6440 Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 

ADDRESSES section for the address and 

phone number). You may also submit 

comments through the internet at 

https://www.regulations.gov. 

Persons wishing the FAA to 

acknowledge receipt of their comments 

on this action must submit with those 

comments a self-addressed stamped 

postcard on which the following 

statement is made: ‘‘Comments to FAA 

Docket No. FAA–2021–0028; Airspace 

Docket No. 21–ASO–41.’’ The postcard 

will be date/time stamped and returned 

to the commenter. 

All communications received before 

the specified closing date for comments 

will be considered before taking action 

on the proposed rule. The proposal 

contained in this document may be 

changed in light of the comments 

received. All comments submitted will 

be available for examination in the 

public docket both before and after the 

comment closing date. A report 

summarizing each substantive public 

contact with FAA personnel concerned 

with this rulemaking will be filed in the 

docket. 

Availability of NPRMs 

An electronic copy of this document 

may be downloaded through the 

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

Recently published rulemaking 

documents can also be accessed through 

the FAA’s web page at https://

www.faa.gov/air_traffic/publications/ 

airspace_amendments/. 

You may review the public docket 

containing the proposal, any comments 

received, and any final disposition in 

person in the Dockets Office (see the 

ADDRESSES section for address and 

phone number) between 9:00 a.m. and 

5:00 p.m., Monday through Friday, 

except federal holidays. An informal 

docket may also be examined between 

8:00 a.m. and 4:30 p.m., Monday 

through Friday, except federal holidays 

at the office of the Eastern Service 

Center, Federal Aviation 

Administration, Room 350, 1701 

Columbia Avenue, College Park, GA 

30337. 

Availability and Summary of 

Documents for Incorporation by 

Reference 

This document proposes to amend 

FAA Order JO 7400.11F, Airspace 

Designations and Reporting Points, 

dated August 10, 2021, and effective 

September 15, 2021. FAA Order JO 

7400.11F is publicly available as listed 

in the ADDRESSES section of this 

document. FAA Order JO 7400.11F lists 

Class A, B, C, D, and E airspace areas, 

air traffic service routes, and reporting 

points. 

The Proposal 

The FAA proposes an amendment to 

14 CFR part 71 to amend Class E surface 

airspace at Dyersburg Regional Airport, 

Dyersburg, TN, due the 

decommissioning of the Nally Dunston 

NDB and cancellation of associated 

approaches. This action would also 

update the airport name (formerly 

Dyersburg Municipal Airport) and 

geographic coordinates to coincide with 

the FAA’s database. 

This action would also replace the 

outdated term Airport/Facility Directory 

with the term Chart Supplement in the 

airport description. 

Controlled airspace is necessary for 

the safety and management of 

instrument flight rules (IFR) operations 

in the area. 

Class E airspace designations are 

published in Paragraph 6002 of FAA 

Order JO 7400.11F, dated August 10, 

2021, and effective September 15, 2021, 

which is incorporated by reference in 14 

CFR 71.1. The Class E airspace 

designations listed in this document 

would be published subsequently in 

FAA Order JO 7400.11. 

FAA Order JO 7400.11, Airspace 

Designations and Reporting Points, is 

published yearly and effective on 

September 15. 

Regulatory Notices and Analyses 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore: (1) Is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under DOT Regulatory Policies 

and Procedures (44 FR 11034; February 

26, 1979); and (3) does not warrant 

preparation of a Regulatory Evaluation 

as the anticipated impact is so minimal. 

Since this is a routine matter that will 

only affect air traffic procedures and air 

navigation, it is certified that this 

proposed rule, when promulgated, will 

not have a significant economic impact 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Environmental Review 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1F, 

‘‘Environmental Impacts: Policies and 

Procedures,’’ prior to any FAA final 

regulatory action. 

Lists of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of Federal Aviation 

Administration Order JO 7400.11F, 

Airspace Designations, and Reporting 

Points, dated August 10, 2021, and 

effective September 15, 2021, is 

amended as follows: 

Paragraph 6002 Class E Surface Airspace. 

* * * * * 

ASO TN E2 Dyersburg, TN [Amended] 

Dyersburg Regional Airport, TN 

(Lat. 35°59′53′′ N, long. 89°24′24′′ W) 

That airspace upward from the surface 

within a 4.7-mile radius of the Dyersburg 

Regional Airport. This Class E airspace is 

effective during the specific dates and times 

established in advance by a Notice to 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Chart Supplement. 

