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withdrawn,object_id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-2005-N-0464-0249,FDA,FDA-2005-N-0464,"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections",Rule,Final Rule,2021-04-01T04:00:00Z,2021,4,2021-04-01T04:00:00Z,,2021-04-01T15:35:43Z,2021-06677,0,0,0900006484a93032
FDA-2005-N-0464-0244,FDA,FDA-2005-N-0464,"Agency Information Collection Activities; Announcement of Office of
Management and Budget Approval; Establishment Registration of
Producers of Drugs and Listing of Drugs in Commercial Distribution and
Blood Establishment Registration and Product Listing",Notice,Announcement,2017-04-25T04:00:00Z,2017,4,2017-04-25T04:00:00Z,,2017-04-25T14:08:22Z,2017-08305,0,0,090000648257352e
FDA-2005-N-0464-0241,FDA,FDA-2005-N-0464,"Tab 3: Draft Final Economic Impact Analysis for a Prospective FDA Rule Governing: Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain Biological Drugs, and Animal Drugs -  dated on 08/03/2005",Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-08-15T14:19:34Z,,0,0,0900006480450bff
FDA-2005-N-0464-0243,FDA,FDA-2005-N-0464,Tab 5: Cost Impacts of the Over-the-Counter Pharmaceutical Labeling Rule - final report dated on 03/05/1999,Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-08-15T14:26:29Z,,0,0,0900006480450bfe
FDA-2005-N-0464-0242,FDA,FDA-2005-N-0464,Tab 4: Profile of the Prescription drug wholesaling Industry: Examination of Entities Defining Supply and Demand in Drug Distribution - Final Report dated on 02/12/2001,Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-08-15T14:24:05Z,,0,0,0900006480450bfa
FDA-2005-N-0464-0240,FDA,FDA-2005-N-0464,Tab 2: Letter from FDA/CDER to Eugene S. Peiser & Associates Dated on 08/25/1997,Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-08-15T14:16:37Z,,0,0,0900006480450bf8
FDA-2005-N-0464-0239,FDA,FDA-2005-N-0464,Tab 1: Letter from National Association of CHAIN DRUG STORES(NACDS) to FDA/CDER on 09/27/2004,Supporting & Related Material,Background Material,2017-01-09T05:00:00Z,2017,1,,,2017-08-15T14:13:32Z,,0,0,0900006480450bfc
FDA-2005-N-0464-0238,FDA,FDA-2005-N-0464,"Requirements for Foreign and Domestic Establishment Registration
and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction",Rule,Final Rule,2016-12-13T05:00:00Z,2016,12,2016-12-13T05:00:00Z,,2016-12-13T14:31:48Z,2016-29774,0,0,09000064823fed93
FDA-2005-N-0464-0235,FDA,FDA-2005-N-0464,"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that Are Regulated Under a Biologics License Application, and Animal Drugs",Supporting & Related Material,Background Material,2016-08-31T04:00:00Z,2016,8,,,2016-08-31T14:33:56Z,,0,0,09000064821b7bb5
FDA-2005-N-0464-0237,FDA,FDA-2005-N-0464,"Ref2_ERG Revisions 1995 DRAFT FINAL REPORT ECONOMIC THRESHOLD AND REGULATORY FLEXIBILITY ASSESSMENT OF PROPOSED CHANGES TO THE CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS FOR MANUFACTURING, PROCESSING, PACKING, OR HOLDING DRUGS
