Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices 47647 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

available data concerning the safety and 

effectiveness of over-the-counter 

(nonprescription) human drug products, 

or any other FDA-regulated product, for 

use in the treatment of a broad spectrum 

of human symptoms and diseases and 

advises the Commissioner either on the 

promulgation of monographs 

establishing conditions under which 

these drugs are generally recognized as 

safe and effective and not misbranded or 

on the approval of new drug 

applications for such drugs. The 

Committee serves as a forum for the 

exchange of views regarding the 

prescription and nonprescription status, 

including switches from one status to 

another, of these various drug products 

and combinations thereof. The 

Committee may also conduct peer 

review of Agency sponsored intramural 

and extramural scientific biomedical 

programs in support of FDA’s mission 

and regulatory responsibilities. 

The Committee shall consist of 10 

voting members including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among authorities knowledgeable in the 

fields of internal medicine, family 

practice, clinical toxicology, clinical 

pharmacology, pharmacy, dentistry, and 

related specialties. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. Federal 

members will serve as Regular 

Government Employees or Ex-Officios. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. In addition to the 

voting members, the Committee may 

include one non-voting representative 

member who is identified with industry 

interests. There may also be an alternate 

industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

human-drug-advisory-committees/ 

nonprescription-drugs-advisorycommittee or by contacting the 

Designated Federal Officer (see FOR

FURTHER INFORMATION CONTACT). In light 

of the fact that no change has been made 

to the committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

advisory-committees. 

Dated: August 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18396 Filed 8–25–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2319] 

Evaluation of Study Data Exchange 

Standards for Submission of Study 

Data to the Center for Veterinary 

Medicine; Request for Comments; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments; 

extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

extending the comment period for the 

request for comments that appeared in 

the Federal Register of June 15, 2021. In 

that notice, FDA requested comments 

on the use of study data exchange 

standards from persons involved in 

study conduct, data collection, data 

management, and submission of animal 

study data intended to support the 

approval of new animal drug 

applications (NDAs), abbreviated new 

animal drug applications (ANDAs), or 

applications for conditional approval. 

The Agency is taking this action in 

response to requests for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is extending the comment 

period on the request for comments 

published on June 15, 2021 (86 FR 

31720). Submit either electronic or 

written comments by November 12, 

2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 12, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 12, 2021. 

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. 

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–2319 for ‘‘Evaluation of Study 

Data Exchange Standards for 

Submission of Study Data to the Center 

for Veterinary Medicine.’’ 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 


jbell on DSKJLSW7X2PROD with NOTICES
47648 Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices 

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 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Charles Andres, Center for Veterinary 

Medicine (HFV–180), Food and Drug 

Administration, 7500 Standish Pl, 

Rockville, MD 20855, 240–402–0653, 

charles.andres@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 15, 2021, FDA 

published a request for comments with 

a 90-day comment period to request 

comments on the use of study data 

exchange standards from persons 

involved in study conduct, data 

collection, data management, and 

submission of animal study data 

intended to support the approval of 

NDAs, ANDAs, or applications for 

conditional approval. Comments on the 

use of study data exchange standards 

will help us evaluate the potential use 

of study data exchange standards for 

animal studies submitted as part of the 

new animal drug approval process 

Interested persons were originally 

given until September 13, 2021, to 

comment on document. The Agency has 

received a request for a 60-day 

extension of the comment period. The 

request conveyed concern that the 

current 90-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response to 

the request for comments. FDA has 

considered the request and is extending 

the comment period for the request for 

comments for 60 days, until November 

12, 2021. The Agency believes that a 60- 

day extension allows adequate time for 

interested persons to submit comments. 

Dated: August 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18395 Filed 8–25–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

Circulatory System Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Circulatory System Devices Panel of the 

Medical Devices 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. 

DATES: The meeting will take place 

virtually on November 2 and 3, 2021, 

from 9 a.m. 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. 

FOR FURTHER INFORMATION CONTACT: 

Akinola Awojope, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5216, Silver Spring, 

MD 20993–0002, Akinola.Awojope@

fda.hhs.gov, 301–636–0512, 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/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 the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On 

November 2, 2021, the committee will 

discuss and make recommendations on 

information about the benefit-risk 

profile of the Endologix AFX 

endovascular graft system with regards 

to the risk of Type III endoleaks. FDA 

requests panel input regarding the 

totality of data collected on AFX devices 

and whether further actions are 

necessary. 

On November 3, 2021, the committee 

will discuss and make 

recommendations on the continued 

safety and effectiveness of endovascular 

stent grafts and how to strengthen realworld data collection on long-term 

performance of the devices, both for 

currently marketed devices and for 

future technologies. FDA intends to 

request panel input on the clinical 

outcomes that are most relevant to 

capture in the real world, along with 

their frequency and duration. 

Additionally, FDA intends to seek input 

on data collection platforms, and how to 

incentivize and optimize real world data 

collection. 

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 on FDA’s 

website at the time of the advisory 

committee meeting, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material and the link to the online 

teleconference meeting room will be 

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

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