id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2006-N-0304-0051,FDA,FDA-2006-N-0304,"Use of Ozone-Depleting Substances: Removal of Essential-Use Designation (Flunisolide, etc.); Correction",Notice,NCR-Notice of Correction,2010-09-17T04:00:00Z,2010,9,2010-09-17T04:00:00Z,,2011-06-11T16:25:59Z,2010-23195,0,0,0900006480b51d24 FDA-2006-N-0304-0050,FDA,FDA-2006-N-0304,"OMB Changes, Executive Order 12866 (E.O.) [Use of Ozone-Depleting Substances; Removal of Essential-Use Designations (Flunisolide, etc.)] - Reference",Other,REF-Reference Material (internal attachments),2010-04-27T04:00:00Z,2010,4,2010-04-27T04:00:00Z,,2013-07-27T23:17:05Z,,0,0,0900006480ae1652 FDA-2006-N-0304-0045,FDA,FDA-2006-N-0304,"Reference 07 - U.S. Environmental Protection Agency. ""The Benefits and Costs of the Clean Air Act: 1990-2010"" [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:50:58Z,,0,0,0900006480ad651c FDA-2006-N-0304-0040,FDA,FDA-2006-N-0304,List of References - [FDA-2006-N-0304 Notice of Final Rule 4/14/2010],Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:50:50Z,,0,0,0900006480ad5ea8 FDA-2006-N-0304-0044,FDA,FDA-2006-N-0304,"Reference 06 - United Nations Environmental Programme, Production and Consumption of Ozone-Depleting Substances: 1986-2004, 2005. [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:50:56Z,,0,0,0900006480ad651b FDA-2006-N-0304-0043,FDA,FDA-2006-N-0304,"Reference 04 - Envrios March, Study on the Use of HFCs for Metered Dose Inhalers In the European Union: Final report following submission to the ECCP (European Commission Climate Change Policy Group) [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:50:55Z,,0,0,0900006480ad5eac FDA-2006-N-0304-0042,FDA,FDA-2006-N-0304,"Reference 03 - US Department of Commerce, Census Bureau; Economics and Statistics Administration, Pharmaceutical Preparation Manufacturing: 2002 [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:50:53Z,,0,0,0900006480ad5eab FDA-2006-N-0304-0049,FDA,FDA-2006-N-0304,"Reference 15 - DeNavas-Walt, C. B. D. Proctor, and J. C Smith, U.S. Census Bureau, Current Population Reports, P60-236(RV), Income, Poverty, and Health Insurance Coverage in the United States: 2008, Table 7, p. 21. 2009 [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:51:03Z,,0,0,0900006480ad6348 FDA-2006-N-0304-0046,FDA,FDA-2006-N-0304,"Reference 08 - American Lung Association, ""Trends in COPD (Chronic Bronchitis and Emphysema): Morbidity and Mortality,"" [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:50:59Z,,0,0,0900006480ad651d FDA-2006-N-0304-0039,FDA,FDA-2006-N-0304,"Use of Ozone-Depleting Substances; Removal of Essential-Use Designation: Flunisolide, etc.",Rule,NFR-Notice of Final Rule,2010-04-14T04:00:00Z,2010,4,2010-04-14T04:00:00Z,,2011-06-11T16:25:59Z,2010-08467,0,0,0900006480ad7218 FDA-2006-N-0304-0041,FDA,FDA-2006-N-0304,"Reference 01 - Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR-3), NIH Publication No. 07-4051 [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:50:52Z,,0,0,0900006480ad5ea9 FDA-2006-N-0304-0047,FDA,FDA-2006-N-0304,"Reference 09 - American Lung Association, ""Trends in Asthma Morbidity and Mortality,"" January 2009 [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:51:01Z,,0,0,0900006480ad651e FDA-2006-N-0304-0048,FDA,FDA-2006-N-0304,"Reference 11 - Analysis completed by FDA based on information provided by IMS Health, [FDA-2006-N-0304 Notice of Final Rule, 4/14/2010]",Supporting & Related Material,BKG-Background Material,2010-04-14T04:00:00Z,2010,4,,,2010-04-14T14:51:02Z,,0,0,0900006480ad6572 FDA-2006-N-0304-0038,FDA,FDA-2006-N-0304,"Graceway