From: Deb Hardy Havens [dh@capitolassociates.com] Sent: Thursday, August 12, 2004 4:26 PM To: fdadockets@oc.fda.gov Subject: 2003P-0029 Joint Council of Allergy Asthma & Immunology ACAAI American College of Allergy Asthma & Immunology August 12, 2004 Food and Drug Administration Division of Dockets Management 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Docket No. 2003P-0029 Comments on June 16, 2004 FDA Proposed Rule on Use of Ozone-Depleting Substances; Removal of Essential-Use Designations To Whom It May Concern: In response to the recent proposed rule on the removal of the essential use designation for albuterol metered-dose inhalers (MDIs) that contain ozone-depleting substances (ODSs), we are writing to advise that our three organizations: The American Academy of Allergy, Asthma and Immunology (AAAAI), The American College of Allergy, Asthma & Immunology (ACAAI), and The Joint Council of Allergy, Asthma and Immunology (JCAAI), representing all of the allergists in the country, support an orderly transition of removal of the ODSs from albuterol MDI's. The phase-out of ODSs from these products should be timed to take into account the following issues and concerns: *the availability of CFC containing medications that do not have substitutes and the supply of generic albuterol products on the market; *the capability and capacity of current manufacturers of the non-CFC albuterol products to meet the overall demands of supplying our nation's patients with HFA albuterol products, and *cost considerations of a potentially higher priced drug on the market and the potential adverse impact such would have on our patients. In taking the above concerns into account as well as the deadline options cited in the proposed regulation, we believe that a 2007 deadline date for ending the exemption for CFC albuterol is feasible and would give sufficient time for production of HFA albuterol and time for public education and awareness to take place. If you should have any questions or need more information, please do not hesitate to let us know. Sincerely, _________________________ Michael Schatz, MD President American Academy of Allergy, Asthma & Immunology 555 East Wells Street, Suite 1100 Milwaukee, WI 53202-3832 Phone: 414-272-6071 Fax: 414-272-6070 Email: michael.x.schatz@kp.org _________________________ Michael S. Blaiss, MD President American College of Allergy, Asthma & Immunology 85 W. Algonquin Rd., #550 Arlington Heights, IL 60005 Phone: 847-427-1200 Fax: 847-427-1294 Email: wheezemd@aol.com _________________________ Stanley M. Fineman, MD President Joint Council of Allergy, Asthma & Immunology 50 N. Brockway Street Suite 3-3 Palatine, IL 60067 Phone: 847-934-1918 Fax: 847-934-1820 Email: info@jcaai.org