CFR Subpart C

CFR Subpart C
in effect

21 C.F.R. § 1107.16 Submission of a substantial equivalence report.

An applicant may submit an SE Report intended to demonstrate that a new tobacco product is substantially equivalent to a predicate tobacco product. The applicant must submit the SE Report at least 90 calendar days prior to the date the applicant intends to introduce or deliver for introduction a new tobacco product into interstate commerce for commercial distribution. The applicant cannot begin commercial distribution of the new tobacco product until FDA has provided the applicant an order stating that the Agency has determined that the new tobacco product is substantially equivalent to a predicate tobacco product, unless the new tobacco product has received authorization to be marketed through another premarket pathway.

21 C.F.R. § 1107.18 Required content and format of an SE Report.

(a) Overview. The SE Report must provide information uniquely identifying the new tobacco product and the predicate tobacco product, and compare the new tobacco product to either a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or a tobacco product that FDA previously found to be substantially equivalent. The SE Report must provide sufficient information as described in this section to enable FDA to determine whether the new tobacco product is substantially equivalent to a tobacco product that was commercially marketed (other than for test marketing) in the United States as of February 15, 2007. If FDA cites deficiencies and requests information to support a statement in the SE Report, the applicant must provide that information for review to continue, or FDA may issue an order under § 1107.48. FDA generally intends to refuse to accept an SE Report for review if it does not comply with § 1105.10 and this section. The SE Report must contain the following information: (1) General information (as described in paragraph (c) of this section); (2) Summary (as described in paragraph (d) of this section); (3) New tobacco product description (as described in paragraph (e) of this section); (4) Predicate tobacco product description (as described in paragraph (f) of this section), including a statement that the predicate tobacco product has not been removed from the market at the initiative of FDA and has not been determined by judicial order to be adulterated or misbranded, and the submission tracking number of the SE order finding the predicate product SE, or the submission tracking number of, or information to support, that the predicate tobacco product was commercially marketed (other than for test marketing) in the United States as of February 15, 2007; (5) Comparison information (as described in paragraph (g) of this section); (6) Comparative testing information (as described in paragraph (h) of this section); (7) Statement of compliance with applicable tobacco product standards (as described in paragraph (i) of this section); (8) Health information summary or statement that such information will be made available upon request (as described in paragraph (j) of this section); (9) Compliance with part 25 of this chapter (as described in paragraph (k) of this section); and (10) Certification statement (as described in paragraph (l) of this section). (b) Format. The applicant must submit the SE Report using the form(s) that FDA provides. The SE Report must contain a comprehensive index and table of contents, be well-organized and legible, and be written in English. As described in § 1107.62, the applicant must submit the SE Report and all information supporting the SE Report in an electronic format that FDA can process, read, review, and archive, unless FDA has provided a waiver under § 1107.62(b). (c) General information. The SE Report must include the following information, using the form FDA provides: (1) The date the SE Report is submitted; (2) Type of submission (e.g., the SE Report or amendment to a report); (3) FDA STN, if previously assigned; (4) Any other relevant FDA STN, such as a voluntary request for a determination that a tobacco product was commercially marketed in the United States as of February 15, 2007, or SE Report previously found substantially equivalent (if applicable), and cross-references to meetings with FDA regarding the new tobacco product; (5) Applicant name, address, and contact information (including email address); (6) Authorized representative or U.S. agent (for a foreign applicant), including the name, address, and contact information (including email address); (7) For both the new and predicate tobacco products, the following information to uniquely identify the products: (i) Manufacturer; (ii) Product name, including the brand and sub brand (or other commercial name used in commercial distribution); and (iii) Product category, product subcategory, and product properties (if the product does not have a listed product property, e.g., ventilation or characterizing flavor, the report must state “none” for that property) as provided in the following table: (8) Address and the FDA Establishment Identifier number(s) of the establishments involved in the manufacture and/or importation of the new and predicate tobacco products. (d) Summary. The SE Report must include a summary at the beginning of the SE Report that includes the following: (1) A concise description of the characteristics of the new tobacco product; (2) A statement as to whether the applicant believes the new tobacco product has the same characteristics as the predicate tobacco product or has different characteristics but any differences in characteristics do not cause the new tobacco product to raise different questions of public health; and (3) A concise description of the similarities and differences between the new tobacco product and the predicate