2003P-0029
BKG 2
Volumes 7-9

Volume 7

References

Tab 1 - U.S. Food and Drug Administration, "Guidance for Industry: Integration of Dose-Counting Mechanisms into MDI Drug Products," March 2003.

Tab 2 - Penick, T.B. et al., "Accuracy of Float Testing for Metered-Dose Inhaler Canisters," Journal of the American Pharmaceutical Association, 42: 582, July/August 2002.

Tab 3 - Craig-McFeely, P.M. et al., "Prospective Observational Cohort Safety Study to Monitor the Introduction of a Non-CFC Formulation of Salbutamol with HFA 134a in England," International Journal of Clinical Pharmacology and Therapeutics, 41: 67-76, 2003.

Tab 4 - Goldman, D.P. et al., "Pharmacy Benefits and the Use of Drugs by the Chronically Ill," The Journal of the America Medical Association, May 19, 2004; 291: 2344-2350, 2349.

Tab 5 - United Nations Environmental Programme, "Production and Consumption of Ozone-Depleting Substances 1986-2000," 2002.

Volume 8

Tab 6 - U.S. Environmental Protection Agency, "The Benefits and Costs of the Clean Air Act: 1990-2010,"1999 (http://www.epa.gov/air/sect812/copy99.html)

Volume 9

Tab 7 - Mannino, D.M. et al., "Chronic Obstructive Pulmonary Disease Surveillance-- United States, 1971-2000," Morbidity and Mortality Weekly Report, 51 (SS06): 1-16, August 2, 2002.

Tab 8 - American Lung Association, "Trends in Asthma Morbidity and Mortality," Epidemiology & Statistics Unit, Research and Scientific Affairs, April 2004.

Tab 9 - Mannino, D.M. et al., "Surveillance for Asthma--United States, 1980-1999," Morbidity and Mortality Weekly Report, 51 (SSO1): 1-13, March 29, 2002.

Tab 10 - Analysis completed by FDA based on information provided by IMS Health, IMS National Prescription Audit, 2004; IMS Health, IMS MIDAS, Q1/2004 - Q2/2004. These data can be purchased from IMS Health. Please send all inquiries to: IMS Health, Attn: Brian Palumbo, Account Manage, 660 W. Germantown Pike, Plymouth Meeting, PA 19462.

Tab 11 - Rozek, R.P., and E.R. Bishko, "Economics Issues Raised in the FDA’s Proposed Rule on Removing the Essential-Use Designation for Albuterol MDIs," National Economic Research Associates, August 13, 2004 (FDA Docket No. 2003P-0029/C25).

Tab 12 - Agency for Healthcare Research and Quality, "Albuterol Inhalers: Prescriptions per User, Price per Prescription and Expenditure Given Use," spreadsheet prepared at FDA’s request for this rulemaking, 2004.

Tab 13 - Ringel, J.S. et al., "The Elasticity of Demand for Health Care," National Defense Research Institute, Rand Health, 2002.

Tab 14 - U.S. Census Bureau, "Income, Poverty, and Health Insurance Coverage in the United States: 2003," Current Population Reports, U.S. Department of Commerce, August 2004, pp. 14-15.

Tab 15 - Morelli, D., and M.R. Koenigsberg, "Sample Medication Dispensing in a Residency Practice," Journal of Family Practice, 34 (1): 42-48, 1992.

Tab 16 - Peterson, M.C. et al., "Disposition of Pharmaceutical Samples from a Private Medical Clinic," Journal of the American Pharmacists Association, 44 (3): 397-398, 2004.

Tab 17 - U.S. Department of Health & Human Services, "Guidance on Proper Consideration of Small Entities in Rulemakings of the U.S. Department of Health and Human Services," May 2003.

Tab 18 - Congressional Budget Office, "How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry," July 1998.