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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

comment_end_date
A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
comment_start_date
A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)

7,453 rows where agency_id = "FDA" and posted_year = 2013 sorted by posted_date descending

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document_type 5

  • Other 6,331
  • Notice 718
  • Supporting & Related Material 222
  • Proposed Rule 107
  • Rule 75

posted_year 1

  • 2013 · 7,453 ✖

agency_id 1

  • FDA · 7,453 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-V-1596-0001 FDA Laser Light Show FDA-2013-V-1596 Duality- Application for Variance Other Application for Variance (VAR) 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z   2013-12-31T18:19:11Z   0 0 09000064814b23ab
FDA-1979-N-0409-0001 FDA Blood & Blood Components Error & Accident Reports - CLOSED FDA-1979-N-0409 Blood and Blood Components; Error and Accident Reports - Notice of Proposed Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z 1980-11-07T04:59:59Z 2014-05-08T14:18:07Z   0 0 090000648055636a
FDA-1979-N-0409-0003 FDA Blood & Blood Components Error & Accident Reports - CLOSED FDA-1979-N-0409 Regulatory Analysis Assessment for Proposed Rule Making for Blood and Blood Components Concerning Error and Accident Reports - Regulatory Analysis Supporting & Related Material Regulatory Analysis 2013-12-31T05:00:00Z 2013 12     2013-12-31T15:35:10Z   0 0 09000064814e3e84
FDA-2011-N-0922-0017 FDA Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food For Animals FDA-2011-N-0922 Request for Extension from American Feed Industry Association Other Request for Extension 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z   2013-12-31T19:44:06Z   0 0 0900006481492bbf
FDA-1979-N-0409-0002 FDA Blood & Blood Components Error & Accident Reports - CLOSED FDA-1979-N-0409 Regulatory Analysis Assessment for Proposed Rule Making for Blood and Blood Components Concerning Error and Accident Reports - Regulatory Analysis Supporting & Related Material Regulatory Analysis 2013-12-31T05:00:00Z 2013 12     2013-12-31T15:28:51Z   0 0 0900006480556369
FDA-2013-V-1595-0001 FDA Laser Light Show FDA-2013-V-1595 Create Nightclub - Application for Variance Other Application for Variance (VAR) 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z   2013-12-31T18:24:52Z   0 0 09000064814b34bd
FDA-1979-N-0028-0035 FDA Lakes of Color Additives FDA-1979-N-0028 Supplement from Colorcon Supporting & Related Material Supplement 2013-12-31T05:00:00Z 2013 12     2014-05-14T14:37:03Z   0 0 0900006480553999
FDA-1979-N-0028-0036 FDA Lakes of Color Additives FDA-1979-N-0028 Letter from SunChemical Corporation to FDA Dated March 20 1997 Other Letter(s) 2013-12-31T05:00:00Z 2013 12 1998-04-15T04:00:00Z   2015-04-01T19:48:32Z   0 0 090000648055399b
FDA-1979-N-0409-0020 FDA Blood & Blood Components Error & Accident Reports - CLOSED FDA-1979-N-0409 Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent Notice Notice of Intent 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z 1991-10-29T04:59:59Z 2014-05-09T14:38:20Z   0 0 090000648055637d
FDA-2013-V-1596-0002 FDA Laser Light Show FDA-2013-V-1596 Acknowledgement Letter to Duality Other Acknowledgement Letter/Receipt 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z   2013-12-31T18:19:19Z   0 0 09000064814b34bb
FDA-2013-V-1595-0002 FDA Laser Light Show FDA-2013-V-1595 Acknowledgement Letter to Create Nightclub Other Acknowledgement Letter/Receipt 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z   2013-12-31T18:25:02Z   0 0 09000064814b34bf
FDA-1979-N-0409-0021 FDA Blood & Blood Components Error & Accident Reports - CLOSED FDA-1979-N-0409 Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal Notice Withdrawal 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z   2014-05-09T14:38:40Z   0 0 090000648055637e