(21CFR210&211) re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under",Supporting & Related Material,Background Material,2016-08-31T04:00:00Z,2016,8,,,2016-08-31T14:37:59Z,,0,0,09000064821b7bb7
FDA-2005-N-0464-0236,FDA,FDA-2005-N-0464,"Ref1_BLS_wages_May_2014_NAICS325400 - Pharmaceutical and Medicine Manufacturing re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs",Supporting & Related Material,Background Material,2016-08-31T04:00:00Z,2016,8,,,2016-08-31T14:36:09Z,,0,0,09000064821b7bb6
FDA-2005-N-0464-0234,FDA,FDA-2005-N-0464,"Requirements for Foreign and Domestic Establishment Registration
and Listing for Human Drugs, Including Drugs That Are Regulated
Under a Biologics License Application, and Animal Drugs",Rule,Final Rule,2016-08-31T04:00:00Z,2016,8,2016-08-31T04:00:00Z,,2016-08-31T14:21:07Z,2016-20471,0,0,09000064821b68af
FDA-2005-N-0464-0232,FDA,FDA-2005-N-0464,Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability,Notice,NAD-Notice of Availability of Data,2009-06-01T04:00:00Z,2009,6,2009-06-01T04:00:00Z,2009-06-02T03:59:59Z,2010-08-13T15:19:06Z,E9-12743,0,0,09000064809c1db8
FDA-2005-N-0464-0231,FDA,FDA-2005-N-0464,Guideline re Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability,Other,Guidance,2009-06-01T04:00:00Z,2009,6,2009-06-01T04:00:00Z,,2016-12-08T18:55:55Z,,0,0,09000064809c15da
FDA-2005-N-0464-0230,FDA,FDA-2005-N-0464,Notice of Availability of Data re Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing; Availability,Notice,Notice of Availability,2009-06-01T04:00:00Z,2009,6,2009-06-01T04:00:00Z,2009-06-02T03:59:59Z,2020-10-10T01:01:27Z,E9-12743,0,0,09000064809c0c71
FDA-2005-N-0464-0233,FDA,FDA-2005-N-0464,Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing,Other,Guidance,2009-05-28T04:00:00Z,2009,5,2009-05-28T04:00:00Z,,2020-10-10T01:01:01Z,,0,0,09000064809c1ad2
FDA-2005-N-0464-0229,FDA,FDA-2005-N-0464,Compressed Gas Association - Supplement Comment [re FDA-2005-N-0464-0080.1],Other,SUP-Supplement,2009-04-16T04:00:00Z,2009,4,2009-04-16T04:00:00Z,,2014-12-16T22:17:42Z,,0,0,090000648095560b
FDA-2005-N-0464-0222,FDA,FDA-2005-N-0464,"Hospira Inc. - ""The Proposed Changes to NDC System Legacy NDC Numbers and Compliance "" (Thomas F. Willer) - Testimony",Other,TS-Testimony,2009-04-15T04:00:00Z,2009,4,2009-04-15T04:00:00Z,,2017-01-18T17:36:54Z,,0,0,0900006480450c46
FDA-2005-N-0464-0223,FDA,FDA-2005-N-0464,"Perrigo - ""Experience with NDC Numbers"" - Testimony",Other,TS-Testimony,2009-04-15T04:00:00Z,2009,4,2009-04-15T04:00:00Z,,2017-01-18T17:38:31Z,,0,0,0900006480450c48
FDA-2005-N-0464-0224,FDA,FDA-2005-N-0464,"Consumer Healthcare Products Association (CHPA) - """"FDA Public Meeting – Proposed Changes to the National Drug Code (NDC) Number System"" (Paul J. Larsen) - Testimony",Other,TS-Testimony,2009-04-15T04:00:00Z,2009,4,2009-04-15T04:00:00Z,,2017-01-18T17:40:20Z,,0,0,0900006480450c4a
FDA-2005-N-0464-0226,FDA,FDA-2005-N-0464,"Guidance for Industry Providing Regulatory Submissions in Electronic
Format -Drug Establishment Registration and Drug Listing",Other,GDL-Guidance (Supporting and Related Materials),2009-04-15T04:00:00Z,2009,4,2009-04-15T04:00:00Z,,2019-10-17T19:56:23Z,,0,0,0900006480667d76
