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HHS/FDA | RIN: 0910-AF18 | Publication ID: Fall 2003 |
Title: ●Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol | |
Abstract: Under the Clean Air Act, the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services, in consultation with the Environmental Protection Agency, is required to determine whether an FDA-regulated product that releases an ozone-depleting substance (ODS) is essential. The two agencies have tentatively determined that the two currently marketed non-ODS metered-dose inhalers (MDIs) will be satisfactory alternatives to albuterol MDIs that contain ODS, and are proposing to remove the essential use designations for albuterol MDIs. If the essential use designation is removed, albuterol MDIs that contain an ODS could not be marketed after a suitable transition period. The proposed rule will specifically ask for comments on which phase-out period length will best ensure a smooth transition and minimize any adverse affects on the public health. | |
Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: Undetermined |
CFR Citation: 21 CFR 2.125 | |
Legal Authority: 15 USC 402 15 USC 409 21 USC 321 21 USC 331 21 USC 335 21 USC 342 21 USC 343 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 |
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Statement of Need: Chlorofluorocarbons (CFCs) are organic compounds that contain carbon, chlorine, and fluorine atoms. CFCs were first used commercially in the early 1930's and were later found to be useful as propellants in self-pressurized aerosol products, such as MDIs. CFCs are very stable in the troposphere--the lowest part of the atmosphere. They move to the stratosphere, a region that begins about 10-16 kilometers (km) (6-10 miles) above Earth's surface and extends up to about 50 km (31 miles) altitude. Within the stratosphere there is a zone about 15 to 40 km (10 - 25 miles) above the Earth's surfaces in which ozone is relatively highly concentrated. The zone in the stratosphere is generally called the ozone layer. Once in the stratosphere, CFCs are broken down by strong ultraviolet light, where they release chlorine atoms that then deplete stratospheric ozone. Depletion of stratospheric ozone by CFCs and other ODS will lead to higher UVB levels, which in turn will cause increased skin cancers and cataracts and potential damage to some marine organisms, plants, and plastics. The link between CFCs and the depletion of stratospheric ozone was discovered in the mid-1970's. Since 1978, the U.S. government has pursued a consistent policy of limiting the production and use of ODS, including CFCs. |
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Summary of the Legal Basis: The Clean Air Act and EPA's implementing regulations contain general prohibitions on the use and manufacture of ODS, such as CFCs. Exceptions to these bans are provided for specific medical products that FDA, in consultation with EPA, has found to be essential. FDA's essential use determinations have been contained in 21 C.F.R. section 2.125. FDA published a new 21 C.F.R. section 2.125 in the Federal Register on July 24, 2002 (67 FR 48370), (corrected in the Federal Registers of July 30, 2002 (67 FR 49396) and September 17, 2002 (67 FR 58678)). Section 2.125 provides criteria for determining when a use is essential and when a use is no longer essential. The procedures to determine when a use is no longer essential were implemented to better carry out responsibilities under both the Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer, (September 16, 1987, S. Treaty Doc. No. 10, 100th Cong., 1st sess., 26 I. L. M. 1541 (1987)). Fran Du Melle, Executive Vice President of the American Lung Association, submitted a citizen petition on behalf of the U.S. Stakeholders Group on MDI Transition on January 29, 2003 (Docket No. 03P-0029/CP1). The petition requested that FDA initiate rulemaking to remove the essential use of albuterol MDIs. After evaluating the petition, comments submitted in response to the petition, and other information, FDA has tentatively determined that albuterol MDIs meet the criteria in section 2.125 for removal of an essential use. |
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Alternatives: In the proposed rule, FDA will specifically request comments on the best effective date for any final rule to remove the essential use status of albuterol. FDA will consider which dates will allow manufacturers to obtain the capacity to produce adequate numbers of non-ODS albuterol MDIs. FDA will also consider which dates might minimize any financial burden on patients who would have to switch to non-ODS albuterol MDIs. |
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Anticipated Costs and Benefits: The expected benefit from this rulemaking, as part of an overall policy to eliminate production and use of ODSs, is the preservation of the Earth's stratospheric ozone. Currently there are generic versions of ODS albuterol MDIs, while there are no generic non-ODS albuterol MDIs. This rulemaking could force patients to switch from lower-priced generic versions of ODS albuterol MDIs to higher-priced non-ODS albuterol MDIs. |
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Risks: FDA is concerned about the possibility that some patients might stop using needed drugs because the prices of non-ODS albuterol MDIs might be higher than those of ODS albuterol MDIs. |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
Small Entities Affected: No | Federalism: Undetermined |
Included in the Regulatory Plan: Yes | |
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 |