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Tobacco Health Document Submission FDA 3743 - Official Federal Forms
| Tobacco Health Document Submission Form. This is a national form and can be used in Food And Drug Administration (FDA) Department Of Health And Human Services (HHS) . |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration TOBACCO HEALTH DOCUMENT SUBMISSION Form Approved: OMB No. 0910-0654 Expiration Date: 10/31/2013 (See page 5 for Burden 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. 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." FDA understands the term "document" in 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. 2. Importer: The term "importer" means the importer of record at the time of entry of a tobacco product into the United States. 3. Pouch: The term "pouch" means a permeable pouch, intended to be filled with pre-portioned tobacco product and placed in the oral cavity with the tobacco product. 4. Tobacco Product: 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)" (section 201(rr) of the act (21 U.S.C. 321(rr))). This term does not include an article that is a drug, a device, or a combination product as defined in the act (section 201(rr) of the act (21 U.S.C. 321(rr))). Thus, the term is not limited to products containing tobacco, but also includes components, parts, and accessories of tobacco products, whether they are sold for further manufacturing or for consumer use. For example, tobacco, papers and filters are tobacco products, whether they are sold to consumers for use with roll-your-own tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette. 5. 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 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. FORM FDA 3743 (10/10) Page 1 PSC Graphics (301) 443-1090 EF 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: 10/31/2013 (See page 5 for Burden Statement) Please type. An item followed by an asterisk (*) denotes a required field. SECTION I - SUBMITTER IDENTIFICATION Submitter Type (Check one)* Manufacturer Company Name* Company Headquarters DUNS Number Address* Company Headquarters FEI Number City* Importer State, Province or Territory* Country* Submitter Point of Contact ZIP or Postal Code* Title (e.g., Mr., Ms., Dr.) Position Title First Name Last Name Email Address FAX Telephone (Include Country Code if applicable) SECTION II - MANUFACTURER IDENTIFICATION Required only for importers Manufacturer Name* Manufacturer Headquarters DUNS Number Address* Manufacturer Headquarters FEI Number City* State, Province or Territory* Country* Manufacturer Point of Contact ZIP or Postal Code* Title (e.g., Mr., Ms., Dr.) Position Title First Name Last Name Email Address FAX Telephone (Include Country Code if applicable) FORM FDA 3743 (10/10) Page 2 American LegalNet, Inc. www.FormsWorkFlow.com Submit a separate copy of this page for each document. Company Name Company Headquarters DUNS Number SECTION III - SUBMISSION FORMAT AND CONTENTS Indicate your submission format (Check all that apply). Electronic Documents 1. 2. 3. Number of documents Media type (e.g., CD) Media quantity (e.g., # of CDs) 4. 5. 6. Size of submission (e.g., MB) File type (e.g., PDF) File software (e.g., Adobe Acrobat 9) 7. If you are submitting electronic documents, please detail any special instructions for loading or accessing your submission, including contact information for IT professionals who may be able to provide additional technical details about your submission. Paper Documents 1. None Number of documents 2. Number of volumes 3. Number of boxes I do not have any documents that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives to submit for this quarter. I do not anticipate having documents in the future. If at anytime in the future I do have such documents I will immediately notify FDA and begin submitting the documents as required by section 904(a)(4) of the Federal Food, Drug, and Cosmetic Act. SECTION IV - CONFIRMATION STATEMENT The data and information in this submission hav
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