21 CFR Part 1114 — Premarket Tobacco Product Applications

PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS Authority: 21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49. Source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted. Subpart A—General Provisions § 1114.1 Scope. (a) This part sets forth the procedures and requirements for submitting a premarket tobacco product application (PMTA), the general procedures FDA will follow when evaluating a PMTA, and postmarket reporting requirements. (b) This part does not apply to modified risk tobacco product applications, except that single applications seeking both a marketing granted order under section 910(c) of the Federal Food, Drug, and Cosmetic Act and an order under section 911(g) of the Federal Food, Drug, and Cosmetic Act must satisfy the requirements of this part in addition to the requirements of section 911 of the Federal Food, Drug, and Cosmetic Act. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (d) This part does not apply to “premium” cigars as defined in § 1114.3. § 1114.3 Definitions. For purposes of this part: Accessory (1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or (2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product, but: (i) Solely controls moisture and/or temperature of a stored tobacco product; or (ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product. Additive Adverse experience Applicant Brand Characteristics Commercially marketed Component part (1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product. Composition Constituent e.g., Container closure system Design Finished tobacco product e.g., Harmful or potentially harmful constituent HPHC (1) Is or potentially is inhaled, ingested, or absorbed into the body, including as an aerosol or any other emission; and (2) Causes or has the potential to cause direct or indirect harm to users or nonusers of tobacco products. Heating source Ingredient Label Labeling Line data Marketing denial order Marketing granted order Material New tobacco product (1) Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or (2) Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. Other features Package packaging Premarket tobacco product application PMTA “Premium” cigar (1) Is wrapped in whole tobacco leaf; (2) Contains a 100 percent leaf tobacco binder; (3) Contains at least 50 percent (of the filler by weight) long filler tobacco ( i.e., (4) Is handmade or hand rolled ( i.e., (5) Has no filter, nontobacco tip, or nontobacco mouthpiece; (6) Does not have a characterizing flavor other than tobacco; (7) Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) Weighs more than 6 pounds per 1,000 units. Serious adverse experience (1) Death; (2) A life-threatening condition or illness; (3) Inpatient hospitalization or prolongation of existing hospitalization; (4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; (5) A congenital anomaly/birth defect; or (6) Any other adverse experience that, based upon appropriate medical judgment, may jeopardize the health of a person and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Submission tracking number STN Tobacco product Tobacco product manufacturer (1) Manufactures, fabricates, assembles, processes, or labels a tobacco product, or (2) Imports a finished tobacco product for sale or distribution in the United States. Unexpected adverse experience (1) The known or foreseeable risks of adverse experiences associated with the use or exposure to the tobacco product as described in the PMTA and other relevant sources of information, such as the product labeling and postmarket reports; (2) The expected natural progression of any underlying disease, disorder, or condition of the persons(s) experiencing the adverse experience and the person's predisposing risk factor profile for the adverse experience; or (3) The results of nonclinical investigations. Vulnerable populations [86 FR 55412, Oct. 4, 2021, as amended at 88 FR 16553, Mar. 20, 2023] Subpart B—Premarket Tobacco Product Applications § 1114.5 Application submission. 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 this part until FDA has issued a marketing granted order for the product. § 1114.7 Required content and format. (a) General. (1) General information (as described in paragraph (c) of this section); (2) Descriptive information (as described in paragraph (d) of this section); (3) Product samples (as described in paragraph (e) of this section); (4) Labeling and description of marketing plans (as described in paragraph (f) of this section); (5) Statement of compliance with 21 CFR part 25 (as described in paragraph (g) of this section); (6) Summary (as described in paragraph (h) of this section); (7) Product formulation (as described in paragraph (i) of this section); (8) Manufacturing (as described in paragraph (j) of this section); (9) Health risk investigations (as described in paragraph (k) of this section); and (10) The effect on the population as a whole (as described in paragraph (l) of this section); (11) Certification statement (as described in paragraph (m) of this section). (b) Format. i.e., e.g., (2) An applicant may include content in a submission by cross-reference to a tobacco product master file or a pending modified risk tobacco product application for the same tobacco product. Applicants using a master file must provide documentation of their right of reference for the master file and clearly identify the specific content being incorporated into the PMTA submission. Except as provided for in §§ 1114.15 and 1114.17, FDA will not consider content included by cross-reference to other sources of information outside of the submission. (c) General information. (1) Applicant name, address, and contact information; (2) Authorized representative or U.S. agent (for a foreign applicant), including the name, address, and contact information; (3) The following information to uniquely identify the product: (i) Manufacturer; (ii) Product name(s), including brand and subbrand (or other commercial name(s) used in commercial distribution); and (iii) The product category, product subcategory, and product properties as provided in the following table. If the product does not have a listed product property, such as ventilation or characterizing flavor, the application must state “none” for that property. Table 1 to Paragraph ( c iii Tobacco product category Tobacco product subcategory Product properties (A) Cigarettes ( 1 —Package type (e.g., hard pack, soft pack, clam shell). —Product quantity (e.g., 20 cigarettes, 25 cigarettes). —Length (e.g., 89.1 millimeters (mm), 100.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Ventilation (e.g., none, 10.0%, 25.0%). —Characterizing flavor(s) (e.g., none, menthol). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type (e.g., hard pack, soft pack, clam shell). —Product quantity (e.g., 20 cigarettes, 25 cigarettes). —Length (e.g., 89.1 mm, 100.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Characterizing flavor(s) (e.g., none, menthol). — Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type (e.g., hard pack, soft pack, clam shell). —Product quantity (e.g., 20 cigarettes, 25 cigarettes). —Length (e.g., 89.1 mm, 100.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Ventilation (e.g., none, 10.0%, 25.0%). —Characterizing flavor(s) (e.g., none, menthol). —Additional properties needed to uniquely identify the tobacco product (if applicable). (B) Roll-Your-Own Tobacco Products ( 1 —Package type (e.g., bag, pouch). —Product quantity (e.g., 20.1 grams [g], 16.0 ounces [oz.]). —Characterizing flavor(s) (e.g., none, menthol). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type (e.g., box, booklet). —Product quantity (e.g., 50 sheets, 200 papers). —Length (e.g., 79.1 mm, 100.0 mm, 110.2 mm). —Width (e.g., 28.1 mm, 33.0 mm, 45.2 mm). —Characterizing flavor(s) (e.g., none, menthol). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type (e.g., bag, box). —Product quantity (e.g., 100 tubes, 200 tubes). —Length (e.g., 89.1 mm, 100.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Ventilation (e.g., none, 10.0%, 25.0%). —Characterizing flavor(s) (e.g., none, menthol, tobacco). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type (e.g., bag, box). —Product quantity (e.g., 100 tubes, 200 tubes). —Length (e.g., 89.1 mm, 100.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Characterizing flavor(s) (e.g., none, menthol, tobacco). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type (e.g., bag, box). —Product quantity (e.g., 100 filters, 200 filters). —Length (e.g., 8.0 mm, 12.1 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Characterizing flavor(s) (e.g., none, menthol, tobacco). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 6 —Package type (e.g., bag, box). —Product quantity (e.g., 200 tips, 275 tips). —Length (e.g., 12.0 mm, 15.1 mm). —Width (e.g., 27.1 mm). —Characterizing flavor(s) (e.g., none, menthol, tobacco). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 7 —Package type (e.g., bag, box). —Product quantity (e.g., 200 tips, 100 filters, 200 tubes. —Characterizing flavor(s) (e.g., none, menthol, tobacco). —Additional properties needed to uniquely identify the tobacco product. (C) Smokeless Tobacco Products ( 1 —Package type (e.g., plastic can with metal lid, plastic can with plastic lid). —Product quantity (e.g., 20.0 g, 2.1 oz.). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable, e.g., fine cut, long cut, straight cut). ( 2 —Package type (e.g., plastic can with metal lid, plastic can with plastic lid). —Product quantity (e.g., 22.5 g, 20.0 g). —Portion count (e.g., 15 pouches, 20 pieces). —Portion mass (e.g., 1.5 g/pouch, 1.0 g/piece). —Portion length (e.g., 15.0 mm, 20.1 mm). —Portion width (e.g., 10.0 mm, 15.1 mm). —Portion thickness (e.g., 5.0 mm, 7.1 mm). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type (e.g., plastic can with metal lid, plastic can with plastic lid). —Product quantity (e.g., 20.0 g, 2.1 oz.). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type (e.g., plastic can with metal lid, plastic can with plastic lid). —Product quantity (e.g., 22.5 g, 20.0 g). —Portion count (e.g., 15 pouches, 20 pieces). —Portion mass (e.g., 1.5 g/pouch, 1.0 g/piece). —Portion length (e.g., 15.0 mm, 20.1 mm). —Portion width (e.g., 10.0 mm, 15.1 mm). —Portion thickness (e.g., 5.0 mm, 7.1 mm). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type (e.g., plastic can with metal lid, plastic can with plastic lid). —Product quantity (e.g., 20.0 g, 2.1 oz.). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 6 —Package type (e.g., plastic can with metal lid, plastic can with plastic lid). —Product quantity (e.g., 22.5 g, 20.0 g) —Portion mass (e.g., 1.5 g/strip, 1.0 g/piece). —Portion length (e.g., 10.0 mm, 15.1 mm). —Portion width (e.g., 5.0 mm, 8.1 mm). —Portion thickness (e.g., 3.0 mm, 4.1 mm). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 7 —Package type (e.g., bag, pouch, wrapped). —Product quantity (e.g., 20.0 g, 3.1 oz). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 8 —Package type (e.g., plastic can with metal lid, plastic can with plastic lid). —Product quantity (e.g., 22.5 g, 20.0 g) —Portion mass (e.g., 2.1 g/bit). —Portion length (e.g., 8.0 mm, 10.1 mm). —Portion width (e.g., 6.0 mm, 8.1 mm). —Portion thickness (e.g., 5.1 mm, 7.0 mm). