121209541d150c"><span class="__cf_email__" data-cfemail="e6808287898b87a6808287c88e8e95c8818990">[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 AnnMarie Williams at <a href="/cdn-cgi/l/email-protection#e1a08f8fac80938884cfb6888d8d88808c92a1878580cf898992cf868e97"><span class="__cf_email__" data-cfemail="85c4ebebc8e4f7ece0abd2ece9e9ece4e8f6c5e3e1e4abededf6abe2eaf3">[email protected]</span></a> or 301-796-
5966 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: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03476 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P


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