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HHS/FDA RIN: 0910-AF92 Publication ID: Fall 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. The final 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 rulemaking 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: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 2.125 (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 351    21 USC 352    21 USC 355    21 USC 360b    21 USC 361    21 USC 362    21 USC 371    21 USC 372    21 USC 374    42 USC 7671 et seq   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/20/2007  72 FR 53711   
NPRM Comment Period End  11/19/2007    
Final Action  10/00/2008    
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: 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

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