FDA-2013-N-1317-0092 FDA Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information FDA-2013-N-1317 Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information; Extension of Comment Period Notice Extension of Comment Period 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z 2014-03-09T04:59:59Z 2015-06-20T01:30:52Z 2013-31294 0 0 09000064814e42b9
FDA-2013-N-1634-0001 FDA Request for Notification from Industry Organizations Interested in Participating in Selection Process for a Nonvoting Industry Representative on the Food Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Food Advisory Committee FDA-2013-N-1634 Request for Notification From Industry Organizations Interested in Participating in Selection Process for a Nonvoting Industry Representative on the Food Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Food Advisory Committee Notice General Notice 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z   2014-01-02T14:51:51Z 2013-31321 0 0 09000064814e428c
FDA-2013-N-0001-0120 FDA Advisory Committee, Workshops & Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc) FDA-2013-N-0001 Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting Notice Meeting 2013-12-31T05:00:00Z 2013 12 2013-12-31T05:00:00Z   2014-01-02T15:01:22Z 2013-31320 0 0 09000064814e431a
FDA-2013-V-1607-0001 FDA Laser Light Show FDA-2013-V-1607 DJ Leo Entertainment - Application for Variance Other Application for Variance (VAR) 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T15:50:09Z   0 0 09000064814baabb
FDA-2013-V-1608-0002 FDA Laser Light Show FDA-2013-V-1608 Acknowledgement Letter to Nu-Salt Other Acknowledgement Letter/Receipt 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T15:10:14Z   0 0 09000064814ba667
FDA-1980-N-0149-0002 FDA Platelet Concentrate & Cryoprecipitated Anthihemophilic - CLOSED FDA-1980-N-0149 Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent Notice Notice of Intent 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z 1991-10-29T04:59:59Z 2014-05-08T12:59:27Z   0 0 09000064805bcf63
FDA-1979-N-0309-0003 FDA Antihemophilic Factor (Human) - CLOSED FDA-1979-N-0309 Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal Notice Withdrawal 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2014-05-12T14:04:10Z   0 0 09000064805551a5
FDA-1980-N-0149-0003 FDA Platelet Concentrate & Cryoprecipitated Anthihemophilic - CLOSED FDA-1980-N-0149 Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal Notice Withdrawal 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2014-05-08T13:00:01Z   0 0 09000064805bcf64
FDA-2013-P-1611-0002 FDA Amend two Regulations Within The Code of Federal Regulations, Title 21 - Food and Drugs, Chapter 1, Supchapter H- Medical Devices, Part 872- Dental Devices (Subpart D-Prosthetic Devices 872.3690 - Tooth Shade Resin Material and Subpart G-Miscellaneous Devices 872.6070 - Ultraviolet Activator for Polymerization) to Include Special Controls Guidance FDA-2013-P-1611 Acknowledgement Letter to Clarissa Clarke Other Acknowledgement Letter/Receipt 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2024-07-25T12:19:07Z   0 0 09000064814ba8c7
FDA-2013-N-1676-0001 FDA International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Tapentadol; N-benzylpiperazine (BZP); gamma-Butyrolactone (GBL); 1,4-Butanediol (I,4 BD); (1-pentyl-1H-indol-3-yl)-1-naphthalenyl-methanone (JWH-018); (1-butyl-1H-indol-3-yl)-1-naphthalenyl-methanone (JWH-073); [1-(5-fluoropentyl)-1H-indol-3-yl]-1-naphthalenyl-methanone; Request for Comments FDA-2013-N-1676 International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Tapentadol; Tramadol; Ketamine; gamma-Butyrolactone; 22 Additional Substances; Request for Comments Notice Request for Comments 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z 2014-01-30T04:59:59Z 2024-11-07T23:00:25Z 2013-31212 1 0 09000064814e192b
FDA-2013-V-1599-0001 FDA Laser Light Show FDA-2013-V-1599 The Living Room - Application for Variance Other Application for Variance (VAR) 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T14:58:50Z   0 0 09000064814b6fb0
