Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 35303 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 240–402–8926; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Alternate Electronic Format.’’ This 

guidance provides recommendations on 

an alternate electronic format for 

submissions that are covered under an 

exemption from or granted a waiver of 

the requirements of section 745A(a) of 

the FD&C Act (21 U.S.C. 379k–1). These 

recommendations pertain to the 

electronic format of content in NDAs, 

ANDAs, certain DMFs, certain BLAs, 

and certain INDs submitted to the 

Center for Drug Evaluation and Research 

or to the Center for Biologics Evaluation 

and Research. 

This guidance includes information 

on: (1) How to submit in alternate 

electronic format (without XML 

backbone), (2) submission of FDA forms, 

(3) pre-submission considerations, (4) 

submission structure, (5) file formats 

and versions, (6) datasets and study 

information, (7) transmitting electronic 

submissions, and (8) receipt dates. 

This guidance finalizes the draft 

guidance of the same title issued on 

March 11, 2020 (85 FR 14202). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to final 

guidance include: (1) Minor edits to 

clarify recommendations for the 

location of the Table of Contents for the 

alternate electronic format, (2) an 

example of the folder structure, and (3) 

the process for submission if an 

electronic signature is not possible. In 

addition, editorial changes were made 

to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This final guidance represents FDA’s 

current thinking on ‘‘Providing 

Regulatory Submissions in Alternate 

Electronic Format.’’ It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.regulations.gov. 

Dated: June 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14201 Filed 7–1–21; 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) 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 August 3, 2021, from 9 a.m. 

Eastern Time to 6 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of the 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/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Aden Asefa, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Bldg. 66, Rm. 5214, Silver 

Spring, MD 20993–0002, 


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35304 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 

aden.asefa@fda.hhs.gov, 301–796–0400, 

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 August 3, 

2021, the committee will discuss and 

make recommendations on information 

regarding the premarket notification 

(510(k)) submission for the TriGUARD 3 

Cerebral Embolic Protection Device. The 

proposed indication for use for the 

TriGUARD 3 Cerebral Embolic 

Protection Device, is as follows: 

The TriGUARD 3 Cerebral Embolic 

Protection Device is designed to 

minimize the risk of cerebral damage by 

deflecting embolic debris away from the 

cerebral circulation during transcatheter aortic valve replacement. 

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. Background 

material and the link to the online 

teleconference meeting room will be 

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: 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 July 27, 2021. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. Eastern Time 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, and an 

indication of the approximate time 

requested to make their presentation on 

or before July 21, 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 July 20, 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 AnnMarie 

Williams at AnnMarie.Williams@

fda.hhs.gov or 301–796–5966 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: June 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14212 Filed 7–1–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2323] 

Assessment of Adhesion for Topical 

and Transdermal Systems Submitted 

in New Drug Applications; 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 

‘‘Assessment of Adhesion for Topical 

and Transdermal Systems Submitted in 

New Drug Applications.’’ Transdermal 

delivery systems are designed to deliver 

a drug across the skin and into systemic 

circulation, whereas topical delivery 

systems are designed to deliver the drug 

to local tissue. There is pharmaceutical 

and other stakeholder interest in the 

development of new transdermal and 

topical products, and this guidance 

provides recommendations on the 

clinical assessment of adhesion for such 

products that will be submitted as new 

drug applications (NDAs) or 

supplemental new drug applications. 

This guidance provides additional study 

design and methodology 

recommendations on conducting in vivo 

adhesion studies. This guidance takes 

these developments into consideration. 

When final, this draft guidance will 

expand upon the recommendation for in 

vivo adhesion studies in section V., 

Special Topics, subsection A., Product 

Adhesion Considerations, in the draft 

guidance for industry Transdermal and 

Topical Delivery Systems—Product 

Development and Quality 

Considerations issued on November 21, 

2019. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 31, 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 


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