16216 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

The proposal informed Ms. Momin of 

the proposed debarment and offered her 

an opportunity to request a hearing, 

providing her 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Ms. 

Momin received the proposal and notice 

of opportunity for a hearing at her 

residence on November 26, 2021. Ms. 

Momin failed to request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

her opportunity for a hearing and 

waived any contentions concerning her 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Ms. Shiba I. 

Momin has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance. 

FDA finds that the offense should be 

accorded a debarment period of 5 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Ms. Momin is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

effective (see DATES). Pursuant to section 

301(cc) of the FD&C Act (21 U.S.C. 

331(cc)), the importing or offering for 

import into the United States of any 

drug or controlled substance by, with 

the assistance of, or at the direction of 

Ms. Momin is a prohibited act. 

Any application by Ms. Momin for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2021– 

N–0417 and sent to the Dockets 

Management Staff (see ADDRESSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20(j). 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: March 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06036 Filed 3–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0336] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC). The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. This meeting will be 

held to discuss considerations for use of 

COVID–19 vaccine booster doses and 

the process for COVID–19 vaccine strain 

selection to address current and 

emerging variants. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held 

virtually on April 6, 2022, from 8:30 

a.m. to 5 p.m. Eastern Time. Submit 

either electronic or written comments 

on this public meeting by April 5, 2022. 

Comments received on or before March 

31, 2022, will be provided to the 

committee. Comments received after 

March 31, 2022, and by April 5, 2022, 

will be taken into consideration by FDA. 

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. The 

online web conference meeting will be 

available at the following link on the 

day of the meeting: https://youtu.be/ 

x8rq247E80I. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0336. 

The docket will close on April 5, 2022. 

Submit either electronic or written 

comments on this public meeting by 

April 5, 2022. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

April 5, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Comments received on or before 

March 31, 2022, will be provided to the 

committee. Comments received March 

31, 2022, and by April 5, 2022, will be 

taken into consideration by FDA. In the 

event that the meeting is cancelled, FDA 

will continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–N–0336 for ‘‘Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC); Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 


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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 16217 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Eastern Time Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ FDA 

will review this copy, including the 

claimed confidential information, in its 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify the information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Prabhakara Atreya or Christina Vert, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Silver Spring, MD 

20993–0002, 240–506–4946, 

CBERVRBPAC@fda.hhs.gov; 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 

FDA’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: Consistent 

with FDA’s regulations, this notice is 

being published with less than 15 days 

prior to the date of the meeting based on 

a determination that convening a 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee as soon as possible is 

warranted. This notice could not be 

published 15 days prior to the date of 

the meeting due to the need for prompt 

discussion regarding considerations for 

use of COVID–19 vaccine booster doses 

and the process for COVID–19 vaccine 

strain selection to address current and 

emerging variants given the COVID–19 

pandemic. 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On April 6, 

2022, the committee will meet in open 

session to discuss considerations for use 

of additional COVID–19 vaccine booster 

doses and the process for COVID–19 

vaccine strain selection to address 

current and emerging variants. 

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 time 

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/Advisory

Committees/Calendar/default.htm. 

Scroll down to the appropriate advisory 

committee meeting link. 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: On April 6, 2022, from 

8:30 a.m. to 5 p.m. Eastern Time, 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. All 

electronic and written submissions 

submitted to the Docket (see ADDRESSES) 

on or before March 31, 2022, will be 

provided to the committee. Comments 

received after March 31, 2022, and by 

April 5, 2022, will be taken into 

consideration by FDA. Oral 

presentations from the public will be 

scheduled between approximately 1:30 

p.m. and 2:30 p.m. Eastern Time. 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 email addresses 

of proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 29, 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 March 30, 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 Prabhakara 

Atreya or 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/AboutAdvisory

Committees/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: March 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06053 Filed 3–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–3462] 

Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs; Draft Guidance for 

Industry; Correction 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 


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