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Notice

Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.” This draft guidance provides responses to questions FDA has received on the Family Smoking Prevention and Tobacco Control Act's (Tobacco Control Act) provisions on new tobacco products and substantial equivalence, including questions on changes to packaging and labeling. This draft guidance is not final nor is it in effect at this time.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 8, 2011.

ADDRESSES:

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments 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Submit written requests for single copies of the draft guidance document entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” to the Center for Tobacco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.

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FOR FURTHER INFORMATION CONTACT:

With regard to the draft guidance: Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373, annette.marthaler@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

I. Background

This draft guidance provides responses to questions we have received on the Federal Food, Drug, and Cosmetic Act's (the FD&C Act) provisions on new tobacco products and Start Printed Page 55928substantial equivalence (sections 905(j) and 910 of the FD&C Act, as amended by the Tobacco Control Act (21 U.S.C. 387e(j) and 387j)). In this draft guidance, FDA provides responses to questions related to the submission of 905(j) (substantial equivalence) reports in specific scenarios, including questions on whether changes to packaging and labeling and changes to additive specifications should be submitted in a 905(j) report to the Center for Tobacco Products. The draft guidance also provides information about discussing submissions.

II. Significance of Guidance

This draft guidance is being issued 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 “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.” 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. Electronic Access

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

IV. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information in sections 905(j) and 910 of the FD&C Act, as amended by the Tobacco Control Act have been approved under OMB control number 0910-0673; the collections of information in 21 CFR part 25 have been approved under OMB control number 0910-0322.

V. Comments

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.

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Dated: September 2, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2011-23100 Filed 9-8-11; 8:45 am]

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