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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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