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| HHS/FDA | RIN: 0910-AF93 | Publication ID: Spring 2008 |
| Title: Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Flunisolide, Triamcinolone, Metaproterenol, Pirbuterol, Albuterol and Ipratropium in Combination, Cromolyn, and Nedocromil] | |
| 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.” This final rule would remove the essential use designations after a specified date for metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Under the provisions of this final rule, these MDIs would have to be removed from the market. This final rule 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: 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 2.125 (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 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Martha Nguyen Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 6224, Silver Spring, MD 20993-0002 Phone:301 796-3601 Fax:301-847-8440 Email: martha.nguyen@fda.hhs.gov |
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