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41 rows where agency_id = "FDA" and docket_id = "FDA-1997-N-0040" sorted by posted_date descending
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document_type 4
- Supporting & Related Material 30
- Notice 5
- Other 5
- Rule 1
agency_id 1
- FDA · 41 ✖
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 | Current Good Tissue Practice for Mfrs. of Human Cellular 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 |
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CREATE TABLE documents (
id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);