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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 FDA is eliminating out-of-date transitional provisions and making other nonsubstantive housekeeping changes to its regulations on ozone-depleting substances.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

Timetable:

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 Email: wayne.mitchell@fda.hhs.gov