Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 6571 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C. 1313, 24 U.S.C. 

321–329. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–02374 Filed 2–3–22; 8:45 am] 

BILLING CODE 4184–PL–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0082] 

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. 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 on 

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

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/ 

nGRNfZ8ZHN8. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0082. 

The docket will close on February 14, 

2022. Submit either electronic or 

written comments on this public 

meeting by February 14, 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 

February 14, 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 

February 10, 2022, will be provided to 

the committee. Comments received after 

February 10, 2022, and by February 14, 

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–0082 for ‘‘Vaccines and Related 

Biological Products Advisory 

Committee; 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., 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, 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 Christina Vert, 

Center for Biologics Evaluation and 


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6572 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Notices 

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 Federal Register notice 

could not be published 15 days prior to 

the date of the meeting due to a recent 

request to amend the Emergency Use 

Authorization (EUA) of the PfizerBioNTech COVID–19 mRNA vaccine for 

administration to children 6 months 

through 4 years of age, and the need for 

prompt discussion of this request given 

the COVID–19 pandemic. 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On February 

15, 2022, the committee will meet in 

open session to discuss a request to 

amend the Emergency Use 

Authorization (EUA) of the PfizerBioNTech COVID–19 mRNA vaccine for 

administration to 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, the background material will 

be made publicly available at the 

location 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/ 

AdvisoryCommittees/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 February 15, 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 February 

10, 2022, will be provided to the 

committee. Comments received after 

February 10, 2022, and by February 14, 

2022, will be taken into consideration 

by FDA. Oral presentations from the 

public will be scheduled between 

approximately 1 p.m. and 2 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 February 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 

February 9, 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: February 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–02390 Filed 2–3–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1411] 

Drug Product Tracing: The Effect of 

Section 585 of the Federal Food, Drug, 

and Cosmetic Act—Questions and 

Answers; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Drug 

Product Tracing: The Effect of Section 

585 of the FD&C Act—Questions and 

Answers.’’ FDA is issuing this guidance 

to assist industry and State and local 

governments in understanding the 

effects of the uniform national policy set 

forth in the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) that was 

added by the Drug Supply Chain 

Security Act, which was enacted on 

November 27, 2013. This guidance is 

intended to help industry and States 

understand the law as it is currently in 

effect and clarify its effect on State 

product tracing. This guidance finalizes 

the draft guidance entitled ‘‘The Effect 

of Uniform National Policy on Drug 

Product Tracing and Wholesale Drug 

Distributor and Third-Party Logistics 

Provider Standards: Questions and 

Answers’’ issued on October 8, 2014. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on February 4, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time 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 


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