4622 Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section and activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden 

per recordkeeping Total hours 

Maintenance of Records for Approved Labeling for Each ‘‘Type B’’ and 

‘‘Type C’’ Feed (510.305).

795 1 795 0.03 (2 minutes) ......... 24 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 17 hours and a 

corresponding decrease of 105 

responses/records. We attribute this 

adjustment to a decrease in the number 

of submissions we received over the last 

few years. 

Dated: January 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01738 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0386] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco 

Product Establishments and Listing of 

Ingredients in Tobacco Products 

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 ‘‘Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco Product 

Establishments and Listing of 

Ingredients in Tobacco Products.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 29, 2022. 

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 March 29, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 29, 2022. 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– 

2012–N–0386 for ‘‘Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco Product 

Establishments and Listing of 

Ingredients in Tobacco Products.’’ 

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 

heading of this document, into the 


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Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 4623 

‘‘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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments and 

Listing of Ingredients in Tobacco 

Products 

OMB Control Number 0910–0650— 

Extension 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Tobacco Control Act) (Pub. 

L. 111–31) was signed into law. The 

Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) by adding, among other 

things, a chapter granting FDA 

important authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. The 

Tobacco Control Act created new 

requirements for the tobacco industry. 

Section 101 of the Tobacco Control Act 

amended the FD&C Act by adding, 

among others, sections 905 and 904 (21 

U.S.C. 387e and 387d). 

Section 905 of the FD&C Act requires 

the annual registration of any 

‘‘establishment in any State engaged in 

the manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products.’’ 

Section 905 requires this registration be 

completed by December 31 of each year. 

The Secretary of Health and Human 

Services (Secretary) has delegated to the 

Commissioner of Food and Drugs the 

responsibility for administering the 

FD&C Act, including section 905. 

Section 905 of the FD&C Act requires 

owners or operators of each 

establishment to register: (1) Their 

name; (2) places of business; (3) a list of 

all tobacco products which are 

manufactured by that person; (4) a copy 

of all labeling and a reference to the 

authority for the marketing of any 

tobacco product subject to a tobacco 

product standard under section 907 of 

the FD&C Act (21 U.S.C. 387g) or to 

premarket review under section 910 of 

the FD&C Act (21 U.S.C. 387j); (5) a 

copy of all consumer information and 

other labeling; (6) a representative 

sampling of advertisements; (7) upon 

request made by the Secretary for good 

cause, a copy of all advertisements for 

a particular tobacco product; and (8) 

upon request made by the Secretary, if 

the registrant has determined that a 

tobacco product contained in the 

product list is not subject to a tobacco 

product standard established under 

section 907 of the FD&C Act, a brief 

statement of the basis upon which the 

registrant made such determination. 

FDA collects the information 

submitted pursuant to section 905 of the 

FD&C Act through an electronic portal, 

and through paper forms (Forms FDA 

3741 https://www.fda.gov/media/77915/ 

download and FDA 3741a https://

www.fda.gov/media/99863/download) 

for those individuals who choose not to 

use the electronic portal. 

FDA has also published a guidance 

for industry entitled ‘‘Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco Product 

Establishments’’ (https://www.fda.gov/ 

downloads/TobaccoProducts/Labeling/ 

RulesRegulationsGuidance/ 

UCM191940.pdf). This guidance is 

intended to assist persons making 

tobacco product establishment 

registration and product listing 

submissions to FDA. 

Section 904(a)(1) of the FD&C Act 

requires that each tobacco product 

manufacturer or importer submit ‘‘a 

listing of all ingredients, including 

tobacco, substances, compounds, and 

additives that are, as of such date, added 

by the manufacturer to the tobacco, 

paper, filter, or other part of each 

tobacco product by brand and by 

quantity in each brand and subbrand’’ 

by December 22, 2009. This section 

applies only to those tobacco products 

manufactured and distributed before 

June 22, 2009, and which are still 

manufactured as of the date of the 

ingredient listing submission. 

Section 904(c) of the FD&C Act 

requires that a tobacco product 

manufacturer: (1) Provide all 

information required under section 

904(a) of the FD&C Act to FDA ‘‘at least 

90 days prior to the delivery for 

introduction into interstate commerce of 

a tobacco product not on the market on 

the date of enactment’’ of the Tobacco 

Control Act; (2) advise FDA in writing 

at least 90 days prior to adding any new 

tobacco additive or increasing in 

quantity an existing tobacco additive, 

except for those additives that have 

been designated by FDA through 

regulation as not a human or animal 

carcinogen, or otherwise harmful to 

health under intended conditions of 

use; and (3) advise FDA in writing at 

least 60 days of such action of 

eliminating or decreasing an existing 

additive, or adding or increasing an 

additive that has been designated by 

FDA through regulation as not a human 

or animal carcinogen, or otherwise 

harmful to health under intended 

conditions of use. 