FDA-2013-V-1599-0002 FDA Laser Light Show FDA-2013-V-1599 Acknowledgement Letter to The Living Room Other Acknowledgement Letter/Receipt 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T14:58:51Z   0 0 09000064814b6ff2
FDA-2013-N-0002-0045 FDA NADA/ANADA Notices FDA-2013-N-0002 New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction Rule Correction 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T15:28:01Z 2013-31184 0 0 09000064814e1974
FDA-1979-N-0307-0001 FDA Allergenic Extract Labeling - CLOSED FDA-1979-N-0307 Allergenic Products; Proposed Testing and Labeling Requirements; Proposed Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z 1980-07-02T03:59:59Z 2014-06-18T16:36:34Z   0 0 090000648055517f
FDA-1979-N-0028-0014 FDA Lakes of Color Additives FDA-1979-N-0028 Comment from Colorcon, Inc. re FDA-1979-N-0028-0040 Supporting & Related Material Background Material 2013-12-30T05:00:00Z 2013 12     2015-02-13T18:50:40Z   0 0 0900006480553968
FDA-1979-N-0084-0002 FDA Food Labeling; Net Weight Labeling Requirements-CLOSED FDA-1979-N-0084 Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent Notice Notice of Intent 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z 1991-10-29T04:59:59Z 2014-05-12T18:35:27Z   0 0 0900006480553e83
FDA-1979-N-0309-0001 FDA Antihemophilic Factor (Human) - CLOSED FDA-1979-N-0309 Additional Standards for Human Blood Products; Antihemophillic Factor (Human) - Notice of Proposed Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2014-05-13T14:33:51Z   0 0 090000648055519b
FDA-1979-N-0084-0001 FDA Food Labeling; Net Weight Labeling Requirements-CLOSED FDA-1979-N-0084 Food Labeling; Net Weight Labeling Requirements - Notice of Proposed Rule Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z 1980-11-07T04:59:59Z 2014-05-12T18:31:25Z   0 0 0900006480553e82
FDA-2012-N-1239-0004 FDA Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis - CLOSED FDA-2012-N-1239 Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis Rule Final Rule 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T15:21:52Z 2013-31217 0 0 09000064814e1b8c
FDA-2013-V-1607-0002 FDA Laser Light Show FDA-2013-V-1607 Acknowledgement Letter to DJ Leo Entertainment Other Acknowledgement Letter/Receipt 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T15:50:09Z   0 0 09000064814baabd
FDA-2013-V-1608-0001 FDA Laser Light Show FDA-2013-V-1608 Nu-Salt - Application for Variance Other Application for Variance (VAR) 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T15:10:13Z   0 0 09000064814ba665
FDA-2013-N-0581-0002 FDA Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation - CLOSED FDA-2013-N-0581 Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non- Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation Rule Final Rule 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T14:52:49Z 2013-31218 0 0 09000064814e1976
FDA-2013-P-1609-0001 FDA Determine Whether the two-Vial Container Closure System That was Previously Used to Package the Following Lupron Depot (Leuprolide Acetate for Depot Suspension) Injection Drug Products was Voluntarily Withdrawn From Sale for Safety or Efficacy FDA-2013-P-1609 Lachman Consultant Services, Inc. - Citizen Petition Other Citizen Petition 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2024-11-07T22:59:08Z   1 0 09000064814ba5ba
FDA-2013-N-1155-0002 FDA Food Labeling Regulations FDA-2013-N-1155 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations Notice General Notice 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z 2014-01-30T04:59:59Z 2014-01-25T02:04:00Z 2013-31215 0 0 09000064814e19fd
FDA-2013-N-0001-0119 FDA Advisory Committee, Workshops & Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc) FDA-2013-N-0001 Strategies To Address Hemolytic Complications of Immune Globulin Infusions; Public Workshop Notice Public Meetings 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T14:17:54Z 2013-31213 0 0 09000064814e18f0
