E9-25235. Draft Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” The draft guidance document is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA under The Family Smoking Prevention and Tobacco Control Act (FSPTCA).

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 30, 2009.

ADDRESSES:

Submit written requests for single copies of the draft guidance document entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments” to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Michele Mital, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 301-796-4800, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

On June 22, 2009, the President signed the FSPTCA (Public Law 111-31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.) by, among other things, 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.

Section 905(b) of the act (21 U.S.C. 395(b)), as amended by the FSPTCA, requires that “every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products” register with FDA the name, places of business, and all establishments owned or operated by that person. Every person must register by December 31 of each year. Section 905(i)(1) of the act, as amended by the FSPTCA, requires that all registrants “shall, at the time of registration under any such subsection, file with [FDA] a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution,” along with certain accompanying consumer information, such as all labeling and a representative sampling of advertisements.

While electronic submission of registration and listing information is not required, FDA is strongly encouraging electronic submission to facilitate efficiency and timeliness of data management and collection. To that end, FDA designed the eSubmitter application to streamline the data entry process for registration and product listing. This tool allows for importation of large quantities of structured data, attachments of files (e.g., in portable document format (PDFs) and certain media files), and automatic acknowledgement of FDA's receipt of submissions.

II. Significance of Guidance

FDA is issuing this draft guidance document consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Paperwork Reduction Act of 1995

This draft guidance contains proposed collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). As required by the PRA, FDA has published an analysis of, among others, the information collection concerning the submission of tobacco product establishment registration and product listing information (74 FR 45219, September 1, 2009, as corrected by 74 FR 47257, September 15, 2009) and will submit them for OMB approval.

V. Electronic Access

An electronic version of the guidance document is available on the Internet at http://www.regulations.gov and http://www.fda.gov/​TobaccoProducts/​GuidanceComplianceRegulatoryInformation/​default.htm.

Dated: October 15, 2009.

David Horowitz,

Assistant Commissioner for Policy.