Food and Drug Administration
June 10, 2004
Briefing Information
Background, FDA (HTM) (PDF) (Word)
Table of Contents (HTM) (PDF) (Word)
Federal Register, December 22, 2003, Vol 68, No. 245, Page 72479 Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol (PDF)
The Vienna Convention and The Montreal Protocol on Substances that Deplete the Ozone Layer - Status of Ratification, United Nations Environment Programme Ozone Secretariat (PDF)
Federal Register, July 24, 2002, Vol 67, No. 142, Page 48370, 21 CFR Part 2 Use of Ozone-Depleting Substances; Essential-Use Determinations (PDF)
Federal Register, July 24, 2002, Vol 67, No. 142, Page 48384, 21 CFR Part 2.125 Use of Ozone-Depleting Substances in Foods, Drugs, Devices, or Cosmetics (PDF)
Federal Register, September 17, 2002, Vol 67, No. 180, Page 58678, 21 CFR Part 2 Use of Ozone-Depleting Substnces; Essential-Use Determinations - Correction (PDF)
Federal Register, July 30, 2002, Vol 67, No. 146, Page 49396, 21 CFR Part 2 Use of Ozone-Depleting Substances; Essential-Use Determinations - Correction (PDF)
Citizen Petition, American Lung Assoc. (PDF)
July 21, 2003 Letter Regarding Docket No. 03P-0029, Citizen Petition Requesting FDA Initiate a Rulemaking to Consider Whether CFC Albuterol MDIs Are an Essential Use of Ozone-Depleting Substances, American Lung Assoc. (PDF)
February 11, 2004 Letter Regarding Docket No. 03P-0029 Citizen Petition on Removal of Essential use Designation for Albuterol, American Lung Assoc. (PDF)
April 1, 2004 Letter Regarding Docket No. 03P-0029 Citizen Petition on Removal of Essential use Designation for Albuterol MDIs, American Lung Assoc. (PDF)
July 2, 2003 Letter Regarding Docket No. 03P-0029 Citizen Petition: Rquesting FDA to Initiate Rulemaking to Remove CFC Albuterol MDIs From FDA's List of Essential uses of Ozone-Depleting Substances, GlaxoSmithKline (PDF)
Appendix I, GlaxoSmithKline (PDF)
August 15, 2003 Letter Regarding Docket No. 03P-0029 Citizen Petition: Rquesting FDA to Initiate Rulemaking to Remove CFC Albuterol MDIs From FDA's List of Essential uses of Ozone-Depleting Substances, GlaxoSmithKline (PDF)
September 8, 2003 Letter Regarding Docket No. 03P-0029 Letter Regarding Docket No. 03P-0029 Citizen Petition: Rquesting that the FDA Initiate a Rulemaking to Remove CFC Albuterol MDIs From the List of Essential Uses of Ozone-Depleting Substances - Economics Analysis of Impact on Patients and Payers, GlaxoSmithKline (PDF)
The Impact on Patients and Payers of Designating Albuterol a Non-Essential Use of an Ozone Depleting Substance, National Economic Research Assoc. (PDF)
Weighted Average Monthly Prices for Proventil and Ventolin CFC MDIs, July 1993-June 1994 (PDF)
IMS Unit Sales for Albuterol MDIs and Selected Market Events, 1992-2002 (PDF)
Vertical Structure of the Pharmaceutical Sector (PDF)
Descriptive Statistics on Groups 1-4, Based on IMS Data 2001-2002 (PDF)
Change in Annual Costs and Costs Per MDI to Patients and Third-Party Payers - Assums FDA Designates Albuterol CFC MDIs Non-Essential, Groups 1-4 (PDF)
Change in Costs to the U.S. Healthcare System for the First Year After the FDA Designates Albuterol CFC MDIs Non-Essential (PDF)
Current and Projected HHIs for Albuterol MDIs (PDF)
March 5, 2004 Letter Regarding Docket No. 03P-0029; Citizen Petition: Requesting FDA to Initiate Rulemaking on CFC Albuterol MDIs, GlaxoSmithKline (PDF)
March 8, 2004 Letter Regarding FDA Rulemaking on Albuterol Non-Essentiality (PDF)
May 3, 2004 Letter Regarding Docket 03P-0029 Citizen Petition: Requesting FDA to Initiate Rulemaking on CFC Albuterol MDIs, GlaxoSmithKline (PDF)
November 10, 2003 Letter Regarding Docket No. 03P-0029 Citizen Petition: Requesting FDA to Initiate Rulemaking on CFC Albuterol MDIs, GlaxoSmithKline (PDF)
Comments on Citizen Petition Submitted by the US Stakeholders Group on MDI Transition (Docket No. 03P-0029), Joseph Ferrara, IPAC (PDF)
Supplemental Submission Regarding Citizen Petition Submitted by the US Stakeholders Group on MDI Transition (Docket No. 03P-0029), Joseph Ferrara, IPAC (PDF)
Second Supplemental Submission Regarding Citizen Petition Submitted by the US Stakeholders Group on MDI Transition (Docket No. 03P-0029), Joseph Ferrara, IPAC (PDF)
Comments Regarding Citizen Petition Submitted by the US Stakeholders Group on MDI Transition (Docket No. 03P-0029), Honeywell (PDF)
Comments Regarding Citizen Petition Submitted by US Stakeholders Group on MDI Transition, Buchanan Ingersoll (PDF)
Comments Regarding Citizen Petition Submitted by the US Stakeholders Group on MDI Transition (Docket No. 03P-0029), Asthma Therapy Coalition (PDF)
Email Comment Regarding Servent, et als (HTM) (PDF) (Word)
Comment Regarding Docket No. 03P-0029 Citizen Petition: Rquesting that the FDA Initiate a Rulemaking to Remove CFC Albuterol MDIs From the List of Essential Uses of Ozone-Depleting Substances, Ellen Lathem, Allergy & Asthma Network (PDF)