FDA-2013-P-1623-0001 FDA Refuse to Receive any ANDA for Asenapine Maleate Sublingual Tablets That Does not Contain the Results of a Bioequivalence Study Performed; Requests That the Fling Acceptance Date of any ANDA for Asenapine Sublingual Tablets be Based on the Date That the Application First Contained the Results of a Bioequivalence Study FDA-2013-P-1623 Sigmapharm Laboratories, LLC - Citizen Petition Other Citizen Petition 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2019-07-08T13:35:40Z   0 0 09000064814bd194
FDA-2013-N-0487-0004 FDA Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina That Is Refractory to Optimal Antianginal Medical Therapy and Without Options for Revascularization; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses - CLOSED FDA-2013-N-0487 Cardiovascular Devices; Reclassification of External Counter- Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter- Pulsating Devices for Other Specified Intended Uses Rule Final Rule 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T14:58:02Z 2013-31216 0 0 09000064814e1adf
FDA-1979-N-0307-0003 FDA Allergenic Extract Labeling - CLOSED FDA-1979-N-0307 Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Withdrawal of Proposed Rule Notice Withdrawal 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T18:42:25Z   0 0 0900006480555185
FDA-1979-N-0309-0011 FDA Antihemophilic Factor (Human) - CLOSED FDA-1979-N-0309 Background Material Items 4 and 5; Appendices I through V Supporting & Related Material Background Material 2013-12-30T05:00:00Z 2013 12     2014-05-12T15:05:06Z   0 0 0900006480555199
FDA-1979-N-0309-0012 FDA Antihemophilic Factor (Human) - CLOSED FDA-1979-N-0309 Background Material items 1 and 2 Supporting & Related Material Environmental Impact Analysis Report 2013-12-30T05:00:00Z 2013 12     2014-05-12T15:18:55Z   0 0 0900006480555198
FDA-1979-N-0309-0010 FDA Antihemophilic Factor (Human) - CLOSED FDA-1979-N-0309 Background Material Items 2 and 3 Supporting & Related Material Regulatory Analysis 2013-12-30T05:00:00Z 2013 12     2014-05-12T14:42:31Z   0 0 090000648055519a
FDA-1979-N-0307-0004 FDA Allergenic Extract Labeling - CLOSED FDA-1979-N-0307 Regulatory Analysis Assessment for Proposed Rule Making Concerning Allergenic Products - Regulatory Assessment Supporting & Related Material Regulatory Analysis 2013-12-30T05:00:00Z 2013 12     2014-05-14T13:06:09Z   0 0 090000648055517d
FDA-2013-P-1623-0002 FDA Refuse to Receive any ANDA for Asenapine Maleate Sublingual Tablets That Does not Contain the Results of a Bioequivalence Study Performed; Requests That the Fling Acceptance Date of any ANDA for Asenapine Sublingual Tablets be Based on the Date That the Application First Contained the Results of a Bioequivalence Study FDA-2013-P-1623 Acknowledgement Letter to Sigmapharm Laboratories LLC Other Acknowledgement Letter/Receipt 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T16:12:16Z   0 0 09000064814bd198
FDA-1980-N-0149-0009 FDA Platelet Concentrate & Cryoprecipitated Anthihemophilic - CLOSED FDA-1980-N-0149 Proposed Rule - Quality Control Testing of Platelet Concentrate (Human) and Cryoprecipitated Antihemophilic Factor (Human) - Regulatory Analysis Assessment Supporting & Related Material Regulatory Analysis 2013-12-30T05:00:00Z 2013 12     2013-12-30T18:35:48Z   0 0 09000064805bcf5c
FDA-2013-N-1425-0003 FDA Focused Mitigation Strategies to Protect Food Against Intentional Adulteration FDA-2013-N-1425 List of References From PRIA Reference 65 Other List (LST) 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T14:09:49Z   0 0 09000064814e179f
FDA-1979-N-0307-0002 FDA Allergenic Extract Labeling - CLOSED FDA-1979-N-0307 Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent Notice Notice of Intent 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z 1991-10-29T04:59:59Z 2013-12-30T18:42:24Z   0 0 0900006480555184