FDA-2005-N-0464-0225,FDA,FDA-2005-N-0464,"AABB - ""National Drug Codes for HCT/Ps"" (M. Allene Carr-Greer) - Testimony",Other,TS-Testimony,2009-04-15T04:00:00Z,2009,4,2009-04-15T04:00:00Z,,2017-01-18T17:41:41Z,,0,0,0900006480450c4f
FDA-2005-N-0464-0220,FDA,FDA-2005-N-0464,Notice re Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing,Notice,General Notice,2008-10-23T04:00:00Z,2008,10,,,2016-12-08T19:05:18Z,E8-25338,0,0,090000648077419a
FDA-2005-N-0464-0150,FDA,FDA-2005-N-0464,Shipping Label re Comment from Bristol-Myers Squibb Company,Supporting & Related Material,Transmittals,2008-09-12T04:00:00Z,2008,9,,,2016-11-17T18:18:40Z,,0,0,0900006480450d18
FDA-2005-N-0464-0073,FDA,FDA-2005-N-0464,Background Material re The Compressed Gas Assaciation (CCA) and the Gases and Welding Distributors Association (GAWDA),Supporting & Related Material,Background Material,2008-09-10T04:00:00Z,2008,9,,,2017-08-14T19:23:12Z,,0,0,0900006480450c6f
FDA-2005-N-0464-0030,FDA,FDA-2005-N-0464,Request Extension of Comment Period from Compressed Gas Association,Other,EXT-Request for Extension Comment Due Date,2008-09-09T04:00:00Z,2008,9,2006-08-23T04:00:00Z,2006-11-28T04:59:59Z,2017-07-21T16:15:19Z,,0,0,0900006480450c0c
FDA-2005-N-0464-0034,FDA,FDA-2005-N-0464,Request for Extension re Comment from L. Perrigo Company,Other,Request for Extension,2008-09-09T04:00:00Z,2008,9,2006-08-23T04:00:00Z,2006-11-28T04:59:59Z,2016-12-13T20:38:04Z,,0,0,0900006480450c13
FDA-2005-N-0464-0033,FDA,FDA-2005-N-0464,Request for Extension re Comment from Consumer Healthcare Products Association (CHPA),Other,Request for Extension,2008-09-09T04:00:00Z,2008,9,2006-08-23T04:00:00Z,2006-11-28T04:59:59Z,2017-08-14T20:26:17Z,,0,0,0900006480450c12
FDA-2005-N-0464-0022,FDA,FDA-2005-N-0464,Notice of Data Availability re Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing; Availability,Notice,Notice of Data Availability,2008-07-11T04:00:00Z,2008,7,2008-07-11T04:00:00Z,2008-09-10T03:59:59Z,2024-11-12T04:16:53Z,E8-15801,1,0,090000648066791e
FDA-2005-N-0464-0021,FDA,FDA-2005-N-0464,"Notice of Extension re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; ReOpening of Comment Period",Proposed Rule,Extension of Comment Period,2007-02-08T05:00:00Z,2007,2,2007-02-07T05:00:00Z,2007-02-27T04:59:59Z,2016-11-10T15:32:42Z,,0,0,0900006480450d0d
FDA-2005-N-0464-0020,FDA,FDA-2005-N-0464,Letter from FDA/CDER Response to National Committee on Vital,Other,Letter(s),2007-01-29T05:00:00Z,2007,1,,,2016-12-13T21:15:43Z,,0,0,0900006480450ca3
FDA-2005-N-0464-0015,FDA,FDA-2005-N-0464,See FDA-2005-N-0464-0014,Supporting & Related Material,TR-Transcript,2007-01-12T05:00:00Z,2007,1,,,2009-04-15T23:58:47Z,,0,0,0900006480450c43
FDA-2005-N-0464-0014,FDA,FDA-2005-N-0464,"Transcript of Public Meeting:  Proposed Changes to the National Drug Code (NDC) System, December 11, 2006",Other,TR-Transcript,2007-01-12T05:00:00Z,2007,1,,,2017-07-24T15:11:28Z,,0,0,0900006480450c42
