76082 Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Kelly Covington, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–5661, 

Kelly.Covington@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 13, 2020, 

FDA published a notice announcing a 

public meeting and requesting 

comments on a concept paper entitled 

‘‘Potential Approach for Ranking of 

Antimicrobial Drugs According to Their 

Importance in Human Medicine: A Risk 

Management Tool for Antimicrobial 

New Animal Drugs’’ with a 94-day 

comment period. 

Interested persons were originally 

given until January 15, 2021, to 

comment on the public meeting and 

request for comments. The Agency 

received several requests to allow 

interested persons additional time to 

comment. The requests conveyed 

concern that the initial 94-day comment 

period did not allow sufficient time to 

develop a comprehensive response. 

FDA believes that an extension of 60 

days allows adequate time for interested 

persons to submit comments. 

Dated: November 20, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26182 Filed 11–25–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1898] 

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 for Emergency 

Use Authorization (EUA) for an 

investigational vaccine to prevent 

Coronavirus Disease 2019 (COVID–19) 

and the need for prompt discussion of 

such submission, given the COVID–19 

pandemic. 

DATES: The meeting will be held on 

December 10, 2020, from 9 a.m. Eastern 

Time 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. The online web conference 

meeting will be available at the 

following link on the day of the 

meeting: https://fda.yorkcast.com/

webcast/Play/d75d80a3eb6e419986181

c1a881fe2671d. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2020–N–1898. 

The docket will close on December 9, 

2020. Submit either electronic or 

written comments on this public 

meeting by December 9, 2020. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before December 9, 2020. The https://

www.regulations.gov electronic filing 

system will accept comments until 

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

December 9, 2020. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Comments received on or before 

December 4, 2020 will be provided to 

the committee. Comments received after 

December 4, 2020, and by December 9, 

2020, will be taken into consideration 

by FDA. In the event that the meeting 

is cancelled, 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– 

2020–N–1898 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. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 76083 

• 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, 240–506–4946 or 301– 

796–7864, respectively; 

CBERAdvisoryCommittees@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 EUA of the 

Pfizer-BioNTech COVID–19 Vaccine for 

the prevention of COVID–19 in 

individuals 16 years of age and older. 

EUA authority allows FDA to help 

strengthen the nation’s public health 

protections against chemical, biological, 

radiological, nuclear (CBRN) threats by 

facilitating the availability and use of 

Medical Countermeasures (MCMs) 

needed during public health 

emergencies. Under section 564 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360bbb–3), FDA may allow 

unapproved medical products or 

unapproved uses of approved medical 

products to be used in an emergency to 

diagnose, treat, or prevent serious or 

life-threatening diseases or conditions 

caused by CBRN threat agents when 

certain statutory criteria have been met, 

including that there are no adequate, 

approved, and available alternatives. 

Additional information about EUAs can 

be found at https://www.fda.gov/ 

emergency-preparedness-and-response/ 

mcm-legal-regulatory-and-policyframework/emergency-useauthorization. 

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 

December 4, 2020, will be provided to 

the committee. Comments received after 

December 4, 2020, and by December 9, 

2020, will be taken into consideration 

by FDA. Oral presentations from the 

public will be scheduled between 

approximately 12 p.m. Eastern Time 

and 1 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 December 2, 2020. 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 

December 3, 2020. 

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 

(CBERAdvisoryCommittees@

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: November 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26229 Filed 11–25–20; 8:45 am] 

BILLING CODE 4164–01–P 


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