FDA-1980-N-0149-0001 FDA Platelet Concentrate & Cryoprecipitated Anthihemophilic - CLOSED FDA-1980-N-0149 Withdrawal of Certain Pre-1986 Proposed Rules - Notice of Proposed Rulemaking Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2014-05-08T12:45:51Z   0 0 09000064805bcf5d
FDA-2013-P-1609-0002 FDA Determine Whether the two-Vial Container Closure System That was Previously Used to Package the Following Lupron Depot (Leuprolide Acetate for Depot Suspension) Injection Drug Products was Voluntarily Withdrawn From Sale for Safety or Efficacy FDA-2013-P-1609 Acknowledgement Letter to Lachman Consultant Services, Inc. Other Citizen Petition 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2013-12-30T16:00:10Z   0 0 09000064814ba662
FDA-1979-N-0084-0004 FDA Food Labeling; Net Weight Labeling Requirements-CLOSED FDA-1979-N-0084 Memorandum from FDA CFSAN to DDM Other Memorandum 2013-12-30T05:00:00Z 2013 12     2014-05-12T18:38:57Z   0 0 0900006480553e85
FDA-1979-N-0084-0003 FDA Food Labeling; Net Weight Labeling Requirements-CLOSED FDA-1979-N-0084 Food Labeling; Net Weight Labeling Requirements - Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Notice of Withdrawal Notice Withdrawal 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2014-05-12T18:35:45Z   0 0 0900006480553e84
FDA-1979-N-0309-0002 FDA Antihemophilic Factor (Human) - CLOSED FDA-1979-N-0309 Withdrawal of Certain Pre-1986 Proposed Rules; Opportunity for Public Comment - Notice of Intent Notice Notice of Intent 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z 1991-10-29T04:59:59Z 2014-05-12T14:03:52Z   0 0 09000064805551a4
FDA-2013-P-1611-0001 FDA Amend two Regulations Within The Code of Federal Regulations, Title 21 - Food and Drugs, Chapter 1, Supchapter H- Medical Devices, Part 872- Dental Devices (Subpart D-Prosthetic Devices 872.3690 - Tooth Shade Resin Material and Subpart G-Miscellaneous Devices 872.6070 - Ultraviolet Activator for Polymerization) to Include Special Controls Guidance FDA-2013-P-1611 Citizen Petition from Clarissa Clarke Other Citizen Petition 2013-12-30T05:00:00Z 2013 12 2013-12-30T05:00:00Z   2024-07-25T12:18:51Z   0 0 09000064814ba6d2
FDA-1977-N-0005-0367 FDA New Animal Drugs for use in Animal Feeds FDA-1977-N-0005 FDA/Office of Legislative Affairs to Hess & Clark, Inc. - Answer Other Answer 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z   2013-12-27T15:16:38Z   0 0 09000064805d7d65
FDA-2013-N-0002-0049 FDA NADA/ANADA Notices FDA-2013-N-0002 Approvals of New Animal Drug Applications Withdrawals Roxarsone Rule Final Rule 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z   2014-01-25T23:25:40Z 2013-30837 0 0 09000064814de405
FDA-2013-N-0002-0044 FDA NADA/ANADA Notices FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Roxarsone Rule Final Rule 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z   2013-12-27T15:39:48Z 2013-30838 0 0 09000064814de527
FDA-2011-P-0438-0006 FDA Ban the marketing of, and recall Bedside Assistant® bed handles manufactured by Bed Handles Inc, models BA10W and A10W-6 FDA-2011-P-0438 FDA/CDRH Response to Public Citizen Health Research Group - Partial Petition Approval and Denial Other Partial Petition Approval and Denial 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z   2013-12-27T12:55:24Z   0 0 09000064814ddf89
FDA-2013-N-0500-0006 FDA Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products FDA-2013-N-0500 Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period Proposed Rule Extension of Comment Period 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z 2014-03-14T03:59:59Z 2014-04-10T01:02:03Z 2013-30881 0 0 09000064814debad
FDA-1977-N-0005-0357 FDA New Animal Drugs for use in Animal Feeds FDA-1977-N-0005 Definitions and General Considerations; Revised Procedures re Medicated Feed Applications - Notice of Extension of Comment Period Notice Notice of Extension 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z 1981-07-09T03:59:59Z 2013-12-27T14:11:12Z   0 0 09000064805d7b84
