E9-30297. Guidance for Industry on the Timeframe for Submission of Tobacco Health Documents; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Timeframe for Submission of Tobacco Health Documents.” This document provides written guidance to tobacco product manufacturers and importers on enforcement of the requirement to submit certain documents to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

DATES:

The guidance is final upon the date of publication. However, you may submit electronic or written comments on the guidance at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document entitled “Timeframe for Submission of Tobacco Health Documents” 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 guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document.

Submit electronic comments to http://www.regulations.gov. 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. 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, 240-276-1717, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

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

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) of the act must be submitted to FDA beginning December 22, 2009. FDA recognizes the challenges associated with the collection, review, organization, and production of documents. We also recognize that additional time may be necessary for the production of documents in a digital format, which FDA strongly encourages in order to improve the management and readability of submitted documents. Therefore, FDA does not intend to enforce the December 22, 2009, initial document submission deadline, provided that manufacturers and importers submit by April 30, 2010, all documents described in section 904(a)(4) of the act developed between June 23, 2009, and March 31, 2010. FDA is in the process of developing a draft guidance document that will explain the requirements of and recommendations for compliance with section 904(a)(4) of the act. We anticipate that the draft guidance document will be issued shortly.

II. Significance of Guidance

FDA is issuing this guidance document as a level 1 guidance consistent with FDA's good guidance practices regulation (§ 10.115 (21 CFR 10.115)). This guidance document is being implemented immediately without prior public comment, under § 10.115(g)(2), because the agency has determined that prior public participation is not feasible or appropriate. This document provides guidance on statutory requirements that are due to take effect on December 22, 2009, and so it is urgent that FDA explain its enforcement policy before that date.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. 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: December 16, 2009.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning, and Budget.