2024-27655. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements

Table 1—Estimated Annual Reporting Burden ^1 2 3

1 CFR part; activity; form FDA #	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
1114.5; Submission of Standard Bundled PMTAs 2	215	1	215	1,713	368,295
PMTA Submission; Form FDA 4057	215	1	215	0.58 (35 minutes)	125
PMTA Amendment and General Correspondence Submission; Form FDA 4057a	80	4	320	0.16 (10 minutes)	51
PMTA Unique Identification for New Tobacco Products; Form FDA 4057b	215	1	215	0.58 (35 minutes)	125
Tobacco Product Grouping Spreadsheet Validator	215	1	215	0.08 (5 minutes)	17
1114.41; Reporting Requirements (periodic reports)	10	3	30	50	1,500
1114.9; Amendments	24	2	48	188	9,024
1114.13; Change in Ownership	10	1	10	1	10
1114.15; Supplemental applications	2	1	2	428	856
1114.17; Resubmissions	5	1	5	565	2,825
1114.49(b) and (c); Waiver from Electronic Submission	1	1	1	0.25 (15 minutes)	1
Total			1,276		382,828
1  There are no capital costs or operating and maintenance costs associated with this collection of information.
2  FDA anticipates that applicants will submit bundled PMTAs, which are single submissions containing PMTAs for several similar or related products. We estimate that a bundle will contain on average between 6 and 11 distinct products.
3  Totals may not sum due to rounding.

Table 1 describes the estimated annual reporting burden. FDA has based these estimates on Agency experience with current PMTA submissions. FDA has based these estimates on experience with this information collection, information available from interactions with industry, and FDA expectations regarding established requirements for premarket review of new tobacco products. We have revised our previous estimates based on these experiences. In addition, FDA is revising this collection to incorporate the burden for PMTA submissions received under OMB control number 0910-0768 (which covers the burden for electronic nicotine delivery system (ENDS) products PMTA ( print page 93303) submissions). We believe the original PMTA burden in OMB control number 0910-0768 is now covered by the current PMTA process under this control number. Although that burden only covered ENDS products these estimates include all categories of products.

FDA estimates that we will receive 215 PMTAs for a new tobacco product each year under part 1114. Our average represents a wide range of hours that will be required for these applications under different circumstances, with some requiring more hours ( e.g., as many as 5,000 hours for early applications that involve complex products and for which the company has no experience conducting studies or preparing analysis of public health impacts, or for which reliance on master files is not possible) as well as many requiring fewer hours ( e.g., as few as 50 hours for applications for products that are very similar to other new products). FDA estimates that it will take each respondent approximately 1,500 hours to prepare a PMTA seeking an order from FDA allowing the marketing of a new tobacco product. FDA also estimates that it would on average take an additional 213 hours to prepare an environmental assessment (EA) in accordance with the requirements of 21 CFR 25.40, for a total of 1,713 hours per PMTA application.

FDA assumes that firms will submit all applications as PMTA bundles. We believe that bundling PMTAs results in efficiencies for applicants when compared to submitting stand-alone, full-text submissions for each product. We expect to receive bundled PMTAs where applicants can use the same evidence to support PMTAs for similar or related products. Bundling PMTAs into a single submission would eliminate the administrative burden of having to reproduce the same evidence in a stand-alone PMTA for each product.

FDA has three forms required for use under §§ 1114.7(b) and 1114.9(a) when submitting PMTA information to the Agency. Form FDA 4057 is for use when submitting PMTA single and bundled submissions. FDA estimates that 215 respondents will submit PMTA bundles using this form at 0.58 (35 minutes) per response. Included in this estimate are the 15 expected bundles submitted for NTN products. The number 215 is accounting for the bundles of ENDS products and the 1 bundle we expect to receive yearly for originally regulated products for a total of 125 hours.

Form FDA 4057a is for use when firms are submitting amendments and other general correspondence; as such, we expect 80 applicants to submit 4057a for either amendments or general correspondence submissions. Our estimate is 0.16 (10 minutes) per response to fill out this form. Included in this estimate are the 15 expected submissions submitted from NTN products. We estimate there will be at least four amendments per application for a total of 51 hours. With most applications being submitted toward the end of our 3-year range, we expect fewer amendments during this period. With updated forms and additional guidance given by the Agency, FDA expects applicants to submit more complete applications, reducing the need for the issuance of Deficiency letters and Environmental Information request letters. As a result, we expect applicants to submit fewer amendments with Form FDA 4057a. However, FDA expects amendments from earlier applications to be submitted during this period. As a result, we have decreased the number of responses per respondent (from 14 to 4 responses) associated with Form FDA 4057.

Form FDA 4057b assists industry and FDA in identifying the products that are the subject of a submission where an applicant groups multiple PMTAs into a single submission (referred to as a bundled submission or a grouped submission). FDA has previously stated that one approach to submitting PMTAs could be to group applications for products that are both from the same manufacturer or domestic importer and in the same product category and subcategory into a single submission. FDA intends to consider information on each tobacco product as a separate, individual PMTA as required under § 1114.7(c)(3)(iii). By having the identifying information for products contained in a submission 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. As a result, we decreased the average burden per response associated with the Form FDA 4057b by 10 minutes (from 45 to 35 minutes per response).

