9066 Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices 

Dated: February 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03430 Filed 2–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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-advisorycommittees/common-questions-andanswers-about-fda-advisory-committeemeetings. 

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, Jarrod.Collier@

fda.hhs.gov, 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-practiceadvisory-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 fdaoma@

fda.hhs.gov 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 AnnMarie.Williams@

fda.hhs.gov 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/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-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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