4086 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

aspects of vitiligo. FDA is interested in 

patients’ (including adult and pediatric 

patients) perspectives on: (1) The 

impact of their vitiligo; (2) treatment 

approaches; and (3) decision factors 

considered when selecting a treatment. 

The questions that will be asked of 

patients and patient representatives at 

the meeting are listed in the following 

section and organized by topic. For each 

topic, a brief initial patient panel 

discussion will begin the dialogue. This 

discussion will be followed by a 

facilitated discussion inviting comments 

from other patients and patient 

representatives. In addition to input 

generated through this public meeting, 

FDA is interested in receiving patient 

and patient representative input 

addressing these questions through 

written comments, which can be 

submitted to the public docket (see 

ADDRESSES). When submitting 

comments, if you are commenting on 

behalf of a patient, please indicate that 

you are doing so and answer the 

following questions as much as possible 

from the patient’s perspective. 

FDA will post the agenda and other 

meeting materials approximately 5 days 

before the meeting at: https://

www.fda.gov/drugs/news-eventshuman-drugs/public-meeting-patientfocused-drug-development-vitiligo03082021-03082021. 

II. Topics for Discussion at the Public 

Meeting 

Topic 1: Health Effects and Daily 

Impacts That Matter Most to Patients 

1. Which aspects of vitiligo have the 

most significant impact on your life? 

(Examples may include depigmentation, 

itching, sensitivity to sunlight, etc.) 

2. Are there specific activities that are 

important to you but that you cannot do 

at all or as fully as you would like 

because of your vitiligo? (Examples of 

activities may include participating in 

social events, playing sports, being 

outside in the sunlight, etc.) 

a. How does your vitiligo and its 

impacts affect your daily life on the best 

days? On the worst days? 

3. How has your vitiligo changed over 

time? 

a. How has your vitiligo changed from 

childhood to adulthood (such as vitiligo 

severity, disease acceptance)? 

b. Would you define your vitiligo 

today as being well-managed? 

4. What worries you most about your 

vitiligo? 

a. Is there a particular body area 

affected by vitiligo (such as face, hands, 

limbs) that is of most concern to you? 

Topic 2: Patients’ Perspectives on 

Current Approaches to Treatment 

1. What are you currently doing to 

help treat your vitiligo? (Examples may 

include prescription medicines, overthe-counter products, and other 

therapies, including non-drug therapies 

such as diet modification.) 

a. How has your treatment regimen 

changed over time, and why? 

2. How well does your current 

treatment regimen treat the most 

significant aspects of your vitiligo? For 

example, how well do your treatments 

improve your ability to do specific 

activities? 

3. What are the most significant 

downsides to your current treatments, 

and how do they affect your daily life? 

(Examples of downsides may include 

bothersome side effects, depigmentation 

of affected area is more noticeable, 

hospital treatments, etc.) 

4. Assuming there is no complete cure 

for your vitiligo, what specific things 

would you look for in an ideal treatment 

for your vitiligo? 

a. Is there a particular body area 

affected by vitiligo (such as face, hands, 

limbs) that you would prioritize for 

treatment? 

5. What factors do you consider when 

making decisions about selecting a 

course of treatment? 

III. Participating in the Public Meeting 

Registration: Persons interested in 

attending this public meeting via 

webcast must register online at https:// 

vitiligopfdd.eventbrite.com. Persons 

without access to the internet can call 

301–796–9208 to register. Contact 

information provided during 

registration will remain confidential and 

will only be used to send meeting 

updates to participants. 

Registration for this virtual event is 

free, although there may be limited 

space for attendance based on 

bandwidth availability. Webcast 

information will be provided upon 

completion of registration. Closed 

captioning will be provided. Please 

check the meeting website for the latest 

information: https://www.fda.gov/drugs/ 

news-events-human-drugs/publicmeeting-patient-focused-drugdevelopment-vitiligo-03082021- 

03082021. 

If you need special accommodations 

due to a disability, please contact 

Shannon Cole (see FOR FURTHER

INFORMATION CONTACT) no later than 

March 1, 2021. 

Streaming Webcast of the Public 

Meeting: This public meeting will be 

streamed via webcast only. The 

recording and presentation slides, along 

with a meeting transcript and summary 

report, will also be made publicly 

available after the meeting. To register 

for the webcast, please visit https://

vitiligopfdd.eventbrite.com. The webcast 

can also be accessed via: https://

fda.yorkcast.com/webcast/Play/ 

46a8899c50914665b27d134db

530bd421d. Simply click on the link 

and hit the ‘‘play’’ button and it will 

start. The webcast link will be activated 

30 minutes prior to the start of the 

meeting. 

