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HHS/FDA | RIN: 0910-AG96 | Publication ID: Fall 2015 |
Title: Format and Content of Reports Intended to Demonstrate Substantial Equivalence | |
Abstract: This regulation would establish the format and content of reports intended to demonstrate substantial equivalence. This regulation also would provide information as to how the Agency will review and act on these submissions. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 1107 | |
Legal Authority: 21 U.S.C. 387e(j) 21 U.S.C. 387j(a) secs 905(j) and 910(a) of the Federal Food, Drug, and Cosmetic Act |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Annette L. Marthaler Deputy Director Department of Health and Human Services Food and Drug Administration Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993 Phone:877 287-1373 Email: ctpregulations@fda.hhs.gov |