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withdrawn,object_id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-1997-N-0040-0086,FDA,FDA-1997-N-0040,Final Rule re Medical Devices: Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment,Rule,Final Rule,2011-06-24T04:00:00Z,2011,6,2011-06-24T04:00:00Z,,2016-02-02T16:10:30Z,2011-15817,0,0,0900006480eb3482
FDA-1997-N-0040-0068,FDA,FDA-1997-N-0040,"Reference 8 - U.S. DHHS, CMS, ""Health Care Financing Review, 2000 Statistical Supplement, Submitted Charges per Person Served, Calendar Year 1998"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T19:44:50Z,,0,0,09000064805cfbd6
FDA-1997-N-0040-0072,FDA,FDA-1997-N-0040,"Reference 26 - AHRQ, HCUP, NIS for 2000, ""Outcomes for Principle Procedure 3, Bacterial Infection, Unspecified Site"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:22:48Z,,0,0,09000064805cfbda
FDA-1997-N-0040-0080,FDA,FDA-1997-N-0040,"Reference 36 - ""Proposed Approach to Regulation of Cellular and Tissue-Based Products,"" Meeting Transcript dated March 17, 1997 (pages 1-100) - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:36:35Z,,0,0,09000064805cfbbb
FDA-1997-N-0040-0064,FDA,FDA-1997-N-0040,"Reference 3 - U.S. DHHS, FDA, CDRH, ""Class II Special Controls Guidance Document: Human Dura Mater; Draft Guidance for Industry and FDA,"" October 2002 - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T19:30:43Z,,0,0,09000064805cfbd0
FDA-1997-N-0040-0078,FDA,FDA-1997-N-0040,"Reference 34 - ""FDA Compliance Guide, Chapter 1 - General: Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:33:46Z,,0,0,09000064805cfbb8
FDA-1997-N-0040-0082,FDA,FDA-1997-N-0040,"Reference 36 - ""Proposed Approach to Regulation of Cellular and Tissue-Based Products,"" Meeting Transcript dated March 17, 1997 (pages 201-285) - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2016-01-29T16:43:27Z,,0,0,09000064805cfbbd
FDA-1997-N-0040-0077,FDA,FDA-1997-N-0040,"Reference 33 - ""International Conference on Harmonisation; Guideline on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; Availability"" (60 FR 11284, March 1, 1995) - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:32:51Z,,0,0,09000064805cfbb7
FDA-1997-N-0040-0084,FDA,FDA-1997-N-0040,"Reference 42 - ""General Principles of Software Validation; Final Guidance for Industry and FDA Staff,"" dated January 11, 2002 - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:44:59Z,,0,0,09000064805cfbc3
FDA-1997-N-0040-0066,FDA,FDA-1997-N-0040,"Reference 4 - U.S. DHHS, FDA, ""Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript,"" June 26, 2002 (part 2 of 2) - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T19:38:32Z,,0,0,09000064805cfbd1
FDA-1997-N-0040-0071,FDA,FDA-1997-N-0040,"Reference 24 - AHRQ, HCUP, NIS for 2000, ""Outcomes for Principle Procedure 43, Heart Valve Procedures"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:15:57Z,,0,0,09000064805cfbca
FDA-1997-N-0040-0062,FDA,FDA-1997-N-0040,Index of References 1 - 42 - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002,Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T19:22:00Z,,0,0,09000064805cfbcc
FDA-1997-N-0040-0085,FDA,FDA-1997-N-0040,Index of References 43 - 45 [Notice of Final Rule - Supplement] re: FDA-1997-N-0040-0002,Other,Supplement (SUP),2010-10-06T04:00:00Z,2010,10,2010-10-06T04:00:00Z,,2017-01-13T21:43:50Z,,0,0,09000064805cfbe9
FDA-1997-N-0040-0067,FDA,FDA-1997-N-0040,"Reference 7 - Health Care Utilization Project (HCUP), Nationwide Inpatient Sample (NIS) for 2000, Outcomes fro Principle Procedure 13, Corneal Transplant - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T19:43:04Z,,0,0,09000064805cfbd5
