Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 42487 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Instructions for 

Use—Patient Labeling for Human 

Prescription Drug and Biological 

Products—Content and Format.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 201 have 

been approved under OMB control 

number 0910–0572; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

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

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: July 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–15161 Filed 7–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3031] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Tobacco Products, 

User Fees, Requirements for the 

Submission of Data Needed To 

Calculate User Fees for Domestic 

Manufacturers and Importers of 

Tobacco Products 

AGENCY: Food and Drug Administration, 

Health and Human Services (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. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by August 15, 

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 0910–0749. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonnalynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, 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. 

Tobacco Products, User Fees, 

Requirements for the Submission of 

Data Needed To Calculate User Fees for 

Domestic Manufacturers and Importers 

of Tobacco Products 

OMB Control Number 0910–0749— 

Extension 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (the 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) and granted FDA authority 

to regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect public health generally and to 

reduce tobacco use by minors. 

FDA issued a final rule on May 10, 

2016 (81 FR 28707) that requires 

domestic manufacturers and importers 

of cigars and pipe tobacco to submit 

information needed to calculate the 

amount of user fees assessed under the 

FD&C Act (https://www.govinfo.gov/ 

content/pkg/FR-2016-05-10/pdf/2016- 

10688.pdf). FDA expanded its authority 

over tobacco products by issuing 

another final rule entitled ‘‘Deeming 

Tobacco Products To Be Subject to the 

Federal Food, Drug, and Cosmetic Act, 

as Amended by the Family Smoking 

Prevention and Tobacco Control Act; 

Restrictions on the Sale and Distribution 

of Tobacco Products and Required 

Warning Statements for Tobacco 

Products’’ (Deeming rule; May 10, 2016, 

81 FR 28974), deeming all products that 

meet the statutory definition of ‘‘tobacco 

product,’’ except accessories of the 

newly deemed tobacco products, to be 

subject to the FD&C Act (https://

www.govinfo.gov/content/pkg/FR-2016- 

05-10/pdf/2016-10685.pdf). The 

Deeming rule, among other things, 

subjected domestic manufacturers and 

importers of cigars and pipe tobacco to 

the FD&C Act’s user fee requirements. 

Consistent with the Deeming rule and 

the requirements of the FD&C Act, the 

user fee final rule requires the 

submission of the information needed to 

calculate user fee assessments for each 

manufacturer and importer of cigars and 

pipe tobacco to FDA. 

As noted, FDA issued a final rule that 

requires domestic tobacco product 

manufacturers and importers to submit 

information needed to calculate the 

amount of user fees assessed under the 

FD&C Act. The U.S. Department of 

Agriculture (USDA) had been collecting 

this information and provided FDA with 

the data the Agency needed to calculate 

the amount of user fees assessed to 

tobacco product manufacturers and 

importers. USDA ceased collecting this 

information in fiscal year 2015 (October 

2014). USDA’s information collection 

did not require OMB approval, per an 

exemption by Public Law 108–357, 

section 642(b)(3). Consistent with the 

requirements of the FD&C Act, FDA 

requires the submission of this 

information to FDA. FDA took this 

action to ensure that the Agency 

continues to have the information 

needed to calculate, assess, and collect 


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42488 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 

user fees from domestic manufacturers 

and importers of tobacco products. 

Section 919(a) of the FD&C Act (21 

U.S.C. 387s(a)) requires FDA to ‘‘assess 

user fees on, and collect such fees from, 

each manufacturer and importer of 

tobacco products’’ subject to the tobacco 

product provisions of the FD&C Act 

(chapter IX of the FD&C Act). The total 

amount of user fees to be collected for 

each fiscal year is specified in section 

919(b)(1) of the FD&C Act and, under 

section 919(a), FDA is to assess and 

collect a proportionate amount each 

quarter of the fiscal year. The FD&C Act 

provides for the total assessment to be 

allocated among the classes of tobacco 

products. The class allocation is based 

on each tobacco product class’s volume 

of tobacco product removed into 

commerce. Within each class of tobacco 

products, an individual domestic 

manufacturer or importer is assessed a 

user fee based on its share of the market 

for that tobacco product class. 

