Senior Regulatory Counsel

0910-AH89 201810 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Format and Content of Reports Intended to Demonstrate Substantial Equivalence

This proposed rule would establish the format and content of reports intended to demonstrate substantial equivalence (SE) in tobacco products and would provide information as to how the Agency will review and act on these submissions.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No Undetermined Deregulatory 21 CFR 1107 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 387 42 U.S.C. 4332 Yes

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), requires premarket submissions for new tobacco products. Substantial equivalence reports are one type of premarket submission that manufacturers of new tobacco products may use to obtain marketing authorization for a new tobacco product. This regulation is necessary to provide information to manufacturers to aid them in preparing and submitting substantial equivalence reports.

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Section 905(j) of the FD&C Act, as amended by the Tobacco Control Act, provides for the submission of substantial equivalence reports and authorizes FDA to prescribe the form and manner of these reports. Section 910 of the FD&C Act mandates the premarket review of new tobacco products, establishes definitions of substantial equivalence and characteristics, and requires health information as part of a submission under section 905(j) of the FD&C Act. Section 909 establishes record and report requirements for tobacco products. Sections 701 and 704 of the FD&C Act authorize the promulgation of regulations to implement the FD&C Act and inspections.

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In addition to the benefits and costs of the proposed rule, FDA assessed the benefits and costs of several alternatives to the proposed rule: 1) Extending the effective date of the rule, 2) allowing for more deficiency letters and review cycles, and 3) allowing for only one review cycle.

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The costs of the rule are compliance costs on affected entities, e.g., to read and understand the rule, to revise internal procedures, and fill out a form for substantial equivalence reports. The quantified benefits of the proposed rule are cost-savings resulting from shorter FDA review times and fewer staff to review substantial equivalence reports. The cost savings to the government is expected to be larger than the compliance cost for industry and the net result is an overall net positive benefit from this proposed rule. The qualitative benefits of the rule include additional clarity to industry about the requirements for the content and format of substantial equivalence reports, as well as the establishment of procedures for substantial equivalence report review and communication with applicants. These changes make the substantial equivalence marketing pathway clearer for both FDA and applicants.

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Premarket submissions for new tobacco products are required by the FD&C Act. But to prepare premarket submissions such as substantial equivalence reports intended to meet those requirements, manufacturers need more information about content and format requirements. This rule provides more information on content and format requirements and describes possible FDA actions on the substantial equivalence report.

]]> NPRM 11/00/2018 No None No No No Annette Marthaler Senior Regulatory Counsel 0910 Food and Drug Administration FDA 240 753-3043 annette.marthaler@fda.hhs.gov Office of Combination Products, 10903 New Hampshire Avenue, WO32, Room 5129, Silver Spring MD 20993