The form assists applicants in providing the unique identifying information for each product in a grouped submission of PMTAs. A respondent would utilize Form FDA 4057b once for each submission. We assume the submitter could include from 1 to 2,000 products in each Form FDA 4057b. Entering data for up to 2,000 rows can take approximately 4 hours on average per Form FDA 4057b for manual data entry. We reflect the average time of 35 minutes per response based on the assumption that we expect to receive an average of nine bundled products per submission. Included in this estimate are the 15 expected submissions submitted from NTN products. Assuming 35 minutes per Form FDA 4057b for 215 applications, we estimate a total burden of 125 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 “FDA 4057b—PMTA Unique Identification for New 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 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 to 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 the use of the validator tool will take an average of 5 minutes per response.

Applicants are required under § 1114.41 to submit two types of reports after receiving a marketing granted order: periodic reports and adverse experience reports. Applicants must submit periodic reports within 60 calendar days of the reporting date specified in the marketing granted order (or potentially sooner if they choose to use the application as the basis for a supplemental PMTA under § 1114.15). FDA anticipates that the reports will be required on an annual basis, but FDA may require, by a specific order, that reports be made more or less frequently depending upon a number of factors ( e.g., the novelty of the type of product). As such, FDA estimates under § 1114.41 that 10 respondents will submit a periodic report with 3 responses per respondent. This number is based on the average number of periodic report ( print page 93304) submissions received between 2020 and 2022. The Agency estimates that periodic reports will take on average of 50 hours per response for a total of 1,500 hours. FDA expects this number to increase as we continue to authorize more products in the PMTA pathway. As FDA continues to grant marketing authorization for more submissions, FDA expects the number of respondents and total responses to grow. As a result, we have increased the number of responses per respondent (from one to three responses per respondent) associated with periodic reports.

Section 1114.13 allows an applicant to transfer ownership of a PMTA to a new owner. FDA believes this will be infrequent, so we have assigned 1 hour acknowledging the requirement.

Section 1114.15 is an alternative format of submitting a PMTA, supplemental PMTA, meeting the requirements of § 1114.7 that would reduce the burden associated with the submission and review of an application. Our estimated number of 2 respondents is based on the number estimated for postmarket reports, which is 4 bundles (approximately 34 products). Not all applicants will resubmit modifications to previously authorized products, so we estimate 2 bundles (which is approximately 17 products). FDA estimates further that a supplemental PMTA will take 25 percent of the time it takes (estimated at 428 hours per response) to complete an original submission (including EA hours). We estimate a total of 856 burden hours for this activity.

Under § 1114.17 an applicant may submit a resubmission for the same tobacco product that received a marketing denial order or for a different new tobacco product that results from changes necessary to address the deficiencies outlined in a marketing denial order. Based on Agency experience, we are estimating that of all bundles received in 2020 through 2023, that an average of three bundles are authorized. If we receive 24 bundles yearly, and based on historical data, 58 percent fail at acceptance (8 bundles remaining), 17 percent fail at filing (7 bundles remaining), and 25 percent receive marketing orders (5 bundles remaining). We estimate that 50 percent will resubmit in a year. Thus, the number of respondents is three. FDA estimates that a resubmission will take 33 percent of the time it takes to complete an original submission (including EA hours) estimated at 565 hours per response for a total of 1,695 hours. As FDA continues to deny marketing authorization for more submissions FDA expects the number of respondents and total responses to grow.

Firms must also submit adverse experience reports (§ 1114.41(a)(2)) for tobacco products with marketing orders. We assume the same number of firms submitting periodic reports will submit adverse experience reports. Firms may submit voluntary and mandatory adverse experience reports using Form FDA 3800 under OMB control number 0910-0291.

Under § 1114.9 firms will prepare amendments to PMTA bundles in response to deficiency letters. These amendments contain additional information that we need to complete substantive review. We anticipate 2 responses back per bundle and therefore, we estimate that 24 respondents will submit 48 amendments (24 × 2). Assuming 1,500 hours as the time to prepare and submit a full PMTA and amendments may on average take 10 percent to 15 percent of that time (150-225 hours). We averaged this time out (12.5 percent of a full submission preparation time) and arrived at 188 hours per response. FDA estimates the total burden hours for preparing amendments is 9,024 hours.

An applicant is required to submit a PMTA and all supporting and related documents to FDA in electronic format that FDA can process, review, and archive unless an applicant requests, and FDA grants, a waiver from this requirement (§ 1114.49). FDA does not believe we will receive many waivers, so we have assigned one respondent 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.

Table 2—Estimated Annual Recordkeeping Burden ¹

21 CFR part; activity	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
1114.45; PMTA records	215	1	215	2	430
1100.204; Pre-existing products records	1	1	1	2	2
1107.3; Exemptions from Substantial Equivalence (SE) records	1	1	1	2	2
Total			217		434
1  There are no capital costs or operating and maintenance costs associated with this collection of information.