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 9 —Package type (e.g., bag, box, can). —Product quantity (e.g., 20.1 g, 22.5 g, 3.0 oz.). —Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen, tobacco). —Additional properties needed to uniquely identify the tobacco product. (D) Electronic Nicotine Delivery System (ENDS) (Also referred to as vapes) ( 1 —Package type (e.g., bottle, box, pod). —Product quantity (e.g., 1 bottle, 5 bottles). —E-liquid volume (e.g., 0.5 milliliters [ml]), 2.0 ml, 5.1 ml). —Nicotine concentration (e.g., 0 milligrams/milliliter [mg/ml], 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/bottle). —Propylene glycol (PG)/vegetable glycerin (VG) ratio (e.g., not applicable [N/A], 0/100, 50/50, 100/0). —Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type (e.g., cartridge, pod). —Product quantity (e.g., 1 cartridge, 5 cartridges). —E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1 ml). —Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 2.0 mg/bottle). —PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0). —Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type (e.g., box, none, plastic clamshell). —Product quantity (e.g., 1 e-cigarette, 5 e-cigarettes). —Length (e.g., 100.0 mm, 120.0 mm). —Diameter (e.g., 6.0 mm, 8.0 mm). —Wattage (e.g., 100 watts [W], 200 W). —Battery capacity (e.g., 100 milliampere hours [mAh], 200 mAh). —E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1 ml). —Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/e-cigarette). —PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0). —Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product. ( 4 —Package type (e.g., box, none, plastic clamshell). —Product quantity (e.g., 1 e-cigarette, 5 e-cigarettes). —Length (e.g., 100.0 mm, 120.0 mm). —Diameter (e.g., 6.0 mm, 8.0 mm). —E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1 ml). —Wattage (e.g., 100 W, 200 W). —Battery capacity (e.g., 100 mAh, 200 mAh). —Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type (e.g., box, none, plastic clamshell). —Product quantity (e.g.,1 coil). —Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 6 —Package type (e.g., box, none, plastic clamshell). —Product quantity (e.g., 1 e-cigarette, 5 bottles). —Characterizing flavor(s) (e.g., none, cherry, wintergreen, tobacco, menthol). —Additional properties needed to uniquely identify the tobacco product. (E) Cigars ( 1 —Package type (e.g., hard pack, soft pack, clam shell). —Product quantity (e.g., 20 filtered cigars, 25 filtered cigars). —Length (e.g., 89.1 mm, 100.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Ventilation (e.g., none, 0%, 10.0%, 25.0%). —Characterizing flavor (e.g., none, menthol). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type (e.g., box, film sleeve). —Product quantity (e.g., 1 cigar, 5 cigarillos). —Length (e.g., 100.1 mm, 140.0 mm). —Diameter (e.g., 8.0 mm, 10.1 mm). —Tip (e.g., none, wood tips, plastic tips). —Characterizing flavor (e.g., none, menthol). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type (e.g., box, film, sleeve, none). —Product quantity (e.g., 1 cigar, 5 cigars). —Length (e.g., 150.1 mm, 200.0 mm). —Diameter (e.g., 8.0 mm, 10.1 mm). —Wrapper material (e.g., burley tobacco leaf, Connecticut shade grown tobacco leaf). —Characterizing flavor (e.g., none, whiskey). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type (e.g., box, booklet). —Product quantity (e.g., 10 wrappers, 20 leaves). —Characterizing flavor (e.g., none, menthol, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type (e.g., bag, pouch). —Product quantity (e.g., 20.0 g, 16.1 oz.). —Characterizing flavor (e.g., none, menthol, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 6 —Package type (e.g., box, booklet). —Product quantity (e.g., 1 cigar, 5 cigars, 20 leaves, 16 g). —Characterizing flavor(s) (e.g., none, menthol, cherry). —Additional properties needed to uniquely identify the tobacco product. (F) Pipe Tobacco Products ( 1 —Package type (e.g., box, none). —Product quantity (e.g., 1 pipe). —Length (e.g., 200.0 mm, 300.1 mm). —Diameter (e.g., 25.1 mm). —Characterizing flavor(s) (e.g., none, menthol, cavendish, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type (e.g., bag, none). —Product quantity (e.g., 20.0 g, 16.1 oz). —Tobacco cut style (e.g., standard cut, such as shag cut, bugler cut, loose cut, etc., or a pressed cut, such as flake, cube cut, roll cake, etc., or a mixture). —Characterizing flavor(s) (e.g., none, menthol, cavendish, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type (e.g., box, bag, none). —Product quantity (e.g., 1 bowl, 1 stem, 100 filters). —Characterizing flavor(s) (e.g., none, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type (e.g., bag, box, none). —Product quantity (e.g., 1 pipe, 1 bowl, 1 stem, 100 filters). —Characterizing flavor(s) (e.g., none, cherry). —Additional properties needed to uniquely identify the tobacco product. (G) Waterpipe Tobacco Products ( 1 —Package type (e.g., box, none). —Product quantity (e.g., 1 waterpipe). —Height (e.g., 200.0 mm, 500.1 mm). —Width (e.g., 100.1 mm, 300.0 mm). —Diameter (e.g., 100.1 mm, 300.0 mm)—Number of hoses (e.g., 1, 2, 4). —Characterizing flavor(s) (e.g., none). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type (e.g., bag, pouch). —Product quantity (e.g., 20.0 g, 16.1 oz.). —Characterizing flavor(s) (e.g., none, tobacco, menthol, apple). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type (e.g., box, film sleeve, bag, none). —Product quantity (e.g., 150.0 g, 680.0 g). —Portion count (e.g., 20 fingers, 10 discs, 1 base). —Portion mass (e.g., 15.0 g/finger, 10.0g/brick). —Portion length (e.g., 40.0 mm, 100.0 mm). —Portion width (e.g., 10.0 mm, 40.0 mm). —Portion thickness (e.g., 10.0 mm, 40.0 mm). —Source of energy (e.g., charcoal, battery, electrical). —Characterizing flavor(s) (e.g., none, menthol, apple). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type (e.g., bag, box, none). —Product quantity (e.g., 1 base, 1 bowl, 1 hose, 10 mouthpieces). —Characterizing flavor(s) (e.g., none, menthol, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type (e.g., bag, box, none). —Product quantity (e.g., 1 base, 1 bowl, 1 hose, 10 mouthpieces). —Characterizing flavor(s) (e.g., none, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). (H) Heated Tobacco Products (HTP) ( 1 —Package type (e.g., box, none, plastic clamshell). —Product quantity (e.g., 1 device, 1 HTP). —Length (e.g., 100.0 mm, 120.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Wattage (e.g., 100 W, 200 W). —Battery capacity (e.g., 100 mAh, 200 mAh). —Characterizing flavor(s) (e.g., none). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type (e.g., box, none, plastic clamshell). —Product quantity (e.g., 1 device, 1 HTP). —Length (e.g., 100.0 mm, 120.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Wattage (e.g., 100 W, 200 W). —Battery capacity (e.g., 100 mAh, 200 mAh). —Characterizing flavor(s) (e.g., none). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type (e.g., hard pack, soft pack, plastic clamshell). —Product quantity (e.g., 20 sticks, 25 cartridges). —Length (e.g., 60.0 mm, 82.0 mm). —Diameter (e.g., 6.0 mm, 8.1 mm). —Ventilation (e.g., none, 10.0%, 25.0%). —Characterizing flavor(s) (e.g., none, menthol). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type (e.g., box, none, plastic clamshell). —Product quantity (e.g., 1 mouthpiece, 1 spacer). —Characterizing flavor(s) (e.g., none, tobacco, menthol). —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type (e.g., box, bag, plastic clamshell, none). —Product quantity (e.g., 1 base, 5 capsules). —Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). (I) Other ( 1 —Package type (e.g., box, bag, plastic clamshell, none). —Product quantity (e.g., 1 base, 5 capsules). —Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry). —Additional properties needed to uniquely identify the tobacco product (if applicable). (4) The type of PMTA ( i.e., (5) Whether the applicant requests that FDA refer the PMTA to the Tobacco Products Scientific Advisory Committee (TPSAC); (6) Identifying information regarding any prior submissions regarding the tobacco product ( e.g., (7) Dates and purpose of any prior meetings with FDA regarding the new tobacco product; (8) If applicable, the dates when the tobacco product was commercially marketed in the United States; (9) Address and the Facility Establishment Identifier (FEI) number(s), if available, of the establishment(s) involved in the manufacture of the new tobacco product; (10) A brief statement regarding how the PMTA satisfies the content requirements of section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act; (11) A brief description of how marketing of the new tobacco product would be appropriate for the protection of the public health; and (12) A list identifying all enclosures, labels, and labeling being submitted with the application. (d) Descriptive information. (1) A concise description of the new tobacco product; (2) A statement identifying all tobacco product standards issued under section 907 of the Federal Food, Drug, and Cosmetic Act that are applicable to the new tobacco product and a brief description of how the new tobacco product fully meets any identified tobacco product standard, or if the new tobacco product deviates from a product standard, if applicable, the application must include adequate information to identify and justify those deviations; (3) The name(s) of the product as designated on the product's label; (4) A description of problems that were identified in prototypes that are the subject of studies in the application and previous or similar versions of the new tobacco product that were marketed, if any. If there are previous or similar versions that are the subject of studies in the application or were marketed, the application must contain a bibliography of all reports regarding the previous or similar version of the product, whether adverse or supportive; and (5) Any restrictions on the sale, distribution, advertising, or promotion of the new tobacco product that the applicant proposes to be included as part of a marketing granted order under section 910(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act to help support a showing that the marketing of the product is appropriate for the protection of the public health. If there are no proposed restrictions, the application must contain a statement to that effect. (e) Samples of new tobacco products. (f) Labeling and description of marketing plans Labeling. (2) Description of Marketing Plans. (i) A description of the specific group(s) to which the labeling, advertising, marketing, promotion, and other consumer-directed activities for the new tobacco product would be targeted ( i.e., (ii) A discussion of how the labeling, advertising, marketing, promotion, and other consumer-directed activities for the new tobacco product would be targeted to reach the intended audience(s) identified in paragraph (i) and what other group(s) would foreseeably be exposed to those materials and activities as a result; (iii) A discussion of, for individuals below the minimum age of sale, how access to the new tobacco product would be restricted and exposure to the labeling, advertising, marketing, promotion, and other consumer-directed activities would be limited; and (iv) A concluding summary describing how the applicant's plans for marketing the new tobacco product are consistent with the applicant's discussion of the increased or decreased likelihood of changes in tobacco product use behavior, including switching, initiation, cessation, and polyuse, under § 1114.7(l) and permits FDA to determine permitting the new tobacco product to be marketed would be appropriate for the protection of public health. (g) Statement of compliance with 21 CFR part 25. (h) Summary. (1) A summary of the product formulation section of the application; (2) A summary of the manufacturing section of the application; (3) A summary of the health risk investigations section of the application, including all information regarding the following items, and identify areas in which there is a lack of information, where applicable: (i) The health risks of the tobacco product to both users and nonusers of the product and whether the tobacco product may present less health risk than other tobacco products; (ii) The impact the product and its marketing will have on the likelihood of changes in tobacco use behavior, including cessation, switching, and polyuse, of tobacco product users; (iii) The impact the product and its marketing will have on the likelihood of tobacco use initiation by tobacco product nonusers; (iv) How users and nonusers perceive the risk of the tobacco product based upon its label, labeling, and advertising, to the extent that advertising has