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HHS/FDA RIN: 0910-AF18 Publication ID: Spring 2005 
Title: Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol 
Abstract: Under the Clean Air Act, the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services, in consultation with the Environmental Protection Agency, is required to determine whether an FDA-regulated product that releases an ozone-depleting substance (ODS) is essential. The two agencies have tentatively determined that the two currently marketed non-ODS metered-dose inhalers (MDIs) will be satisfactory alternatives to albuterol MDIs that contain ODS, and have proposed to remove the essential use designations for albuterol MDIs. If the essential use designation is removed, albuterol MDIs that contain an ODS could not be marketed after a suitable transition period. The proposed rule specifically asked for comments on which phase-out period length will best ensure a smooth transition and minimize any adverse affects on the public health. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 2.125   
Legal Authority: 15 USC 402    15 USC 409    21 USC 321    21 USC 331    21 USC 335    21 USC 342    21 USC 343    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  06/16/2004  69 FR 33602   
NPRM Comment Period End  08/16/2004    
Final Action  04/04/2005  70 FR 17168   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses, Governmental Jurisdictions  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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