TABLE OF CONTENTS

 

Tab # 1: Unified Agenda-This document provides notice of the agency’s plan to revise 21 CFR 2.125

 

Tab # 2: Montreal Protocolweb address and information

 

Tab # 3: Preamble to 21 CFR 2.125-Use of Ozone-Depleting Substances; Essential-Use Determinations

 

Tab # 4: 21 CFR 2.125-Use of Ozone-Depleting Substances in foods, drugs, devices, or cosmetics

 

Tab # 5: Minor Corrections to 21 CFR 2.125 (Item # 3)

 

Tab # 6: Citizen Petition

 

 

 

Responses Received by FDA to Citizen Petition

 

 

Tab # 7: U.S. Stakeholders Group

·        Letter to FDA dated July 21, 2003

·        Letter to FDA dated February 11, 2004

·        Letter to FDA dated April 1, 2004

 

Tab # 8: GlaxoSmithKline

·        Comments to FDA dated July 2, 2003

·        Letter to FDA dated August 5, 2004

·        Economic Analysis dated September 8, 2003-by NERA (National Economic Research Associates, Inc.) on behalf of GSK

·        Letter to FDA dated November 10, 2003

·        Letter to FDA dated March 5, 2004

·        Letter to Dr. McClellan dated March 8, 2004

·        Letter to FDA dated May 3, 2004 to clarify letter dated November 10, 2004

 

Tab # 9: IPAC (International Pharmaceutical Aerosol Consortium)

·        Letter to Dr. Meyer dated March 7, 2003

·        Letter to FDA dated September 3, 2003

·        Letter to FDA dated March 8, 2004

 

Tab # 10: Honeywell Chemicals

·        Letter to FDA dated April 20, 2004

 

Tab # 11: Buchanon Ingersoll

·        Letter to FDA dated June 3, 2003

·        Letter to FDA dated April 7, 2004-from ATC (Asthma Therapy Coalition) by  Buchanon Ingersoll

 

Tab # 12: Miscellaneous responses

·        Email from private citizen dated July 21, 2003

·        Letter to Dr. McClellan dated October 29, 2003-from Allergy & Asthma Network