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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-N-2889]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) 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 December 26, 2024.
 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 0910-0879. Also include the FDA docket number found in brackets in the heading of this document.
 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Premarket Tobacco Product Applications and Recordkeeping Requirements OMB Control Number 0910-0879—Revision This information collection supports FDA regulations. Tobacco products are governed by chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920) (21 U.S.C. 387 through 21 U.S.C. 387t). Section 910(a) established requirements for premarket review of new tobacco products. The Consolidated Appropriations Act of 2022 (the Appropriations Act), that was enacted on March 15, 2022, amended the definition of the term “tobacco product” in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) to include products that contain nicotine from any source. As a result, non-tobacco nicotine (NTN) products that were not previously subject to the FD&C Act (
                    *e.g.,*
                     products containing synthetic nicotine) are now subject to all of the tobacco product provisions in the FD&C Act beginning on April 14, 2022, including the requirement of premarket review for new tobacco products. The Appropriations Act also makes all rules and guidances applicable to tobacco products apply to NTN products on that same effective date. Additionally, the Appropriations Act includes a transition period for premarket review requirements, directing companies to submit premarket tobacco product applications (PMTAs) for NTN products by May 14, 2022, to receive an additional 60-day period of marketing without being considered in violation of premarket review requirements. The PMTAs and Recordkeeping Requirements regulation (21 CFR 1114.45 (§ 1114.45)) outlines requirements for the content, format, submission, and review of PMTAs, as well as other requirements related to PMTAs, including recordkeeping requirements, and postmarket reporting. FDA also requires recordkeeping regarding the legal marketing of Pre-Existing Tobacco Products (
                    *i.e.,*
                     those products that were commercially marketed as of February 15, 2007) and products that are exempt from the requirements of demonstrating substantial equivalence. Section 910(a)(2) of the FD&C Act requires that a new tobacco product be the subject of a PMTA marketing granted order unless FDA has issued an order finding it to be substantially equivalent to a predicate product or exempt from the requirements of demonstrating substantial equivalence. An applicant may submit a PMTA to demonstrate that a new tobacco product meets the requirements to receive a marketing granted order. A new tobacco product may not be introduced or delivered for introduction into interstate commerce under FDA regulations until FDA has issued a marketing granted order for the product (21 CFR 1114.5 (§ 1114.5)). Further, 21 CFR 1114.7 (§ 1114.7) describes the required content and format of the PMTA. The PMTA must contain sufficient information for FDA to determine whether any of the grounds for denial specified in section 910(c)(2) of the FD&C Act apply. The application must contain the following sections: general information, descriptive information, product samples, labeling, a statement of compliance with 21 CFR part 25, a summary, product formulation, manufacturing, health risk investigations, effect on the population as a whole, and a certification statement. Submitters can visit the following web page, which describes the process for submitting a PMTA (
                    *https://www.fda.gov/​tobacco-products/​market-and-distribute-tobacco-product/​premarket-tobacco-product-applications*). FDA has three forms required for use under §§ 1114.7(b) and 1114.9(a) (21 CFR 1114.9(a)) when submitting PMTA information to the Agency: Form FDA 4057; Form FDA 4057a; and Form FDA 4057b. Form FDA 4057 is for use when submitting PMTA single and bundled submissions. For the purposes of this notice, no significant changes have been made to Form FDA 4057. Form FDA 4057a is for use when firms are submitting amendments and other general correspondence. Form FDA 4057a and the corresponding instructions have been updated to assist industry users in completing the form efficiently and correctly. The flow and organization of the form have been updated to follow a consistent style and sequence with Form FDA 4057. Form FDA 4057a instructions have been updated to reflect plain language principles as well as accurately mapped to correspond to the updates made to Form FDA 4057a. 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). Form FDA 4057b has been updated to add the following columns: Brand; Subbrand; Manufacturer. This update aligns with the requirements of part 1114 (21 CFR part 1114). Additionally, Characterizing Flavor has been included as a required field. The Center for Tobacco Products (CTP) is planning a significant upgrade to the submission process for PMTA applications. This upgrade, known as the CTP Portal Next Generation (CTP Portal NG), is a pivotal step forward in streamlining the application process for the tobacco industry. Presently, the tobacco industry uses multiple tools in the preparation and submission of PMTA applications to CTP, including PDF-editing software, FDA's eSubmitter 
                    ( print page 93301)
                    Desktop Tool, and FDA's CTP Portal web application. A submitter must first download and complete PDF versions of FDA Form 4057 and/or 4057a for PMTA applications and amendments, respectively, using any PDF-editing software. After the PDF form is complete, the tobacco industry uses the eSubmitter Desktop tool (
                    *https://www.fda.gov/​industry/​fda-esubmitter/​using-esubmitter-prepare-tobacco-product-submissions*) to prepare the submission for delivery to CTP, which requires creating a new submission using eSubmitter's electronic CTP Transmittal Form and providing contact information, the completed FDA Form 4057 and/or 4057a, and any supporting documentation. When complete, the eSubmitter tool then packages the submission form, data, and documents into a ZIP file, saved locally, and the tobacco industry must log into their CTP Portal account (
                    *https://www.fda.gov/​tobacco-products/​manufacturing/​submit-documents-ctp-portal*) and upload the packaged submission ZIP file. To use the CTP Portal, an organization must first go through the process of setting up an Industry Account Manager (IAM) (
                    *https://www.fda.gov/​tobacco-products/​manufacturing/​request-industry-account-manager-iam-ctp-portal*), which will then allow the IAM to manage CTP Portal accounts for their organization and submit submissions. The new CTP Portal NG application transforms this process by providing the tobacco industry with the ability to create, prepare, and deliver their submissions in one place. CTP Portal NG will provide web forms of the FDA Forms 4057 and 4057a for PMTA applications and amendments, respectively, which will improve the submission preparation process for the tobacco industry as it will provide tools to expedite the entry of data and supporting documentation, dynamically guide users to relevant sections of the forms based on their input, and improve quality by providing helpful information on the questions being requested and verifying all required data has been provided. CTP Portal NG has a built-in process for applicants to upload Form FDA 4057b after applicants complete Form FDA 4057b and validate it using a new validator tool. When complete, CTP Portal NG allows applicants to submit the completed web forms to CTP for review. This innovation eliminates the current three-step process using PDF-editing software, eSubmitter, and CTP Portal, and provides a more integrated and user-friendly experience. Existing CTP Portal user accounts will be migrated to CTP Portal NG. Users may be prompted for a password reset during their initial login to the new system. The process for creating new user accounts and overall user account management will largely remain consistent with the current system. CTP is committed to ensuring a smooth transition to CTP Portal NG and will provide necessary support and guidance throughout this change. After submission of a PMTA, FDA may request, and an applicant may submit, an amendment to a pending PMTA. FDA generally expects that when an applicant submits a PMTA, the submission will include all information required