tobacco product with respect to their characteristics (materials, ingredients, design, composition, heating source, or other features). (e) New tobacco product description. The applicant must identify one new tobacco product in the SE Report for comparison to one predicate tobacco product. The SE Report must describe the new tobacco product in sufficient detail to enable FDA to evaluate its characteristics. This part of the SE Report must include: (1) A narrative description of the new tobacco product and detailed drawings or schematics of the new tobacco product, including its container closure system, illustrating all components or parts of the product. For a portioned tobacco product, the SE Report must also include a diagram illustrating all components or parts of the individual unit of use; (2) A description and the function of each component or part of the new tobacco product, and an explanation of how each component or part is integrated into the design of the new tobacco product; and (3) A concise overview of the process used to manufacture the new tobacco product. If the manufacturing process for the new tobacco product does not affect the characteristics of the new tobacco product beyond what is described elsewhere in the SE Report, an applicant must state that to satisfy this provision. (f) Description of predicate tobacco product. (1) The applicant must identify a predicate tobacco product that is either a tobacco product commercially marketed (other than for test marketing) as of February 15, 2007, or a tobacco product that FDA previously found to be substantially equivalent. (2) A tobacco product to which a new tobacco product is compared must: (i) Have been either: (A) Commercially marketed (other than for test marketing) in the United States as of February 15, 2007, as shown by either specific information sufficient to support this in the SE Report, including a statement that “I, (insert name and position title of responsible official), confirm that the predicate tobacco product associated with this submission, (insert name of predicate tobacco product), was commercially marketed (other than for test marketing) in the United States as of February 15, 2007,” and, if applicable, reference to an STN for a previous determination by FDA that the predicate product was commercially marketed (other than for test marketing) in the United States as of February 15, 2007; or (B) Previously determined to be substantially equivalent by FDA; (ii) Be an individual product and not a composite of multiple products; (iii) Not be the subject of a rescission action by FDA, as described in § 1107.50; and (iv) Not have been removed from the market at the initiative of FDA and not have been determined by judicial order to be adulterated or misbranded. (g) Comparison information. The SE Report must include a comparison of the characteristics of the new tobacco product and the predicate tobacco product. If the new tobacco product has limited changes to a characteristic(s) when compared to the predicate tobacco product, and all other characteristics are identical (e.g., a change to product quantity), the applicant must provide comparison information related to any characteristic(s) that have changed, but may certify that the other characteristics are identical under paragraph (l)(2) of this section. The applicant must maintain records supporting the certification consistent with § 1107.58. (h) Comparative testing information. Other than for characteristics that are identical, and for which the applicant has certified that the characteristics are identical under paragraph (l)(2) of this section, the SE Report must provide comparative testing information that has been demonstrated to be fully validated on the characteristics of the new and predicate tobacco products except where the applicant adequately justifies that such comparative testing information is not necessary to demonstrate that the new product: (1) Has the same characteristics as the predicate or (2) Does not raise different questions of public health. (i) Statement of compliance with applicable tobacco product standards. The SE Report must either: (1) List and describe the action(s) taken by the applicant to comply with applicable requirements under section 907 of the Federal Food, Drug, and Cosmetic Act; or (2) State there are no applicable requirements under section 907 of the Federal Food, Drug, and Cosmetic Act. (j) Health information summary or statement regarding availability of such information. The SE Report must include either a health information summary or a statement that such information will be made available upon request, as provided in section 910(a)(4) of the Federal Food, Drug, and Cosmetic Act, in accordance with the following: (1) Health information summary. If including a health information summary with the SE Report, the applicant must provide a copy of the full SE Report that excludes research subject identifiers and trade secret and confidential commercial information as defined in §§ 20.61 and 20.63 of this chapter; and either (i) Provide accurate, complete, and not false or misleading, additional health information, including information, research, or data about adverse health effects, that the applicant has or knows about concerning the new tobacco product that is not contained in the SE Report; or (ii) Provide the following statement, if true, about the new tobacco product: “Applicant does not have or know of any additional health information, including information, research or data regarding adverse health effects, about the new tobacco product that is the subject of this SE Report.” (2) Statement regarding availability of health information. If the applicant chooses to make the health information available upon request, the SE Report must