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 


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Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 26211 

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 

by using the search function. The OMB 

control number for this information 

collection is 0910–0337. 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. 

Medicated Feed Mill License 

Application—21 CFR Part 515 

OMB Control Number 0910–0337— 

Extension 

Feed manufacturers that seek to 

manufacture a Type B or Type C 

medicated feed using Category II, Type 

A medicated articles or manufacture 

certain liquid and free-choice feed using 

Category I, Type A medicated articles 

that must follow proprietary formulas or 

specifications, are required to obtain a 

facility license under section 512 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360b). Our 

regulations in 21 CFR part 515 establish 

the procedures associated with applying 

for a facility license. We require that a 

manufacturer seeking a facility license 

submit a completed medicated feed mill 

license application using Form FDA 

3448 (21 CFR 515.10(b)). We use the 

information submitted to establish that 

the applicant has made the certifications 

required by section 512 of the FD&C 

Act, to register the mill and to schedule 

a preapproval inspection. 

We require the submission of a 

supplemental medicated feed mill 

license application for a change in 

facility ownership or a change in facility 

address (§ 515.11(b) (21 CFR 515.11(b))). 

If a licensed facility is no longer 

manufacturing medicated animal feed 

under § 515.23 (21 CFR 515.23), a 

manufacturer may request voluntary 

revocation of a medicated feed mill 

license. An applicant also has the right 

to file a request for hearing under 

§ 515.30(c) (21 CFR 515.30(c)) to give 

reasons why a medicated feed mill 

license should not be refused or 

revoked. 

Under § 510.305 (21 CFR 510.305) we 

require each applicant to maintain in a 

single accessible location: (a) A copy of 

the approved medicated feed mill 

license (Form FDA 3448) on the 

premises of the manufacturing 

establishment; and (b) approved or 

index listed labeling for each Type B 

and/or Type C feed being manufactured 

on the premises of the manufacturing 

establishment or the facility where the 

feed labels are generated. 

In the Federal Register of January 28, 

2022 (87 FR 4620), FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. Although two comments 

were received, the comments were not 

responsive to the four collection of 

information topics solicited. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section and activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Medicated Feed Mill License Application using Form FDA 3448 

(§ 515.10(b)).

5 1 5 0.25 (15 minutes) .... 1.25 

Supplemental Feed Mill License Application using Form FDA 3448 

(§ 515.11(b)).

14 1 14 0.25 (15 minutes) .... 3.5 

Voluntary Revocation of Medicated Feed Mill License (§ 515.23) ............. 15 1 15 0.25 (15 minutes) .... 3.75 

Filing a Request for a Hearing on Medicated Feed Mill License 

(§ 515.30(c)).

1 1 1 4 .............................. 4 

Total ..................................................................................................... ........................ ........................ ........................ .................................. 12.5 

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 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: April 27, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09462 Filed 5–2–22; 8:45 am] 

BILLING CODE 4164–01–P 


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