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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

31 rows where docket_id = "FDA-1997-N-0040" and posted_year = 2010 sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 25
  • Other 5
  • Notice 1

posted_year 1

  • 2010 · 31 ✖

agency_id 1

  • FDA 31
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0040-0068 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FDA-1997-N-0040 Reference 3 - U.S. DHHS, FDA, CDRH, "Class II Special Controls Guidance Document: Human Dura Mater; Draft Guidance for Industry and FDA," October 2002 - [Notice of Final Rule - Background Material] re: FDA-1997-N-0040-0002 Supporting & Related Material Background Material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

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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);
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