Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is proposing to amend its regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDA- regulated product that releases an ODS is an essential use of the ODS. Two albuterol MDIs that do not use an ODS are currently marketed. FDA has tentatively determined that the two non-ODS MDIs will be satisfactory alternatives to albuterol MDIs containing ODSs and are proposing to remove the essential-use designation for albuterol MDIs. If the essential-use designation is removed, albuterol MDIs containing an ODS could not be marketed after a suitable transition period.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 2 [Docket No. 2003P-0029] RIN 0910-AF18 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. Two albuterol MDIs that do not use an ODS are currently marketed. FDA has tentatively determined that the two non-ODS MDIs will be satisfactory alternatives to albuterol MDIs containing ODSs and are proposing to remove the essential-use designation for albuterol MDIs. If the essential-use designation is removed, albuterol MDIs containing an ODS could not be marketed after a suitable transition period. DATES: Submit written or electronic comments by August 16, 2004. ADDRESSES: You may submit comments, identified by [Docket No. 2003P-0029], by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Agency Web site: http://www.fda.gov/​dockets/​ecomments . Follow the instructions for submitting comments on the agency Web site. E-mail: …
Other Federal Register documents from the same docket.
Citation: 69 FR 33602