include the following statement, with the appropriate applicant information inserted as indicated by parenthetical text, signed by an authorized representative of the applicant, made on a separate page of the SE Report, and clearly identified as “910(a)(4) health information statement”: “I certify that, in my capacity as (the position held in company by person required to submit the SE Report, preferably the responsible official of the applicant) of (company name), I will make available, upon request, the information identified in 21 CFR 1107.18(j)(3) within 30 calendar days of a request.” (3) Content of health information. The health information the applicant agrees to make available in paragraph (j)(2) of this section must be a copy of the full SE Report, excluding all research subject identifiers, trade secrets, and confidential commercial information, as defined in §§ 20.61 and 20.63 of this chapter; and either: (i) Accurate, complete, and not false or misleading, additional health information, including information, research, or data about adverse health effects, that the applicant has or knows about concerning the new tobacco product and that is not contained in the SE Report; or (ii) The following statement, if true, about the new tobacco product: “(Company name) does not have or know of any additional health information, including information, research or data regarding adverse health effects about the new tobacco product that is the subject of the provided SE Report.” (4) Requests for information. All requests for information under paragraph (j)(2) of this section must be made in writing to the authorized representative of the applicant, whose contact information will be posted on the FDA website listing substantial equivalence determinations. The applicant must provide FDA any updated information if the contact information changes. (5) No modified risk violations. To the extent information is included in the health information summary or health information provided upon request under paragraphs (j)(1) and (2) of this section that is not required by section 910(a)(4) of the Federal Food, Drug, and Cosmetic Act or this paragraph (j), that information must not contain a statement that would cause the tobacco product to be in violation of section 911 of the Federal Food, Drug, and Cosmetic Act upon the introduction or delivery for introduction of the proposed new product into interstate commerce. (k) Compliance with part 25 of this chapter. (1) The SE Report must include an environmental assessment prepared in accordance with § 25.40 of this chapter, or a valid claim of categorical exclusion. If the applicant believes that the action qualifies for an available categorical exclusion, the applicant must state under § 25.15(a) and (d) of this chapter that the action requested qualifies for a categorical exclusion, citing the particular exclusion that is claimed, and that to the applicant's knowledge, no extraordinary circumstances exist under § 25.21. (2) The environmental assessment must include a statement explaining whether the new tobacco product is intended to replace the predicate tobacco product after the new tobacco product receives market authorization, is intended to be a line extension of the predicate tobacco product, is intended to be introduced as an additional product by the same manufacturer, or if the new tobacco product will be introduced as an additional product but by a different manufacturer. (l) Certification statement. (1) The SE Report must contain the following certification, with the appropriate information inserted (as indicated by parenthetical text), and be signed by an authorized representative of the applicant: “I (name of responsible official) on behalf of (applicant), hereby certify that (applicant) will maintain all records to substantiate the accuracy of this SE Report for the period of time required in 21 CFR 1107.58 and ensure that such records remain readily available to the FDA upon request. I certify that this information and the accompanying submission are true and correct, that no material fact has been omitted, and that I am authorized to submit this on the applicant's behalf. I understand that under section 1001 of title 18 of the United States Code anyone who knowingly and willfully makes a materially false, fictitious, or fraudulent statement or representation in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States is subject to criminal penalties.” (2) The SE Report must include the following certification, as well as a justification for the certification, if an applicant chooses to certify that certain characteristics are identical in lieu of providing data for each characteristic of the new and predicate tobacco products. This certification must include the appropriate information inserted (as indicated by parenthetical text) and be signed by an authorized representative of the applicant: “I, (name of responsible official), on behalf of (name of company), certify that (new tobacco product name) has the following modification(s) as compared to (name of predicate tobacco product): (describe modification(s), e.g., change in product quantity or change in container closure system). Aside from these modifications, the characteristics of (new tobacco product name) and (name of predicate tobacco product) are identical. I certify that (name of company) understands this means there is no other modification to the materials, ingredients, design features, heating source, or any other feature. I also certify that (name of company) will maintain records to support the comparison information in 21 CFR 1107.19 that substantiate the accuracy of this statement for the period of time required in 21 CFR 1107.58, and ensure that such records remain readily available to FDA upon request.”