been studied; (v) Whether users are able to understand the labeling and instructions for use, and use the product in accordance with those instructions; and (vi) The impact of human factors on the health risks to product users and nonusers (as described in paragraph (k)(1)(v) of this section); (4) A concluding discussion describing how the data and information contained in the PMTA both constitute valid scientific evidence and establish that permitting marketing of the new tobacco product is appropriate for the protection of the public health, as determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product. This discussion must specifically describe the effects on youth, young adults, and other relevant vulnerable populations with an emphasis on populations that are most likely to use the new tobacco product. The summary must also identify any key or pivotal studies on which an applicant is relying to establish that permitting the marketing of the new tobacco product would be APPH. (i) Product formulation. (1) Components or parts, materials, ingredients, additives, and constituents. (i) Components or parts. (A) A description of the software or technology ( e.g., (B) The purpose of the software or technology, such as monitoring where tobacco products are located, activated, or used; (C) A description of the data collected by the software and how it will be used. (ii) Materials. (A) The material name and common name(s), if applicable; (B) The component or part of the tobacco product where the material is located; (C) The subcomponent or subpart where the material is located, if applicable; (D) The function of the material; (E) The quantities (including ranges or means and acceptance limits) of the material(s) in the new tobacco product (with any specification variation, if applicable); (F) The specification(s) (including quality/grades and suppliers) used for the new tobacco product (including any specification variations, if applicable); and (G) Any other material properties to fully characterize the new tobacco product. (iii) Ingredients other than tobacco. (A) The International Union of Pure and Applied Chemistry (IUPAC) chemical name and common name, if applicable; (B) The Chemical Abstracts Service (CAS) number or FDA Unique Ingredient Identifier (UNII), if applicable; (C) The function of the ingredient; (D) The quantity of the ingredient in the tobacco product, with the unit of measure (including ranges or means and acceptance limits) reported as mass per gram of tobacco for nonportioned tobacco products and as mass per portion for portioned tobacco products (with any specification variation, if applicable); (E) The specification(s) (including purity or grade and supplier); and (F) For complex purchased ingredients, each single chemical substance reported separately. (iv) Tobacco ingredients. (A) The type(s) ( e.g., (B) The quantity with the unit of measure (including ranges or means, acceptance limits) of each tobacco ingredient in the tobacco product reported as mass per gram of tobacco for nonportioned tobacco products and as mass per portion for portioned tobacco products (with any specification variation, if applicable); (C) The specification of tobacco used for the new tobacco product (with any specification variation, if applicable); and (D) A description of any genetic engineering of the tobacco that impacts product characteristics. (v) Constituents. (A) The constituent names in alphabetical order; (B) The common name(s); (C) The Chemical Abstract Services number; (D) The mean quantity and variance with unit of measure; (E) The number of samples and measurement replicates for each sample; (F) A description of method procedure, method validation information and rationale for selecting each test method; (G) The name and location of 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) Test data including test protocols, any deviation(s) from the test protocols, quantitative acceptance (pass/fail) criteria, and line data for all testing performed. Test data for combusted or inhaled products must reflect testing conducted using both intense and nonintense smoking or aerosol-generating regimens, where established; and (K) 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. (vi) Container closure system. (A) Information describing how the container closure system protects and preserves the product from damage during transport, environmental contaminants, and potential leaching and migration of packaging constituents into the new tobacco product; and (B) Information describing design features developed to prevent the risk of accidental exposure, if any. (vii) Statement of tobacco blending, reconstitution, or manipulation. (2) Other properties. (i) Product dimensions and construction. (ii) Design parameters and test data. (B) A quantitative description of the performance criteria, including test protocols, line data, and a summary of the results, for each applicable intermediate and final design parameter and manufacturing step, that includes, but is not limited to the test data specified in tables 1 to 22 of this paragraph for the product category as applicable. If the test data specified in the applicable table does not apply to the tobacco product, applicants must explain why the test data does not apply or how alternative test data would satisfy this requirement. Where tobacco cut size or particle size is a required design parameter for a product category or subcategory and the 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; Table 2 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Cigarette length (mm). • Tobacco filler mass (mg). • Cigarette circumference or diameter (mm). • Tobacco rod density (g/cm 3 • Tobacco filler mass (mg). • Tobacco cut size (mm or CPI). • Tobacco rod density (g/cm 3 • Tobacco moisture or oven volatiles (%). • Tobacco cut size (mm or CPI). • Cigarette paper base paper porosity (permeability) (CU). • Tobacco moisture or oven volatiles (%). • Cigarette paper band porosity or permeability (CU) or Cigarette paper band diffusivity (cm 2 • Cigarette paper length (mm). • Filter pressure drop (mm H 2 • Cigarette paper base paper porosity (permeability) (CU). • Cigarette paper band porosity (permeability) (CU) [alternatively, band diffusivity (cm 2 • Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged (e.g., denier per filament, total denier, and filter density)). • Cigarette paper band width (mm). • Filter ventilation (%). • Cigarette paper band space (mm). • Filter length (mm). • Filter pressure drop (mm H 2 • Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged (e.g., denier per filament, total denier, and filter density)). • Tipping paper length (mm). • Filter ventilation (%). Table 3 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance Portioned Smokeless Tobacco Products • Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). • Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). • Tobacco moisture (%). • Tobacco moisture (%). • Portion length (mm). • Portion mass (mg). • Portion width (mm). • Pouch material basis weight (g/m 2 • Portion mass (mg). • Pouch material porosity (CU) (permeability) (L/m 2 • Portion material thickness (mm) (if applicable). • Nicotine dissolution rate (%/min). • Pouch material basis weight (g/m 2 • Pouch material porosity (permeability) (CU or L/m 2 • Nicotine dissolution rate (%/min). Nonportioned Smokeless Tobacco Products • Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron) • Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). • Tobacco moisture (%) • Tobacco moisture (%). Table 4 to Paragraph (i)(2)(ii)—Required Design Parameter Information for RYO Tobacco Rolling Papers Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Roll-your-own (RYO) paper length (mm). • RYO mass per paper (mg). • RYO paper width (mm). • RYO paper base paper basis weight (g/m 2 • RYO mass per paper (mg). • RYO paper base paper porosity (permeability) (CU). • RYO paper base paper basis weight (g/m 2 • RYO paper band porosity (permeability) (CU) or [alternatively, RYO paper band diffusivity (cm 2 • RYO paper base paper porosity (permeability) (CU). • RYO paper band porosity (permeability) (CU) or [alternatively, RYO paper band diffusivity (cm 2 • RYO paper band width (mm) (if applicable). • RYO paper band space (mm) (if applicable). Table 5 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Tube mass (mg). • Tube mass (mg). • Tube length (mm). • Tube paper base paper basis weight (g/m 2 • Tube circumference or diameter (mm). • Tube paper base paper porosity (permeability) (CU). • Tube paper width (mm). • Tube paper band porosity (permeability) (CU) (if applicable) or Tube paper band diffusivity (cm 2 • Tube paper base paper basis weight (g/m 2 • Tube paper base paper porosity (permeability) (CU). • Tube paper band porosity (permeability) (CU) (if applicable) or Tube paper band diffusivity (cm 2 • Tube paper band width (mm) (if applicable). • Tube paper band space (mm) (if applicable). Table 6 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Tube mass (mg). • Tube paper base paper basis weight (g/m 2 • Tube length (mm). • Tube paper base paper porosity (permeability) (CU). • Tube circumference or diameter (mm). • Tube mass (mg). • Tube paper length (mm). • Tube paper band porosity (permeability) (CU) (if applicable) or Tube paper band diffusivity (cm 2 • Nonfilter tube length (mm). • Filter pressure drop (mm H 2 • Tube paper width (mm). • Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged (e.g., denier per filament (DPF), total denier (g/9000m), and filter density (g/cm 3 • Tube paper base paper basis weight (g/m 2 • Filter ventilation (%). • Tube paper base paper porosity (permeability) (CU). • Tube paper band porosity (permeability) (CU) (if applicable) or Tube paper band diffusivity (cm 2 • Tube paper band width (mm) (if applicable). • Tube paper band space (mm) (if applicable). • Filter length (mm). • Filter pressure drop (mm H 2 • Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged (e.g., denier per filament (DPF), total denier (g/9000m), and filter density (g/cm 3 • Tipping paper length (mm). • Filter ventilation (%). Table 7 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Tobacco cut size (mm or CPI). • Tobacco cut size (mm or CPI). • Tobacco moisture or oven volatiles (%). • Tobacco moisture or oven volatiles (%). Table 8 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • RYO paper tip length (mm). • RYO paper base paper basis weight (g/m 2 • RYO paper tip width (mm). • RYO paper porosity (permeability) (CU). • RYO paper tip mass (mg). • RYO paper tip ventilation (%). • RYO paper base paper basis weight (g/m 2 • RYO paper porosity (permeability) (CU). • RYO paper tip ventilation (%). Table 9 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Cigar mass (mg). • Cigar mass (mg). • Cigar wrapper basis weight (g/m 2 • Puff count. • Cigar binder length (mm). • Cigar wrapper basis weight (g/m 2 • Cigar binder width (mm). • Cigar wrapper porosity (permeability) (CU). • Cigar binder basis weight (g/m 2 • Cigar binder porosity (permeability) (CU). • Cigar length (mm). • Cigar binder basis weight (g/m 2 • Cigar overall diameter (mm). • Tobacco filler mass (mg). • Cigar minimum diameter (mm) if applicable. • Tobacco rod density (g/cm 3 • Cigar maximum diameter (mm) if applicable. • Tobacco cut size (CPI or mm). • Tobacco filler mass (mg). • Tobacco moisture or oven volatiles (%). • Tobacco rod density (g/cm 3 • Cigar wrapper band porosity (permeability) (CU) [alternatively, band diffusivity (cm 2 • Tobacco cut size (CPI or mm). • Cigar binder band porosity (permeability) (CU) [alternatively, band diffusivity (cm 2 • Tobacco moisture or oven volatiles (%). • Cigar minimum diameter (mm) (if applicable). • Cigar wrapper porosity (permeability) (CU). • Cigar maximum diameter (mm) (if applicable). • Cigar wrapper length (mm). • Filter pressure drop (mm H 2 • Cigar wrapper width (mm). • Filter efficiency (%) (if no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density (g/cm 3 • Cigar wrapper band porosity (permeability) (CU) (if applicable). • Filter