FDA-2005-N-0464-0016,FDA,FDA-2005-N-0464,"FDA/CDER - ""Proposed Revised 21 CFR 207 Electronic Drug Registration and Listing Systems (e-DRLS)"" - Testimony",Other,TS-Testimony,2007-01-12T05:00:00Z,2007,1,,,2017-01-18T17:37:35Z,,0,0,0900006480450c44
FDA-2005-N-0464-0017,FDA,FDA-2005-N-0464,Testimony re FDA-2005-N-0464-0016,Supporting & Related Material,Testimony,2007-01-12T05:00:00Z,2007,1,,,2016-12-13T20:44:03Z,,0,0,0900006480450c45
FDA-2005-N-0464-0008,FDA,FDA-2005-N-0464,"Notice of Extension re Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs; Public Meeting; Extension of Comment Period",Proposed Rule,Extension of Comment Period,2006-10-31T05:00:00Z,2006,10,2006-10-30T05:00:00Z,2007-01-27T04:59:59Z,2016-12-19T17:17:44Z,,0,0,0900006480450c15
FDA-2005-N-0464-0006,FDA,FDA-2005-N-0464,"REF 1 - OMB Changes re The September 30, 1993, Executive Order 12866 (E.O.) --Regulatory Planning and Review sets forth the Administration's principles and requirements for the Federal regulatory process",Supporting & Related Material,REF-Reference (internal unless indicated),2006-09-08T04:00:00Z,2006,9,,,2017-07-24T14:15:25Z,,0,0,0900006480450c08
FDA-2005-N-0464-0005,FDA,FDA-2005-N-0464,"REF 1 - OMB Changes re The September 30, 1993, Executive Order 12866 (E.O.) --Regulatory Planning and Review sets forth the Administration's principles and requirements for the Federal regulatory process",Supporting & Related Material,REF-Reference (internal unless indicated),2006-09-08T04:00:00Z,2006,9,,,2017-07-24T14:17:07Z,,0,0,0900006480450c07
FDA-2005-N-0464-0007,FDA,FDA-2005-N-0464,"REF 1 - OMB Changes re The September 30, 1993, Executive Order 12866 (E.O.) --Regulatory Planning and Review sets forth the Administration's principles and requirements for the Federal regulatory process",Supporting & Related Material,REF-Reference (internal unless indicated),2006-09-08T04:00:00Z,2006,9,,,2017-07-24T14:12:42Z,,0,0,0900006480450c09
FDA-2005-N-0464-0002,FDA,FDA-2005-N-0464,"Proposed rule on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Pages 201-300)",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2006-08-23T04:00:00Z,2006,8,2006-08-23T04:00:00Z,2006-11-28T04:59:59Z,2017-08-15T14:33:55Z,,0,0,0900006480450bee
FDA-2005-N-0464-0001,FDA,FDA-2005-N-0464,"Proposed rule on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Pages 301-319)",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2006-08-23T04:00:00Z,2006,8,2006-08-23T04:00:00Z,2006-11-28T04:59:59Z,2017-08-15T14:32:51Z,,0,0,0900006480450bce
FDA-2005-N-0464-0003,FDA,FDA-2005-N-0464,"Proposed rule on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Pages 1-100)",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2006-08-23T04:00:00Z,2006,8,2006-08-23T04:00:00Z,2006-11-28T04:59:59Z,2017-08-15T14:35:39Z,,0,0,0900006480450bf2
FDA-2005-N-0464-0004,FDA,FDA-2005-N-0464,"Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Pages 101-200)",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2006-08-23T04:00:00Z,2006,8,2006-08-23T04:00:00Z,2006-11-28T04:59:59Z,2016-03-14T19:19:42Z,,0,0,0900006480450bf3