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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

20 rows where docket_id = "FDA-1997-N-0103" sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 17
  • Notice 2
  • Proposed Rule 1

posted_year 1

  • 2016 20

agency_id 1

  • FDA 20
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0103-0107 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Reference 3 Biological Product Deviation Report Form (Form FDA-3486) and Instructions re: Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule Supporting & Related Material Background Material 2016-01-28T05:00:00Z 2016 1     2016-01-28T17:24:02Z   0 0 0900006481e36f00
FDA-1997-N-0103-0106 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Reference 2: Presidential Memorandum on Plain Language, June 1, 1998 re: Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule Supporting & Related Material Background Material 2016-01-28T05:00:00Z 2016 1     2016-01-28T17:19:13Z   0 0 0900006481e36eff
FDA-1997-N-0103-0108 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Reference 4: Internet Biological Product Deviation Report Instructions and Screen Examples re: Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule Supporting & Related Material Background Material 2016-01-28T05:00:00Z 2016 1     2016-01-28T17:28:17Z   0 0 0900006481e36f01
FDA-1997-N-0103-0110 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Supporting Statement: Biological Products: Reporting of Biological Product Deviations in Manufacturing OMB No. 0910-0458 Supporting & Related Material Background Material 2016-01-28T05:00:00Z 2016 1     2016-01-28T17:36:48Z   0 0 0900006481e3747d
FDA-1997-N-0103-0103 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule Notice Notice of Final Rule 2016-01-28T05:00:00Z 2016 1 2016-01-28T05:00:00Z 2001-05-05T03:59:59Z 2016-01-28T17:06:52Z   0 0 09000064805d070a
FDA-1997-N-0103-0109 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Agency Information Collection Activities; Announcement of OMB Approval; Biological Products: Reporting of Biological Product Deviations in Manufacturing; Notice Notice Notice of Approval 2016-01-28T05:00:00Z 2016 1 2016-01-28T05:00:00Z   2016-01-28T17:32:36Z   0 0 09000064805d070c
FDA-1997-N-0103-0104 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 List of References re: Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule Supporting & Related Material Background Material 2016-01-28T05:00:00Z 2016 1     2016-01-28T17:11:58Z   0 0 0900006481e36f02
FDA-1997-N-0103-0105 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Reference 1: Memorandum from Inspector General to DHHS, May 31, 1995 re: Biological Products: Reporting of Biological Product Deviations in Manufacturing; Final Rule Supporting & Related Material Background Material 2016-01-28T05:00:00Z 2016 1     2016-01-28T17:15:49Z   0 0 0900006481e36efe
FDA-1997-N-0103-0065 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Appendix A American Red Cross Blood Services Error and Accident Report re: Comment from American Red Cross Supporting & Related Material Background Material 2016-01-20T05:00:00Z 2016 1     2016-01-20T15:25:49Z   0 0 0900006481e21228
FDA-1997-N-0103-0051 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Attachment 1 Sample of Administrative Procedure re: Comment from University of California, Davis Supporting & Related Material Background Material 2016-01-20T05:00:00Z 2016 1     2016-01-20T14:21:28Z   0 0 0900006481e20afd
FDA-1997-N-0103-0066 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Appendix B Instructions for Completing the American Red Cross re: Appendix A American Red Cross Blood Services Error and Accident Report re: Comment from American Red Cross Supporting & Related Material Background Material 2016-01-20T05:00:00Z 2016 1     2016-01-20T15:31:05Z   0 0 0900006481e21227
FDA-1997-N-0103-0062 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Attachment 1 AABB Written Comments on the Information Collection Provisions re: Comment from William Beaumont Hospital Supporting & Related Material Background Material 2016-01-20T05:00:00Z 2016 1     2016-01-20T15:05:33Z   0 0 0900006481e20eff
FDA-1997-N-0103-0047 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Attachment 1 Comment from AABB Dated October 22, 1997 re: Comment from American Association of Blood Banks Supporting & Related Material Background Material 2016-01-19T05:00:00Z 2016 1     2016-01-19T19:47:04Z   0 0 0900006481e1b614
FDA-1997-N-0103-0001 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2016-01-13T05:00:00Z 2016 1 1997-09-23T04:00:00Z 1997-12-23T04:59:59Z 2016-01-13T16:47:30Z   0 0 09000064805d06a5
FDA-1997-N-0103-0006 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Tab D Error and Accident Report - Annual Summary for FY 96 re: Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule Supporting & Related Material Background Material 2016-01-13T05:00:00Z 2016 1     2016-01-13T17:08:48Z   0 0 0900006481e07e23
FDA-1997-N-0103-0007 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Tab E GAO Blood Supply FDA Oversight and Remaining Issues of Safety February 1997 re: Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule Supporting & Related Material Background Material 2016-01-13T05:00:00Z 2016 1     2016-01-13T17:12:21Z   0 0 0900006481e07e24
FDA-1997-N-0103-0002 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 List of References re: Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule Supporting & Related Material Background Material 2016-01-13T05:00:00Z 2016 1     2016-01-13T16:51:43Z   0 0 09000064805d0709
FDA-1997-N-0103-0003 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Tab A Memorandum from FDA CBER to All Registered Blood Establishments List of References re: Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule Supporting & Related Material Background Material 2016-01-13T05:00:00Z 2016 1     2016-01-13T16:56:17Z   0 0 09000064805d070b
FDA-1997-N-0103-0004 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Tab B Report from DHHS OIG "Reporting Process for Blood Establishments to Notify the Food and Drug Administration of Errors an Accidents Affecting Blood" re: Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule Supporting & Related Material Background Material 2016-01-13T05:00:00Z 2016 1     2016-01-13T17:00:09Z   0 0 0900006481e07d7a
FDA-1997-N-0103-0005 FDA BIOLOGICAL PRODUCTS; REPORTING OF ERROR & ACCIDENTS MANUFACTURING FDA-1997-N-0103 Tab C Federal Register Notice Guideline for Quality Assurance in Blood (60FR36290) July 11, 1995 re: Biological Products; Reporting of Errors and Accidents in Manufacturing; Proposed Rule Supporting & Related Material Background Material 2016-01-13T05:00:00Z 2016 1     2016-01-13T17:05:03Z   0 0 0900006481e07d7b

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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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