ventilation (%). • Cigar wrapper band width (mm) (if applicable). • Cigar wrapper band space (mm) (if applicable). • Cigar binder porosity (permeability) (CU). • Cigar binder band porosity (permeability) (CU) (if applicable). • Cigar binder band width (mm) (if applicable). • Cigar binder band space (mm) (if applicable). • Filter length (mm). • Filter diameter (mm). • Filter pressure drop (mm H 2 • Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm 3 • Tipping paper length (mm). • Filter ventilation (%). Table 10 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Cigar mass (mg). • Puff count. • Cigar length (mm). • Cigar mass (mg). • Cigar overall diameter (mm). • Tobacco rod density (g/cm 3 • Cigar minimum diameter (mm) (if applicable). • Tobacco cut size (CPI or mm). • Cigar maximum diameter (mm) (if applicable). • Tobacco moisture or oven volatiles (%). • Tobacco rod density (g/cm 3 • Tobacco filler mass (mg). • Tobacco moisture or oven volatiles (%). • Cigar minimum diameter (mm) (if applicable). • Tobacco cut size (CPI or mm). • Cigar maximum diameter (mm) (if applicable). • Tobacco filler mass (mg). • Cigar wrapper porosity (permeability) (CU). • Cigar wrapper porosity (permeability) (CU). • Cigar wrapper basis weight (g/m 2 • Cigar wrapper length (mm). • Cigar binder basis weight (g/m 2 • Cigar wrapper width (mm). • Cigar binder porosity (permeability) (CU). • Cigar wrapper basis weight (g/m 2 • Cigar tip mass (mg) (if applicable). • Cigar binder porosity (permeability) (CU). • Cigar wrapper band porosity (permeability) (CU) [alternately, band diffusivity (cm2/s)] (if applicable). • Cigar binder width (mm) • Cigar binder band porosity (permeability) (CU) [alternately, band diffusivity (cm2/s)] (if applicable). • Cigar binder basis weight (g/m 2 • Cigar tip length (mm) (if applicable). • Cigar tip inner diameter (mm) (if applicable). • Cigar tip mass (mg) (if applicable). • Cigar wrapper band space (mm) (if applicable). • Cigar wrapper band width (mm) (if applicable). • Cigar binder band width (mm) (if applicable). • Cigar binder band space (mm) (if applicable). • Cigar wrapper band porosity or permeability (CU) [alternately, band diffusivity (cm2/s)] (if applicable). • Cigar binder band porosity (permeability) (CU) [alternately, band diffusivity (cm2/s)] (if applicable). Table 11 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Cigar mass (mg). • Puff count. • Cigar length (mm). • Cigar mass (mg). • Overall diameter (mm). • Cigar minimum diameter (mm). • Cigar minimum diameter (mm). • Cigar maximum diameter (mm). • Cigar maximum diameter (mm). • Cigar wrapper basis weight (g/m 2 • Tobacco moisture or oven volatiles (%). • Cigar binder basis weight (g/m 2 • Tobacco filler mass (mg). • Tobacco filler mass (mg). • Tobacco rod density (g/cm 3 • Tobacco rod density (g/cm 3 • Tobacco cut size (CPI or mm). • Tobacco cut size (CPI or mm). • Tobacco moisture or oven volatiles (%). • Tobacco moisture or oven volatiles (%). • Cigar wrapper length (mm). • Cigar wrapper width (mm). • Cigar wrapper basis weight (g/m 2 • Cigar binder width (mm). • Cigar binder basis weight (g/m 2 Table 12 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Tobacco cut size (CPI or mm) • Tobacco cut size (CPI or mm). • Tobacco moisture or oven volatiles (%) • Tobacco moisture or oven volatiles (%). Table 13 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Cigar wrapper length (mm). • Cigar wrapper length (mm). • Cigar wrapper width (mm). • Cigar wrapper width (mm). • Cigar wrapper basis weight (g/cm 2 • Cigar wrapper basis weight (g/cm 2 Table 14 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Hose length (mm). • Hose length (mm). • Hose materials. • Hose internal diameter (mm). • Hose internal diameter (mm). • Stem length (mm). • Stem length (mm). • Stem internal diameter (mm). • Stem internal diameter (mm). • Base diameter (mm). • Base diameter (mm). • Base volume (cm 3 • Base volume (cm 3 • Pressure drop (mm H 2 • Base shape. • Water filter efficiency (%). • Pressure drop (mm H 2 • Head height (mm). • Water filter efficiency (%). • Head top diameter (mm). • Hose air permeability (CU). • Head bottom diameter (mm). • Head height (mm). • Head volume (mm 3 • Head top diameter (mm). • Head bottom diameter (mm). • Number of holes. • Head volume (mm 3 • Heating source type. • Head materials. Table 15 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Tobacco cut size (CPI or mm). • Tobacco cut size (CPI or mm). • Tobacco moisture or oven volatiles (%). • Tobacco moisture or oven volatiles (%). Table 16 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Heating element temperature range ( °C). • Heating element temperature range ( °C). • Heating element mass (mg). • Heating element mass (mg). • Heating element density (g/cm 3 • Heating element density (g/cm 3 • Heating element resistance (ohms) (if applicable). • Heating element resistance (ohms) (if applicable). • Number of heating elements. • Heating element diameter (gauge). • Heating element configuration. • Battery current rating (mA) (if applicable). • Heating element diameter (gauge) (if applicable). • Battery capacity (mAh) (if applicable). • Battery current rating (mA) (if applicable). • Battery voltage operating range (volts) (if applicable). • Battery capacity (mAh) (if applicable) • Battery current operating range (amps) (if applicable). • Battery voltage operating range (volts) (if applicable). • Power delivery unit (PDU) temperature cut-off ( °C) (if applicable). • Battery current operating range (amps) (if applicable). • Power delivery unit (PDU) voltage operating range (volts) (if applicable). • Power delivery unit (PDU) temperature cut-off ( °C) (if applicable). • PDU current operating range (amps) (if applicable). • Power delivery unit (PDU) voltage operating range (volts) (if applicable). • PDU wattage operating range (watts) (if applicable). • PDU current operating range (amps) (if applicable). • PDU wattage operating range (watts) (if applicable). Table 17 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Foil length (mm) (for square or rectangular shape foil). • Foil length (mm) (for square or rectangular shape foil). • Foil width (mm) (for square or rectangular shape foil). • Foil width (mm) (for square or rectangular shape foil). • Diameter (mm) (for circular shape foil). • Diameter (mm) (for circular shape foil). • Foil thickness (mm). • Foil thickness (mm). • Number of holes. • Diameter of the holes (mm). • Diameter of the holes (mm). Table 18 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Head height (mm), • Head height (mm). • Head top diameter (mm), • Head top diameter (mm). • Head bottom diameter (mm), • Head bottom diameter (mm). • Number of holes, • Head volume (mm 3 • Head volume (mm 3 • Head materials, Table 19 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Bowl chamber cover outer diameter (mm). • Bowl chamber volume (cm 3 • Bowl chamber cover inner diameter (mm). • Pipe pressure drop (mm H 2 • Draught hole diameter (mm). • Air flow through air valve (cc/min). • Screen (if applicable). • Airway volume (cm 3 • Draught hole shape. • Filter pressure drop (mm H 2 • Draught hole location. • Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm 3 • Bowl chamber hole shape. • Bowl chamber volume (cm 3 • Airway volume (cm 3 • Stem length (mm). • Stem diameter (mm). • Shank length (mm). • Shank diameter (mm). • Draught hole dimension. • Pressure drop through air valve (mm H 2 • Air flow through air valve (cc/min). • Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm 3 • Filter pressure drop (mm H 2 • Filter length (mm). Table 20 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Tobacco cut size (CPI or mm). • Tobacco cut size (CPI or mm). • Tobacco moisture or oven volatiles (%). • Tobacco moisture or oven volatiles (%). Table 21 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, • Draw resistance (mm H 2 • Puff count (for full tank/cartridge). • Draw resistance (mm H 2 • Atomizer tank/cartridge volume (mL). • Puff count (for full tank/cartridge). • Number of heating elements (e.g., coil). • Atomizer tank/cartridge volume (mL). • Heating Element diameter (gauge). • Heating Element diameter (gauge). • Heating Element length (mm). • Heating Element resistance (Ohms). • Heating Element resistance (Ohms). • Heating Element temperature range ( °C). • Heating Element temperature range ( °C). • Battery voltage operating range (V). • Heating Element configuration (target only). • Battery current operating range (mA). • Battery voltage operating range (V). • PDU voltage operating range (V). • Battery current operating range (mA). • PDU current operating range (mA). • Battery Capacity (mAh). • PDU wattage operating range (watts). • Battery Nominal Voltage (V). • PDU Current cut-off (mA) (if applicable). • Battery Current rating (mA). • PDU temperature cut-off ( °C) (if applicable). • Battery charging temperature limits ( °C). • Battery Capacity (mAh). • Battery discharge temperature limits ( °C). • Battery Nominal Voltage (V). • Battery end of discharge voltage (V). • Battery Current rating (mA). • Battery maximum charging current (mA). • Battery charging temperature limits ( °C). • Battery maximum discharging current (mA). • Battery discharge temperature limits ( °C). • Battery upper limits charging voltage (V). • Battery maximum charging current (mA). • Power Delivery Unit (PDU) voltage operating range (V). • Battery maximum discharging current (mA). • PDU current operating range (mA). • Battery upper limits charging voltage (V). • PDU wattage operating range (watts). • Inhaled aerosol temperature ( °C). • PDU temperature cut-off ( °C) (if applicable). • Airflow rate (L/min) (if applicable). • Airflow rate (L/min) (if applicable). • Ventilation (%). • PDU Current cut-off (mA) (if applicable). • PDU Temperature cut-off ( °C) (if applicable). • Inhaled aerosol temperature ( °C). • Ventilation (%). Table 22 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • E-liquid viscosity (at 20 °C). • E-liquid viscosity (at 20 °C). • E-liquid volume (ml). • E-liquid volume (ml). • Particle number concentration (#/cm 3 • Particle number concentration (#/cm 3 • Count median diameter (nm). • Count median diameter (nm). • PM 2.5 3 • PM 2.5 3 Table 23 to Paragraph ( i ii Provide target specification with upper and lower range limits for: Provide test data (include test protocols, quantitative acceptance • Overall Product. • Overall Product. ○ Mass (mg). ○ Draw resistance (mm H 2 ○ Length (mm). ○ Puff count (for full tank/cartridge). ○ Width (mm). ○ Product volume (mL). ○ Height (mm). ○ Airflow rate (L/min) (if applicable). ○ Diameter (mm). ○ Ventilation (%). ○ Draw resistance (mm H 2 ○ Operational Temperature ( °C). ○ Puff Count (for full tank/cartridge). ○ Temperature sensor (if applicable). ○ Puff volume (mL). ○ Material wrapper length (mm) (if applicable). ○ Product volume (mL). ○ Material wrapper width (mm) (if applicable). ○ Airflow rate (L/min) (if applicable). ○ Material wrapper basis weight (g/m 2 ○ Ventilation (%). ○ Material porosity (permeability) (CU) (if applicable). ○ Operational Temperature ( °C). • Heating element. ○ Temperature sensor (if applicable). ○ Heating Element diameter (gauge). ○ Material wrapper length (mm) (if applicable). ○ Heating Element resistance (Ohms). ○ Material wrapper width (mm) (if applicable). ○ Heating Element temperature range ( °C). ○ Material wrapper basis weight (g/m 2 • E-liquid. ○ Material porosity (permeability) (CU) (if applicable). ○ E-liquid viscosity (at 20 °C). • Heating element. ○ E-liquid volume (ml). ○ Heating element source/type/approach (electrical, carbon, aerosol, etc.). • Tobacco (if applicable). ○ Heating element temperature range ( °C). ○ Tobacco moisture (%). ○ Heating element operational temperature ( °C). ○ Tobacco cut size (CPI or mm). ○ Heating element maximum temperature (boost temperature) ( °C). ○ Tobacco density (g/cm 3 ○ Heating element material. • Battery. ○ Heating element Configuration (i.e., the shape and design of the heating element. If the heating element is a coil, it is the shape and arrangement