Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 26209 

In the Federal Register of November 

22, 2021 (86 FR 66315), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

communicating general support for the 

information collection. Although the 

comment suggested the Agency’s 

burden estimate may be too low, no 

figures were provided. 

We estimate 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 

Administrative detention reporting requirements—800.55(g) and (h) .................. 1 1 1 25 25 

Banned devices reporting requirements—895.21(d)(8) and 895.22(a) ................ 26 1 26 16 416 

Total ............................................................................................................... ........................ ........................ ........................ ........................ 441 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Records regarding device adulteration or misbranding and records of distribution of detained devices—800.55(k) .................................................................. 1 1 1 20 20 

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

During the past several years, there 

has been an average of less than one 

new administrative detention action per 

year. Each administrative detention will 

have varying amounts of data and 

information that must be maintained. 

Administrative Detention Reporting— 

§ 800.55(g)(1) and (2): A person who 

would be entitled to claim the devices, 

if seized, may appeal a detention order 

by submitting a written request to the 

FDA District Director in whose district 

the devices are located. This written 

appeal could include a request for an 

informal hearing as defined in section 

201(y) of the FD&C Act (21 U.S.C. 

321(y)). In some cases, the appellant 

must include documents showing that 

that person has the legal right to appeal 

this order. 

Movement of Detained Devices— 

§ 800.55(h)(2): If detained devices are 

not in final form for shipment, the 

manufacturer may move them within 

the establishment where they are 

detained to complete the work needed 

to put them in final form. As soon as the 

devices are moved for this purpose, the 

individual responsible for their 

movement shall orally notify the FDA 

representative who issued the detention 

order, or another responsible district 

office official, of the movement of the 

devices. As soon as the devices are put 

in final form, they shall be segregated 

from other devices, and the individual 

responsible for their movement shall 

orally notify the FDA representative 

who issued the detention order, or 

another responsible district office 

official, of their new location. The 

devices put in final form shall not be 

moved further without FDA approval. 

Administrative Detention 

Recordkeeping—§ 800.55(k): The firm 

shall have, or establish, and maintain 

records relating to how the detained 

devices may have become adulterated or 

misbranded, records on any distribution 

of the devices before and after the 

detention period, records on the 

correlation of any in-process detained 

devices that are put in final form, 

records of any changes in, or process of, 

the devices permitted under the 

detention order, and records of any 

movement of the detained devices. 

Procedures for Banned Devices 

Informal Hearing Request— 

§ 895.21(d)(8): Section 895.21(d) 

describes the procedures for banning a 

device when the Commissioner decides 

to initiate such a proceeding. Under 

§ 895.21(d), the Commissioner may 

decide to initiate a proceeding to make 

a device a banned device. In that event, 

any interested persons may submit 

written comments and request an 

informal hearing within 30 days after 

the date of the publication of the 

proposed regulation. 

Banned Devices Reporting— 

§ 895.22(a): A manufacturer, distributor, 

or importer of a device may be required 

to submit to FDA all relevant and 

available data and information to enable 

the Commissioner to determine whether 

the device presents substantial 

deception, unreasonable and substantial 

risk of illness or injury, or unreasonable, 

direct, and substantial danger to the 

health of individuals. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: April 27, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09455 Filed 5–2–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0125] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Establishing That a 

Tobacco Product Was Commercially 

Marketed in the United States as of 

February 15, 2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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 June 2, 

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 


lotter on DSK11XQN23PROD with NOTICES1
26210 Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 

1FDA changed the term from ‘‘grandfathered 

tobacco product’’ to ‘‘Pre-Existing Tobacco 

Product’’ in the recently published final SE (86 FR 

55224) and PMTA (86 FR 55300) rules because it 

more appropriately describes these products by 

using the more precise term ‘‘Pre-Existing’’ in place 

of ‘‘grandfathered.’’ 

by using the search function. The OMB 

control number for this information 

collection is 0910–0775. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007 

OMB Control Number 0910–0775— 

Extension 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) authorizes FDA to 

regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Tobacco products are governed by 

chapter IX of the FD&C Act (sections 

900 through 920) (21 U.S.C. 387 through 

21 U.S.C. 387u). Section 910 of the 

FD&C Act (21 U.S.C. 387j) provides for 

the submission of applications for 

review of certain tobacco products. New 

tobacco products are those products, 

including those products in test 

markets, not commercially marketed in 

the United States as of February 15, 

2007, or where the modified tobacco 

product was commercially marketed in 

the United States after February 15, 

2007 (section 910(a)(1) of the FD&C 

Act). 

To assist new tobacco product 

manufacturers with requirements in 

section 910 of the FD&C Act, we 

developed the guidance document 

entitled, ‘‘Establishing That a Tobacco 

Product Was Commercially Marketed in 

the United States as of February 15, 

2007’’ (https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/establishing-tobaccoproduct-was-commercially-marketedunited-states-february-15-2007). The 

guidance provides information on how 

a manufacturer may establish that a 

tobacco product was commercially 

marketed in the United States as of 

February 15, 2007. The guidance 

includes a description of the types of 

evidence FDA recommends that the 

manufacturer submit to demonstrate 

that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. Examples 

of such information may include, but 

are not limited to, the following: Dated 

copies of advertisements, dated catalog 

pages, dated promotional material, and 

dated bills of lading. The guidance also 

provides instruction on how to submit 

a request for a Pre-Existing Tobacco 

Product status review (Section III.B.).1

As discussed in the guidance, 

electronic submission is not required, 

although we strongly encourage 

electronic submission via FDA’s 

Electronic Submissions Gateway (ESG) 

using FDA’s eSubmitter tool. FDA’s ESG 

system requires users to apply for a free 

account before submitting data, a 

process which can take 1 to 3 weeks to 

complete. Once approved, the user can 

send all submissions to CTP using the 

eSubmitter tool and FDA ESG. 

Instructions on obtaining an ESG 

account are available at https://

www.fda.gov/industry/electronicsubmissions-gateway/create-esgaccount. Alternatively, respondents can 

mail submissions to FDA, as instructed 

in the guidance. 

In the Federal Register of December 9, 

2021 (86 FR 70139), 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

Activity; guidance document Sec. III.B Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Submit evidence of commercial marketing in the United 

States as of February 15, 2007 ....................................... 1,000 1 1,000 5 5,000 

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

FDA’s estimate of the number of 

respondents is based on the fact that 

submissions are voluntary and also on 

the pre-existing status of a tobacco 

product submissions received. The 

number of hours to gather the evidence 

is FDA’s estimate of how long it might 

take a manufacturer to review, gather, 

and submit dated information if making 

a request for Agency determination. 

FDA further estimates it would take a 

manufacturer approximately 5 hours to 

put together this collection of evidence 

and to submit the package to FDA for 

review. FDA estimates that it would 

take approximately 5,000 hours 

annually to respond to this collection of 

information. 

Dated: April 27, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09434 Filed 5–2–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4428] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medicated Feed 

Mill License Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 


lotter on DSK11XQN23PROD with NOTICES1