21 C.F.R. § 1107.19 Comparison information.

The SE Report must include a comparison of the characteristics of the new tobacco product to the predicate tobacco product. Where test data is submitted, the testing information must include the test protocols, quantitative acceptance criteria, and test results (including means and variances, data sets, and a summary of the results). Comparison testing must be conducted on a sufficient sample size and on test samples that reflect the finished tobacco product composition and design. The SE report must state whether the same test methods were used for the new tobacco product and the predicate product, and if the methods differed, an explanation as to how the results of the different test methods can be compared. The SE report must identify national and international standards used to test the new and predicate tobacco products and explain any deviations from the standard, or state that no standards were used for the testing. The SE report must include the following: (a) Comparison of product design. The SE Report must include a description of the product designs of the new and predicate tobacco products and an identification of any differences. The SE Report must include, in a tabular format, a side-by-side comparison of each design parameter of the new and predicate tobacco products. The target specification and upper and lower range limits must be provided for each design parameter. Test data (including test protocols, quantitative acceptance criteria, data sets (i.e., measured values), and a summary of the results) must be provided for the new and predicate tobacco products when the target specification or range limits of the new tobacco product differ from the predicate tobacco product. For tobacco cut size or particle size, when target specifications and range limits are not available, the following alternative information may be submitted in place of this information: A description of the tobacco cutting process (including a complete description of the milling, cutting, and sifting process; the control parameters of the miller or cutter; and any sift specifications) or the measured particle size distribution for the new and predicate tobacco products. (1) Cigarettes. For cigarettes, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (2) Smokeless Tobacco. For portioned and non-portioned smokeless tobacco products, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (3) Roll-your-own tobacco, rolling papers. For roll-your-own tobacco rolling papers, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (4) Roll-your-own tobacco, non-filtered tubes. For roll-your-own tobacco non-filtered tubes, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (5) Roll-your-own tobacco, filtered tubes. For roll-your-own tobacco filtered tubes, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (6) Roll-your-own tobacco. For roll-your-own tobacco, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (7) Filtered, sheet-wrapped cigars. For filtered, sheet-wrapped cigars, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (8) Unfiltered, sheet-wrapped cigars. For unfiltered, sheet-wrapped cigars, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (9) Unfiltered, leaf-wrapped cigars. For unfiltered, leaf-wrapped cigars, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (10) Cigar filler. For cigar filler, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (11) Cigar component. For cigar components, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (12) Pipes. For pipes, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (13) Pipe filler. For pipe filler, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (14) Waterpipes. For waterpipes, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (15) Waterpipe, heating source. For waterpipe heating sources, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (16) Waterpipe component, head. For waterpipe heads, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (17) Waterpipe component, foil. For waterpipe foil, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (18) Waterpipe filler. For waterpipe filler, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (19) Electronic Nicotine Delivery System (ENDS). For ENDS (vapes), the required design parameter information to be provided for each predicate and new tobacco product is as follows: (20) E-liquids. For e-liquids, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (21) Heated Tobacco Products (HTP). For HTPs, the required design parameter information to be provided for each predicate and new tobacco product is as follows: (b) Comparison of heating sources. The SE Report must include a description of the heating source for the new and predicate tobacco products and identify any differences, or state that there is no heating source. (c) Comparison of product composition. The SE Report must include descriptions of the product composition of the new and predicate tobacco products and identify any differences. The SE Report must include, in a tabular format, a side-by-side comparison of the materials and ingredients for each component or part of the new and predicate tobacco products. For each material and ingredient quantity, the target specifications and range of acceptable values, actual measured value (where applicable), and range of measured values (where applicable) reported as mass per component or part, must be provided. (1) Materials. For each material in the products include: (i) The material name and common name(s), if applicable; (ii) The component or part of the tobacco product where the material is located; (iii) The subcomponent or subpart where the material is located, if applicable; (iv) The function of the material; (v) The quantities (including ranges or means, acceptance