**Table of Contents to References for the Proposed Rule**

**on**

**Use of Ozone-Depleting Substances; Removal of Essential-Use
Designation (Epinephrine)**

1\. National Center for Health Statistics, "Early Release of Selected
Estimates Based on Data From the 2005 National Health Interview Survey,"
figure 15.4, available at
[http://www.cdc.gov/nchs/data/nhis/earlyrelease/200606_15.pdf.\
pdf]{.underline}.

2\. Alkermes, Inc., press release, dated March 22, 2004, available at
[http://www.alkermes.com/newsroom/showArticle.aspx?id=267]{.underline}.

3\. Fu, K. et al., "Air^®^-Epinephrine: Inhalation Therapy for the
Emergency Self-Treatment of Anaphylaxis," [Journal of Aerosol
Medicine]{.underline}, Vol. 16(2):190, June 2003.

4\. Hendeles, L. et al., "Response to Nonprescription Epinephrine
Inhaler During Nocturnal Asthma," [Annals of Allergy, Asthma, and
Immunology]{.underline}, 95:530, December 2005.

5\. National Heart, Lung, and Blood Institute, "Expert Panel Report 2:
Guidelines for the Diagnosis and Management of Asthma," NIH publication
No. 97-4051, July 1997.

6\. National Heart, Lung, and Blood Institute, "Expert Panel Report:
Update on Selected Topics 2002: Guidelines for the Diagnosis and
Management of Asthma," NIH publication No. 02-5074, June 2003.

7\. National Asthma Council Australia Ltd., "Asthma Management Handbook:
2002," Melbourne:2002.

8\. Boulet, J. P. et al., "Canadian Asthma Consensus Report, 1999,"
[Canadian Medical Association Journal]{.underline}, 161(11 Supp.):S1,
November 30, 1999.

9\. Dickinson, B. D. et al., "Safety of Over-the-Counter Inhalers for
Asthma: Report of the Council on Scientific Affairs,"
[Chest]{.underline}, 118(2):522, August 2000.

10\. Cohen, R. A. and M. E. Martinez, "Health Insurance Coverage:
Estimates from the National Health Interview Survey, 2005," National
Center for Health Statistics, June 2006, available at
[http://www.cdc.gov/nchs/data/nhis/earlyrelease/insur200606.pdf]{.underline}.

11\. U.S. Census Bureau, "Table HI01. Health Insurance Coverage Status
and Type of Coverage by Selected Characteristics: 2004: All Races,"
available at
[http://pubdb3.census.gov/macro/032005/health/h01_001.htm]{.underline}.

12\. National Center for Health Statistics, "Asthma Prevalence, Health
Care Use and Mortality, 2002," fig. 1. Available at
[http://www.cdc.gov/nchs/products/pubs/pubd/hestats/asthma/asthma.htm]{.underline}.

13\. Agency for Health Quality and Research, [2005 National Healthcare
Disparities Report]{.underline}, AHQR publication 06-0017, December
2005, available at
[http://www.ahrq.gov/qual/nhdr05/nhdr05.htm]{.underline}.

14\. Crain, E. F. et al., "Reported Difficulties in Access to Quality
Care for Children with Asthma in the Inner City," [Archives of Pediatric
and Adolescent Medicine]{.underline}," 152:333, April 1998

15\. Evans, R. et al., "A Randomized Clinical Trial to Reduce Asthma
Morbidity Among Inner-City Children: Results of the National Cooperative
Inner-City Asthma Study," [Journal of Pediatrics]{.underline},
135(3):332, September 1999.

16\. Bauman, L. J. et al., "Relationship of Adherence to Pediatric
Asthma Morbidity Among Inner-City Children," [Pediatrics]{.underline},
110(1):1, June 2006.

17\. Bender, B. et al. "Measurement of Children's Asthma Medication
Adherence by Self Report, Mother Report, Canister Weight, and Doser CT,"
[Annals of Allergy, Asthma, and Immunology]{.underline}, 85:416,
November 2000.

18\. Erickson S. R. et al., "Compliance From Self-Reported versus
Pharmacy Claims Data With Metered-Dose Inhalers," [The Annals of
Pharmacotherapy]{.underline}, 35(9): 997, September 2001.

19\. Joyce, D. P., K. R. Chapman, and S. Kesten, "Prior Diagnosis and
Treatment of Patients with Normal Results of Methocholine Challenge and
Unexplained Respiratory Symptons," [Chest]{.underline}, 109(3):697,
March 1996.

20\. Kuschner, W. G. et al. "Nonprescription Bronchodilator Medication
Use in Asthma," [Chest]{.underline}, 112(4):987, October 1997.

21\. Gibson, P., "Association Between Availability of Non-Prescription
β~2~ Agonist Inhalers and Undertreatment of Asthma," [British Medical
Journal]{.underline}, 306:1514, June 5, 1993.

22\. Giraud, V., and N. Roche, "Misuse of Corticosteroid Metered-Dose
Inhaler Is Associated With Decreased Asthma Stability," [European
Respiratory Journal]{.underline}, 19:246, 2002.