FDA-1997-N-0040-0076,FDA,FDA-1997-N-0040,"Reference 32 - U.S. Department of Labor, Bureau of Labor Statistics, ""Employer Costs for Employee Compensation Per Hour Worked for Civilian Workers in Private Industry and State and Local Governments"", March 2003 - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:30:29Z,,0,0,09000064805cfbb4
FDA-1997-N-0040-0081,FDA,FDA-1997-N-0040,"Reference 36 - ""Proposed Approach to Regulation of Cellular and Tissue-Based Products,"" Meeting Transcript dated March 17, 1997 (pages 101-200) - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:37:18Z,,0,0,09000064805cfbbc
FDA-1997-N-0040-0079,FDA,FDA-1997-N-0040,"Reference 35 - ""Draft 'Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing -- Current Good Manufacturing Practice'"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:35:11Z,,0,0,09000064805cfbb9
FDA-1997-N-0040-0069,FDA,FDA-1997-N-0040,"Reference 11 - U.S. DHHS, CDC, ""Detailed Diagnosis and Procedures Data, National Hospital Discharge Survey 2000, Series 13, No. 13, Table 46,"" November 2002 - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:03:48Z,,0,0,09000064805cfbdd
FDA-1997-N-0040-0063,FDA,FDA-1997-N-0040,"Reference 1 - U.S. DHHS, CDC, ""Update: Allograft-Associated Bacterial Infections--United States"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T19:25:23Z,,0,0,09000064805cfbcd
FDA-1997-N-0040-0075,FDA,FDA-1997-N-0040,"Reference 29 - U.S. DHHS, CDC, ""2000 Assisted Reproductive Technology Success Rates, National Summary and Fertility Clinic Reports"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:27:19Z,,0,0,09000064805cfbb6
FDA-1997-N-0040-0073,FDA,FDA-1997-N-0040,"Reference 27 - U.S. Department of Labor, Bureau of Labor Statistics - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:24:15Z,,0,0,09000064805cfbdb
FDA-1997-N-0040-0074,FDA,FDA-1997-N-0040,"Reference 28, AHRQ, HCUP, NIS for 2001, ""Outcomes for Principle Procedure 142, Partial Excision of Bone"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:25:07Z,,0,0,09000064805cfbe4
FDA-1997-N-0040-0065,FDA,FDA-1997-N-0040,"Reference 4 - U.S. DHHS, FDA, ""Transmissible Spongiform Encephalopathies Advisory Committee Meeting Transcript,"" June 26, 2002 (part 1 of 2) - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T19:31:33Z,,0,0,09000064805cfbcf
FDA-1997-N-0040-0083,FDA,FDA-1997-N-0040,"Reference 40 - ""Compliance Program 7341.002 - Inspection of Tissue Establishments"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:43:39Z,,0,0,09000064805cfbc1
FDA-1997-N-0040-0070,FDA,FDA-1997-N-0040,"Reference 23 - HCUP, NIS for 2000, ""Outcomes for Principle Procedure 157, Amputation of Lower Extremity"" - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002",Supporting & Related Material,BKG-Background Material,2010-10-06T04:00:00Z,2010,10,,,2017-01-13T20:15:08Z,,0,0,09000064805cfbc9
FDA-1997-N-0040-0060,FDA,FDA-1997-N-0040,Supplement from Foundation for the Accreditation of Cellular Therapy (FACT),Other,Supplement (SUP),2010-10-01T04:00:00Z,2010,10,2010-10-01T04:00:00Z,,2016-01-28T21:11:29Z,,0,0,09000064805cfbb1
FDA-1997-N-0040-0051,FDA,FDA-1997-N-0040,Memorandum of Meeting Between FDA and Eye Bank Association of America (EBAA),Other,Memorandum,2010-10-01T04:00:00Z,2010,10,2010-10-01T04:00:00Z,,2016-01-28T17:31:47Z,,0,0,09000064805cfba8
FDA-1997-N-0040-0046,FDA,FDA-1997-N-0040,Attachment - Addendum: Tab A - EBAA Medical Standards - [Eye Bank Association of America (EBAA) - Comment] re: FDA-1997-N-0040-0045,Supporting & Related Material,Background Material,2010-10-01T04:00:00Z,2010,10,,,2016-02-01T20:31:13Z,,0,0,0900006480b65c3a
