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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act of 1995.


Fax written comments on the collection of information by June 2, 2011.


To ensure that comments on the information collection are received, OMB recommends that the written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer. Fax: 202-395-7285, or e-mailed to All comments should be identified with the OMB control number 0910-0673. Also include the FDA docket number found in brackets in the heading of this document.

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Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792,

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance: Information Request Regarding Guidance for Industry and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products—(OMB Control Number 0910-0673)—Extension.

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C 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.

Section 905(j)(1) of the FD&C Act authorizes FDA to establish the form and manner for the submission of information related to substantial equivalence (21 U.S.C. 387e(j)(1)). In a level 1 guidance document issued under the Good Guidances Practices regulation (21 CFR 10.115), FDA provides recommendations intended to assist persons submitting reports under section 905(j) of the FD&C Act, and explains, among other things, FDA's interpretation of the statutory sections related to substantial equivalence (see “Guidance for Industry and FDA Staff—Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products” (January 6, 2011, 76 FR 789).)

In the Federal Register of January 24, 2011 (76 FR 4116), FDA published a 60-day notice requesting public comment on the proposed information collection.

FDA received one comment in response to the 60-day notice. The commenter indicated that the substantial equivalence requirements were “burdensome to industry in the extreme,” that FDA's estimation of the number of reports to be received was too low, and that the current burden hours to complete each report was unrealistic. Although the commenter asserted that the burden hours were too low and unrealistic, no alternative estimates were provided.

The recommendations in the “Guidance for Industry and FDA Staff—Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products” are the information that FDA suggests a manufacturer include in a report submitted under section 905(j)(1)(A)(i) of the FD&C Act. The recommendations reflect the information FDA believes is necessary for it to make the required findings under section 910(a) of the FD&C Act (21 U.S.C. 387j(a)). FDA has also articulated current enforcement policies in its guidances that are intended to address some of the burden associated with premarket requirements for new tobacco products (manufacturers and interested parties may refer to FDA's Start Printed Page 24889Web site for guidance documents with current enforcement policies related to premarket requirements for tobacco products (​TobaccoProducts/​default.htm)).

With regard to the comment that the number of section 905(j)(1)(A)(i) substantial equivalence reports which FDA estimated to be submitted (150 per year) was too low, FDA has revised its estimate based on information it now has from initial submissions, interactions with industry, and other information, such as the comment received on the 60-day notice on the information collection. As shown below, FDA is increasing the annual estimate of the number of reports received from 150 to 1,000.

With regard to the comment that the number of hours to prepare and submit each report is unrealistic, FDA continues to believe that the currently estimated hours (360 hours annually) is appropriate, particularly given that the premarket requirements for new tobacco products (Section 910 of the FD&C Act) are new and manufacturers' experience with preparing a submission is just beginning to develop. As the requirements and program become more familiar to respondents, FDA may be able to refine these estimates. In addition, as discussed previously, the commenter did not suggest an alternative number of hours. FDA's estimate of 360 hours reflects an amount of time that should provide each submitter enough time to prepare and submit a section 905(j)(1)(A)(i) substantial equivalence report to the Agency.

Estimation of Burden

FDA estimates the burden for this collection of information as follows:

Table 1—Estimated Annual Reporting Burden 1

FD&C Act sectionsNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per response (in hours)Total hours
905(j)(a)(A)(i) and 910(a)1,00011,000360360,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA has based these estimates on information it now has available from interactions with the industry, comments regarding the submission of 905(j)(1)(A)(i) substantial equivalence reports, and comments on the 60-day information collection notice request for comments published in the Federal Register on January 24, 2011 (76 FR 4116). Table 1 of this document describes the annual reporting burden as a result of the implementation of the substantial equivalence requirements of sections 905(j)(1)(A)(i) and 910(a) of the FD&C Act. FDA estimates that it will receive 1,000 section 905(j) substantial equivalence reports each year and that it will take a manufacturer approximately 360 hours to prepare a report of substantial equivalence for a new tobacco product. Therefore, FDA estimates the burden for submission of substantial equivalence information will be 360,000 hours.

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Dated: April 27, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2011-10618 Filed 5-2-11; 8:45 am]