of the coil. If the heating element is a novel design, provide the configuration and its design targets.). ○ Heating element length (mm). ○ Heating element mass (mg). ○ Heating element location. ○ Number of heating elements (e.g., coil) (dimensionless). ○ Battery voltage operating range (V). ○ Heating Element diameter (gauge) (if applicable). ○ Battery current operating range (mA). ○ Heating Element resistance (Ohms) (if applicable). ○ PDU voltage operating range (V). • Tobacco/E-liquid. ○ PDU current operating range (mA) PCO wattage operating range (W). ○ Tobacco mass (mg) (if applicable). ○ Tobacco density (g/cm 3 ○ PDU Current cut-off (mA) (if applicable). ○ Tobacco moisture or oven volatiles (%) (if applicable). ○ PDU temperature cut-off ( °C). ○ Tobacco cut size (CPI or mm) (if applicable). ○ Battery Capacity (mAh). ○ E-liquid volume (mL) (if applicable). ○ Battery Nominal Voltage (V). ○ E-liquid viscosity (at 20 °C) (if applicable). ○ Battery Current rating (mA). • Battery (if applicable). ○ Battery charging temperature limits ( °C). ○ Battery capacity (mA). ○ Battery discharge temperature limits ( °C). ○ Battery Voltage Operating Range (V) or Wattage (W). ○ Battery maximum charging current (mA). ○ Battery Current Charging range (amps). ○ Battery maximum discharging current (mA). ○ Battery Nominal Voltage (V). ○ Battery upper limits charging voltage (V). ○ Battery Current rating (mA). • Aerosol. ○ Battery charging temperature limits ( °C). ○ Battery discharge temperature limits ( °C). ○ Battery end of discharge voltage (V). ○ Inhaled aerosol temperature ( °C). ○ Battery maximum charging current (mA). ○ Aerosol Particle number concentration (#/cm 3 ○ Battery maximum discharging current (mA). ○ Count median diameter (nm). ○ Battery upper limits charging voltage (V). ○ PM 2.5 3 ○ Power Delivery Unit (PDU) voltage operating range (V). • Filter (if applicable). ○ PDU current operating range (mA). ○ Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm 3 ○ PDU wattage operating range (watts). ○ Filter ventilation (%). ○ PDU temperature cut-off ( °C) (if applicable) ○ Filter pressure drop (mm H 2 ○ PDU Current cut-off (mA) (if applicable). • Aerosol. ○ Inhaled aerosol temperature ( °C). ○ Aerosol Particle number concentration (#/cm 3 ○ Count median diameter (nm). ○ PM 2.5 3 • Filter (if applicable). ○ Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm 3 ○ Filter pressure drop (mm H 2 ○ Filter length (mm). ○ Filter diameter (mm). ○ Filter ventilation (%). (iii) Function. (iv) Product pH and nicotine formulation. e.g., (v) Fermentation process. (A) Description of the fermentation process; (B) Composition of the inoculum (starter culture) with genus and species name(s) and concentration(s) (if applicable); (C) Any step(s) taken to reduce endogenous microbes ( e.g., (D) Specifications and test data for pH, temperature, moisture content, and water activity; (E) Frequency of aeration or turning (if applicable); (F) Duration of fermentation; (G) Added ingredients; (H) Method used to stabilize or stop fermentation ( e.g., e.g., (I) Storage conditions of the fermented tobacco prior to further processing or packaging and duration of storage (if applicable). (vi) Heat treatment process. (A) Description of the heat treatment process; (B) Type of heat treatment; (C) Conditions of heat treatment, including time, temperature, and moisture; and (D) Method validation data, including microbial loads (including bacteria, spores, yeast, and fungi) and TSNAs before and after heat treatment. (vii) Shelf life and stability information. (A) The length of the shelf life, a description of how the shelf life is determined, and a description of how shelf life is indicated on the tobacco product, if applicable; (B) 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: Microbial content data, including total aerobic microbial count and total yeast and mold count; water activity; tobacco-specific nitrosamines (TSNAs) yields (total TSNAs, N′-nitrosonor-nicotine (NNN), 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK)); and preservatives content. (C) Stability testing details for each microbial and chemical endpoint, including: The mean quantity and variance with unit of measures; the number of samples and measurement replicates for each sample; the methods used, including any deviation(s) from the methods, associated reference(s), and full validations reports for each method; 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; length of time between date of tobacco product manufacture and date(s) of testing; storage conditions of the tobacco product before it was tested; 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 full test data (including quantitative acceptance (pass/fail) criteria, complete data sets, and a summary for the results) for all stability testing performed. (viii) Product and packaging design risks and misuse hazards. (3) Principles of operation. (i) The way in which a typical consumer will use the new tobacco product, including a description of how a consumer operates the product, how long a single unit of product is expected to last ( e.g., (ii) A justification for an applicant's determination of what constitutes a single unit of product as described in the PMTA; and (iii) Whether the product incorporates a heating source, and if so, a description of the heating source. (4) Product testing and analysis information. (i) The name and location of 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; (ii) The length of time between dates of manufacture and date(s) of testing; (iii) The storage conditions of the tobacco product before it was tested; (iv) The number of samples and measurement replicates for each sample; (v) A description of method procedure, method validation information and rationale for selecting each test method, including relevant voluntary testing standards, test protocols, quantitative acceptance criteria, line data, and a summary of the results; (vi) Reports of product formulation testing that include test protocols, quantitative acceptance criteria, line data, and a summary of the results, for each applicable design parameter; and (vii) 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. (j) Manufacturing. (1) A list of all manufacturing, packaging, storage, and control facilities for the product, including the facility name, address, and FEI number, if applicable, and a contact name and telephone number for a representative from each facility; (2) A narrative description, accompanied by a list and summary, of all standard operating procedures (SOPs) and examples of relevant forms and records for the following categories of information for all manufacturing, design controls, packing, and storage for the tobacco product: (i) Manufacturing and production process activities at each establishment, including a description of each establishment, all production steps, and process controls, process specifications with relevant acceptance criteria, and monitoring and acceptance activities; (ii) Managerial oversight and employee training related to the manufacture, processing, packing, and installation of the tobacco product, as applicable; (iii) Monitoring procedures and manufacturing controls for product design, product characteristics, and changes in products, specifications, methods, processes, or procedures, including a hazard analysis that details the correlation of the product design attributes with public health risk, as well as any mitigation strategies implemented; (iv) Activities related to identifying and monitoring suppliers and the products supplied (including, for example, purchase controls and product acceptance activities); (v) Handling of complaints, nonconforming products and processes, and corrective and preventative actions; (vi) Testing procedures carried out before the product is released to market, including: (A) A list and summary of any standards used for all testing methods; (B) Validation and verification activities for all test methods used to ensure that the tobacco product meets specifications; (C) Documentation of accreditation information for all testing laboratories; (D) Complete description of smoking or aerosol-generating regimes used for analytical testing, if any; and (E) Tobacco product specifications (including any physical, chemical, and biological specifications) and acceptance criteria for those specifications; (F) Reports of release testing performed on finished products to demonstrate conformity with established specifications, including test protocols, line data, and a summary of the results for each applicable testing. (k) Health risk investigations Study types. (i) Health risks of the product. (A) The health effects of the constituents, including HPHCs, at the quantitative levels delivered to both users and nonusers under the range of conditions under which the product might be used; (B) The toxicological profile of the new tobacco product related to the route of administration, including the genotoxicity, carcinogenicity, reproductive toxicity, immunotoxicity, acute toxicity, and repeat dose (chronic) toxicity of the new tobacco product relative to other tobacco products. The toxicological profile also includes information on the toxicity of the ingredients, additives, and HPHCs, relative to the route of administration and the range of potential levels of exposure resulting from the use of, or exposure to, the new tobacco product, including studies which discuss the toxicological effects of any leachables and extractables that can appear from the container closure system and the ingredient mixture, such as additive or synergistic effects; (C) The pharmacological profile of the new tobacco product, including the pharmacokinetics, pharamacodynamics, metabolism, and elimination profile, of any of the ingredients, additives, and HPHCs for the range of potential levels of exposure resulting from the use of, or exposure to, the new tobacco product relative to other tobacco products. The applicant must specify whether the studies were conducted in vitro, in vivo, ex vivo, or in silico; and (D) The health risks of the tobacco product compared to other tobacco products on the market, never using tobacco products, quitting tobacco product use, and using the tobacco product in conjunction with other tobacco products. (ii) Impacts on tobacco use behavior of tobacco product users. (A) The abuse liability of the tobacco product; (B) How users actually use the product, including use topography, product use frequency, use trends over time, and how such use affects the health risks of the product to individual users; (C) The likelihood that users will use the product in conjunction with other tobacco products; (D) The likelihood that current tobacco product users will start using the product; (E) The likelihood that current tobacco users who adopt the product will switch to or switch back to other tobacco products that may present increased risks to individual health; and (F) The likelihood that current tobacco users who may have otherwise quit using tobacco products will instead start or continue to use the product. (iii) Impacts on tobacco use initiation by nonusers, including youth, young adults, and other relevant vulnerable populations. (A) The likelihood that consumers who have never used tobacco products, particularly youth, young adults, and other relevant vulnerable populations, will initiate use of the tobacco product; (B) The likelihood that nonusers of tobacco products who adopt the tobacco product will switch to other tobacco products that may present higher levels of individual health risk; and (C) The likelihood that former users of tobacco products will re-initiate use with the tobacco product. (iv) Perceptions and use intentions. (A) Perception of the product; (B) Use intentions; and (C) Ability to understand the labeling and instructions for use and use the product in accordance with those instructions. (v) Human factors. (2) Literature search. (3) Study reports. (i) Full copies of any published articles and other reference materials; (ii) Documentation of all actions taken to ensure