FDA collects the information 

submitted pursuant to section 904(a)(1) 

and 904(c) of the FD&C Act through an 

electronic portal, and through a paper 

form (Form FDA 3742 https://

www.fda.gov/media/77661/download) 

for those individuals who choose not to 

use the electronic portal. 

In addition to the development of the 

electronic portal and paper form, FDA 

published a guidance entitled ‘‘Listing 

of Ingredients in Tobacco Products’’ 

(https://www.fda.gov/media/101162/ 

download). This guidance is intended to 

assist persons making tobacco product 

ingredient listing submissions. FDA also 

provides a technical guide, embedded 

hints, and a web tutorial to the 

electronic portal. 


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4624 Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 

The Tobacco Control Act also gave 

FDA the authority to issue a regulation 

deeming all other products that meet the 

statutory definition of a tobacco product 

to be subject to Chapter 9 of the FD&C 

Act (section 901(b) of the FD&C Act (21 

U.S.C. 387a(b))). On May 10, 2016, FDA 

issued that rule, extending FDA’s 

tobacco product authority to all 

products that meet the definition of 

tobacco product in the law (except for 

accessories of newly regulated tobacco 

products), including electronic nicotine 

delivery systems, cigars, hookah 

tobacco, pipe tobacco, nicotine gels, and 

dissolvables that were not already 

subject to the FD&C Act, and other 

tobacco products that may be developed 

in the future (81 FR 28974 at 28976) 

(‘‘the final deeming rule’’). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA form; activity; tobacco control act section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

recordkeeping 

Total 

hours 

Tobacco Product Establishment Initial Registration and Listing; Form FDA 3741 Registration 

and Product Listing for Owners and Operators 

of Domestic Establishments (Electronic and 

Paper submissions); sections 905(b)–(d), 

905(h), or 905(i).

100 1 100 1.6 ................................. 160 

Tobacco Product Establishment Renewal Registration and Listing; Form FDA 3741 Registration and Product Listing for Owners and Operators of Domestic Establishments (Electronic 

and Paper submissions); sections 905(b)–(d), 

905(h), or 905(i).

2,572 1 2,572 0.16 (10 minutes) ......... 412 

Tobacco Product Listing; Form FDA 3742 Listing 

of Ingredients (Electronic and Paper submissions); section 904(a)(1).

1 1 1 2 .................................... 2 

Tobacco Product Listing; Form FDA 3742 Listing 

of Ingredients (Electronic and Paper submissions); section 904(c).

35 10 350 0.40 (24 minutes) ......... 140 

Obtaining a Dun and Bradstreet (D–U–N–S) 

Number.

100 1 100 0.5 (30 minutes) ........... 50 

Total ............................................................... ........................ ........................ ........................ ....................................... 764 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The PRA burden estimates have been 

updated to fully incorporate the use of 

an electronic system known as Tobacco 

Registration & Product Listing Module 

Next Generation (TRLM NG) for 

submitting registration and product 

listing information to FDA. With the 

TRLM NG, manufacturers can enter 

information quickly and easily. For 

example, product label pictures can be 

uploaded directly. We anticipate that 

most, if not all companies, already have 

electronic versions of their labels for 

printing, sales, or marketing purposes. 

Product listing information is 

provided at the time of registration. 

Currently, registration and listing 

requirements only apply to domestic 

establishments engaged in the 

manufacture, preparation, 

compounding, or processing of a 

tobacco product. This includes 

importers to the extent that they engage 

in the manufacture, preparation, 

compounding, or processing of a 

tobacco product, including repackaging 

or otherwise changing the container, 

wrapper, or labeling of any tobacco 

product package. Foreign 

establishments are not required to 

register and list until FDA issues 

regulations establishing such 

requirements in accordance with section 

905(h) of the FD&C Act. To account for 

the foregoing, we include both domestic 

manufacturing establishments and 

importers in our estimates. 

As the deadline for initial 

establishment registration and product 

listing for both statutorily regulated and 

deemed products has passed, FDA 

estimates that few (up to 100) new 

establishments will submit 1 initial 

establishment registration and product 

listing report each year. Such new 

establishments potentially include new 

vape shop locations that mix or 

assemble tobacco products on the 

market as of the final deeming rule 

effective date. The Agency estimates 

that up to 100 tobacco establishments 

will each submit 1 initial establishment 

registration and product listing report 

each year, which is expected to take 1.6 

hours, for a total 160 burden hours. 

FDA estimates that the confirmation 

or updating of establishment registration 

and product listing information as 

required by section 905 of the FD&C Act 

will take 10 minutes annually per 

confirmation or update per 

establishment. Based on FDA’s 

experience with current establishment 

registration and product listings 

submitted to the Agency, the Agency 

estimates that on average 2,572 

establishments will each submit 1 

confirmation or updated report each 

year, which is expected to take 0.16 

hours (10 minutes) for a total 412 

burden hours. 

FDA estimates that the submission of 

ingredient listings required by section 

904(a)(1) of the FD&C Act for each 

establishment will take 2 hours initially. 

