Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 76081 

costs for those components throughout 

the cost statement. The A series of 

schedules collects the HO/CO trial 

balance of expenses, reclassifications, 

and adjustments, for allocation of the 

HO/CO costs to its components. On the 

B series of schedules, the home office 

directly allocates costs directly 

attributable to specific components. On 

the C and D series of schedules, the HO/ 

CO functionally allocates costs to 

components in a manner that reasonably 

relates to the services provided to the 

components. On the E series of 

schedules, the HO/CO allocates pooled 

costs (costs not directly assigned or 

functionally allocated) to the 

components. On the F series of 

schedule, the HO/CO summarizes the 

cost allocations by component. On the 

G series of schedules, the HO/CO 

reports financial data from their balance 

sheet and income statement. Form 

Number: CMS–287–21 (OMB control 

number 0938–0202); Frequency: 

Annually; Affected Public: Private 

Sector, State, Business, and Not-for 

Profits; Number of Respondents: 1,626; 

Number of Responses: 1,626; Total 

Annual Hours: 757,716. (For questions 

regarding this collection, contact Gail 

Duncan at 410–786–7278.) 

Dated: November 20, 2020. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2020–26156 Filed 11–25–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1736] 

Potential Approach for Ranking of 

Antimicrobial Drugs According to 

Their Importance in Human Medicine: 

A Risk Management Tool for 

Antimicrobial New Animal Drugs; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting and 

request for comments; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice announcing a public meeting and 

requesting comments that appeared in 

the Federal Register of October 13, 

2020. In that notice, FDA announced a 

public meeting, held on November 16, 

2020, and requested public input on a 

potential revised approach for 

considering the human medical 

importance of antimicrobial new animal 

drugs when assessing and managing the 

antimicrobial resistance risks associated 

with the use of antimicrobial drugs in 

animals. Specifically, the Agency 

requested comments on the potential 

revised process for ranking 

antimicrobials according to their 

relative importance in human medicine, 

on the potential criteria for their 

ranking, and on the resulting ranked list 

of antimicrobial drugs. FDA is taking 

this action in response to several 

requests for extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period announced in the notice of 

public meeting and request for 

comments published October 13, 2020 

(85 FR 64481). Submit either electronic 

or written comments by March 16, 2021, 

to ensure that the Agency considers 

your comments regarding this public 

meeting and request for comments. 

ADDRESSES: 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–1736 for ‘‘Potential Approach 

for Ranking of Antimicrobial Drugs 

According to Their Importance in 

Human Medicine: A Risk Management 

Tool for Antimicrobial New Animal 

Drugs.’’ 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.’’ The 

Agency 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 to 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 this 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 


jbell on DSKJLSW7X2PROD with NOTICES
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