Pharmaceuticals, LLC - Supplement Comment re FDA-2006-N-0304-0032",Other,SUP-Supplement,2010-02-03T05:00:00Z,2010,2,2010-02-03T05:00:00Z,,2013-07-27T23:05:37Z,,0,0,0900006480a8731b FDA-2006-N-0304-0031,FDA,FDA-2006-N-0304,Use of Ozone-Depleting Substances; Removal of Essential-Use Designations; Extension of Comment Period [re FDA-2006-N-0304-0005 and FDA-2006-N-0304-0001],Notice,NEC-Notice of Extension,2009-05-29T04:00:00Z,2009,5,2009-05-29T04:00:00Z,,2009-06-30T18:48:45Z,,0,0,09000064809bf51d FDA-2006-N-0304-0028,FDA,FDA-2006-N-0304,"Background Information - American Lung Association, Trends in Asthma Morbidity and Mortality, Epidemiology & Statistics Unit, Research and Program Services, July 2006.",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:26:08Z,,0,0,09000064804593a8 FDA-2006-N-0304-0024,FDA,FDA-2006-N-0304,"Background Information - 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 [Article continues in FDA-2006-N-0304-0025]",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:36:51Z,,0,0,090000648045939c FDA-2006-N-0304-0016,FDA,FDA-2006-N-0304,"Background Information - Reference: Analysis completed by FDA based on information provided by IMS Health, IMS National Sales Perspective (TM), 2005, extracted March 2006. These data are available for purchase from IMS Health. Please send all inquiries to: IMS Health, Attn: Brian Palumbo, Account Manager, 660 West Germantown Pike, Plymouth Meeting, PA 19462",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:25:54Z,,0,0,0900006480459369 FDA-2006-N-0304-0020,FDA,FDA-2006-N-0304,"Background Information - Reference: ""Surveillance for Asthma — United States, 1980–1999 -- Malaria Surveillance — United States, 1999,"" MMWR Morbidity andMortality Weekly Report, 2002",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:25:59Z,,0,0,0900006480459377 FDA-2006-N-0304-0023,FDA,FDA-2006-N-0304,Background Information - References,Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:26:02Z,,0,0,0900006480459387 FDA-2006-N-0304-0022,FDA,FDA-2006-N-0304,"Background Information - 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 - Continued [Article begins in FDA-2006-N-0304-0027]",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:35:31Z,,0,0,0900006480459385 FDA-2006-N-0304-0027,FDA,FDA-2006-N-0304,"Background Information - 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 (continued in FDA-2006-N-0304-0022)",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:33:28Z,,0,0,09000064804593a5 FDA-2006-N-0304-0026,FDA,FDA-2006-N-0304,"Background Information - United Nations Environmental Programme, Production and Consumption of Ozone-Depleting Substances: 1986-2004, 2005",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:26:06Z,,0,0,09000064804593a3 FDA-2006-N-0304-0025,FDA,FDA-2006-N-0304,"Background Information - 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 - continued",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:26:05Z,,0,0,090000648045939f FDA-2006-N-0304-0017,FDA,FDA-2006-N-0304,"Background Information - Reference: Rozek, R.P., and E.R. Bishko, Economics Issues Raised in the FDA's Proposed Rule on Removingthe Essential-Use Designation for Albuterol MDIs, National Economic Research Associates, August 13, 2004 (FDA Docket No. 2003P-0029 C 25)",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:25:55Z,,0,0,090000648045936a FDA-2006-N-0304-0019,FDA,FDA-2006-N-0304,"Background Information - Reference: U.S. Environmental Protection Agency, The Benefits and Costs of the Clean nAir Act: 1990-2010. (http://www.epa.gov/air/sect812/copy99.html) (November 