FDA-2013-N-1147-0002 FDA Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition FDA-2013-N-1147 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition Notice General Notice 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z 2014-01-28T04:59:59Z 2013-12-27T15:48:56Z 2013-30998 0 0 09000064814de952
FDA-2011-N-0179-0019 FDA Information Required in Prior Notice of Imported Food FDA-2011-N-0179 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Notice General Notice 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z 2014-01-28T04:59:59Z 2014-04-04T17:00:53Z 2013-30996 0 0 09000064814deaed
FDA-2013-N-1558-0001 FDA Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products re FDA-2010-D-0635 FDA-2013-N-1558 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products Notice 60 Day Proposed Information Collection 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z 2014-02-26T04:59:59Z 2015-02-14T00:29:34Z 2013-30880 0 0 09000064814debdd
FDA-1977-N-0005-0385 FDA New Animal Drugs for use in Animal Feeds FDA-1977-N-0005 FDA/Office of Legislative Affairs to Cooper Evans - Answer Other Answer 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z   2013-12-27T16:52:54Z   0 0 09000064805d7d66
FDA-1977-N-0005-0366 FDA New Animal Drugs for use in Animal Feeds FDA-1977-N-0005 Department of Health & Human Services, Public Health Service, Region 5 - Letter Other Letter(s) 2013-12-27T05:00:00Z 2013 12 2013-12-27T05:00:00Z   2013-12-27T15:11:24Z   0 0 09000064805d7b8f
FDA-2013-N-1620-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Community FDA-2013-N-1620 Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Community Notice General Notice 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z 2014-02-25T04:59:59Z 2024-11-07T23:00:22Z 2013-30804 1 0 09000064814dcb64
FDA-2013-M-1605-0001 FDA Premarket Approval FDA-2013-M-1605 Premarket Approval of W.L. Gore and Associates, Inc. P130006 Other Approval 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T15:12:16Z   0 0 09000064814dab0f
FDA-2013-E-1694-0002 FDA Patent Extension Application for TriVascular Ovation Abdominal Stent Graft System, Patent No. 6,395,019 FDA-2013-E-1694 TriVascular, Inc. - Patent Term Application Other Application 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T17:49:36Z   0 0 09000064814dd643
FDA-2013-E-1694-0001 FDA Patent Extension Application for TriVascular Ovation Abdominal Stent Graft System, Patent No. 6,395,019 FDA-2013-E-1694 U.S. Patant and Trademark Office - Letter Other Letter(s) 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T17:49:28Z   0 0 09000064814dd644
FDA-2013-E-1691-0001 FDA Patent Extension Application for KADCYLA™ Patent No. 8,337,856 FDA-2013-E-1691 U.S.. Patatent and Trademark Office - Letter Other Letter(s) 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T14:10:36Z   0 0 09000064814dc7e9
FDA-2013-D-1566-0002 FDA Naming of Drug Products Containing Salt Drug Substances FDA-2013-D-1566 Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances Other Guidance 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2024-11-07T23:00:18Z   1 0 09000064814dcd46
FDA-2013-N-0001-0118 FDA Advisory Committee, Workshops & Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc) FDA-2013-N-0001 Allergenic Products Advisory Committee; Notice of Meeting Notice Meeting 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T14:51:40Z 2013-30799 0 0 09000064814dc88e
FDA-2013-E-1692-0001 FDA Patent Extension Application for KADCYLA™ Patent No. 7,097,840 FDA-2013-E-1692 U.S. Patent and Trademark Office - Letter Other Letter(s) 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T14:45:07Z   0 0 09000064814dc7ee
FDA-2013-E-0296-0003 FDA Patent Extension Application for COFLEX U.S. Patent No. 5,645,599 FDA-2013-E-0296 U.S. Patent and Trademark Office - Letter Other Letter(s) 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T15:48:59Z   0 0 09000064814dcd48
