2024-27654. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Equivalence Reports for Tobacco Products

Table 1—Estimated Annual Reporting Burden  ^1 3

Activity; FDA form; 21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
SE Report—1107.18	1,139	1	1,139	300	341,700
SE Report where applicant provides certification for identical characteristics—1107.18(g) and 1107.18(l)(2)	431	1	431	10	4,310
Form FDA 3965—Tobacco Substantial Equivalence Report Submission	1,570	1	1,570	0.75 (45 minutes)	1,178
( print page 93307)
Form FDA 3965a 2 —Tobacco Amendment and General Correspondence Report	628	1	628	0.16 (10 minutes)	100
Form FDA 3965b—SE Unique Identification for New and Predicate Tobacco Products	1,570	1	1,570	1	1,570
SE Grouping Spreadsheet Validator	1,570	1	1,570	0.08 (5 minutes)	126
Waiver from Electronic submission—1107.62(b)	5	1	5	0.25 (15 minutes)	1
Totals			6,913		348,985
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  Formerly Form FDA 3964, Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission.
3  Totals may not sum due to rounding.

FDA has based these estimates on experience with this information collection, information we have available from interactions with industry, registration and listing data, information related to other regulated products, and FDA expectations regarding the tobacco industry's use of the substantial equivalence pathway to market their products. We have revised our previous estimates based on these experiences. Utilizing registration and listing data for deemed tobacco products, the estimated annual number of SE Reports is expected to be 1,570.

When several full SE Reports contain identical content, these SE Reports may be bundled into a single submission. Similarly, SE Reports in which the characteristics of the products are certified as identical and the contents of the SE Reports are also identical, these may also be bundled. FDA anticipates the burden for an applicant to be generally the same if they submit bundled submissions or individual applications as such, both are captured under SE Reports. As mentioned previously, NTN products that were not previously subject to the FD&C Act ( e.g., products containing synthetic nicotine) are now subject to all tobacco product provisions in the FD&C Act beginning on April 14, 2022. Based on this new authority, we do not believe a change is needed in our burden estimates because FDA has received significantly fewer NTN SE Reports than anticipated.

Table 1 describes the annual reporting burden per the requirements in §§ 1107.18 and 1107.19. FDA estimates that we will receive 1,139 full initial SE Reports for a new tobacco product each year under § 1107.18 that take a manufacturer approximately 300 hours to prepare. We have consolidated our previous numbers in the burden chart of full and bundled SE Reports (683 and 456) to reach the 1,139 estimate. In addition, anyone submitting an SE Report is required to submit an environmental assessment prepared in accordance with 21 CFR 25.40 under § 1107.18(k). The burden for environmental reports has been included in the burden per response for each type of SE Report.

FDA estimates receiving 239 SE Reports where applicants provide a certification for some identical characteristics under §§ 1107.18(g) and 1107.18(l)(2). We also estimate receiving 192 bundled SE Reports where applicants provide a certification for some identical characteristics under §§ 1107.18(g) and 1107.18(l)(2) (other than the initial SE Report in the bundle). FDA anticipates the burden for an applicant to be generally the same if they submit bundled submissions or individual applications as such, both are captured under SE Report where applicant provides certification for identical characteristics. We believe that the number of SE Reports that include a certification will increase because applicants may certify that certain characteristics are identical in the new tobacco product and the predicate tobacco product. However, in the absence of specific information on how many more applicants might choose to certify, we are maintaining our previous estimates at this time. As certification statements and additional guidance are given by the Agency within Form FDA 3965, FDA expects applicants to submit less technical information. As a result, we expect applicants total burden hours per applications to decrease. Therefore, we have decreased the burden per response for these SE Reports.

Manufacturers are required to submit SE Reports electronically (§ 1107.62 (21 CFR 1107.62)). We estimate that it would initially take about 45 minutes per product to fill out the Form FDA 3965. However, for amendments, we estimate that filling out Form FDA 3965a will take 10 minutes as applicants can copy and paste from the first submission. Section 1107.62(b) also allows applicants to request a waiver from the electronic format requirement. Based on experience since implementing the Premarket Tobacco Product Application (PMTA) rule, FDA does not believe we will receive many waivers, so we have decreased the number of respondents to five respondents to acknowledge the option to submit a waiver. Consistent with our other application estimates for waivers, we believe it would take 0.25 hours (15 minutes) per waiver for a total of 1 hour.

FDA is revising this collection to include a new form (Form FDA 3965b) and a validator tool for Form FDA 3965b that will help applicants submit information for their SE Reports in the correct format. Form FDA 3965b assists industry and FDA in identifying the products that are the subject of a submission, particularly where an applicant groups multiple new tobacco products into a single submission. This includes grouping products that are from the same manufacturer or domestic importer and in the same product category and subcategory into a single submission. FDA discussed bundled submissions in the SE rule (86 FR 55224) and noted that FDA intends to consider information on each new tobacco product and its corresponding predicate tobacco product as a separate, individual SE Report as required under § 1107.18(c)(7), § 1107.18(g), and § 1107.19. By having the identifying information for products contained in an SE Report be more clearly organized within the required forms, FDA will be able to process and review the applications contained in a grouped submission more efficiently.

The form assists applicants in providing the unique identifying information for each product in single and grouped submissions of SE Reports. A respondent would utilize Form FDA ( print page 93308) 3965b once for each submission. We assume the submitter could include from 1 to 2,000 products in each Form FDA 3965b. Entering data for up to 2,000 rows can take approximately 4 hours on average per Form FDA 3965b for manual data entry. We reflect the average time of 60 minutes per response based on the assumption that we expect to receive an average of 25 bundled products per submission. Assuming 60 minutes per Form FDA 3965b for 1,570 applications, we estimate a total burden of 1,570 hours for this activity.

The FDA Tobacco Product Grouping Spreadsheet Validator (Validator) is a free software that validates the content of FDA product grouping spreadsheets such as “Form FDA 3965b—SE Unique Identification for New and Predicate Tobacco Products.” The Validator is available for voluntary use by the tobacco industry (sponsors, manufacturers, and importers) prior to submitting a product grouping spreadsheet to FDA.

The Validator allows industry users to validate product attributes in their product grouping spreadsheet with the defined and accepted product data standards and to make corrections as needed. If there are no errors found in a spreadsheet, the Validator will produce a certificate of completion that can be saved locally and included with the applicants FDA submission voluntarily. If errors are found during validation, the Validator will provide the applicants with the error at the end of each impacted row of the spreadsheet, allowing applicants to make necessary changes.

The software and any output files reside locally on an applicant's computer, allowing them to work on the product grouping spreadsheet offline. The Validator does not transmit any data across the web to FDA. FDA does not have the ability to access, review, or supplement the information on local computers through this application. We estimate that use of the Validator will take an average of 5 minutes per response.

Table 2—Estimated Annual Recordkeeping Burden ¹

Activity; 21 CFR section	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
Recordkeeping SE Report under 1107.18-1107.58	471	1	471	5	2,355
1  There are no capital costs or operating and maintenance costs associated with this collection of information.