limits) of the material(s) in each new tobacco product and predicate tobacco product (with any specification variation, if applicable); (vi) The specification(s) (including quality/grades, suppliers) used for the new tobacco product and predicate tobacco product (with any specification variations, if applicable); and (vii) Any other material properties necessary to characterize the new and predicate tobacco products. (2) Ingredients other than tobacco. For each ingredient other than tobacco in each material or component or part of the product include: (i) The International Union of Pure and Applied Chemistry (IUPAC) chemical name and common name, if applicable; (ii) The Chemical Abstracts Service (CAS) number(s) or FDA Unique Ingredient Identifier (UNII); (iii) The function of the ingredient; (iv) The quantity with the unit of measure (including ranges or means, acceptance limits) of the ingredient in the new tobacco product and predicate tobacco product reported as mass per gram of tobacco for non-portioned tobacco products and as mass per portion for portioned tobacco products (with any specification variation, if applicable); (v) The specification(s) (including purity or grade and supplier); (vi) For complex purchased ingredients, each single chemical substance reported separately; and (vii) Any other ingredient information necessary to characterize the new and predicate tobacco products. (3) Tobacco ingredients. For tobacco include: (i) The type (e.g., Bright, Burley, reconstituted); (ii) The curing method (e.g., flue cured, dark air cured); (iii) The quantity of each type with the unit of measure (including ranges or means, acceptance limits) of tobacco in the new tobacco product and predicate tobacco product reported as mass per gram of tobacco for non-portioned tobacco products and as mass per portion for portioned tobacco products; (iv) A description of any genetic engineering of the tobacco; and (v) Any other information necessary to characterize the new and predicate tobacco products. (vi) If the new tobacco product does not contain tobacco, then include a statement that the new tobacco product does not contain tobacco. (4) Container closure system. A description of the container closure system for the new and predicate tobacco products, including a side-by-side quantitative comparison of the components and materials and annotated illustrations. (d) Comparison of other features. The SE Report must include descriptions of any other features of the new and predicate tobacco products, such as those described in paragraphs (d)(1) and (2) of this section, and identify any differences. If a specific feature specified in paragraphs (d)(1) and (2) of this section is not applicable to the product design, this must be stated clearly. If FDA requests a scientific justification explaining why a feature is not applicable, the applicant must provide the justification to FDA. The comparison of other features must include information on: (1) Constituents. HPHCs and other constituents, as appropriate, to demonstrate that: (i) The new tobacco product has the same characteristics as the predicate tobacco product, or (ii) Any differences in characteristics between the new and predicate product do not cause the new tobacco product to raise different questions of public health, including: (A) The constituent names in alphabetical order; (B) The common name(s); (C) The Chemical Abstract Services number(s); (D) The mean quantity and variance with unit of measure; (E) The number of samples and measurement replicates for each sample; (F) The analytical methods used, associated reference(s), and full validation reports for each analytical method; (G) The testing laboratory or laboratories and documentation showing that the laboratory or laboratories is (or are) accredited by a nationally or internationally recognized external accreditation organization; (H) Length of time between dates of manufacture and date(s) of testing; (I) Storage conditions of the tobacco product before it was tested; (J) Reference product datasets (if applicable); (K) Full test data (including test protocols, any deviation(s) from the test protocols, quantitative acceptance (pass/fail) criteria and complete data sets) for all testing performed. Test data for combusted or inhaled tobacco products must reflect testing conducted using both intense and non-intense smoking or aerosol-generating regimens, where established; and (L) Complete descriptions of any smoking or aerosol-generating regimens used for analytical testing that are not standardized or widely accepted by the scientific community, if applicable. (2) Any other features. A description and comparison of any other features of the new tobacco product and the predicate tobacco product. (e) Comparison of tobacco processing. The SE Report must include information on the tobacco processes in paragraphs (e)(1) and (2) of this section for the new and predicate tobacco products, if applicable, and identify any differences. (1) Fermentation process. For smokeless tobacco products and tobacco products that contain fermented tobacco (including naturally fermented tobacco), the SE Report must contain the following information regarding the fermentation process of the new and predicate tobacco products and identify any differences: (i) Description of the fermentation process; (ii) Composition of the inoculum (starter culture) with genus and species name(s) and concentration(s) (if applicable); (iii) Any step(s) taken to reduce microbes already present during processing (e.g., cleaning of contact surfaces); (iv) Specifications and test data for pH, temperature, and moisture content or water activity; (v) Frequency of aeration or turning (if applicable); (vi) Duration of fermentation; (vii) Added ingredients; (viii) Method