View Rule
| Printer-Friendly Version Download RIN Data in XML |
| 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 FDA is eliminating out-of-date transitional provisions and making other nonsubstantive housekeeping changes to its regulations on ozone-depleting substances.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:
|
| 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 |
|