Issued in College Park, Georgia, on January 

27, 2022. 

Andreese C. Davis, 

Manager, Airspace & Procedures Team South, 

Eastern Service Center, Air Traffic 

Organization. 

[FR Doc. 2022–02342 Filed 2–3–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Census Bureau 

15 CFR Part 30 

[Docket Number 220124–0033] 

RIN 0607–AA58 

Foreign Trade Regulations (FTR): 

Electronic Export Information (EEI) 

Filing Requirements for Shipments 

Between the United States and Puerto 

Rico and the U.S. Virgin Islands (USVI) 

AGENCY: Census Bureau, Commerce 

Department. 

ACTION: Advance Notice of Proposed 

Rulemaking; withdrawal. 


lotter on DSK11XQN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 6441 

SUMMARY: The Census Bureau published 

an Advance Notice of Proposed Rule 

Making (ANPRM) in the Federal 

Register on September 17, 2020 to 

request comments on the overall impact 

of the removal of the Electronic Export 

Information (EEI) filing requirements for 

shipments between the United States, 

Puerto Rico and the U.S. Virgin Islands. 

The Census Bureau has decided to 

continue the current EEI filing 

requirement for Puerto Rico and the 

USVI and continue to publish the U.S. 

Trade with Puerto Rico and U.S. 

Possessions (FT–895) Publication 

Series. This decision was made after 

careful consideration based on the 

feedback received from the ANPRM and 

discussions between the Census Bureau 

and several stakeholders. The Census 

Bureau will continue to collect the EEI 

because there is no alternative data 

source that yields the same high-quality 

data for Puerto Rico and the U.S. Virgin 

Islands. The EEI data meets the Census 

Bureau’s statistical objectives and the 

needs of its data users, including the 

Bureau of Economic Analysis (BEA), 

who produces the Gross Domestic 

Product estimates for Puerto Rico and 

the U.S. Virgin Islands, which is a 

Principal Federal Economic Indicator. 

Both the Census Bureau and BEA are 

open to considering proposed 

alternative data sources which will be 

evaluated, tested, and verified to 

determine whether the data meet the 

statistical objectives of the current EEI. 

FOR FURTHER INFORMATION CONTACT: Lisa 

E. Donaldson, Division Chief, Economic 

Management Division (EMD), Census 

Bureau, by phone (301) 763–7296 or by 

email at lisa.e.donaldson@census.gov or 

Kiesha Downs, Chief, Trade Regulations 

Branch, EMD, Census Bureau, by phone 

(301) 763–7079 or by email at 

kiesha.downs@census.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Census Bureau is responsible for 

collecting, compiling, and publishing 

export trade statistics for the United 

States under the provisions of Title 13, 

United States Code (U.S.C.), Chapter 9, 

Section 301. Collecting and compiling 

trade statistics between the United 

States, Puerto Rico, and other territories 

is part of the U.S. Census Bureau’s 

monthly processing of EEI. Ultimately, 

these statistics are sourced from the EEI 

filings in the Automated Export System 

(AES) and published in the FT–895 

Publication Series. This FT–895 

monthly program presents total quantity 

and value of detailed commodities 

shipped between the United States, 

Puerto Rico, and U.S. territories, 

including the U.S. Virgin Islands 

(USVI). 

The ANPRM published in the Federal 

Register on September 17, 2020, (85 FR 

58016) received 93 comments on the 

overall impact of the removal of the EEI 

filing requirements for shipments 

between the United States, Puerto Rico 

and the USVI. The Census Bureau 

received 50 comments in support of 

maintaining the current EEI filing 

requirement and 43 comments 

supporting the removal of the EEI filing 

requirement. A summary of the 

comments is provided below. 

Comments provided in support of 

removing the EEI filing requirement to 

Puerto Rico and the USVI fell under the 

following themes: 

1. Inequality: Several commenters 

support removing the EEI filing 

requirement were concerned about 

unfair treatment of U.S. territories. 