by section 910(b)(1) of the FD&C Act and part 1114 to enable FDA to determine whether it should authorize the marketing of a new tobacco product. However, FDA recognizes that additional information may be needed to complete the review of a PMTA and, therefore FDA allows the submission of amendments to a pending application. An applicant may transfer ownership of its PMTA at any time, including when FDA has yet to act on it. Section 1114.13 describes the steps that an applicant would be required to take when it changes ownership of a PMTA. This section is intended to facilitate transfers of ownership and help ensure that FDA has current information regarding the ownership of a PMTA. Supplemental PMTAs are an alternative format of submitting a PMTA (§ 1114.15). Applicants that have received a marketing granted order are able to submit a supplemental PMTA to seek marketing authorization for a new tobacco product that results from a modification or modifications to the original tobacco product that received the marketing granted order. FDA restricts the use of supplemental PMTAs to only changes that require the submission of limited information or revisions to ensure that FDA can efficiently review the application. If an applicant receives a marketing denial order, they may submit a resubmission to respond to the deficiencies outlined in the marketing denial order (§ 1114.17). A resubmission may be submitted 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. This application format allows an applicant to address the deficiencies described in a marketing denial order without having to undertake the effort of submitting a standard PMTA. The resubmission format is not available for PMTAs that FDA refused to accept, refused to file, canceled, or administratively closed, or that the applicant withdrew because FDA has not previously completed reviews of such applications upon which it can rely, and such applications may need significant changes to be successfully resubmitted. FDA requires applicants that receive a marketing granted order to submit postmarket reports. Postmarket reports determine or facilitate a determination of whether there may be grounds to withdraw or temporarily suspend a marketing granted order (§ 1114.41). Additionally, § 1114.41 describes the reports that FDA would require through this regulation; however, FDA may require additional reporting in an individual applicant's marketing granted order. Applicants are required to submit two types of postmarket reports after receiving a marketing granted order: periodic reports and adverse experience reports. Periodic reports are required to be submitted within 60 calendar days of the reporting date specified in the marketing granted order. FDA anticipates that the reports would be required on an annual basis, but FDA may require in a specific order that reports be made more or less frequently depending upon several factors. Applicants are also required to report all serious and unexpected adverse experiences associated with the tobacco product that have been reported to the applicant or of which the applicant is aware. The serious and unexpected adverse experience reports must be submitted to the CTP's Office of Science through the HHS Safety Reporting Portal (
                    *https://www.safetyreporting.hhs.gov/​*) within 15 calendar days after receiving or becoming aware of a serious or unexpected adverse experience. FDA's Safety Reporting Portal is approved under OMB control number 0910-0291. Applicants receiving a marketing granted order are required to maintain all records necessary to facilitate a determination of whether there are or may be grounds to withdraw or temporarily suspend the marketing granted order, including records related to both the application and postmarket reports, and ensure that such records remain readily available to FDA upon request (§ 1114.45). Under § 1114.45(a)(1), an applicant must also retain any additional documentation supporting the application and postmarket reports that was not submitted to FDA. Section 1114.49 requires an applicant to submit a PMTA and all supporting 
                    ( print page 93302)
                    and related documents to FDA in electronic format. Under § 1114.49(c), an applicant that has a waiver would submit a paper submission to the address that FDA provides in the letter granting the waiver. Submitters can visit the following web page, which describes the process for submitting a PMTA (
                    *https://www.fda.gov/​tobacco-products/​market-and-distribute-tobacco-product/​premarket-tobacco-product-applications*). In the 
                    **Federal Register**
                     of July 16, 2024 (89 FR 57907), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment responsive to the four information collection topics solicited and nine comments that were not responsive to those topics. (Comment) FDA should provide clarity around how Portal Next Generation will operate and hold a workshop to solicit feedback from regulated industry prior to its implementation. In addition, FDA should focus on other PMTA process reforms that can have an even greater impact on efficiency. (Response) Thank you for your detailed comments in response to the 
                    **Federal Register**
                     Notice regarding the proposed information collection for PMTA reports and associated recordkeeping requirements. We appreciate your engagement and value your feedback on the planned upgrade to the submission process through the CTP Portal NG. The purpose of the 
                    **Federal Register**
                     Notice was to introduce modifications to the FDA Form 4057a and to inform stakeholders that FDA Forms 4057 and 4057a would be made available as web-based forms through the new CTP Portal NG. The wireframes provided in the Notice were intended to serve as an approximate representation of the planned web-form fields and workflow specifically associated with the new 4057 and 4057a web forms for public comment, and as such, do not detail all the planned functionality for CTP Portal NG nor do they represent the final versions of the forms. The CTP acknowledges and agrees with the need for further clarity regarding the implementation and functionality of CTP Portal NG. To address these concerns, CTP will provide the regulated industry, and other stakeholders, an opportunity to engage directly with the new system, navigate the platform, and offer substantive feedback on the workflow and usability of the new Portal. Additionally, we would like to clarify that PMTAs submitted under the current system will be seamlessly integrated into the new platform. The intent of CTP Portal NG is to streamline and enhance the efficiency of the submission process by providing web-based forms that simplify data entry, minimize the need for multiple tools, and support the submission of required information in a structured manner. CTP looks forward to engaging with our industry partners and will take all feedback into consideration to ensure that the final implementation of CTP Portal NG meets the needs of the regulated community while fulfilling CTP's regulatory and statutory obligations. FDA is also actively working on improving the application review process. As new processes are developed, FDA is committed to transparency with industry and other stakeholders. CTP Portal NG is in line with our intent to improve application review. It helps the applicant provide information required by the Premarket Tobacco Product Applications and Recordkeeping Requirements regulations in an identifiable format. Additionally, the guidance provided in CTP Portal NG will reduce applicant burden by highlighting missing information in fields that contain required content prior to submission and providing applicants with an opportunity to include missing content. FDA estimates the burden of this collection of information as follows: 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 hours1114.5; Submission of Standard Bundled PMTAs 2
215
1
215
1,713
368,295PMTA Submission; Form FDA 4057
215
1
215
0.58 (35 minutes)
125PMTA Amendment and General Correspondence Submission; Form FDA 4057a
80
4
320
0.16 (10 minutes)
51PMTA Unique Identification for New Tobacco Products; Form FDA 4057b
215
1
215
0.58 (35 minutes)
125Tobacco Product Grouping Spreadsheet Validator
215
1
215
0.08 (5 minutes)
171114.41; Reporting Requirements (periodic reports)
10
3
30
50
1,5001114.9; Amendments
24
2
48
188
9,0241114.13; Change in Ownership
10
1
10
1
101114.15; Supplemental applications
2
1
2
428
8561114.17; Resubmissions
5
1
5
565
2,8251114.49(b) and (c); Waiver from Electronic Submission
1
1
1
0.25 (15 minutes)
1Total