FDA-1997-N-0040-0061,FDA,FDA-1997-N-0040,"Attachment - ""NETCORD-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release"" - [Foundation for the Accreditation of Cellular Therapy (FACT) - Supplement] re: FDA-1997-N-0040-0060",Supporting & Related Material,SUP-Supplement (Supporting and Related Material),2010-10-01T04:00:00Z,2010,10,,,2010-10-01T21:07:58Z,,0,0,0900006480b65c41
FDA-1997-N-0040-0020,FDA,FDA-1997-N-0040,Letter from American Society for Reproductive Medicine (ASRM),Other,Letter(s),2010-09-30T04:00:00Z,2010,9,2010-09-30T04:00:00Z,,2016-02-02T15:21:35Z,,0,0,09000064805cfb89
FDA-1997-N-0040-0011,FDA,FDA-1997-N-0040,Request for Extension from American Association of Tissue Banks (AATB),Other,Request for Extension,2010-09-30T04:00:00Z,2010,9,2010-09-20T04:00:00Z,2001-05-09T03:59:59Z,2017-01-13T16:59:05Z,,0,0,09000064805cfb7f
FDA-1997-N-0040-0009,FDA,FDA-1997-N-0040,Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement - Notice of Proposed Rule,Notice,Notice of Final Rule,2010-09-20T04:00:00Z,2010,9,2010-09-20T04:00:00Z,2001-05-09T03:59:59Z,2016-02-05T17:32:19Z,,0,0,09000064805cfb7e
FDA-1997-N-0040-0005,FDA,FDA-1997-N-0040,Reference - OMB Review of 11/24/2004 Final Rule (pages 1-99) - [re: FDA-1997-N-0040-0002],Supporting & Related Material,Reference (internal unless indicated),2005-04-08T04:00:00Z,2005,4,,,2016-02-01T19:33:45Z,,0,0,09000064805cfbed
FDA-1997-N-0040-0007,FDA,FDA-1997-N-0040,Reference - OMB Review of 11/24/2004 Final Rule (pages 200-299) - [re: FDA-1997-N-0040-0002],Supporting & Related Material,Reference (internal unless indicated),2005-04-08T04:00:00Z,2005,4,,,2016-02-01T19:34:29Z,,0,0,09000064805cfbef
FDA-1997-N-0040-0008,FDA,FDA-1997-N-0040,Reference - OMB Review of 11/24/2004 Final Rule (pages 300-380) - [re: FDA-1997-N-0040-0002],Supporting & Related Material,Reference (internal unless indicated),2005-04-08T04:00:00Z,2005,4,,,2016-02-01T19:34:45Z,,0,0,09000064805cfbf0
FDA-1997-N-0040-0006,FDA,FDA-1997-N-0040,Reference - OMB Review of 11/24/2004 Final Rule (pages 100-199) - [re: FDA-1997-N-0040-0002],Supporting & Related Material,Reference (internal unless indicated),2005-04-08T04:00:00Z,2005,4,,,2016-02-01T19:34:11Z,,0,0,09000064805cfbee
FDA-1997-N-0040-0004,FDA,FDA-1997-N-0040,"Notice of Final Rule re Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement (pages 201-285)",Notice,Notice of Final Rule,2004-11-24T05:00:00Z,2004,11,2004-11-18T05:00:00Z,,2017-01-13T19:09:28Z,,0,0,09000064805cfbe8
FDA-1997-N-0040-0002,FDA,FDA-1997-N-0040,"Notice of Final Rule re Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement",Notice,Notice of Final Rule,2004-11-24T05:00:00Z,2004,11,2004-11-18T05:00:00Z,,2017-01-13T19:08:49Z,,0,0,09000064805cfbe5
FDA-1997-N-0040-0003,FDA,FDA-1997-N-0040,"Notice of Final Rule re Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement (pages 201-285)",Notice,Notice of Final Rule,2004-11-24T05:00:00Z,2004,11,2004-11-18T05:00:00Z,,2017-01-13T19:09:08Z,,0,0,09000064805cfbe6
FDA-1997-N-0040-0001,FDA,FDA-1997-N-0040,"Notice of Final Rule re Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspecition and Enforcement (pages 1-100)",Notice,Notice of Final Rule,2004-11-24T05:00:00Z,2004,11,2004-11-18T05:00:00Z,,2017-01-13T19:08:25Z,,0,0,09000064805cfb7b
FDA-1997-N-0040-0010,FDA,FDA-1997-N-0040,Background Material (Book 1 of 2) - Cited Articles (1 of 4) - [Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement - Notice of Proposed Rule]  re: FDA-1997-N-0040-0009,Supporting & Related Material,,2001-01-09T00:00:00Z,2001,1,,,2017-01-13T18:48:38Z,,0,1,09000064805cfb7d