{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-1997-N-0040\" sorted by posted_date descending", "rows": [["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", null, "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, null, null, "2017-01-13T19:44:50Z", null, 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, null, null, "2017-01-13T20:22:48Z", null, 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, null, null, "2017-01-13T20:36:35Z", null, 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"Reference 3 - U.S. DHHS, FDA, CDRH, \"Class II Special Controls Guidance Document: Human Dura Mater; Draft Guidance for Industry and FDA,\" October 2002 - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002", "Supporting & Related Material", "Background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, null, null, "2017-01-13T19:30:43Z", null, 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, null, null, "2017-01-13T20:33:46Z", null, 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, null, null, "2016-01-29T16:43:27Z", null, 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, null, null, "2017-01-13T20:32:51Z", null, 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, null, null, "2017-01-13T20:44:59Z", null, 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, null, null, "2017-01-13T19:38:32Z", null, 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, null, null, "2017-01-13T20:15:57Z", null, 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, null, null, "2017-01-13T19:22:00Z", null, 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", null, "2017-01-13T21:43:50Z", null, 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, null, null, "2017-01-13T19:43:04Z", null, 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, null, null, "2017-01-13T20:30:29Z", null, 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, null, null, "2017-01-13T20:37:18Z", null, 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, null, null, "2017-01-13T20:35:11Z", null, 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, null, null, "2017-01-13T20:03:48Z", null, 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, null, null, "2017-01-13T19:25:23Z", null, 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, null, null, "2017-01-13T20:27:19Z", null, 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, null, null, "2017-01-13T20:24:15Z", null, 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, null, null, "2017-01-13T20:25:07Z", null, 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, null, null, "2017-01-13T19:31:33Z", null, 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, null, null, "2017-01-13T20:43:39Z", null, 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, null, null, "2017-01-13T20:15:08Z", null, 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", null, "2016-01-28T21:11:29Z", null, 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", null, "2016-01-28T17:31:47Z", null, 0, 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