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HHS/FDA | RIN: 0910-AG96 | Publication ID: Spring 2017 |
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 1107 | |
Legal Authority: 21 U.S.C. 387e(j) 21 U.S.C. 387j(a) 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 387b 21 U.S.C 387c 21 U.S.C. 387i |
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 |