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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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 35305 

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–D–2323 for ‘‘Assessment of 

Adhesion for Topical and Transdermal 

Systems Submitted in New Drug 

Applications.’’ 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 

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. 

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 draft 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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Kober, Center for Drug 

Evaluation and Research (HFD–580), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 22, Rm. 

5376, Silver Spring, MD 20993–0002, 

301–796–0934. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Assessment of Adhesion for Topical 

and Transdermal Systems Submitted in 

New Drug Applications.’’ This draft 

guidance provides recommendations on 

the clinical assessment of the adhesive 

properties of topical and transdermal 

delivery systems (collectively referred to 

as TDS) intended for submission in an 

NDA or supplemental NDA. The 

amount of drug delivered into and 

through the patient’s skin from a TDS is 

dependent, in part, on the ability of the 

TDS to remain in direct contact with the 

skin (adhesive properties). Adhesive 

properties are clinically important as a 

loss of TDS adhesion during wear can 

reduce the amount of drug delivered to 

the patient, potentially compromising 

effectiveness. Additionally, partial or 

full detachment of a TDS from a 

patient’s skin may result in 

unintentional exposure of the drug to 

others, potentially compromising safety. 

This draft guidance includes key 

considerations for the design of the TDS 

adhesion clinical study, including the 

selection of endpoints and FDA’s 

current thinking on acceptable adhesion 

performance in the in vivo setting. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Assessment of Adhesion for Topical 

and Transdermal Systems Submitted in 

New Drug Applications’’ and will 

supersede in vivo recommendations in 

section V., Special Topics in the draft 

guidance for industry ‘‘Transdermal and 

Topical Delivery Systems—Product 

Development and Quality 

Considerations’’ issued on November 

21, 2019 (84 FR 64319). 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 314 have 

been approved under OMB control 

number 0910–0001, and the collections 

of information for the electronic 

submission of drug establishment 

registration and drug listing information 

have been approved under OMB control 

number 0910–0045. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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

guidances-drugs or https://

www.regulations.gov. 

Dated: June 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14202 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–0938] 

Evaluating Cancer Drugs in Patients 

With Central Nervous System 

Metastases; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 


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