FDA has verified the website 

addresses in this document, as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

meeting website at https://www.fda.gov/ 

drugs/news-events-human-drugs/publicmeeting-patient-focused-drugdevelopment-vitiligo-03082021- 

03082021. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00832 Filed 1–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4337] 

Prescription Drug User Fee Act of 

2017; Electronic Submissions and Data 

Standards; Public Meeting; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the following virtual public 

meeting entitled ‘‘Prescription Drug 

User Fee Act of 2017; Electronic 

Submissions and Data Standards.’’ The 

purpose of the virtual public meeting 

and the request for comments is to 

fulfill FDA’s commitment to seek 

stakeholder input related to data 

standards and the electronic submission 

system’s past performance, future 

targets, emerging industry needs, and 

technology initiatives. FDA will use the 

information from the public meeting as 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4087 

well as from comments submitted to the 

docket to provide input into data 

standards initiatives, the FDA 

Information Technology (IT) Strategic 

Plan, and electronic submissions 

gateway target timeframes. 

DATES: The public meeting will be held 

on April 7, 2021, from 9 a.m. to 1 p.m. 

Eastern Time and will take place 

virtually, held by webcast only. Submit 

either electronic or written comments 

on this public meeting by March 7, 

2021. See the SUPPLEMENTARY

INFORMATION section for registration date 

and information. 

ADDRESSES: Registration to attend the 

meeting and other information can be 

found at https://www.fda.gov/industry/ 

prescription-drug-user-fee-amendments/ 

pdufa-vi-information-technology-goalsand-progress. 

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 March 7, 2021. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

March 7, 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– 

2018–N–4337 for ‘‘Prescription Drug 

User Fee Act of 2017; Electronic 

Submissions and Data Standards.’’ 

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 laws. 

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: 

Bryan Spells, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1117, Silver Spring, 

MD 20993–0002, 240–402–6511, 

bryan.spells@fda.hhs.gov, or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911, stephen.ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is committed to achieve the longterm goal of improving the 

predictability and consistency of the 

electronic submission process and 

enhancing transparency and 

accountability of FDA information 

technology-related activities. In the 

document containing the performance 

goals and procedures for the 

Prescription Drug User Fee Act 

(PDUFA) reauthorization for fiscal years 

2018 through 2022 (the PDUFA VI 

commitment letter), FDA agreed to hold 

annual public meetings to seek 

stakeholder input related to electronic 

submissions and data standards to 

inform the FDA IT Strategic Plan and 

published targets. The PDUFA VI 

commitment letter outlines FDA’s 

performance goals and procedures 

under the PDUFA program for the years 

2018 through 2022. The PDUFA VI 

commitment letter can be found at 

https://www.fda.gov/media/99140/ 

download. 

FDA will consider all comments made 

at this meeting or received through the 

docket (see ADDRESSES). 

II. Participating at the Public Meeting 

Registration: To register to attend 

‘‘Prescription Drug User Fee Act of 

2017; Electronic Submissions and Data 

Standards,’’ please visit the following 

website to register: https://

www.eventbrite.com/e/pdufa-vi-2021- 

public-meeting-on-electronicsubmissions-and-data-standards-tickets126816546705. Please provide complete 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. A draft 

agenda will be posted approximately 1 

month prior to the meeting. 

Opportunity for Public Comment: 

Those who register online by March 7, 

4088 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

1 Medtronic, Inc. v. Lohr, 518 U.S. 470, 476 

(1996). 

2 Id. at 476–77. 

2021, will receive a notification about 

an opportunity to participate in the 

public comment session of the meeting. 

If you wish to speak during the public 

comment session, follow the 

instructions in the notification and 

identify which topic(s) you wish to 

address. We will do our best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

comments and request time jointly. All 

requests to make a public comment 

during the meeting must be received by 

March 7, 2021, 11:59 p.m. Eastern Time. 