We expect all section 904(a)(1) tobacco 

ingredient submissions to have been 

received prior to November 8, 2018, and 

for small manufacturers and large 

manufacturers, May 8, 2018. While all 

manufacturers have been expected to 

submit 904(a)(1) tobacco ingredient 

submissions, there may be a small 

number of firms that have missed this 

deadline. We are estimating 

approximately three manufacturers may 

have missed their deadline. This is 

based on estimates of how many late 

submissions FDA has received after the 

deadline. Because this burden estimate 

covers 3 years, we are dividing by 3, to 

yield one respondent as a yearly average 

for this estimate. Therefore, FDA 


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Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices 4625 

1For example, collections that collect PII to 

provide remuneration for participants of focus 

groups and cognitive laboratory studies will be 

submitted under this request. All Privacy Act 

requirements will be met. 

2As defined in OMB and Agency Information 

Quality Guidelines, ‘‘influential’’ means that ‘‘an 

agency can reasonably determine that 

dissemination of the information will have or does 

have a clear and substantial impact on important 

public policies or important private sector 

decisions.’’ 

estimates that one establishment will 

initially submit one report annually at 2 

hours per report, for a total of 2 hours. 

Submissions under section 904(c) of 

the FD&C Act are for any new product 

that is not yet on the market (e.g., if on 

the market due to deeming compliance 

period), deemed product manufacturers 

should have submitted under section 

904(a)(1) of the FD&C Act. This includes 

any statutorily regulated product that 

would receive a marketing authorization 

and any new deemed product not 

subject to the deeming compliance 

period. For deemed product categories, 

while we anticipate receiving a large 

number of premarket applications, there 

is a portion of these applicants who will 

have reported their ingredients under 

section 904(a)(1) of the FD&C Act as 

most of these submissions are expected 

to be for products subject to the 

deeming compliance period. 

Based on FDA’s experience and the 

number of new products authorized to 

be introduced or delivered for 

introduction into interstate commerce 

submitted over the past 3 years, FDA 

estimates that 35 establishments will 

each submit 10 reports (1 every 6 

months). FDA also estimates that the 

confirmation or updating of product 

(ingredient) listing information 

(required by section 904(c) of the FD&C 

Act) is expected to take 0.40 hours (24 

minutes) for a total 140 burden hours. 

FDA estimates that obtaining a data 

universal numbering system (DUNS) 

number will take 30 minutes. FDA 

assumes that all new establishment 

facilities that will be required to 

initially register under section 905 of 

the FD&C Act would obtain a DUNS 

number. FDA estimates that up to 100 

establishments that would need to 

obtain this number each year. The total 

industry burden to obtain a DUNS 

number is 50 hours. 

FDA estimates the total burden for 

this collection to be 764 hours. We have 

adjusted our burden estimate, which has 

resulted in a decrease of 66 hours to the 

currently approved burden. Based on 

data we reviewed from the past 3 years, 

we note a decrease in the number of 

establishments submitting a renewal 

registration listing, an increase of the 

number of applications received for 

deemed products and potential 

modifications to those, and by 

projecting the number of remaining 

establishments that have not registered 

and submitted product ingredient 

listings, we revised the number of 

respondents and burden hours in this 

information collection. 

Dated: January 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01798 Filed 1–27–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3037] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Generic Clearance 

for Quantitative Testing for the 

Development of Food and Drug 

Administration Communications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(PRA). 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

28, 2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0865. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Generic Clearance for Quantitative 

Testing for the Development of FDA 

Communications 

OMB Control Number 0910–0865— 

Extension 

This notice requests extension of 

OMB approval of the FDA information 

collection for a generic clearance that 

allows FDA to use quantitative social/ 

behavioral science data collection 

techniques (i.e., surveys and 

experimental studies) to test consumers’ 

reactions to FDA communications or 

educational messaging about FDAregulated food and cosmetic products, 

dietary supplements, and animal food 

and feed. To ensure that 

communications activities and 

educational campaigns have the highest 

potential to be received, understood, 

and accepted by those for whom they 

are intended, it is important to assess 

communications while they are under 

development. Understanding 

consumers’ attitudes, motivations, and 

behaviors in response to potential 

communications and education 

messaging plays an important role in 

improving FDA’s communications. 

If the following conditions are not 

met, FDA will submit an information 

collection request to OMB for approval 

through the normal PRA process: 

• The collections are voluntary; 

• The collections are low burden for 

participants (based on considerations of 

total burden hours, total number of 

participants, or burden hours per 

participant) and are low cost for both 

the participants and the Federal 

Government; 

• The collections are 

noncontroversial; 

• Personally identifiable information 

(PII) is collected only to the extent 

necessary 1 and is not retained; 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 2

and 

• Information gathered will yield 

qualitative findings; the collections will 

not be designed or expected to yield 

statistical data or used as though the 

results are generalizable to the 

population of study. 


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