2011-35. Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled “Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.” In general, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires a premarket application and market authorization order for new tobacco products before they may be marketed; alternatively, manufacturers may submit a 905(j) report intended to demonstrate substantial equivalence to a predicate tobacco product. The guidance provides recommendations on submitting information intended to demonstrate that a new tobacco product is substantially equivalent to a predicate tobacco product. Manufacturers of tobacco products first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, must submit a report no later than March 22, 2011, or the products can no longer be legally marketed. Manufacturers of a new tobacco product first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007 and before March 22, 2011, who submit a substantial equivalence report before March 23, 2011, may continue to market the tobacco product unless FDA issues an order finding that the product is not substantially equivalent. Because it is important that FDA's recommendations on submitting a substantial equivalence reports be available to assist new tobacco product manufacturers in preparing substantial equivalence reports in advance of March 23, 2011, this guidance document will be implemented immediately. This guidance, however, remains subject to comment in accordance with the Agency's good guidance practices (GGPs).

DATES:

Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.

ADDRESSES:

Submit electronic comments on the guidance, including comments regarding the proposed collection of information, to http://www.regulations.gov. Submit written comments on the guidance, including comments regarding the proposed collection of information, 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.

Submit written requests for single copies of the guidance document entitled “Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products” 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.

FOR FURTHER INFORMATION CONTACT:

Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance that provides recommendations related to reports under section 905(j) of the FD&C Act (21 U.S.C. 387e(j)), as amended by the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111-31). Section 905(j) authorizes FDA to establish the form for the submission of information related to substantial equivalence. The guidance is intended to assist persons submitting reports under section 905(j) of the FD&C Act. It explains, among other things, FDA's interpretation of the statutory sections related to substantial equivalence, and provides recommendations on the form and content of section 905(j) reports. The guidance also provides information on FDA's review of 905(j) reports.

II. Significance of Guidance

FDA is issuing this guidance document as a level 1 guidance consistent with FDA's GGPs (§ 10.115 (21 CFR 10.115)). The guidance discusses premarket statutory requirements that include certain submissions to be made to FDA no later than March 22, 2011. 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, as interested parties need clarity as to FDA's expectations regarding 905(j) reports and sufficient time to prepare submissions in advance of the statutory deadline.

Manufacturers of tobacco products first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, must submit the report no later than March 22, 2011, or the tobacco product can no longer be legally marketed. If a 905(j) report is submitted prior to March 23, 2011, the tobacco product may continue to be marketed unless FDA issues an order that the tobacco product is not substantially equivalent to the predicate tobacco product (section 910(a)(2)(B) of the FD&C Act (21 U.S.C. 387j(a)(2)(B)), as amended by the Tobacco Control Act). It is important that this guidance be available in advance of March 23, 2011, to assist manufacturers in preparing 905(j) reports.

For 905(j) reports for tobacco products first marketed between February 15, 2007, and March 22, 2011 (many of which are from small manufacturers) that are submitted prior to March 23, 2011, FDA intends to allow manufacturers who have acted diligently in preparing their submissions a reasonable amount of time to supplement their initial submissions, provided these manufacturers submit a 905(j) report by the statutory deadline. FDA intends to determine what constitutes a reasonable period of time on a case-by-case basis.

This guidance 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. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0673.

IV. Comments

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, as interested parties need clarity as to FDA's expectations regarding 905(j) reports and sufficient time to prepare submissions in advance of the statutory deadline. You may submit written comments to FDA on this guidance at any time for Agency consideration; in addition, we request that you submit any comments regarding any significant oversight in this guidance within 30 days of the issuance of this guidance (refer to the title page of the guidance for the issue date). Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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. FDA will review any comments we receive and revise the guidance document when appropriate.

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: January 3, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.