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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

22 rows where docket_id = "FDA-2000-N-0163" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 6

  • 2009 17
  • 2000 1
  • 2001 1
  • 2003 1
  • 2004 1
  • 2010 1

document_type 3

  • Supporting & Related Material 15
  • Notice 4
  • Other 3

agency_id 1

  • FDA 22
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2000-N-0163-0023 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Reclassifications of Category IIIA Biological Products, Bacterial Vaccines and Related Biological Products, etc.: Delmont Laboratories, Inc.; Denial of Request for Hearing and Revocation of License Notice NFR-Notice of Final Rule 2010-12-06T05:00:00Z 2010 12 2010-12-06T05:00:00Z   2010-12-06T17:22:07Z 2010-30441 0 0 0900006480bafeaf
FDA-2000-N-0163-0022 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab G - "Bacterial Vaccines and Bacterial Antigens with No U.S. Standard of Potency, dated October 27, 1978" - [Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request] re: FDA-2000-N-0163-0018 Supporting & Related Material SUP-Supplement (Supporting and Related Material) 2009-09-22T04:00:00Z 2009 9     2009-09-22T19:06:00Z   0 0 09000064804d1a2f
FDA-2000-N-0163-0010 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab 2 - "License Revocation Letter to BioPort Corporation," dated November 20, 2000 - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002 Supporting & Related Material BKG-Background Material 2009-09-17T04:00:00Z 2009 9     2009-09-17T14:48:08Z   0 0 09000064804d1a1b
FDA-2000-N-0163-0021 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab C - "Delmont Comments of January 8, 1978 (Docket No. 77N-0091), w/attachments" - [Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request] re: FDA-2000-N-0163-0018 Supporting & Related Material SUP-Supplement (Supporting and Related Material) 2009-09-17T04:00:00Z 2009 9     2009-09-17T21:03:48Z   0 0 09000064804d1a39
FDA-2000-N-0163-0015 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab B - "FDA/CBER Response to Delmont Laboratories, Inc., dated October 12, 1993" - [Delmont Laboratories, Inc. - Comment] re: FDA-2000-N-0163-0013 Supporting & Related Material C-Comment (Supporting and Related Material) 2009-09-17T04:00:00Z 2009 9     2009-09-17T18:56:41Z   0 0 09000064804d1a0a
FDA-2000-N-0163-0014 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab A - "Bacterial Vaccines and Bacterial Antigens with No U.S. Standard of Potency: Revocation of Licenses and Reclassification" - [Delmont Laboratories, Inc. - Comment] re: FDA-2000-N-0163-0013 Supporting & Related Material C-Comment (Supporting and Related Material) 2009-09-17T04:00:00Z 2009 9     2009-09-17T18:51:09Z   0 0 09000064804d1a0f
FDA-2000-N-0163-0016 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab D - "Minutes and Attendance List from Meeting between Delmont Laboratories, Inc., and FDA/CBER" - [Delmont Laboratories, Inc. - Comment] re: FDA-2000-N-0163-0013 Supporting & Related Material C-Comment (Supporting and Related Material) 2009-09-17T04:00:00Z 2009 9     2009-09-17T19:49:06Z   0 0 09000064804d1a14
FDA-2000-N-0163-0019 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab A - "Table of Attachments" - [Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request ] re: FDA-2000-N-0163-0018 Supporting & Related Material SUP-Supplement (Supporting and Related Material) 2009-09-17T04:00:00Z 2009 9     2009-09-17T20:55:10Z   0 0 09000064804d1a3f
FDA-2000-N-0163-0017 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Delmont Laboratories, Inc. - Appearance Request Other APE-Appearance Request 2009-09-17T04:00:00Z 2009 9 2009-09-17T04:00:00Z   2013-07-27T21:05:57Z   0 0 09000064804d1a24
FDA-2000-N-0163-0011 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab 1 - "License Revocation Letter to Hollister-Stier Laboratories, LLC, dated August 3, 2000" - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002 Supporting & Related Material BKG-Background Material 2009-09-17T04:00:00Z 2009 9     2009-09-17T14:48:56Z   0 0 09000064804d1a1c
