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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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