1999).",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:25:57Z,,0,0,0900006480459373 FDA-2006-N-0304-0021,FDA,FDA-2006-N-0304,"Background Information - Reference: DeNavas-Walt, C., B.D. Proctor, and C.H. Lee, U.S. Census Bureau, Current Population Reports, P60-229, Income, Poverty, and Health Insurance Coverage in the United States: 2004, p. 18, 2005",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:26:00Z,,0,0,0900006480459378 FDA-2006-N-0304-0018,FDA,FDA-2006-N-0304,"Background Information - Reference: ""Chronic Obstructive Pulmonary Disease Surveillance — United States, 1971–2000"" MMWR Morbidity and Mortality Weekly Report, CDC",Supporting & Related Material,BKG-Background Material,2008-12-08T05:00:00Z,2008,12,,,2008-12-08T18:25:56Z,,0,0,0900006480459371 FDA-2006-N-0304-0014,FDA,FDA-2006-N-0304,"Graceway Pharmaceuticals, LLC (Graceway) - Addendum to Comment",Other,AMD-Amendment,2008-07-21T04:00:00Z,2008,7,2008-07-21T04:00:00Z,,2008-12-09T19:09:49Z,,0,0,0900006480650364 FDA-2006-N-0304-0015,FDA,FDA-2006-N-0304,Abbott - Withdrawal,Other,WDL-Withdrawal,2008-07-21T04:00:00Z,2008,7,2008-07-21T04:00:00Z,,2013-07-27T22:18:53Z,,0,0,0900006480680030 FDA-2006-N-0304-0012,FDA,FDA-2006-N-0304,"Graceway Pharmaceuticals, LLC - Request for Extension of Comment Due Date",Other,EXT-Request for Extension Comment Due Date,2008-07-21T04:00:00Z,2008,7,2008-07-21T04:00:00Z,,2013-07-27T20:44:31Z,,0,0,09000064804593ad FDA-2006-N-0304-0013,FDA,FDA-2006-N-0304,Graceway Pharmaceuticals - Request for Extension of Comment Due Date,Other,EXT-Request for Extension Comment Due Date,2008-07-21T04:00:00Z,2008,7,2008-07-21T04:00:00Z,,2013-07-27T20:44:31Z,,0,0,09000064804593bc FDA-2006-N-0304-0009,FDA,FDA-2006-N-0304,University of Alabama at Birmingahm (UAB) - Letter,Other,LET-Letter,2008-06-02T04:00:00Z,2008,6,2008-06-02T04:00:00Z,,2008-06-03T00:17:05Z,,0,0,09000064804593b9 FDA-2006-N-0304-0010,FDA,FDA-2006-N-0304,Lisa Delaney Correspondence to the Center for Drug Evaluation and Research - Electronic Letter,Other,ELET-Electronic Letter,2008-06-02T04:00:00Z,2008,6,2008-06-02T04:00:00Z,,2008-06-03T00:17:06Z,,0,0,090000648045aaf8 FDA-2006-N-0304-0002,FDA,FDA-2006-N-0304,See FDA-2006-N-0304-0030,Supporting & Related Material,,2007-09-26T00:00:00Z,2007,9,,,2009-03-11T19:34:10Z,,0,1,090000648045b7c1 FDA-2006-N-0304-0005,FDA,FDA-2006-N-0304,Use of Ozone-Depleting Substances; Removal of Essential-Use Designations; Extension of Comment Period,Notice,NEC-Notice of Extension,2007-08-07T04:00:00Z,2007,8,2007-08-06T04:00:00Z,2007-09-11T03:59:59Z,2009-05-29T18:06:16Z,,0,0,09000064804597f1 FDA-2006-N-0304-0004,FDA,FDA-2006-N-0304,Use of Ozone-Depleting Substances; Removal of Essential-Use Designations; Public Meeting,Notice,NM-Notice of Meeting,2007-07-09T04:00:00Z,2007,7,2007-07-06T04:00:00Z,,2008-06-03T00:07:41Z,,0,0,09000064804593af FDA-2006-N-0304-0001,FDA,FDA-2006-N-0304,Use of Ozone-Depleting Substances; Removal of Essential-Use Designations,Proposed Rule,NPR-Notice of Proposed Rule-Making,2007-06-06T04:00:00Z,2007,6,2007-06-06T04:00:00Z,2007-08-11T03:59:59Z,2008-12-08T18:38:09Z,,0,0,09000064804592b2 FDA-2006-N-0304-0006,FDA,FDA-2006-N-0304,Environmental Assessment [FDA-2006-N-0304-0001],Supporting & Related Material,EA-Environmental Assessment,2007-06-06T04:00:00Z,2007,6,,,2008-06-03T00:14:44Z,,0,0,090000648045935f FDA-2006-N-0304-0008,FDA,FDA-2006-N-0304,Findings of No Significant Impact [FDA-2006-N-0304-0001],Supporting & Related Material,FONS-Finding of no Significant Impact,2007-06-06T04:00:00Z,2007,6,,,2008-06-03T00:16:19Z,,0,0,0900006480459367