{"abstract":"The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is proposing to amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for oral pressurized metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Under the Clean Air Act, FDA, in consultation with the EPA, is required to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. Therapeutic alternatives that do not use an ODS are currently marketed and appear to provide all of the important public health benefits of the listed drugs. If the applicable essential-use designations are removed, flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil MDIs containing an ODS could not be marketed after a suitable transition period. We will hold an open public meeting on removing these essential-use designations in the near future.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2007/06/11/07-2883.html","cfr_references":[{"chapter":null,"citation_url":null,"part":2,"title":21}],"citation":"72 FR 32030","comment_url":null,"comments_close_on":"2007-08-10","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments by August 10, 2007.","disposition_notes":null,"docket_ids":["Docket No. 2006N-0454"],"dockets":[],"document_number":"07-2883","effective_on":null,"end_page":32049,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2007/06/11/07-2883.xml","html_url":"https://www.federalregister.gov/documents/2007/06/11/07-2883/use-of-ozone-depleting-substances-removal-of-essential-use-designations","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/07-2883?publication_date=2007-06-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2007-06-11/07-2883/mods.xml","not_received_for_publication":null,"page_length":20,"page_views":{"count":150,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2007-06-11/pdf/07-2883.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2007-06-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2007/06/11/07-2883.txt","regulation_id_number_info":{"0910-AF93":{"issue":"201010","html_url":"https://www.federalregister.gov/regulations/0910-AF93/use-of-ozone-depleting-substances-removal-of-essential-use-designations-flunisolide-triamcinolone-me","title":"Use of Ozone-Depleting Substances; Removal of Essential Use Designations [Flunisolide, Triamcinolone, Metaproterenol, Pirbuterol, Albuterol and Ipratropium in Combination, Cromolyn, and Nedocromil]","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201010&RIN=0910-AF93&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AF93"],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T21:57:56Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":32030,"subtype":null,"title":"Use of Ozone-Depleting Substances; Removal of Essential-Use Designations","toc_doc":"Oral pressurized metered-dose inhalers containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol, etc.; removed","toc_subject":"Administrative rulings and decisions:","topics":["Administrative practice and procedure","Cosmetics","Drugs","Foods"],"type":"Proposed Rule","volume":72}