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HHS/FDA | RIN: 0910-AF92 | Publication ID: Spring 2007 |
Title: Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Epinephrine] | |
Abstract: Medical products using chlorofluorocarbons (CFCs) and other ozone-depleting substances may only be legally marketed if they are listed in 21 CFR part 2.125 as “essential uses.” This proposed rule would remove the essential use designations after a specified date for metered-dose inhalers (MDIs) containing epinephrine. Under the provisions of this proposed rule these MDIs would have to be removed from the market. This proposed rule is consistent with obligations under the Clean Air Act and the Montreal Protocol on Substances That Deplete the Ozone Layer. | |
Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Yes | Unfunded Mandates: Private Sector |
CFR Citation: 21 CFR 1.25 (Revision) 40 CFR 82.4 40 CFR 82.64 40 CFR 82.66 | |
Legal Authority: 21 USC 321 21 USC 331 21 USC 335 21 USC 342 21 USC 346a 21 USC 348 21 USC 355 42 USC 7671 et seq |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
Agency Contact: Martha Nguyen Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 51, Room 6250, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 Email: martha.nguyen@fda.hhs.gov |