23\. Scarfone, R. J. et al., "Demonstrated Use of Metered-Dose Inhalers
and Peak Flow Meters by Children and Adolescents with Acute
Exacerbations," [Archives of Pediatric and Adolescent
Medicine]{.underline}," 156:378, April 2002.

24\. Williams, M. V., "Inadequate Literacy Is a Barrier to Asthma
Knowledge and Self-Care," [Chest]{.underline}, 114(4):1008, October
1998.

25\. Cloutier, M. et al., "Use of Asthma Guidelines by Primary Care
Providers to Reduce Hospitalizations and Emergency Department Visits in
Poor, Minority, Urban Children," [Journal of Pediatrics]{.underline},
146:591, May 2005.

26\. Overbeek, S. E. et al., "Is Delayed Introduction of Inhaled
Corticosteroids Harmful in Patients With Obstructive Airways Disease
(Asthma and COPD)?" [Chest]{.underline}, 110(1):35, July 1996.

27\. Selroos, O. et al., "Effect of Early vs Late Intervention With
Inhaled Corticosteroids in Asthma," [Chest]{.underline}, 108(5):1228,
November 1995.

28\. Salpeter, S. R., T. M. Ormiston, and E. E. Salpeter,
"Meta-Analysis: Respiratory Tolerance to Regular β~2~ Agonist Use in
Patients with Asthma," [Annals of Internal Medicine]{.underline},
140(10):802, May 18, 2004.

29\. Szefler, S. et al., "Long--Term Effects of Budesonide or Nedocromil
in Children With Asthma," [New England Journal of Medicine]{.underline},
343:1054, October 12, 2000.

30\. Guilbert, T. et al., "Long-Term Inhaled Corticosteroids in
Pre-School Children at High Risk for Asthma," [New England Journal of
Medicine]{.underline}, 354:1985, May 11, 2006.

31\. Bisgaard, H. et al., "Intermittent Inhaled Corticosteroids in
Infants with Episodic Wheezing," [New England Journal of
Medicine]{.underline}, 354:1998, May 11, 2006.

32\. Bousquet, J. et al., "Asthma: From Bronchoconstriction to Airways
Inflammation and Remodeling," [American Journal of Respiratory and
Critical Care Medicine]{.underline}, 161:1720, 2000.

33\. United Nations Environmental Programme, 2006 Assessment Report of
the Technology and Economic Assessment Panel, 2006.

34\. United Nations Environmental Programme, Production and Consumption
of Ozone-Depleting Substances: 1986-2004, 2005.

35\. U.S. Environmental Protection Agency, "The Benefits and Costs of
the Clean Air Act: 1990--2010,"
([http://www.epa.gov/air/sect812/copy99.html]{.underline}) November
1999.

36\. National Center for Health Statistics, "Early Release of Selected
Estimates Based on Data From the January-September 2006 National Health
Interview Survey" March 28, 2007, available at
[http://www.cdc.gov/nchs/about/major/nhis/released200703.htm#15]{.underline}.

37\. American Lung Association, "Trends in Asthma Morbidity and
Mortality," Epidemiology & Statistics Unit, Research and Scientific
Affairs, July 2006.

38\. Blanc, P. D. et al., "Use of Herbal Products, Coffee or Black Tea,
and Over-the-Counter Medications as Self-Treatments Among Adults with
Asthma," [Journal of Allergy and Clinical Immunology]{.underline},
100:(6\\1) 789, December 1997.

39\. Mannino, D. M. et al., "Surveillance for Asthma----United States,
1980-1999," [Morbidity and Mortality Weekly Report]{.underline},
51(SS01):1-13, March 29, 2002.

40\. Analysis completed by FDA based on retail sales data from drug
stores and supermarkets provided by ACNielsen for the 52 weeks ending
September 9, 2006.

41\. U.S. Environmental Protection Agency, final rule, "Protection of
Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar
Year 2006," 71 FR 58504, October 4, 2006.

42\. 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).

43\. Analysis completed by FDA based on prescription data provided by
IMS Health, National Prescription Audit, 2004; IMS Health, IMS MIDAS
(TM), Q1/2004--Q2/2004.

44\. Gal, A., and N. R. Chari, "TEVA, SEPR: SGP to Phase Out CFC
Albuterol Production by Early 2007; TEVA and SEPR Likely to Benefit,"
report prepared for Sanford C. Bernstein & Co., LLC (New York), October
17, 2006.

45\. Berger, W. E. et al., "The Utility of the Health Plan Employer Data
and Information Set (HEDIS) Asthma Measure to Predict Asthma-Related
Outcomes," [Annals of Allergy, Asthma and Immunology]{.underline},
93:538, December 2004.

46\. Centers for Medicare and Medicaid Services, [Medicaid at-a-Glance
2005: A Medicaid Information Source,]{.underline} available at
[http://www.cms.hhs.gov/MedicaidEligibility/downloads/MedGlance05.pdf]{.underline}.

47\. Department of Health and Human Services, notice, "Annual Update of
the HHS Poverty Guidelines," 71 FR 3848, January 24, 2006.