DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration TOBACCO HEALTH DOCUMENT SUBMISSION Form Approved: OMB No. 0910-0654 Expiration Date: 6/30/2019 (See page 5 for PRA Statement) FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. STATUTORY REQUIREMENTS Section 904(a)(4) of the act requires each tobacco product manufacturer or importer, or agent thereof, to submit all documents developed after June 22, 2009 "that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives." Information required under section 904(a) (4) must be submitted to FDA beginning December 22, 2009. DEFINITIONS FDA intends to use the following definitions in implementing the health document submission requirements of section 904(a)(4) of the act. 1. Component or part: The term component or part means any software or assembly of materials intended or reasonably expected: (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. FDA notes that component and part are separate and distinct terms within chapter IX of the FD&C Act. However, for purposes of this form, FDA is using the terms component and part interchangeably and without emphasizing the distinction. FDA may clarify the distinctions between component and part in the future. 2. Document: FDA views Federal Rule of Civil Procedure (FRCP) 34 as providing guidance in this area. Rule 34 defines "documents or electronically-stored information" as including "writings, drawings, graphs, charts, photographs, sound recordings, images, and other data or data compilations - stored in any medium from which information can be obtained either directly or, if necessary, after translation by the responding party into a reasonably usable form" (Fed. R. Civ. P. 34(a)(1)(A)). FDA understands the term document in section 904(a) (4) to include the types of documents or electronically stored information referenced in FRCP Rule 34. The term document includes any original or any modified version or draft varying in any way, which is saved or stored separately from other versions and/or distributed to others. 3. Finished tobacco product: The term finished tobacco product means a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits). 4. Importer: The term importer means any person who imports any tobacco product that is intended for sale or distribution to consumers in the United States. 5. Small-scale tobacco product manufacturer: The term small-scale tobacco product manufacturer means a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with. FORM FDA 3743 (3/17) General Information � Page i PSC Publishing Services (301) 443-6740 EF American LegalNet, Inc. www.FormsWorkFlow.com 6. Tobacco product: The term tobacco product is defined in section 201(rr) of the FD&C Act, which states in relevant part: (1) The term "tobacco product" means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). (2) The term "tobacco product" does not mean an article that is a drug under [section 201(g)(1)], a device under [section 201(h)], or a combination product described in section 503(g) [of the FD&C Act]. Note that this definition includes accessories and components and parts of tobacco products, whether they are made or derived from tobacco and whether they are sold or distributed as finished tobacco products. 7. Tobacco product manufacturer: The term tobacco product manufacturer means "any person, including any repacker or relabeler, who (A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or (B) imports a finished tobacco product for sale or distribution in the United States" (section 900(20) of the FD&C Act (21 U.S.C. 387(20)). Thus, the term is not limited to persons who manufacture products containing tobacco, but includes anyone who manufactures any tobacco product as defined above.1 1 However, accessories of tobacco products subject to the deeming rule are explicitly excluded from the rule's deeming provision . Thus, although they meet the definition of tobacco product, such accessories are not currently subject to regulation under the FD&C Act (including section 904(a)(4)). Reference the deeming rule for further information about accessories (81 FR 28974). FORM FDA 3743 (3/17) General Information � Page ii American LegalNet, Inc. www.FormsWorkFlow.com DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration TOBACCO HEALTH DOCUMENT SUBMISSION See page 6 for Instructions Form Approved: OMB No. 0910-0654 Expiration Date: 6/30/2019 (See page 5 for PRA Statement) Please type. An item followed by an asterisk (*) denotes a required field. SECTION I - SUBMITTER IDENTIFICATION Submitter Type (Check one)* Company Name* Company Headquarters D&B D-U-N-S � Number Company Headquarters FDA-assigned Facility Establishment Identifier (FEI) Number City* Manufacturer Importer (Complete Section II) Address* State, Province or Territory* Country* ZIP or Postal Code* Authorized Representative (Responsible official authorized to represent the applicant) Prefix (e.g., Mr., Ms., Dr.): First/Given Name M.I. Last Name Generational Suffix (e.g.,Sr., Jr., III) Email Address Professional Suffix (e.g., MD, Ph.D.) Position Title Telephone (I