While Puerto Rico and the USVI are not 

states, they are territories of the United 

States and exports to and from these 

territories are considered domestic, not 

international shipments. Several 

commenters believe federal agencies 

should employ consistent treatment of 

Puerto Rico and the USVI for statistical 

data. Another commenter indicated, 

other agencies under the Department of 

Commerce (DOC), such as the Bureau of 

Industry and Security (BIS) and the 

International Trade Administration do 

not treat shipments to and from Puerto 

Rico and the USVI as exports. Another 

commenter stated that the requirement 

of EEI is the reason many businesses 

deny service to the trade community 

located in U.S. Caribbean territories. 

Another commenter indicated the EEI 

filing requirement hinders trade 

competitiveness and negatively impacts 

job creation. 

2. Increased cost and burden: Several 

commenters were concerned that 

requiring EEI filing to U.S. territories 

has increased the cost and time of the 

shipping process for U.S. exporters and 

freight forwarders. Some commenters 

indicate the need to dedicate staff and/ 

or hire additional personnel to manage 

EEI filings has increased labor cost for 

businesses. Commenters were also 

concerned that the requirement to file 

EEI between the mainland U.S., Puerto 

Rico and the USVI imposes substantial 

regulatory and economic burden on 

exporters. Several commenters stated 

that the Department of Commerce 

should minimize any governmental 

paperwork burden (electronic or 

otherwise) on U.S. citizens engaged in 

lawful commercial transactions within 

the U.S. Several commenters also 

indicated the EEI filing process imposes 

unnecessary burden on commerce by 

impeding the flow of trade and 

economic development in these 

territories due to the additional 

paperwork and administrative costs 

imposed by the EEI filing requirement. 

Several commenters stated that the costs 

are significant in terms of time lost, 

human resources required; many 

shippers and manufacturers in the U.S. 

have decided not to ship to these 

territories due to these additional steps 

in the shipping process and restrictions 

on trade. Additionally, some 

commenters pointed out that the cost of 

the EEI filing limits sourcing of U.S. 

products and increases the cost of goods 

in Puerto Rico and the USVI. 

3. Possible alternative data sets: 

Several commenters identified the 

possibility of alternative methods for 

collecting export statistics data. One 

commenter stated that Puerto Rico is a 

part of the same U.S. Customs system 

and should use the same data collection 

methods as the other 50 states. Other 

commenters suggested that EEI is viable 

through data that already exists from 

multiple sources. One commenter 

suggested that EEI filing is repetitive 

and duplicative to manifest 

requirements of other agencies. Several 

commenters suggested specific 

alternative data sets such as the DOC’s 

Bureau of Economic Analysis (BEA) 

data, which collects trade data that is 

used to calculate U.S. Gross Domestic 

Product (GDP) activity, state-to-state 

activity, and U.S. international 

transactions. Several commenters also 

proposed the use of Customs and Border 

Protection (CBP) manifest data, Puerto 

Rico’s Sistema Unificado de Rentas 

Internas (SURI), Puerto Rico Port 

Authority data, monthly reporting 

similar to the current pipeline reporting, 

and the FT–895 report as alternative 

data sources. 

Comments provided for maintaining 

the EEI filing requirement to Puerto Rico 

and USVI fell under the following 

themes: 

1. Statistical purposes: The EEI 

reporting requirement yields high 

quality data for Puerto Rico and the 

USVI that serve several specific 

statistical objectives. Eliminating the 

mandatory requirement would remove 

an additional step in the shipping 

process. However, there would be 

several statistical implications 

associated with this change. Statistical 

data provides insight on policy 

decisions, GDP estimates, business 

development and marketing, economic 

recovery, research and academia as well 

as historical data and methodology, 

critical in measuring economic growth 

for Puerto Rico and the USVI. 


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A. Public Policy Decisions: Several 

commenters noted, EEI is utilized by the 

Government of Puerto Rico to produce 

statistical reports, gauge economic 

activity, and assist in sound policy 

making. A federal agency commented 

that it uses the data in its initiative to 

estimate Puerto Rico GDP statistics. 

Specifically, the agency commented that 

reliable GDP statistics for U.S. territories 

contribute to a better understanding of 

economic development, such as the 

impact of federal disaster relief 

spending in these areas. For example, to 

date, Congress has appropriated more 

than $60 billion for Puerto Rico 

recovery efforts following hurricanes in 

2017 and earthquakes in 2020. Without 

high-quality GDP statistics, it is difficult 

for policy makers to gauge the impact of 

such funding on the Puerto Rican 

economy. Additionally, another federal 

agency has concerns about the loss of 

data, specifically, petroleum trade 

between the United States and Puerto 

Rico. This federal agency uses the data 

for calculation of the total shipped 

volumes of petroleum and other fuels. 

