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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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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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);