50136 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity/21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Total ...................................................................... ........................ ........................ 432,929 ............................... 1,881,839 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

New drug product and biological 

product applicants must: (1) Design and 

create prescription drug labeling 

containing ‘‘Highlights,’’ ‘‘Contents,’’ 

and ‘‘Full Prescribing Information’’; (2) 

test the designed labeling (for example, 

to ensure that the designed labeling fits 

into carton-enclosed products); and (3) 

submit it to FDA for approval. Based on 

our experience with the information 

collection, we estimate 414 applicants 

will prepare an average of 549 

prescription drug labels and assume it 

will require 3,349 hours to design, test, 

and submit to FDA as part of a new drug 

application or a biologics license 

application. Similarly, new medical gas 

containers must meet applicable 

requirements found in part 211, as well 

as specific labeling requirements in 

§ 201.328. We estimate that 260 

respondents will incur burden for the 

design, testing, production, and 

submission of labeling for new medical 

gas containers as required under 

§ 201.328 and assume an average of 10 

minutes (0.17) is required for these 

activities. 

Our estimated burden for the 

information collection reflects an 

overall increase resulting from an 

increase in submissions for new product 

labeling as well as from the revision to 

include burden associated with 

requirements in § 201.328. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19218 Filed 9–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0965] 

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 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. 

The meeting will be open to the public. 

FDA is establishing a docket for public 

comment on this document. 

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 

a recent submission of a request to 

supplement the approved Biologics 

License Application for COMIRNATY 

for administration of a third dose, or 

‘‘booster’’ dose, of the COVID–19 

vaccine, in individuals 16 years of age 

and older and the need for prompt 

discussion of such submission given the 

COVID–19 pandemic. 

DATES: The meeting will be held on 

September 17, 2021, from 8:30 a.m. to 

3:45 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. The 

online web conference meeting will be 

available at the following link on the 

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

WFph7-6t34M. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2021–N–0965. 

The docket will close on September 16, 

2021. Submit either electronic or 

written comments on this public 

meeting by September 16, 2021. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before September 16, 2021. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

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

September 16, 2021. 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 

September 13, 2021, will be provided to 

the committee. Comments received after 

September 13, 2021, and by September 

16, 2021, will be taken into 

consideration by FDA. In the event that 

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 


sradovich on DSKJLST7X2PROD with NOTICES
Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 50137 

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– 

2021–N–0965 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 

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 Kathleen Hayes, 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

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

MD 20993–0002, 240–818–7798, 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: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

committee will meet in open session to 

discuss the Pfizer-BioNTech 

supplemental Biologics License 

Application for COMIRNATY for 

administration of a third dose, or 

‘‘booster’’ dose, of the COVID–19 

vaccine, in individuals 16 years of age 

and older. 

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: 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 

September 13, 2021, will be provided to 

the committee. Comments received after 

September 13, 2021, and by September 

16, 2021, will be taken into 

consideration by FDA. Oral 

presentations from the public will be 

scheduled between approximately 12:30 

p.m. Eastern Time and 1:30 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 addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before September 13, 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 

September 14, 2021. 

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 Kathleen Hayes 

(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: September 2, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19394 Filed 9–2–21; 4:15 pm] 

BILLING CODE 4164–01–P 


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