Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 71873 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

80.21 and 80.22; Request for certification accompanied by sample.67 112 7,504 0.22 (13 minutes) .......... 1,651 

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; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

80.39; Record of distribution ................................ 67 112 7,504 0.25 (15 minutes) ......... 1,876 

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

We base our estimate on our review 

of the certification requests received 

over the past 3 years. Using information 

from industry personnel, we estimate 

that an average of 0.22 hour per 

response is required for reporting 

(preparing certification requests and 

accompanying samples) and an average 

of 0.25 hour per response is required for 

recordkeeping. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have slightly 

decreased our burden estimate based on 

our experience with this program. As a 

result, although the number of 

respondents increased, the number of 

responses per respondent decreased. 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22971 Filed 10–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4128] 

Guidance Documents Referencing PreExisting Tobacco Products; Guidance 

for Industry; Availability; Withdrawal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of revised final guidances 

for industry entitled ‘‘Demonstrating the 

Substantial Equivalence of a New 

Tobacco Product: Responses to 

Frequently Asked Questions,’’ and 

‘‘Establishing That a Tobacco Product 

Was Commercially Marketed in the 

United States as of February 15, 2007.’’ 

Following the issuance of the final rules 

entitled ‘‘Content and Format of 

Substantial Equivalence Reports; Food 

and Drug Administration Actions on 

Substantial Equivalence Reports’’ (SE) 

and ‘‘Premarket Tobacco Product 

Applications and Recordkeeping 

Requirements’’ (PMTA), FDA has made 

minor updates to these guidances for 

consistency with the terminology used 

in those rules. FDA is also announcing 

the withdrawal of the final guidances 

entitled ‘‘Section 905(j) Reports: 

Demonstrating Substantial Equivalence 

for Tobacco Products,’’ and 

‘‘Investigational Use of Deemed, 

Finished Tobacco Products That Were 

on the U.S. Market on August 8, 2016, 

During the Deeming Compliance 

Periods,’’ and a draft guidance entitled 

‘‘Substantial Equivalence Reports: 

Manufacturer Requests for Extensions or 

to Change the Predicate Tobacco 

Product,’’ which are obsolete due to the 

issuance of the SE final rule or the end 

of the compliance period for deemed, 

finished tobacco products that were on 

the U.S. market on August 8, 2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 18, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2023–D–4128 for ‘‘Guidance Documents 

Referencing Pre-Existing Tobacco 

Products.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 


ddrumheller on DSK120RN23PROD with NOTICES1
71874 Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 

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 

‘‘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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of these guidances to the Center 

for Tobacco Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993–0002. Send one self-addressed 

adhesive label to assist that office in 

processing your request or include a Fax 

number to which the guidances may be 

sent. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance 

documents. 

FOR FURTHER INFORMATION CONTACT: 

Natalie Gibson, Center for Tobacco 

Products, Food and Drug 

Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993–0002, 877–287–1373, email: 

CTPRegulations@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Pub. L. 111–31) (Tobacco 

Control Act) was signed into law. The 

Tobacco Control Act grants FDA 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect public health 

generally and to reduce tobacco use by 

youth. FDA is announcing the 

availability of revised final guidances 

for industry, collectively entitled 

‘‘Guidance Documents Referencing PreExisting Tobacco Products.’’ 

In the PMTA final rule (86 FR 55300, 

October 5, 2021) and the SE final rule 

(86 FR 55224, October 5, 2021), FDA has 

changed the term ‘‘grandfathered 

tobacco product’’ to ‘‘pre-existing 

tobacco product’’ because it more 

appropriately describes these products. 

Specifically, FDA considers a ‘‘preexisting tobacco product’’ to mean a 

tobacco product that was commercially 

marketed in the United States as of 

February 15, 2007. FDA also made other 

minor changes to the revised guidances 

to reflect updated terminology used in 

the SE final rule, when appropriate. 

Details of the changes are described in 

the revision history page included with 

each guidance. 

FDA is also withdrawing three 

guidances that are obsolete due to the 

issuance of the SE final rule or due to 

the end of the compliance period for 

deemed, finished tobacco products that 

were on the U.S. market on August 8, 

2016. The guidances along with their 

docket numbers and status are listed in 

table 1. 

TABLE 1—REVISED AND WITHDRAWN GUIDANCES

Title Docket No. Status 

Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.FDA–2011–D–0147 .... Revised. 

Establishing That a Tobacco Product Was Commercially Marketed in the United States as of 

February 15, 2007.

FDA–2011–D–0125 .... Revised. 

Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on 

August 8, 2016, During the Deeming Compliance Periods.

FDA–2016–D–3276 .... Withdrawn. 

Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products ............. FDA–2010–D–0635 .... Withdrawn. 

Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the 

Predicate Tobacco Product, Draft Guidance.

FDA–2014–D–0800 .... Withdrawn. 

The revised final guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115) and represent the current 

thinking of FDA on, among other things, 

the incorporation of the term ‘‘preexisting tobacco product.’’ They do not 

establish any rights for any person and 

are 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 these guidances contain no 

collections of information, they do refer 

to previously approved FDA collections 

of information. The previously 

approved collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501–3521). The 

collections of information in FDA’s 

guidance entitled ‘‘Establishing That a 

Tobacco Product Was Commercially 

Marketed in the United States as of 

February 15, 2007’’ have been approved 

under OMB control number 0910–0775. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

guidances at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/TobaccoProducts/ 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 200 / Wednesday, October 18, 2023 / Notices 71875 

Labeling/RulesRegulationsGuidance/ 

default.htm, or https:// 

www.regulations.gov. 

Dated: October 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22976 Filed 10–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3595] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Improving the 

Quality and Representativeness of the 

Treatment Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on a proposed 

information collection entitled 

‘‘Improving the Quality and 

Representativeness of the Treatment 

Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

December 18, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. eastern time at the end of 

December 18, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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– 

2023–N–3595 for ‘‘Improving the 

Quality and Representativeness of the 

Treatment Center Program Data—Data 

Modifications to the Current Survey 

Instrument Format to Minimize 

Misclassification.’’ 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 

‘‘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: 

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: 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 

before submitting the collection to OMB 

for approval. To comply with this 


ddrumheller on DSK120RN23PROD with NOTICES1