the reliability of the study. For all studies, to the extent reasonably available or obtainable, the application must contain a certification that investigators do not have, or documentation fully disclosing, any financial conflicts of interest, such as the financial arrangements specified in the Financial Disclosure by Clinical Investigators regulation in part 54 of this chapter. Additionally, for nonclinical laboratory studies, the application must contain, for each study, documentation of all actions taken to ensure the reliability of the study, e.g., (iii) Copies of all versions of protocols and amendments that were used in the study; (iv) Copies of all versions of investigator instructions, if any were produced in addition to the protocol; (v) The statistical analysis plan, including a detailed description of the statistical analyses used (including all variables, confounders, and subgroup analyses), the scientific rationale for the choice of sample sizes, and any amendments to the plan; (vi) Line data, including data definition files that include the names of the variables, codes, and formats in each dataset, and copies of programs and any necessary macro-programs used to create derived datasets, and the results included in the study reports; (vii) A list of sites and clinical investigators that conducted the study, including contact information and physical address(es); (viii) The location of all source data. If the site where the study was conducted has not maintained all of the source data, indicate where the data are located; (ix) The format of the records and data ( e.g., (x) A list of all sites that had early termination and the reason for early termination, if applicable; (xi) A list of contractors who participated in the study, the role of each contractor, and the initiation and termination dates of the participation of each contractor; (xii) A signed full report of all findings; (xiii) For human subject studies: (A) All versions of study materials ( e.g., (B) All versions of case report forms used; and (C) Individual case report forms related to participant deaths, other serious and unexpected adverse experiences, withdrawals, and participant discontinuation where the study participant was exposed to the tobacco product that is the subject of the PMTA or similar products; and (xiv) For tobacco product perception and use intention studies that use advertising as stimuli, a statement describing whether the advertising used is representative of advertising that the applicant intends to use in marketing the product. If the advertising is not representative of the advertising an applicant intends to use in marketing the product, the applicant must describe whether the study results are still relevant to the likely impact of the advertising on tobacco product perceptions and use intentions. ( l The effect on the population as a whole. (m) Certification statement. “I ( name of responsible official applicant name § 1114.9 Amendments. (a) General. (b) Review of an amendment. (1) If the amendment is a major amendment ( e.g., (2) If FDA requests a minor amendment ( i.e., (c) Failure to respond to amendment request. (d) No amendment to closed or withdrawn application. § 1114.11 Withdrawal by applicant. (a) An applicant may at any time make a written request using the appropriate form to withdraw a PMTA that FDA has not acted on as described in § 1114.29. The withdrawal request must state: (1) Whether the withdrawal is due to a health concern related to the tobacco product and, if so, a description of those concerns, including the extent, duration, and frequency of the health effects, and what gave rise to the concerns, such as reports of adverse experiences; (2) The application STN; and (3) The name(s) of the new tobacco product that is the subject of the application. (b) An application will be considered withdrawn when FDA issues an acknowledgement letter stating that the application has been withdrawn. (c) The application is an Agency record, even if withdrawn. FDA will retain the withdrawn application under Federal Agency records schedules. The availability of the withdrawn application will be subject to FDA's public information regulation in Part 20 of this chapter. § 1114.13 Change in ownership of an application. An applicant may transfer ownership of a PMTA. At or before the time of transfer, the new owner and the former owner must submit information to FDA using the appropriate form as follows: (a) The new and former owner must sign and submit a notice to FDA stating that all of the former applicant's rights and responsibilities relating to the PMTA have been transferred to the new owner. This notice must identify the name and address of the new owner and the PMTA transferred by tobacco product name(s) and STN. (b) The new owner must sign and submit a notice to FDA containing the following: (1) The new owner's commitment to agreements, promises, and conditions made by the former owner and contained in the application and marketing granted order, if applicable; (2) The date that the change in ownership is effective; (3) Either a statement that the new owner has a complete copy of the application, including all amendments, the marketing granted order (if applicable), and any records that are required to be kept under § 1114.45, or a request for a copy of the application, including all amendments, and the modified risk order (if applicable) from FDA's files in accordance with part 20 of this chapter. In accordance with the Freedom of Information Act, FDA will provide a copy of the application to the new owner 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 tobacco product since the application, including amendments (if any), was submitted to FDA. § 1114.15 Supplemental applications. (a) Supplemental PMTA submission. (1) Modifications to the product that result in the new tobacco product require the submission of new information or revisions to the PMTA for the original product to the extent that reviewing a supplemental application for the new tobacco product would be confusing, cumbersome, or otherwise inefficient and submitting a standard PMTA under § 1114.7 would better facilitate review. (2) The marketing granted order for the original tobacco product has been withdrawn; or (3) The marketing granted order for the original tobacco product has been temporarily suspended or is subject to temporary suspension or withdrawal proceedings by FDA, except where authorized in writing by FDA. (b) Required format. (c) Required content. (1) The application must contain the full text of all the information described in the following sections: (i) General information that identifies the submission as a supplemental PMTA (as described in § 1114.7(c)); (ii) New product information (as described in paragraph (d) of this section); (iii) Statement of compliance with 21 CFR part 25 (as described in § 1114.7(g)); (iv) Labeling (as described in § 1114.7(f)) if the labeling is not identical to the labeling submitted in the PMTA or postmarket reports for the original product; (v) Postmarket information (as described in paragraph (e) of this section); and (vi) Certification statement (as described in paragraph (f) of this section); (2) The application must include the following sections by cross-reference to the PMTA for the original tobacco product and contain any additional information that is necessary to supplement or update the cross-referenced information: (i) Descriptive information (as described in § 1114.7(d)); (ii) Product samples (as described in § 1114.7(e)); (iii) Labeling (as described in § 1114.7(f)) if the labeling is identical to the labeling that was submitted in the PMTA or postmarket reports for the original tobacco product; (iv) Summary of all research findings (as described in § 1114.7(h)); (v) Product formulation (as described in § 1114.7(i)); (vi) Manufacturing (as described in § 1114.7(j)); and (vii) Health risk investigations (as described in § 1114.7(k)). (d) New product information. (1) Full descriptions of each modification to the product and comparisons to the original product version described in the previously authorized PMTA; (2) A statement as to whether the new tobacco product, if it receives a marketing granted order, will replace the original tobacco product, will be a line extension of the original tobacco product, or will be introduced as an additional product by the same manufacturer; (3) All data and information relating to each modification to the product that would be required in an application under § 1114.7; and (4) A concluding summary of how the new tobacco product meets the requirements to receive a marketing granted order, including how the data and information contained in both the supplemental PMTA and cross-referenced from the previously authorized PMTA constitute valid scientific evidence and establishes that the PMTA meets the requirements of section 910(c) of the Federal Food, Drug, and Cosmetic Act to receive a marketing granted order, including that permitting the new tobacco product to be marketed would be appropriate for the protection of the public health determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product. (e) Postmarket reports. (2) If an applicant is required to, but has not yet submitted a postmarket report, the applicant must submit a report as part of its application that contains all of the information for the original tobacco product that would otherwise be required in a report under § 1114.41 covering the period of time from when it received a marketing granted order for the original tobacco product to when it submits the supplemental PMTA. (f) Certification statement. “I, ( name of responsible official name of applicant new tobacco product name describe each modification to the product name of original tobacco product STN of the PMTA for the original product name(s) of original tobacco product name of applicant name of applicant § 1114.17 Resubmissions. (a) General. (1) It incorporates new information or revisions to the PMTA for the original product to the extent that reviewing a resubmission for the new tobacco product would be confusing, cumbersome, or otherwise inefficient and submitting a standard PMTA under § 1114.7 would better facilitate review; or (2) The marketing denial order states that the applicant may not submit a resubmission. (b) Required format. (c) Required content. (1) The application must include the full text of the information described in the following paragraphs: (i) General information that identifies the submission as a resubmission (as described in paragraph § 1114.7(c)); (ii) Response to deficiencies (as described in paragraph (d) of this section); and (iii) Certification statement (as described in paragraph (e) of this section). (2) The application must include the following sections from the PMTA that received a marketing denial order by cross-reference to the PMTA and contain all additional information, in full text or by reference to a tobacco product master file, that is necessary to supplement or update the cross-referenced information: (i) Descriptive information (as described in § 1114.7(d)); (ii) Product samples (as described in § 1114.7(e)); (iii) Labeling (as described in § 1114.7(f)); (iv) Statement of compliance with 21 CFR part 25 (as described in § 1114.7(g)); (v) Summary of all research findings (as described in § 1114.7(h)); (vi) Product formulation (as described in § 1114.7(i)); (vii) Manufacturing (as described in § 1114.7(j)); and (viii) Health risk investigations (as described in § 1114.7(k)). (d) Response to deficiencies. (2) Where an applicant modifies the product in a way that would result in a new tobacco product under section 910(a)(1) of the Federal Food, Drug, and Cosmetic Act in order to address the deficiencies, the application must also include: (i) A full description of each modification to the product and comparisons of that change to the original version of the product described in the previously submitted PMTA; and (ii) All data and information relating to each modification to the product that would be required