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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Federal Register / Vol. 86, No. 163 / Thursday, August 26, 2021 / Notices 47649 

circulatory-system-devices-panel. Select 

the link for the 2021 Meeting Materials. 

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. Written 

submissions may be made to the contact 

person on or before October 21, 2021. 

Oral presentations from the public will 

be scheduled on November 2 and 

November 3, 2021, between 

approximately 1 p.m. and 2 p.m. Eastern 

Time. Those individuals interested in 

making formal oral presentations should 

notify the contact person (see FOR

FURTHER INFORMATION CONTACT). The 

notification should include a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, the date which 

they want to present, and an indication 

of the approximate time requested to 

make their presentation on or before 

October 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 October 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 Artair Mallett 

at Artair.Mallett@fda.hhs.gov or 301– 

796–9638 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: August 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18403 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–D–0691] 

Pharmacokinetic-Based Criteria for 

Supporting Alternative Dosing 

Regimens of Programmed Cell Death 

Receptor-1 or Programmed Cell DeathLigand 1 Blocking Antibodies for 

Treatment of Patients With Cancer; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Pharmacokinetic-Based Criteria for 

Supporting Alternative Dosing 

Regimens of Programmed Cell Death 

Receptor-1 (PD–1) or Programmed Cell 

Death-Ligand 1 (PD–L1) Blocking 

Antibodies for Treatment of Patients 

with Cancer.’’ This draft guidance 

provides recommendations for sponsors 

of investigational new drug applications 

(INDs) and biologics license 

applications (BLAs) on the use of 

pharmacokinetic (PK)-based criteria to 

support the approval of alternative 

dosing regimens for programmed cell 

death receptor-1 (PD–1) or programmed 

cell death-ligand 1 (PD–L1) blocking 

antibodies. This draft guidance is based 

on accumulated scientific and 

regulatory experience for PD–1 and PD– 

L1 drugs, and as such, does not address 

development of alternative dosing 

regimens for any other drugs or 

biologics, changes in route of 

administration, or novel formulations of 

previously approved PD–1/PD–L1 

products. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 25, 2021 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 

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– 

2021–D–0691 for ‘‘PharmacokineticBased Criteria for Supporting 

Alternative Dosing Regimens of 

Programmed Cell Death Receptor-1 (PD– 

1) or Programmed Cell Death-Ligand 1 

(PD–L1) Blocking Antibodies for 

Treatment of Patients with Cancer.’’ 

Received comments 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 


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