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HHS/FDA RIN: 0910-AF18 Publication ID: Fall 2004 
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 have proposed 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 specifically asked 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: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final 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

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 15-40 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.

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 CFR section 2.125. FDA published a new 21 CFR 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 designation 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, and proposed a rule to remove other essential-use designations.

Alternatives: In the proposed rule, FDA specifically requested comments on the best effective date for any final rule to remove the essential use status of albuterol MDIs. FDA is considering which dates will allow manufacturers to obtain the capacity to produce adequate numbers of non-ODS albuterol MDIs. FDA is also considering which dates might minimize any financial burden on patients who would have to switch to non-ODS albuterol MDIs.

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.

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.

Action Date FR Cite
NPRM  06/16/2004  69 FR 33602   
NPRM Comment Period End  08/16/2004    
Final Action  03/00/2005    
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

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