We will determine the amount of time 

allotted to each commenter, the 

approximate time each comment is to 

begin, and will select and notify 

participants by March 21, 2021. No 

commercial or promotional material 

will be permitted to be presented at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be held via Adobe Connect webcast: 

https://collaboration.fda.gov/ 

pdufavify21/. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

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

forindustry/userfees/prescription

druguserfee/ucm446608.htm. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00831 Filed 1–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

RIN 0991–ZA52 

Making Permanent Regulatory 

Flexibilities Provided During the 

COVID–19 Public Health Emergency by 

Exempting Certain Medical Devices 

From Premarket Notification 

Requirements; Request for 

Information, Research, Analysis, and 

Public Comment on Opportunities for 

Further Science and Evidence-Based 

Reform of Section 510(k) Program 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice; request for information. 

SUMMARY: To provide Americans with 

expanded access to certain medical 

devices to respond to the COVID–19 

Public Health Emergency, FDA issued 

guidance documents providing 

numerous regulatory flexibilities, 

including a temporary waiver of 

premarket notification requirements 

under section 510(k) of the Food, Drug, 

and Cosmetic Act. For seven class I 

devices for which 510(k) premarket 

review as temporarily waived during the 

PHE, the Department of Health and 

Human Services is permanently 

exempting those seven (7) class I 

devices from the 510(k) requirement and 

is also proposing to exempt an 

additional 83 class II devices and 1 

unclassified device class from the 510(k) 

requirement, for which premarket 

review had also been waived during the 

PHE. The Department is soliciting the 

public’s views on whether premarket 

review should be permanently waived 

for some or all of these 83 devices and 

views on ways to improve the 510(k) 

premarket notification program. 

DATES: Part III.A of this Notice shall be 

effective immediately on publication in 

the Federal Register. To be considered, 

responses and comments related to Part 

III.B of this Notice must be received 

electronically, within sixty days of 

publication in the Federal Register as 

provided below. The Department will 

consider information submitted by the 

public in response to Part IV of this 

Notice on a rolling basis, and until 

further notice. 

ADDRESSES: You may submit comments 

through the Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulatory 

Information Number (RIN) for this 

rulemaking. All comments received will 

be posted to http://regulations.gov, 

including any personal information 

provided. For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov. Comments must 

be identified by 0991–ZA52. Because of 

staff and resource limitations, all 

comments must be submitted 

electronically to www.regulations.gov. 

Follow the ‘‘Submit a comment’’ 

instructions. 

Warning: Do not include any 

personally identifiable information 

(such as name, address, or other contact 

information) or confidential business 

information that you do not want 

publicly disclosed. All comments may 

be posted on the internet and can be 

retrieved by most internet search 

engines. No deletions, modifications, or 

redactions will be made to comments 

received. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including 

personally identifiable or confidential 

business information that is included in 

a comment. You may wish to consider 

limiting the amount of personal 

information that you provide in any 

voluntary public comment submission 

you make. HHS may withhold 

information provided in comments from 

public viewing that it determines may 

impact the privacy of an individual or 

is offensive. For additional information, 

please read the Privacy Act notice that 

is available via the link in the footer of 

http://www.regulations.gov. Follow the 

search instructions on that website to 

view the public comments. 

FOR FURTHER INFORMATION CONTACT: Dan 

Barry, 200 Independence Ave. SW, 

Washington, DC 20201; or by email at 

daniel.barry@hhs.gov; or by telephone 

at 1–877–696–6775. 

SUPPLEMENTARY INFORMATION: The 

Administration is committed to creating 

a data-based regulatory process that 

appropriately balances benefits and 

costs. Consistent with the President’s 

executive order on COVID–19 regulatory 

flexibilities, and Congress’ direction in 

the 21st Century Cures Act, the 

Department is issuing this Notice to 

permanently exempt or proposing to 

permanently exempt certain class I and 

class II medical devices from the 

premarket notification requirement in 

section 510(k) of the Food, Drug, and 

Cosmetic Act, 21 U.S.C. 360(k). Under 

this notice, the Department is 

immediately making permanent the 

exemption of 7 class I device classes 

from the section 510(k) requirement and 

proposes to exempt an additional 84 

class II and unclassified device classes 

from the same requirement on a 

permanent basis. These 91 devices were 

all subject a 510(k) waiving during the 

PHE. 

I. Background 

A. Statutory Framework 

Under the Food, Drug, and Cosmetic 

Act (FD&C Act), medical devices are 

placed ‘‘in three categories based on the 

risk that they pose to the public.’’ 1 Class 

I devices, products ‘‘that present no 

unreasonable risk of illness or injury,’’ 2

are subject to general controls. FD&C 

Act 513(a)(1)(A), 21 U.S.C.