in an application under § 1114.7. (e) Certification statement. (1) Same tobacco product certification. “I, ( name of responsible official), name of applicant new tobacco product name(s) STN of the previously submitted PMTA name of applicant name of applicant (2) Different tobacco product certification. “I, ( name of responsible official name of applicant new tobacco product name(s) STN of the previously submitted PMTA describe each modification to the product name(s) of original tobacco product STN of the previously submitted PMTA name(s) of original tobacco product STN of the previously submitted PMTA name of applicant describe each modification to the tobacco product name of applicant Subpart C—FDA Review § 1114.25 Communication between FDA and applicants. During the course of reviewing an application, FDA may communicate with an applicant about relevant matters, including scientific, medical, and procedural issues that arise during the review process and inspections. These communications may take the form of telephone conversations, letters, electronic communications, or meetings, and will be documented in the administrative file in accordance with § 10.65 of this chapter. § 1114.27 Review procedure. (a) Acceptance review. (i) Does not comply with the applicable format requirements in § 1114.7(b), § 1114.15, or § 1114.17 (as applicable); (ii) Is not administratively complete because it does not appear to contain the information required by § 1114.7 (excluding product samples), § 1114.15 or § 1114.17, as applicable; (iii) Does not pertain to a tobacco product subject to chapter IX of the Federal Food, Drug, and Cosmetic Act (as required by § 1105.10 of this chapter); or (iv) FDA can otherwise refuse to accept under § 1105.10. (2) If FDA accepts an application for further review, FDA will issue an acknowledgement letter to the applicant that specifies the PMTA STN. If FDA determines that it will require product samples as part of the PMTA, it will send instructions on how and where to submit product samples, as described in § 1114.7(e) of this chapter. (3) If FDA refuses to accept an application, FDA will issue a letter to the applicant identifying the deficiencies, where practicable, that prevented FDA from accepting the application. (b) Filing review. (i) The PMTA does not contain sufficient information required by section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act and by § 1114.7, § 1114.15, or § 1114.17, as applicable, to permit a substantive review of the application; (ii) The application does not contain any substantive information, including information from published literature or bridged from an investigation of another tobacco product, regarding each of the following topics. (A) The health risks of the new tobacco product as described in either § 1114.7(k)(1)(i)(A), (B), or (C)); (B) The health risks of the new tobacco product compared to the health risks generally presented by products in the same product category as well as products in at least one different category that are used by the consumers an applicant expects will use its new tobacco product (as described in a portion of § 1114.7(k)(1)(i)(D)). (C) The abuse liability of the new tobacco product (as set forth in § 1114.7(k)(1)(ii)(A)); (D) How consumers would be expected to actually use the product, such as use frequency, use trends over time, and how such use affects the health risks of the product to individual users (as described in § 1114.7(k)(1)(ii)(B)); (E) The potential impact that the marketing of the new tobacco product would have on the likelihood that current tobacco product users would change their tobacco product use behavior, such as starting to using the new tobacco product, using the product in conjunction with other tobacco products, or, after using the product, switching to or switch back to other tobacco products that may present increased risks to individual health ( i.e., (F) The impact of the tobacco product and its label, labeling, or advertising, to the extent that advertising has been studied, on tobacco product use behavior of current nonusers of tobacco products ( i.e., (G) The impact of the product and its label, labeling, or advertising, to the extent that advertising has been studied, on individuals' perception of the product and their use intentions ( i.e., (H) The ways in which human factors can affect the health risks of the new tobacco product ( i.e., (iii) The PMTA contains a false statement of material fact; (iv) The PMTA is a supplemental PMTA that does not comply with § 1114.15; or (v) The PMTA is a resubmission that does not comply with § 1114.17. (2) If FDA refuses to file an application, FDA will issue a letter to the applicant identifying the deficiencies, where practicable, that prevented FDA from filing the application. (3) If FDA files an application, FDA will issue a filing letter to the applicant. (c) Application review. (2) FDA will begin substantive review of the application after it is filed under paragraph (b) of this section. FDA may communicate with the applicant as set forth under § 1114.25 to seek additional or clarifying information. (3) FDA may refer the PMTA or portions of the PMTA, upon its own initiative or applicant request, to TPSAC for reference and for the submission of a report and recommendation respecting the application, together with all underlying data and the reasons or basis for the recommendation. (4) FDA may conduct inspections of the applicant's manufacturing sites, and sites and entities involved with clinical and nonclinical research (including third parties and contract research organizations) to support FDA's review of the PMTA. Where an applicant prevents FDA from scheduling and conducting inspections that are necessary for FDA to complete its review of the PMTA in a timely manner, FDA may pause the 180-day review period for the number of days necessary to complete the inspection. (5) FDA may defer review of a PMTA for a new product that, if introduced or delivered for introduction into interstate commerce, would be adulterated or misbranded due to the manufacturer or importer's failure to comply with user fee payment and reporting requirements under part 1150. § 1114.29 FDA action on an application. After receipt of an application, FDA will: (a) Refuse to accept the application as described in § 1114.27(a); (b) Issue a letter administratively closing the application; (c) Issue a letter canceling the application if FDA finds that it mistakenly accepted the application or that the application was submitted in error; (d) Refuse to file the application as described in § 1114.27(b); (e) Issue a marketing granted order as described in § 1114.31; or (f) Issue a marketing denial order as described in § 1114.33. § 1114.31 Issuance of a marketing granted order. (a) FDA will issue a marketing granted order if it finds that none of the grounds for denial listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply. A marketing granted order becomes effective on the date it is issued. (b) FDA may include, as part of the marketing granted order: (1) Restrictions on the sale and distribution of the product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, to the extent that it would be authorized to impose such restrictions under a regulation issued under section 906(d) of the Federal Food, Drug, and Cosmetic Act; (2) Any restrictions on the sales, distribution, advertising, and promotion of the new tobacco product that the applicant proposed to be included as part of a marketing granted order under section 910(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act to support a finding by FDA that permitting the product to be marketed would be appropriate for the protection of the public health; and (3) Requirements to establish and maintain records, and submit postmarket reports under section 910(f) of the Federal Food, Drug and Cosmetic Act in addition to those described in § 1114.41, including but not limited to information such as labeling, advertising, marketing, promotional materials, or marketing plans not previously submitted to FDA. § 1114.33 Issuance of a marketing denial order. (a) Issuance. (1) Upon the basis of the information submitted as part of the application and any other information before FDA with respect to the new tobacco product, FDA finds that any of the grounds for denial listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act apply; (2) The applicant does not permit an authorized FDA employee, at a reasonable time and in a reasonable manner, an opportunity to: (i) Inspect the facilities and controls described in the application; or (ii) Have access to, copy, and verify all records pertinent to the application,

which results in FDA finding that one or more of the grounds for denial specified in section 910(c)(2) of the Federal Food, Drug and Cosmetic Act apply. (b) Description of deficiencies. § 1114.35 Withdrawal of a marketing granted order. (a) Grounds for withdrawal. (1) Any of the grounds for withdrawal under section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act apply; or (2) Any postmarket requirement imposed by the marketing granted order or by this part has not been met, which results in FDA finding that one or more of the grounds for withdrawal specified in section 910(d)(1) of the Federal Food, Drug and Cosmetic Act apply. (b) Advice and other information. (2) FDA may use information other than that submitted by the applicant in deciding whether to withdraw a marketing granted order. (c) Informal hearing. (d) Order issuance. (e) Public notice. § 1114.37 Temporary suspension of a marketing granted order. (a) FDA will temporarily suspend a marketing granted order if FDA determines that there is a reasonable probability that the continued distribution of such tobacco product would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market. (b) Before temporarily suspending a marketing granted order of a tobacco product, FDA will offer the holder of the marketing granted order an opportunity for an informal hearing under part 16 of this chapter. (c) If, after offering the holder of the marketing granted order an opportunity for a part 16 hearing, the Agency decides to proceed with the temporary suspension, FDA will issue an order temporarily suspending the marketing granted order for a tobacco product. (d) After issuing an order temporarily suspending the marketing granted order, FDA will proceed expeditiously to withdraw the marketing granted order for the tobacco product. Subpart D—Postmarket Requirements § 1114.39 Postmarket changes. A marketing granted order authorizes the marketing of a new tobacco product in accordance with the terms of the order. Prior to the introduction or delivery for introduction into interstate commerce of a new tobacco product that results from modification(s) to the product, an applicant must submit a new PMTA under § 1114.7 or a supplemental PMTA under § 1114.15 and obtain a marketing granted order for the new tobacco product, unless the new tobacco product can be legally marketed through another premarket pathway. § 1114.41 Reporting requirements. (a) Required reports. e.g., (1) Periodic reports. (i) A cover letter that contains the PMTA STN, tobacco product name(s) (including the original name described in the PMTA if different), company name, date of report, and reporting period; (ii) A description of all changes made to the manufacturing, facilities, or controls during the reporting period, including: (A) A comparison of each change to what was described in the PMTA; (B) The rationale for making each change and, if any, a listing of any associated changes; and (C) The basis for concluding that each change does not result in a new tobacco product that is outside the scope of the marketing granted order and will not result in a finding that the marketing granted order must be withdrawn or temporarily suspended under section 910(d) of the Federal Food, Drug, and Cosmetic Act; (iii) An inventory of ongoing and completed studies about the tobacco product conducted by, or on behalf of, the applicant that are within