1,276

382,8281
                         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 hours1114.45; PMTA records
215
1
215
2
4301100.204; Pre-existing products records
1
1
1
2
21107.3; Exemptions from Substantial Equivalence (SE) records
1
1
1
2
2Total


217

4341
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Table 2 describes the annual recordkeeping burden. FDA estimates that 215 recordkeepers will maintain records at 2 hours per record. Included in this estimate are the 15 expected recordkeepers of NTN products. Firms are also required to establish and maintain records related to SE exemption requests and pre-existing products. We expect the burden hours to be negligible for SE exemption requests. Firms would have already established the required records when submitting the SE exemption request. Similarly, we expect the hours to be negligible for any pre-existing tobacco products that have already submitted stand-alone pre-existing tobacco product submissions, because firms would have established the required records when submitting the stand-alone pre-existing tobacco product submissions. We estimate that it would take 2 hours per record to establish the required records for a total of 4 hours for pre-existing products records and SE exemptions. Our estimated burden for the information collection reflects an overall increase of 369,555 hours and a corresponding increase of 1,302 responses/records. We attribute this to the validator tool and reevaluating our current estimates. Dated: November 20, 2024. P. Ritu Nalubola, Associate Commissioner for Policy.


[FR Doc. 2024-27655 Filed 11-25-24; 8:45 am] BILLING CODE 4164-01-P