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HHS/FDA

RIN: 0910-AF92

Publication ID: Fall 2007

Title: Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Epinephrine]
Abstract: Medical products using chlorofluorocarbons (CFCs) and other ozone-depleting substances may only be legally marketed if they are listed in 21 CFR part 2.125 as essential uses. The final rule would remove the essential use designations after a specified date for metered-dose inhalers (MDIs) containing epinephrine. Under the provisions of this proposed rule these MDIs would have to be removed from the market. This rulemaking is consistent with obligations under the Clean Air Act and the Montreal Protocol on Substances That Deplete the Ozone Layer.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Final Rule Stage
Major: Yes	Unfunded Mandates: Private Sector
CFR Citation: 21 CFR 2.125 (Revision) 40 CFR 82.4 40 CFR 82.64 40 CFR 82.66
Legal Authority: 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 362 21 USC 371 21 USC 372 21 USC 374 42 USC 7671 et seq

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	09/20/2007	72 FR 53711
NPRM Comment Period End	11/19/2007
Final Action	10/00/2008

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: None
Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Martha Nguyen Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 51, Room 6250, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301 847-8440 Email: martha.nguyen@fda.hhs.gov