50130 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 

affected by lead exposure, as 

appropriate. 

At least half of the committee will 

consist of Federal representatives from a 

range of agencies that may include the 

Department of Housing and Urban 

Development; the Environmental 

Protection Agency; the Consumer 

Product Safety Commission; the Centers 

for Medicare and Medicaid Services; the 

Health Resources and Services 

Administration; the Food and Drug 

Administration; the U.S. Department of 

Agriculture; the Occupational Safety 

and Health Administration; the National 

Institute of Environmental Health 

Sciences; the U.S. Geological Survey; 

and such additional federal, state, tribal, 

and local public and private officials as 

the Secretary deems necessary for the 

committee to carry out its function. The 

rest of the committee will consist of 

non-Federal members. Only non-Federal 

members are being solicited with this 

announcement. 

The U.S. Department of Health and 

Human Services policy stipulates that 

committee membership be balanced in 

terms of points of view represented, and 

the committee’s function. Appointments 

shall be made without discrimination 

on the basis of age, race, ethnicity, 

gender, sexual orientation, gender 

identity, HIV status, disability, and 

cultural, religious, or socioeconomic 

status. Nominees must be U.S. citizens 

and cannot be full-time employees of 

the U.S. Government. Current 

participation on federal workgroups or 

prior experience serving on a federal 

advisory committee does not disqualify 

a candidate; however, HHS policy is to 

avoid excessive individual service on 

advisory committees and multiple 

committee memberships. 

Committee members are Special 

Government Employees, requiring the 

filing of financial disclosure reports at 

the beginning and annually during their 

terms. CDC reviews potential candidates 

for LEPAC membership each year and 

provides a slate of nominees for 

consideration to the Secretary of HHS 

for final selection. HHS notifies selected 

candidates of their appointment as soon 

as the HHS selection process is 

completed. Note that the need for 

different expertise varies from year to 

year and a candidate who is not selected 

in one year may be reconsidered in a 

subsequent year. Candidates should 

submit the following items: 

• Current curriculum vitae, including 

complete contact information 

(telephone numbers, mailing address, 

email address). 

• At least one letter of 

recommendation from person(s) not 

employed by the U.S. Department of 

Health and Human Services. 

(Candidates may submit letter(s) from 

current HHS employees if they wish, 

but at least one letter must be submitted 

by a person not employed by an HHS 

agency (e.g., CDC, NIH, FDA, etc.) 

Nominations may be submitted by the 

candidate him- or herself or by the 

person/organization recommending the 

candidate. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–19222 Filed 9–3–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0929] 

Food and Drug Administration New Era 

of Smarter Food Safety Summit on ECommerce; 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 we) is 

announcing a virtual public meeting 

entitled ‘‘FDA New Era of Smarter Food 

Safety Summit on E-Commerce: 

Ensuring the Safety of Foods Ordered 

Online and Delivered Directly to 

Consumers.’’ The purpose of the public 

meeting is to engage with stakeholders 

and invite input on various topics 

pertaining to the implementation of 

Core Element 3.1 of the New Era of 

Smarter Food Safety Blueprint. We 

intend to use information resulting from 

the public meeting to determine what 

action(s), if any, should be taken to help 

ensure the safe production and delivery 

of human and animal foods sold 

through new e-commerce business 

models. 

DATES: The public meeting will be held 

over 3 days on October 19, 2021, from 

11:30 a.m. to 5:30 p.m. Eastern Time; 

October 20, 2021, from 11:30 a.m. to 

5:15 p.m. Eastern Time, and October 21, 

2021, from 11:30 a.m. to 3:45 p.m. 

Eastern Time. Submit either electronic 

or written comments on this public 

meeting by November 20, 2021. See 

‘‘Participating in the Public Meeting’’ in 

the SUPPLEMENTARY INFORMATION section 

of this document for registration and 

other information regarding meeting 

participation. 

ADDRESSES: The public meeting will be 

held virtually. For more information on 

the public meeting, see: https://

www.fda.gov/food/workshops-meetingswebinars-food-and-dietarysupplements/new-era-smarter-foodsafety-summit-e-commerce-ensuringsafety-foods-ordered-online-anddelivered. 

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 20, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

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

of November 20, 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’’). 


sradovich on DSKJLST7X2PROD with NOTICES
Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 50131 

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–N–0929 for ‘‘FDA New Era of 

Smarter Food Safety Summit on ECommerce.’’ 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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: 

Juanita Yates, Center for Food Safety 

and Applied Nutrition, (HFS–009), Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

1731, juanita.yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In April 2019, we announced the New 

Era of Smarter Food Safety initiative 

and in July 2020, we released the New 

Era of Smarter Food Safety Blueprint 

(see https://www.fda.gov/food/new-erasmarter-food-safety/new-era-smarterfood-safety-blueprint) (Blueprint). The 

Blueprint outlines the effort to 

modernize approaches to food safety as 

we respond to unique demands on our 

food system and work to ensure the 

safety and security of our food supply. 