FDA-2013-N-1618-0001 FDA Draft Prescription Drug User Fee Act V Information Technology Plan FDA-2013-N-1618 Draft Prescription Drug User Fee Act V Information Technology Plan; Availability for Comment Notice General Notice 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z 2014-02-25T04:59:59Z 2024-11-07T23:00:00Z 2013-30818 1 0 09000064814dc9f4
FDA-1977-N-0005-0329 FDA New Animal Drugs for use in Animal Feeds FDA-1977-N-0005 FDA/Office of Legislative Affairs to the Honorable Paul Findley - Comment Other Answer 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T18:05:15Z   0 0 09000064805d7d64
FDA-2013-E-1691-0002 FDA Patent Extension Application for KADCYLA™ Patent No. 8,337,856 FDA-2013-E-1691 Morrison & Foerster LLP (on behalf of Genenetech, Inc) - Patent Term Application Other Application 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T14:27:36Z   0 0 09000064814db700
FDA-2013-E-1690-0002 FDA Patent Extension Application for SYNRIBO®, Patent No. 6,987,103 FDA-2013-E-1690 CEPHALON, Inc. - Patent Term Application Other Application 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T13:38:09Z   0 0 09000064814db6fc
FDA-2013-E-1692-0002 FDA Patent Extension Application for KADCYLA™ Patent No. 7,097,840 FDA-2013-E-1692 Morrison & Foerster LLP (on behalf of Genenetech, Inc) - Patent Term Application Other Application 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T14:45:22Z   0 0 09000064814dc7ed
FDA-2013-N-1615-0002 FDA Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment FDA-2013-N-1615 16452 GDUFA IT Plan Supporting & Related Material Background Material 2013-12-26T05:00:00Z 2013 12     2013-12-26T16:58:52Z   0 0 09000064814dd570
FDA-2013-D-1566-0001 FDA Naming of Drug Products Containing Salt Drug Substances FDA-2013-D-1566 Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability Notice Notice of Availability 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z 2014-03-27T03:59:59Z 2014-03-27T01:02:38Z 2013-30800 0 0 09000064814dcb61
FDA-2013-E-1690-0001 FDA Patent Extension Application for SYNRIBO®, Patent No. 6,987,103 FDA-2013-E-1690 U.S. Patent and Trademark Office - Letter Other Letter(s) 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z   2013-12-26T13:38:00Z   0 0 09000064814db6fd
FDA-2013-N-1618-0002 FDA Draft Prescription Drug User Fee Act V Information Technology Plan FDA-2013-N-1618 16451 PDUFA IT Plan Supporting & Related Material Background Material 2013-12-26T05:00:00Z 2013 12     2013-12-26T17:04:34Z   0 0 09000064814dd571
FDA-2013-N-1615-0001 FDA Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment FDA-2013-N-1615 Draft Generic Drug User Fee Act Information Technology Plan; Availability for Comment Notice General Notice 2013-12-26T05:00:00Z 2013 12 2013-12-26T05:00:00Z 2014-02-25T04:59:59Z 2014-02-25T02:03:09Z 2013-31008 0 0 09000064814dcba6
FDA-2013-N-0001-0117 FDA Advisory Committee, Workshops & Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc) FDA-2013-N-0001 Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting Notice Meeting 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T14:55:25Z 2013-30578 0 0 09000064814d558a
FDA-2009-E-0087-0013 FDA Patent Term Extension Application for CONVENIA® (Cefovecin Sodium), U.S. Patent No. 6,020,329 FDA-2009-E-0087 U.S. Patent and Trademark Office to Zoetis - Letter Other Letter(s) 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T13:04:38Z   0 0 09000064814d407b
FDA-2013-V-1559-0002 FDA Laser Light Show FDA-2013-V-1559 Acknowledgement Letter to Coast Digital Solutions, Inc. Other Acknowledgement Letter/Receipt 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T18:13:20Z   0 0 09000064814a5fa4
FDA-2013-N-1563-0001 FDA Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability FDA-2013-N-1563 Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability Proposed Rule Request for Comment 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z 2014-04-01T03:59:59Z 2014-01-01T02:04:13Z 2013-30375 0 0 09000064814d536f