used to stabilize or stop fermentation ((e.g., heat treatment), if applicable), including parameters of the method (e.g., length of treatment, temperature) and method validation data; and (ix) Storage conditions of the fermented tobacco prior to further processing or packaging and duration of storage (if applicable). (2) Heat treatment process. For tobacco products that are heat treated, the SE Report must contain the following information regarding the heat treatment process of the new and predicate tobacco products and identify any differences: (i) Description of the heat treatment process; (ii) Type of heat treatment; (iii) Conditions of heat treatment, including time, temperature, and moisture; and (iv) Method validation data, including microbial loads (including bacteria, spores, yeast and fungi) and tobacco-specific nitrosamines (TSNAs) before and after heat treatment. (f) Shelf life and stability information. With the exception of SE Reports for roll-your-own tobacco products and cigarettes that are not HTPs, SE Reports for all tobacco products must contain information on the stability of the new and predicate tobacco products over the shelf life, including the following information: (1) The length of the shelf life, a description of how shelf life is determined, and a description of how shelf life is indicated on the tobacco product, if applicable. If a tobacco product does not have a defined shelf life, state as such; (2) Any known or expected impacts of the differences between the new and predicate products on the product stability. If no impact is known or expected, state that; (3) Stability data assessed at the beginning (zero time), middle, and end of the expected shelf life. If a tobacco product does not have a defined shelf life, provide stability data over a specified amount of time and a justification for why that time period is appropriate. Stability testing must be performed for the microbial and chemical endpoints as follows: (i) Microbial content data including total aerobic microbial count and total yeast and mold count; (ii) Water activity; and (iii) Tobacco-specific nitrosamine yields (total, N-nitrosonornicotine (NNN), and 4-methylnitrosamino)-1-(3-pydridyl)-1-butanone) (NNK)). (4) Stability testing details for each microbial and chemical endpoint, including: (i) The mean quantity and variance with unit of measure; (ii) The number of samples and measurement replicates for each sample; (iii) The methods used, associated reference(s), and full validation reports for each method (as applicable); (iv) The testing laboratory or laboratories and documentation showing that the laboratory or laboratories is (or are) accredited by a nationally or internationally recognized external accreditation organization; (v) Length of time between dates of tobacco product manufacture and date(s) of testing; (vi) Storage conditions of the tobacco products before they were tested; (vii) A statement that the testing was performed on a tobacco product in the same container closure system in which the tobacco product is intended to be marketed; and (viii) Full test data (including test protocols, any deviation(s) from the test protocols, quantitative acceptance (pass/fail) criteria, complete data sets, and a summary of the results) for all stability testing performed. (g) Applicant's basis for substantial equivalence determination. The applicant must state that the new tobacco product has either: (1) The same characteristics as the predicate tobacco product and the basis for this determination, or (2) Different characteristics than the predicate tobacco product. Where an applicant states that its new tobacco product has different characteristics than the predicate tobacco product, the applicant must also include an explanation as to why a difference in any of the following characteristics do not cause the new product to raise different questions of public health: Product design (paragraph (a) of this section); heating source (paragraph (b) of this section); materials and ingredients (paragraph (c) of this section); and other features (paragraph (d) of this section). In addition, to demonstrate that a new tobacco product is substantially equivalent, an applicant must also explain why any differences in the manufacturing process between the new tobacco product and the predicate tobacco product would not change the characteristics of the new tobacco product such that the new tobacco product could raise different questions of public health (§ 1107.18(e)). Similarly, for smokeless tobacco products and tobacco products that contain fermented tobacco, an applicant must explain why any difference in stability between the new tobacco product and the predicate tobacco product does not cause the new tobacco product to raise different questions of public health (paragraph (f) of this section). (h) Comparison to original predicate tobacco product. If the applicant is comparing the new tobacco product to a predicate tobacco product that FDA has previously found to be substantially equivalent, FDA may request that the applicant include information related to the original predicate tobacco product that was commercially marketed (other than for test marketing) in the United States as of February 15, 2007, even if that original predicate tobacco product is back several predicate tobacco products. FDA will request this information when necessary to ensure that any order the Agency issues finding the new tobacco product substantially equivalent complies with section 910(a)(2)(A)(i)(I) of the Federal Food, Drug, and Cosmetic Act. FDA may need to review the first SE Report that received a finding of substantial equivalence using the original predicate tobacco product as a predicate tobacco product in order to make this finding.