There is currently no other source of 

information or method for tracking trade 

flows of oil and other energy-related 

commodities between the United States 

and Puerto Rico. There is no alternative 

data source to collect this information 

because Puerto Rico does not locally 

collect the data and these data are not 

included in any other U.S. Census 

Bureau economic surveys. Commenters 

are concerned because this information 

can aid federal agencies in developing 

strategic plans to ensure Puerto Rico has 

resilient power generation systems for 

the future, as the current Administration 

starts to steer away from oil and towards 

sustainable energy and information. 

B. Business Development and 

Marketing: One commenter stated that 

accurate and precise data is critical for 

the development of small businesses in 

Puerto Rico and to develop and update 

business and marketing plans to move 

Puerto Rico’s economy forward. 

Another commenter noted that 

businesses in these territories and the 

U.S. mainland use this detailed data to 

inform choices and services around new 

and existing markets, which allows for 

more competition and better consumer 

options. 

C. Economic Recovery: Several 

commenters noted, keeping the EEI 

filing requirement for Puerto Rico and 

the USVI allows these territories to 

rebuild their economies and accurately 

measure, project, and plan economic 

development. One commenter noted, 

the lack of reliable statistics is the worst 

scenario for a country in economic crisis 

as they work towards restructuring their 

debt and attaining a sustainable 

economy. Several other commenters 

noted that without a viable and tested 

alternative data source, the proposal to 

remove the requirements will make it 

impossible to measure and analyze 

Puerto Rico’s economy. Other 

commenters noted that an economic 

development plan is urgent, and it 

cannot be attained without having 

complete, accurate and confident data 

that includes the information for 

shipments between the United States 

and Puerto Rico and USVI. 

D. Research and Academic 

Importance: Several commenters were 

concerned that the proposed rule to 

eliminate the EEI filing requirement to 

Puerto Rico and the USVI will have a 

significant impact on research and 

academia. Commenters noted that 

without the filing requirement, 

economic students, scholars, 

entrepreneurs and citizens will not be 

able to access updated Census Bureau 

data for research policy purposes. One 

scholar specifically noted that the 

Census Bureau’s statistical information 

for economic and agricultural economic 

courses is useful to students completing 

projects and thesis papers within their 

master’s program. Another commenter 

was also concerned that the loss of this 

data will directly impact the agricultural 

industry with current global economic 

and climatic change. 

2. Enforcement Purposes: We received 

several comments against removing the 

EEI filing requirement for export control 

and enforcement purposes. One 

commenter noted that without the 

collection of data from the U.S. 

mainland to Puerto Rico and USVI, 

enforcement agencies lose visibility on 

potential criminal activity. The Census 

Bureau consulted with one federal 

agency on this comment. This agency 

noted that the removal of the EEI filing 

requirements for shipments from the 

U.S. to those territories would adversely 

impact the agency’s ability to ensure the 

effective enforcement of items subject to 

the Export Administration Regulations, 

potentially diverted to foreign countries. 

3. No valid alternative data set: 

Though commenters presented potential 

alternative data sets, one commenter 

noted that the level of detail would not 

be similar to that obtained through the 

EEI requirement, and the data would not 

be compiled with the rigorousness as 

that by the Census Bureau. One federal 

agency also noted that the EEI is highquality economic data which is not 

typical for the U.S. territories because 

the U.S. territories are not included in 

most federal surveys. Territory-level 

surveys and administrative data are 

limited. Several commenters noted, 

there is currently no substitute for EEI 

that is routinely available, continuous, 

current, high frequency and published 

with documentation and technical 

support. Without an alternative data 

source that meets the same statistical 

objectives, it is not possible to continue 

to produce GDP estimates for Puerto 

Rico or the USVI. Should the broader 

FT–895 report be eliminated as a result 

of the discontinuation of the EEIsourced data, GDP estimates for the 

territory of American Samoa will also be 

at risk. 