FDA-2013-V-1559-0001 FDA Laser Light Show FDA-2013-V-1559 Coast Digital Solutions, Inc. - Application for Variance Other Application for Variance (VAR) 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T18:13:19Z   0 0 09000064814a5f9f
FDA-2013-E-0682-0004 FDA Patent Term Extension Application for, Zilver-PTX Drug Eluting Peripheral Stent, U.S. Patent No. 5,616,608 FDA-2013-E-0682 U.S. Patent and Trademark Office to Venable LLP - Letter Other Letter(s) 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T13:23:43Z   0 0 09000064814d407d
FDA-2013-N-1496-0001 FDA Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Generic Rapid Response Surveys FDA-2013-N-1496 Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance) Notice General Notice 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z 2014-02-25T04:59:59Z 2013-12-24T15:06:13Z 2013-30630 0 0 09000064814d55d8
FDA-2013-V-1560-0002 FDA Laser Light Show FDA-2013-V-1560 Acknowledgement Letter to Davaine Lighting Other Acknowledgement Letter/Receipt 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T18:19:41Z   0 0 09000064814a5c89
FDA-2013-V-1560-0001 FDA Laser Light Show FDA-2013-V-1560 Davaine Lighting - Application for Variance Other Application for Variance (VAR) 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T18:19:25Z   0 0 09000064814a5c85
FDA-2013-P-0380-0003 FDA Regarding Removal of the Black Box Warning on Package Labeling for the Injectable Contraceptive Depot Medroxyprogesterone Acetate (DMPA) FDA-2013-P-0380 FDA/CDER Interim Response to the University of Florida College of Medicine - Jacksonville and the UNC School of Medicine - Letter Other Letter(s) 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2015-07-07T22:14:36Z   0 0 09000064814414e8
FDA-2011-P-0086-0006 FDA Asking FDA to Adopt and Apply Specific Bioequivalence Requirements in its Review of Proposed Follow-on Version of RISPERDAL® CONSTA® FDA-2011-P-0086 Janssen Research & Development, LLC. - Supplement Other Supplement (SUP) 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T20:07:39Z   0 0 09000064814ba9d1
FDA-2012-N-0284-0009 FDA Pediatric Studies of Sodium Nitroprusside Conducted in Accordance with Section 409 I of the Public Health Service Act-CLOSED FDA-2012-N-0284 FDA CDER Memorandum December 17 2013 re for use of Sodium Nitroprusside to Reduce Blood Pressure in Pediatric Patients Other Memorandum 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T13:59:09Z   0 0 09000064814d51b8
FDA-2013-N-1425-0001 FDA Focused Mitigation Strategies to Protect Food Against Intentional Adulteration FDA-2013-N-1425 Focused Mitigation Strategies To Protect Food Against Intentional Adulteration; Public Meeting on Proposed Rule Proposed Rule Public Meeting 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T15:38:06Z 2013-30372 0 0 09000064814d54bf
FDA-2013-N-0001-0115 FDA Advisory Committee, Workshops & Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc) FDA-2013-N-0001 Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice Meeting 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T14:49:23Z 2013-30579 0 0 09000064814d52cb
FDA-2013-N-1425-0002 FDA Focused Mitigation Strategies to Protect Food Against Intentional Adulteration FDA-2013-N-1425 Focused Mitigation Strategies to Protect Food Against Intentional Adulteration Proposed Rule Notice of Proposed Rulemaking (NPRM) 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z 2014-04-01T03:59:59Z 2014-04-04T01:02:32Z 2013-30373 0 0 09000064814d53fc
FDA-2013-N-0001-0116 FDA Advisory Committee, Workshops & Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc) FDA-2013-N-0001 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice Meeting 2013-12-24T05:00:00Z 2013 12 2013-12-24T05:00:00Z   2013-12-24T14:52:21Z 2013-30580 0 0 09000064814d531a

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    posted_date TEXT,
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CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;
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