This virtual public meeting (Summit) 

will focus on Core Element 3.1: Ensure 

Safety of Food Produced or Delivered 

Using New Business Models. 

Specifically, we invite discussion and 

input on human and animal foods sold 

through Business to Consumer (B2C) ecommerce. B2C e-commerce is the 

manufacturing, packaging, labeling, 

storage, and delivery of human and 

animal foods sold directly to consumers, 

through commercial transactions 

conducted electronically on the 

internet. 

The Summit is an opportunity for us 

to share our current understanding of 

human and animal foods sold through 

new business models and hear from the 

public. The Summit will enhance our 

knowledge of possible food safety risks 

related to these new business models 

and help us identify what additional 

courses of action, if any, are needed to 

address potential food safety 

vulnerabilities. 

We invite industry, consumers, 

consumer and public health 

organizations, academia, Federal, State, 

local, and tribal governments, foreign 

governments, and other interested 

parties to join the discussion and 

provide their perspectives on these 

issues. 

II. Topics for Discussion at the Public 

Meeting 

The Summit will address a variety of 

topics related to human and animal 

foods sold through B2C e-commerce, 

including: 

• Types of B2C e-commerce models 

(e.g., produce and meal kit subscription 

services, ghost kitchens, dark stores); 

• Safety risks associated with foods 

sold through B2C e-commerce; 

• Standards of care used by industry 

to control these safety risks; 

• Types of delivery models (e.g., 

third-party delivery, autonomous 

delivery models); 

• Regulatory approaches to food sold 

through B2C e-commerce, including 

challenges and gaps that need to be 

addressed; and 

• Labeling of foods sold through B2C 

e-commerce. 

During the Summit, experts from 

FDA, industry, academia, consumer and 

public health organizations, domestic 

and foreign governments will be asked 

to address these topics. Each day, there 

will also be an opportunity for 

registered participants to ask questions 

and engage with these experts, as well 

as to offer open public comment for 

those who select this option when 

registering (see Part III, ‘‘Participating in 

the Public Meeting’’). 

Before the meeting date, we will post 

the agenda and additional background 

materials on the internet at: https://

www.fda.gov/food/workshops-meetingswebinars-food-and-dietarysupplements/new-era-smarter-foodsafety-summit-e-commerce-ensuringsafety-foods-ordered-online-anddelivered. Registered participants will 

be notified when these materials are 

posted. There will be an opportunity for 

interested stakeholders to submit 

written comments following the 

meeting. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website to register: https://www.fda.gov/ 

food/workshops-meetings-webinarsfood-and-dietary-supplements/new-erasmarter-food-safety-summit-ecommerce-ensuring-safety-foodsordered-online-and-delivered. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. 

This is a virtual public meeting. 

Registration is free and will be open 

through the day of the meeting. Persons 

interested in attending this public 

meeting must register at: https://

www.fda.gov/food/workshops-meetingswebinars-food-and-dietarysupplements/new-era-smarter-foodsafety-summit-e-commerce-ensuringsafety-foods-ordered-online-anddelivered. Upon registering, they will 

receive a confirmation email with a link 

for the public meeting. Approximately 


sradovich on DSKJLST7X2PROD with NOTICES
50132 Federal Register / Vol. 86, No. 170 / Tuesday, September 7, 2021 / Notices 

24 to 48 hours before the event, 

registrants will receive an email with 

the meeting link and a formal calendar 

invitation. 

Request to Provide Open Public 

Comment: During online registration, 

you may indicate if you wish to make 

open public comments during the 

public meeting and which topic(s) you 

would like to address. All requests to 

make public comments must be 

received by October 8, 2021 at 11:59 

p.m. Eastern Time. We will do our best 

to accommodate requests to make public 

comments. We are seeking to have a 

broad representation of ideas and issues 

presented at the meeting. Individuals 

and organizations with common 

interests are urged to consolidate or 

coordinate their comments. FDA will 

determine the amount of time allotted to 

each commenter, the meeting day, the 

approximate time open public 

comments are to be provided and notify 

all registrants who requested to make 

public comments. 

Streaming Webcast of the Public 

Meeting: This public meeting will be 

broadcast via YouTube. 

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 (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20850. A link to 

the transcript will also be available on 

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

food/workshops-meetings-webinarsfood-and-dietary-supplements/new-erasmarter-food-safety-summit-ecommerce-ensuring-safety-foodsordered-online-and-delivered. 

Dated: August 31, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19219 Filed 9–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1529] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Reclassification 

Petitions for Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with 

reclassification of medical devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 8, 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 8, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 8, 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– 

2013–N–1529 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Reclassification Petitions for Medical 

Devices.’’ 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 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 


sradovich on DSKJLST7X2PROD with NOTICES