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HHS/FDA | RIN: 0910-AG96 | Publication ID: Fall 2014 |
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 USC 387e(j) 21 USC 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: Gerie Voss Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Tobacco Products, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone:877 287-1373 Fax:301 595-1426 Email: ctpregulations@fda.hhs.gov |