FDA-2000-N-0163-0020 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab B - "Delmont Laboratories, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 229" - [Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request] re: FDA-2000-N-0163-0018 Supporting & Related Material SUP-Supplement (Supporting and Related Material) 2009-09-17T04:00:00Z 2009 9     2009-09-17T20:57:04Z   0 0 09000064804d1a3d
FDA-2000-N-0163-0018 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Covington & Burling [Delmont Laboratories, Inc.] - Supplement Appearance Request Other SUP-Supplement 2009-09-17T04:00:00Z 2009 9 2009-09-17T04:00:00Z   2013-08-11T04:10:38Z   0 0 09000064804d1a40
FDA-2000-N-0163-0012 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 "Index of Supporting Documents" - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002 Supporting & Related Material BKG-Background Material 2009-09-17T04:00:00Z 2009 9     2009-09-17T14:49:58Z   0 0 09000064804d1a1e
FDA-2000-N-0163-0009 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab 3 - "Letter from Hollister-Stier Laboratories, LLC Surrendering License," dated June 19, 2000 - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002 Supporting & Related Material BKG-Background Material 2009-09-15T04:00:00Z 2009 9     2009-09-15T19:53:44Z   0 0 09000064804d1a19
FDA-2000-N-0163-0005 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 "Reports for Submission to Docket 00N-1219" - [Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review - Notice] - Background re: FDA-2000-N-0163-0001 Supporting & Related Material BKG-Background Material 2009-09-15T04:00:00Z 2009 9     2009-09-15T19:37:43Z   0 0 09000064804d19e3
FDA-2000-N-0163-0008 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab 4 - "Letter from BioPort Corporation Surrendering License," dated August 9, 2000" - [Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice] - Background re: FDA-2000-N-0163-0002 Supporting & Related Material BKG-Background Material 2009-09-15T04:00:00Z 2009 9     2009-09-15T19:51:01Z   0 0 09000064804d1a17
FDA-2000-N-0163-0006 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab 1 - "Panel on Review of Allergenic Extracts Category IIIA Reclassification, Final Report, December 1983" - [Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review - Notice] - Background re: FDA-2000-N-0163-0001 Supporting & Related Material BKG-Background Material 2009-09-15T04:00:00Z 2009 9     2009-09-15T19:40:18Z   0 0 09000064804d1a04
FDA-2000-N-0163-0007 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Tab 2 - "Final Report: Addendum to Previous Panel Reports for the Reclassification of Category IIIA Biologics" - [Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review - Notice] - Background re: FDA-2000-N-0163-0001 Supporting & Related Material BKG-Background Material 2009-09-15T04:00:00Z 2009 9     2009-09-15T19:41:53Z   0 0 09000064804d1a06
FDA-2000-N-0163-0004 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Separation of Functions: Delmont Laboratories, Inc.; Opportunity for a Hearing on a Proposal to Revoke U.S. License No. 229 - Memorandum Other M-Memorandum 2004-06-08T04:00:00Z 2004 6     2009-09-11T16:30:09Z   0 0 09000064804d1a44
FDA-2000-N-0163-0003 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Delmont Laboratories, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 229 - Notice of Opportunity of Hearing Notice NPH-Notice of Opportunity of Hearing 2003-02-27T05:00:00Z 2003 2 2003-02-27T05:00:00Z 2003-04-29T03:59:59Z 2009-09-11T16:25:50Z   0 0 09000064804d1a22
FDA-2000-N-0163-0002 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Biological Products; Bacterial Vaccines and Related Biological Products; Revocation of Biologics Licenses - Notice Notice N-Notice 2001-05-29T04:00:00Z 2001 5     2009-09-09T18:32:17Z   0 0 09000064804d1a21
FDA-2000-N-0163-0001 FDA Bacterial Vaccines & Related Biological Products FDA-2000-N-0163 Biological Products; Bacterial Vaccines and Related Biological Products; Implementation of Efficacy Review; Proposed Order - Notice Notice N-Notice 2000-05-16T04:00:00Z 2000 5 2000-05-16T04:00:00Z 2000-08-14T03:59:59Z 2009-09-09T14:56:32Z   0 0 09000064804d19cb

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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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