32420 Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 

of proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before 6 p.m. Eastern Time on June 

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 June 23, 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 Sussan Paydar (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/Advisory

Committees/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: May 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11670 Filed 5–26–22; 11:15 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0904] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Vaccines and Related Biological 

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. This 2-day virtual 

meeting will be held to discuss recent 

requests to amend the Emergency Use 

Authorization (EUA) of the Moderna 

COVID–19 mRNA vaccine to include 

the administration of a primary series to 

infants, children, and adolescents 6 

months through 17 years of age and to 

amend the EUA of the Pfizer-BioNTech 

COVID–19 mRNA vaccine to include 

the administration of a primary series to 

infants and children 6 months through 

4 years of age. The meeting will be open 

to the public on both days. FDA is 

establishing a docket for public 

comment on this document. 

DATES: The meeting will be held June 14 

and June 15, 2022, from 8:30 a.m. to 5 

p.m. Eastern Time (ET). Comments 

received on or before June 7, 2022, will 

be provided to the committee. 

Comments received after June 7, 2022, 

and by June 13, 2022, 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 separate links 

on the respective days of the meeting: 

Day 1: https://youtu.be/GbNpaZeDPiA 

Day 2: https://youtu.be/Ixm4UmldTGQ 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0904. 

The docket will close on June 13, 2022. 

Submit either electronic or written 

comments on this public meeting by 

June 13, 2022. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before June 13, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. ET at the 

end of June 13, 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 June 

7, 2022, will be provided to the 

committee. Comments received after 

June 7, 2022, and by June 13, 2022, will 

be taken into consideration by FDA. If 

the meeting is canceled, FDA will 

continue to evaluate any relevant 

applications, submissions, 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–0904 for ‘‘Vaccines and Related 

Biological Products; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be 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., 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 32421 

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, September 18, 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 Sussan Paydar, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 6306, Silver Spring, 

MD 20993–0002, 240–506–4946, via 

email at 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 

Agency’s website at https://

www.fda.gov/advisory-committees and 

scroll down to the appropriate advisory 

committee meeting link or call the 

advisory committee information line to 

learn about possible modifications 

before joining 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 Federal Register notice 

could not be published 15 days prior to 

the date of the meeting due to recent 

requests to amend the EUA of the 

Moderna COVID–19 mRNA vaccine to 

include the administration of a primary 

series to infants, children, and 

adolescents 6 months through 17 years 

of age and to amend the EUA of the 

Pfizer-BioNTech COVID–19 mRNA 

vaccine to include the administration of 

a primary series to infants and children 

6 months through 4 years of age, and the 

need for prompt discussion of such 

requests given the COVID–19 pandemic. 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On June 14, 

2022, under Topic 1, the committee will 

meet in open session to discuss 

amending the EUA of the Moderna 

COVID–19 mRNA vaccine to include 

the administration of the primary series 

to children and adolescents 6 years 

through 17 years of age. On June 15, 

2022, under Topic II, the committee will 

meet in open session to discuss 

amending the EUA of the Moderna 

COVID–19 mRNA vaccine to include 

the administration of the primary series 

to infants and children 6 months 

through 5 years of age and to discuss 

amending the EUA of the PfizerBioNTech COVID–19 mRNA vaccine to 

include the administration of the 

primary series to infants and children 6 

months through 4 years of age. 

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, background material will be 

made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

advisory-committees/advisorycommittee-calendar. 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 June 14 and June 15, 

2022, from 8:30 a.m. to 5 p.m. ET, 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 June 7, 2022, will be 

provided to the committee. Comments 

received after June 7, 2022, and by June 

13, 2022, will be taken into 

consideration by FDA. Oral 

presentations from the public will be 

scheduled approximately between 1 

p.m. and 2 p.m. ET on June 14, 2022, 

and approximately between 1 p.m. and 

2 p.m. ET on June 15, 2022. 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 date and 

time requested to make their 

presentation on or before 6 p.m. ET on 

June 8, 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 June 10, 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 Sussan Paydar 

(CBERVRBPAC@fda.hhs.gov) 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: May 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11669 Filed 5–26–22; 11:15 am] 

BILLING CODE 4164–01–P 


khammond on DSKJM1Z7X2PROD with NOTICES