the scope of § 1114.7(k) and that have not been previously reported; (iv) Full reports of information published or known to, or which should be reasonably known to, the applicant concerning scientific investigations and literature about the tobacco product that have not been previously reported, including significant findings from publications not previously reported; (v) A summary and analysis of all serious and unexpected adverse experiences associated with the tobacco product that have been reported to the applicant or that the applicant is aware of, accompanied by a statement of any changes to the overall risk associated with the tobacco product, and a summary of any changes in the health risks, including the nature and frequency of the adverse experience, and potential risk factors; (vi) A summary of sales and distribution of the tobacco product for the reporting period, to the extent that the applicant collects or receives such data, including: (A) Total U.S. sales reported in dollars, units, and volume with breakdowns by U.S. census region, major retail markets, and channels in which the product is sold; (B) The Universal Product Code that corresponds to the product(s) identified in the PMTA; and (C) Demographic characteristics of product(s) purchasers, such as age, gender, race or ethnicity, geographic region, and tobacco use status; (vii) A summary of the implementation and effectiveness of policies and procedures regarding verification of the age and identity of purchasers of the product; and (viii) A summary of all formative consumer research studies conducted (if any), among any audiences, in the formation of new labeling, advertising, marketing, or promotional materials, not previously submitted, including qualitative and quantitative research studies used to determine message effectiveness, consumer knowledge, attitudes, beliefs, intentions and behaviors toward using the products, and including the findings or these studies and copies of the stimuli used in testing; (xi) A summary of all consumer evaluation research studies conducted (if any), among any audiences, not previously submitted, to determine the effectiveness of labeling, advertising, marketing, or promotional materials and shifts in consumer knowledge, attitudes, beliefs, intentions, and behaviors toward using the products, and including the findings of these studies and copies of the stimuli used in testing; (xii) A summary of the creation and dissemination of the products' labeling, advertising, marketing, and promotional materials (if any), including a list of all entities involved and a description of their involvement, including a description of contractual agreements with such entities; (xiii) Specimens of all labeling and descriptions of all labeling changes that have not been previously submitted under section 905(i) of the Federal Food, Drug, and Cosmetic Act, including the date the labeling was first disseminated and the date when dissemination was completely terminated; (xiv) Full color copies of all advertising for the tobacco product that has not been previously submitted, and the original date the materials were first disseminated and the date when their dissemination was completely terminated; (xv) A description of the implementation of all advertising and marketing plans, not previously submitted to FDA, by channel and by product, including strategic creative briefs and paid media plans, and the dollar amount(s) and flighting of such plans, by channel and by product, including a description of any of the following activities that an applicant may have engaged in: (A) Use of competent and reliable data sources, methodologies, and technologies to establish, maintain, and monitor highly targeted advertising and marketing plans and media buys, including a list of all data sources used to target advertising and marketing plans and media buys; (B) Targeting of specific group(s) by age-range(s), including young adults, ages 21 to 24, and other demographic or psychographic characteristics that reflect the intended target audience, including the source of such data; (C) With respect to individuals below the minimum age of sale, actions taken to restrict access to the products and exposure to the products' labeling, advertising, marketing, or promotion, or other consumer-directed activities; (D) Use of owned, earned, shared, or paid media to create labeling for, advertise, market, or promote the product; (E) Use of partners, influencers, bloggers, or brand ambassadors to create labeling for, advertise, market, or promote the product; (F) Consumer engagements conducted by the applicant, on its behalf, or at its direction, including events at which the products were demonstrated and how access was restricted to individuals at or above the minimum age of sale; (G) Use of public-relations or other communications outreach to create labeling for, advertise, market, or promote the products; (xvi) A summary of media tracking and optimization, by channel, by product, and by audience demographics ( e.g., (xvii) An analysis of the actual delivery of advertising impressions, by channel, by product, and by audience demographics, that have not been previously submitted, and verified against post-launch delivery-verification reports submitted to the applicant from an accredited source, where applicable; (xviii) Additional information required to be reported under the terms of a marketing granted order (if applicable); and (xix) An overall assessment of how the tobacco product continues to be appropriate for the protection of the public health. (2) Serious and unexpected adverse experience reporting. (b) FDA review of postmarket reports. (2) FDA may notify an applicant that FDA has determined that a change described in a periodic report made under this section results in a new tobacco product outside the scope of the marketing granted order, requiring the submission of a new PMTA under § 1114.7 or a supplemental PMTA under § 1114.15 and issuance of a marketing granted order if the applicant seeks to market the new tobacco product, unless the new tobacco product can be legally marketed through a different premarket pathway. Subpart E—Miscellaneous § 1114.45 Record retention. (a) Record retention by the applicant. (i) All documents submitted to FDA as part of an application, periodic postmarket reports, and adverse experience reports; (ii) All documentation demonstrating whether each: (A) Nonclinical laboratory study was conducted in accordance with good laboratory practices that support the reliability of the results, such as the records described in part 58 of this chapter; and (B) Clinical investigator has any financial conflicts of interest that may be a source of bias, such as the documentation described in part 54 of this chapter; (iii) All other documents generated during the course of a study necessary to substantiate the study results, including: (A) Communications related to the investigation between the investigator and the sponsor, the monitor, or FDA; and (B) All source data for human subject and nonclinical investigations included in the application and postmarket reports, including records of each study subject's case history and exposure to tobacco products used in the investigation, including case report forms, progress notes, hospital records, clinical charts, X-rays, lab reports, and subject diaries; and (iv) A list of each complaint, and a summary and analysis of all complaints, associated with the tobacco product reported to the applicant; (2) These records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. Documents that have been translated from another language into English ( e.g., (3) All records must be retained as follows: (i) Records related to and including the PMTA must be retained for a period of at least 4 years from the date that the marketing granted order is issued. (ii) Records related to postmarket reports, including both periodic and adverse experience reports, must be retained for a period of at least 4 years from the date the report was submitted to FDA or until FDA inspects the records, whichever occurs sooner. (b) Record retention by FDA. § 1114.47 Confidentiality. (a) General. (b) Confidentiality of data and information prior to an order. (1) FDA will not publicly disclose the existence of an application unless: (i) The applicant has publicly disclosed or acknowledged (as such disclosure is defined in § 20.81 of this chapter), or has authorized FDA in writing to publicly disclose or acknowledge, that the applicant has submitted an application to FDA; or (ii) FDA refers the application to TPSAC. (2) Except as described in paragraph (b)(4) of this section, FDA will not disclose the existence or contents of an FDA communication with an applicant regarding its application except to the extent that the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence or contents of that particular FDA communication. (3) Except as described in paragraph (b)(4) of this section, FDA will not disclose the existence or contents of information contained in an application unless the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence or contents of that particular information. If the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence or contents of that particular information contained in an application, FDA may disclose the existence or contents of that particular information. (4) If FDA refers an application to TPSAC, the contents of the application will be available for public disclosure, except information that is exempt from disclosure under part 20 of this chapter. (c) Disclosure of data and information after issuance of a marketing granted order. (1) All data previously disclosed to the public, as such disclosure is defined in § 20.81 of this chapter; (2) Any protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in § 20.61 of this chapter; (3) Information and data submitted to demonstrate that the new tobacco product is appropriate for the protection of public health, unless the information is shown to fall within the exemptions established in § 20.61 of this chapter for trade secrets and confidential commercial information, or in § 20.63 of this chapter for personal privacy; (4) Correspondence between FDA and the applicant, including any requests FDA made for additional information and responses to such requests, and all written summaries of oral discussions between FDA and the applicant, unless it is shown to fall within the exemptions in § 20.61 of this chapter for trade secrets and confidential commercial information, or in § 20.63 of this chapter for personal privacy; (5) In accordance with § 25.51(b) of this chapter, the environmental assessment or, if applicable, the claim for categorical exclusion from the requirement to submit an environmental assessment under part 25 of this chapter; and (6) Information and data contained in postmarket reports submitted to FDA, unless the information is shown to fall within the exemptions established in § 20.61 of this chapter for trade secrets and confidential commercial information, or in § 20.63 of this chapter for personal privacy (d) Disclosure of data and information after the issuance of a marketing denial order. e.g., e.g., § 1114.49 Electronic submission. (a) Electronic format requirement. (b) Waivers from electronic format requirement. www.fda.gov/tobacco-products (1) The name and address of the applicant, a list of individuals authorized by the applicant to serve as the contact person and contact information. If the applicant has submitted a PMTA previously, the regulatory correspondence should also include any identifying information about the previous submission. (2) A statement that creation and/or submission of information in electronic format is not reasonable for the applicant, and an explanation of why creation and/or submission in electronic format is not reasonable. This statement must be signed by the applicant or by a representative who is authorized to make the declaration on behalf of the applicant. (c) Paper submission.

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