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HHS/FDA RIN: 0910-AF92 Publication ID: Fall 2006 
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 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: 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 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
Action Date FR Cite
NPRM  07/00/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Wayne H. Mitchell
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-7,
Rockville, MD 20857
Phone:301 594-2041
Fax:301 827-0951

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