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HHS/FDA | RIN: 0910-AH45 | Publication ID: Fall 2016 |
Title: ●Record-keeping Requirements for Certain Submissions to FDA | |
Abstract:
The Food and Drug Administration is proposing regulations to establish recordkeeping requirements for certain submissions to FDA. This regulation would establish recordkeeping requirements for premarket tobacco product applications, modified risk tobacco product applications, requests for exemption from substantial equivalence, and abbreviated reports. This regulation would also establish recordkeeping requirements for tobacco products that were commercially marketed (other than exclusively in test markets) in the United States as of February 15, 2007. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
CFR Citation: 21 CFR 1100 21 CFR 1107 | |
Legal Authority: 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 387i to 387k |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Darin Achilles Regulatory Counsel Department of Health and Human Services Food and Drug Administration Office of Clinical Policy, 10903 New Hampshire Avenue, WO 51, Room 5198, Silver Spring, MD 20993 Phone:301 796-4040 Email: darin.achilles@fda.hhs.gov Bryant Godfrey Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Ave., , Silver Spring, MD 20993 Phone:877 287-1373 Email: ctpregulations@fda.hhs.gov |