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
Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 42489 

Kit. FDA revoked this Authorization 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). The 

revocation, which includes an 

explanation of the reasons for 

revocation, is reprinted in this 

document. 

DATES: The Authorization for the 

ScienCell SARS–CoV–2 Coronavirus 

Real-time RT–PCR (RT–qPCR) Detection 

Kit is revoked as of June 7, 2022. 

ADDRESSES: Submit a written request for 

a single copy of the revocation to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the 

revocation may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocation. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

240–402–8155 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On April 

3, 2020, FDA issued an EUA to 

ScienCell for the ScienCell SARS–CoV– 

2 Coronavirus Real-time RT–PCR (RT– 

qPCR) Detection Kit, subject to the terms 

of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

June 5, 2020 (85 FR 34638), as required 

by section 564(h)(1) of the FD&C Act. 

Subsequent updates to the 

Authorization were made available on 

FDA’s website. The authorization of a 

device for emergency use under section 

564 of the FD&C Act may, pursuant to 

section 564(g)(2) of the FD&C Act, be 

revoked when the criteria under section 

564(c) of the FD&C Act for issuance of 

such authorization are no longer met 

(section 564(g)(2)(B) of the FD&C Act), 

or other circumstances make such 

revocation appropriate to protect the 

public health or safety (section 

564(g)(2)(C) of the FD&C Act). 

II. EUA Revocation Request 

In a request received by FDA on June 

2, 2022, ScienCell requested revocation 

of, and on June 7, 2022, FDA revoked, 

the Authorization for the ScienCell 

SARS–CoV–2 Coronavirus Real-time 

RT–PCR (RT–qPCR) Detection Kit. 

Because ScienCell notified FDA that 

ScienCell decided to discontinue 

distribution of the ScienCell SARS– 

CoV–2 Coronavirus Real-time RT–PCR 

(RTqPCR) Detection Kit and requested 

FDA revoke the EUA for the ScienCell 

SARS-CoV–2 Coronavirus Real-time 

RT–PCR (RT–qPCR) Detection Kit, FDA 

has determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocation is available on the internet at 

https://www.regulations.gov/. 

IV. The Revocation 

Having concluded that the criteria for 

revocation of the Authorization under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUA of 

ScienCell for the ScienCell SARS–CoV– 

2 Coronavirus Real-time RT–PCR 

(RTqPCR) Detection Kit. The revocation 

in its entirety follows and provides an 

explanation of the reasons for 

revocation, as required by section 

564(h)(1) of the FD&C Act. 


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42490 Federal Register / Vol. 87, No. 135 / Friday, July 15, 2022 / Notices 

Dated: July 8, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–15160 Filed 7–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Molecular 

and Cellular Aspects of Obesity and 

Metabolic Disease. 


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