4. Cost Benefit: Several commenters 

noted that the Automated Export 

System (AES) is a mature system the 

trade industry understands and knows 

how to operate. There is concern that 

creating an entirely new system to 

capture the same data in today’s current 

environment is an unnecessary burden. 

Additionally, creating a new system 

would come at a significant cost to the 

U.S. Government during a time of 

increased strain on Government 

funding, as well as costs to the industry. 

One commenter noted that many EEI 

filers for Puerto Rico’s data also use the 

AES for international shipments to 

foreign countries and adding an 

alternative system would add a burden 

to their current operations and 

workflow. Several economists 

commented that the requirement to file 

EEI does not add significant burden on 

business and the cost and value of the 

EEI data is greater than the 

inconvenience to the trade compared to 

the potential sales acquired, the current 

information technologies and the fact 

that the bulk of the shipments to the 

U.S. are done by large U.S. corporations. 

5. GDP Estimates: Several 

commenters noted that the Census 

Bureau’s FT–895 reports and other 

statistical trade documents provide 

routine, consistent, and continuous 

monthly and annual data that is 

necessary and relevant for statistical and 

time-series compatibility. These 

commenters also added that consistent 

definitions are critical to ensure GDP 

estimates and the loss of the FT–895 

and EEI reporting will adversely affect 

the computations of GDP estimates. One 

commenter specifically stated that the 

methodology should include a monthly 

total of the value of goods between the 

U.S., Puerto Rico and the USVI rather 

than presenting it on an annual 

frequency. Another commenter who has 

used the data for many years is 

concerned that interruptions or 

inconsistencies with the current 

dissemination of the Census Bureau 

data would create problems. 

Additionally, one federal agency noted 

that they significantly rely on trade data 


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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules 6443 

from the FT–895 in constructing reliable 

and consistent economic statistics, 

including GDP for U.S. territories. Such 

statistics provide key insight into the 

territorial economies, and meaningful 

information to businesses and decision 

makers alike. Territorial GDP are highly 

reliant on export and import data 

provided from the Census Bureau’s FT– 

895. The direct concern is that an 

elimination of EEI reporting 

requirements could directly impact the 

availability of import data used in the 

USVI GDP statistics. To illustrate the 

significance of this information loss, in 

2018 exports reported in the FT–895 

accounted for 59-percent and 9-percent 

of American Samoa and the USVI GDP, 

respectively. The direct and indirect 

impact associated to the elimination of 

the EEI reporting requirements could 

severely affect the usefulness of 

American Samoa, Northern Mariana 

Islands, Guam and USVI GDP as time 

series statistics. Should the reporting 

requirement be eliminated, it remains 

unclear if the Census Bureau will 

continue to make non-EEI-sourced trade 

data available for these territories. Other 

commenters stated that the lack of data 

with no other avenue for gathering the 

information would be harmful and 

unfortunate if such a longtime source of 

information were to disappear. 

Similarly, a commenter noted that the 

FT–895 constitutes an excellent and 

unique tool benefitting individuals, 

businesses, academia, etc. and for which 

there is no viable substitute available. 

Robert L. Santos, Director, Census 

Bureau, approved the publication of this 

notice of proposed rulemaking in the 

Federal Register. 

Dated: January 31, 2022. 

Sheleen Dumas, 

Department PRA Clearance Officer, Office of 

the Chief Information Officer, Commerce 

Department. 

[FR Doc. 2022–02341 Filed 2–3–22; 8:45 am] 

BILLING CODE 3510–07–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 203 

[Docket No. FDA–2020–N–1819] 

RIN 0910–AH56 

Certain Requirements Regarding 

Prescription Drug Marketing 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to amend certain 

prescription drug marketing regulations 

to reflect changes to affected provisions 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) resulting from 

enactment of the Drug Supply Chain 

Security Act (DSCSA), Title II of the 

Drug Quality and Security Act (DQSA). 

This action, if finalized, will remove or 

revise outdated and conflicting 

regulatory requirements to align with 

changes to affected provisions of the 

FD&C Act following enactment of the 

DSCSA. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by April 5, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

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

April 5, 2022. Electronic comments 

must be submitted on or before that 

date. 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– 

2020–N–1819 for ‘‘Certain Requirements 

Regarding Prescription Drug 

Marketing.’’ 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 

available 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 


lotter on DSK11XQN23PROD with PROPOSALS1