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HHS/FDA RIN: 0910-AA99 Publication ID: Spring 2002 
Title: Use of Ozone-Depleting Substances 
Abstract: FDA is amending the regulation that permits the use of ozone-depleting substances in particular circumstances to set the standard FDA will use to determine when the use of ozone-depleting substances (ODS) is no longer essential under the Clean Air Act (CAA) and set a new standard to determine when a new essential-use designation should be granted after the effective date of the rule. FDA is also amending the regulations to better conform to other statutes and regulations relating to ozone-depleting substances to eliminate potential confusion and conflicts. FDA is eliminating out-of-date transitional provisions and making other nonsubstantive housekeeping changes to its regulations on ozone-depleting substances. The intended effect of the rule is to protect the health and safety of medical product users while complying with the CAA and the Montreal Protocol. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 2   
Legal Authority: 15 USC 402    15 USC 409    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 371   
Legal Deadline:  None
Action Date FR Cite
ANPRM  03/06/1997  62 FR 10242   
ANPRM Comment Period End  05/05/1997    
NPRM  09/01/1999  64 FR 47719   
NPRM Comment Period End  11/30/1999    
Final Action  10/00/2002    
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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