To make reporting requirements for 

this collection easier for respondents, 

FDA offers respondents the ability to 

provide their user fee submission 

information via an electronic form 

(Form FDA 3852). To learn more about 

the electronic submission process and 

download Form FDA 3852 respondents 

may go to: https://www.fda.gov/tobaccoproducts/manufacturing/electronicsubmissions-tobacco-products. 

In the Federal Register of November 

19, 2021 (86 FR 64948), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

1150.5(a), (b)(1), and (2), and Form FDA 3852; General 

identifying information provided by manufacturers and 

importers of FDA regulated tobacco products and identification and removal information (monthly) ...................... 700 12 8,400 3 25,200 

1150.5(b)(3); Certified copies (monthly) .............................. 700 12 8,400 1 8,400 

1150.13; Submission of user fee information (identifying 

information, fee amount, etc.) (quarterly) ......................... 376 4 1,504 1 1,504 

1150.15(a); Submission of user fee dispute (annually) ....... 5 1 5 10 50 

1150.15(d); Submission of request for further review of 

dispute of user fee (annually) .......................................... 3 1 3 10 30 

Total .............................................................................. ........................ ........................ ........................ ........................ 35,184 

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

Recordkeeping burden hours for 

§ 1150.5(a) and (b), Form FDA 3852, and 

§ 1150.13 appearing in the notice 

published in the Federal Register on 

November 19, 2021, are obsolete due to 

fiscal year (FY) 2021 data. Table 1 of 

this document contains the updated 

estimates. 

FDA estimates that entities will 

submit tobacco product user fee reports 

for approximately 700 Alcohol and 

Tobacco Tax and Trade Bureau (TTB) 

permits in a given month. The permit 

count was derived from aggregate data 

of active permit holders provided by the 

TTB and reflects that in FY21, there was 

an average of 234 total permitted 

manufacturers and 466 permitted 

importers reporting tobacco user fees 

over all tobacco product types for which 

TTB assesses excise taxes (including 

cigarettes, cigars, snuff, chewing 

tobacco, pipe tobacco, and roll-yourown tobacco). 

FDA estimates it will take 3 hours for 

each of these submission types for a 

total of 25,200 hours annually. Under 

§ 1150.5(b)(3), these respondents are 

also expected to provide monthly 

certified copies of the returns and forms 

that relate to the removal of tobacco 

products into domestic commerce and 

the payment of Federal excise taxes 

imposed under chapter 52 of the 

Internal Revenue Code of 1986 to FDA. 

We estimate that each monthly report 

will take 1 hour for a total of 8,400 

hours annually. 

The estimate of 376 respondents 

required to submit payment of user fee 

information under § 1150.13 reflects an 

average across the 4 quarters for FY21 

assessments issued to entities. FDA 

estimates the quarterly submission will 

take approximately 1 hour for a total of 

1,504 hours annually. 

FDA estimates that five of those 

respondents assessed user fees will 

dispute the amounts under § 1150.15(a), 

for a total amount of 50 hours. FDA also 

estimates that three respondents who 

dispute their user fees will ask for 

further review by FDA under 

§ 1150.15(d), for a total amount of 30 

hours. FDA has received nine dispute 

submissions since fiscal year 2015. 

Based on this data, the Agency does not 

believe we will receive more than five 

disputes and three requests for further 

reviews in the next 3 years. 

FDA estimates the total annual 

burden for this collection of information 

is 35,184 hours. The estimated burden 

for the information collection reflects an 

overall decrease of 444 hours. We 

attribute this adjustment to a slight 

decrease in the number of entities 

submitting tobacco user fee information 

to FDA. 

Dated: July 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–15157 Filed 7–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0412] 

Revocation of Authorization of 

Emergency Use of an In Vitro 

Diagnostic Device for Detection and/or 

Diagnosis of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorization (EUA) (the Authorization) 

issued to ScienCell Research 

Laboratories (ScienCell) for the 

ScienCell SARS–CoV–2 Coronavirus 

Real-time RT–PCR (RT–qPCR) Detection 


jspears on DSK121TN23PROD with NOTICES1