21 C.F.R. § 1107.20 Amendments.

(a) Except as provided in paragraphs (b) and (c) of this section, the applicant may submit an amendment to an SE Report in accordance with subpart C of this part. If an applicant chose to submit a health information summary with its SE Report under § 1107.18(j)(1), the applicant must submit with the amendment a redacted copy of the amendment that excludes research subject identifiers and trade secret and confidential commercial information as defined in §§ 20.61 and 20.63 of this chapter. (b) An applicant may not amend an SE Report to change the predicate tobacco product. (c) An applicant may not amend an SE Report after FDA has closed the SE Report under § 1107.44 or it has been withdrawn under § 1107.22. (d) In general, amendments will be reviewed in the next review cycle as described in § 1107.42.

21 C.F.R. § 1107.22 Withdrawal by applicant.

(a) An applicant may at any time make a written request to withdraw an SE Report for which FDA has not issued an order. The withdrawal request must state: (1) Whether the withdrawal is due to a health or safety concern related to the tobacco product; (2) The submission tracking number; and (3) The name of the new tobacco product that is the subject of the SE Report. (b) An SE Report will be considered withdrawn when FDA issues a notice stating the SE Report has been withdrawn. (c) The SE Report is an Agency record, even if withdrawn. FDA will retain the withdrawn SE Report under Federal Agency records schedules. The availability of the withdrawn SE Report will be subject to FDA's public information regulations in part 20 of this chapter.

21 C.F.R. § 1107.24 Change in ownership of an SE Report.

An applicant may transfer ownership of its SE Report. On or before the time of transfer, the new and former applicants are required to submit information to FDA as follows: (a) The former applicant must sign and submit a notice to FDA that states that all of the former applicant's rights and responsibilities relating to the SE Report have been transferred to the new applicant. This notice must identify the name and address of the new applicant and the SE Report transferred. (b) The new applicant must sign and submit a notice to FDA containing the following: (1) The new applicant's commitment to agreements, promises, and conditions made by the former applicant and contained in the SE Report; (2) The date that the change in ownership is effective; (3) Either a statement that the new applicant has a complete copy of the SE Report and order (if applicable), including amendments and records that are required to be kept under § 1107.58, or a request for a copy of the SE Report from FDA's files by submitting a request in accordance with part 20 of this chapter. In accordance with the Freedom of Information Act, FDA will provide a copy of the SE Report to the new applicant under the fee schedule in FDA's public information regulations in § 20.45 of this chapter; and (4) A certification that no modifications have been made to the new tobacco product since the SE Report was submitted to FDA.

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