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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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718 rows where agency_id = "FDA", document_type = "Notice" and posted_year = 2013 sorted by posted_date descending

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posted_year 1

  • 2013 · 718 ✖

document_type 1

  • Notice · 718 ✖

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  • FDA · 718 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-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-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 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 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 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-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-N-1676-0001 FDA 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-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-2013-N-1155-0002 FDA 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 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-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-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-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-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 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 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 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-2013-N-1620-0001 FDA 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-N-0001-0118 FDA 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-N-1618-0001 FDA 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-2013-D-1566-0001 FDA 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-N-1615-0001 FDA 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 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-2013-N-1496-0001 FDA 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-N-0001-0115 FDA 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-0001-0116 FDA 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
FDA-1997-N-0057-0009 FDA Human Cellular and Tissue-Based Products FDA-1997-N-0057 See FDA-1997-N-0057-0008 Notice Correction 2013-12-23T05:00:00Z 2013 12 2013-12-23T05:00:00Z   2013-12-24T02:03:01Z   0 0 09000064814d1f30
FDA-2013-N-0001-0114 FDA FDA-2013-N-0001 Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel Endpoints for Premium Intraocular Lenses; Public Workshop Notice Meeting 2013-12-19T05:00:00Z 2013 12     2013-12-19T18:54:11Z 2013-30148 0 0 09000064814cb583
FDA-2013-N-0796-0002 FDA FDA-2013-N-0796 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products Notice 30 Day Proposed Information Collection 2013-12-19T05:00:00Z 2013 12 2013-12-19T05:00:00Z   2016-10-28T12:27:02Z 2013-30149 0 0 09000064814cb0ec
FDA-2013-D-0636-0024 FDA FDA-2013-D-0636 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Unique Device Identification System Notice   2013-12-19T05:00:00Z 2013 12     2013-12-19T18:18:35Z 2013-30147 0 0 09000064814cb540
FDA-2013-N-1588-0001 FDA FDA-2013-N-1588 Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, Exemptions From Substantial Equivalence Requirements Notice 60 Day Proposed Information Collection 2013-12-19T05:00:00Z 2013 12 2013-12-19T05:00:00Z 2014-02-19T04:59:59Z 2022-07-25T17:27:30Z 2013-30137 0 0 09000064814cb538
FDA-2008-D-0150-0019 FDA FDA-2008-D-0150 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims Notice Notice of Approval 2013-12-19T05:00:00Z 2013 12 2013-12-19T05:00:00Z   2013-12-19T17:20:33Z 2013-30146 0 0 09000064814cb007
FDA-2013-N-1619-0001 FDA FDA-2013-N-1619 Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Notice 60 Day Proposed Information Collection 2013-12-19T05:00:00Z 2013 12 2013-12-19T05:00:00Z 2014-02-19T04:59:59Z 2024-11-07T23:01:20Z 2013-30185 1 0 09000064814cb57f
FDA-2013-N-1204-0006 FDA FDA-2013-N-1204 Draft Risk Profile on Pathogens and Filth in Spices: Availability; Extension of Comment Period Notice Extension of Comment Period 2013-12-18T05:00:00Z 2013 12 2013-12-18T05:00:00Z 2014-03-04T04:59:59Z 2014-03-07T02:03:54Z 2013-30055 0 0 09000064814c936a
FDA-2010-N-0308-0045 FDA FDA-2010-N-0308 See FDA-2010-N-0308-0046 Notice General Notice 2013-12-18T05:00:00Z 2013 12 2013-12-18T05:00:00Z 2014-03-04T04:59:59Z 2014-03-09T03:44:59Z 2013-30055 0 0 09000064814c8a96
FDA-2010-N-0308-0046 FDA FDA-2010-N-0308 Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program Notice General Notice 2013-12-18T05:00:00Z 2013 12 2013-12-18T05:00:00Z 2014-03-04T04:59:59Z 2014-03-06T21:48:24Z 2013-29822 0 0 09000064814c8999
FDA-2013-N-0001-0113 FDA FDA-2013-N-0001 Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting Notice Meeting 2013-12-17T05:00:00Z 2013 12 2013-12-17T05:00:00Z   2013-12-17T14:24:41Z 2013-29917 0 0 09000064814c48d2
FDA-2013-N-0001-0112 FDA FDA-2013-N-0001 Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting Notice Meeting 2013-12-17T05:00:00Z 2013 12 2013-12-17T05:00:00Z   2013-12-17T14:21:02Z 2013-29933 0 0 09000064814c4854
FDA-2013-N-0001-0111 FDA FDA-2013-N-0001 Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting Notice General Notice 2013-12-17T05:00:00Z 2013 12 2013-12-17T05:00:00Z   2013-12-17T14:17:28Z 2013-29945 0 0 09000064814c478b
FDA-2013-D-0117-0005 FDA FDA-2013-D-0117 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act Notice General Notice 2013-12-16T05:00:00Z 2013 12 2013-12-16T05:00:00Z 2014-01-16T04:59:59Z 2013-12-16T15:33:09Z 2013-29796 0 0 09000064814c1d1f
FDA-2011-D-0889-0156 FDA FDA-2011-D-0889 Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209; Availability Notice Notice of Availability 2013-12-12T05:00:00Z 2013 12 2013-12-12T05:00:00Z   2013-12-12T16:37:47Z 2013-29697 0 0 09000064814b9f8c
FDA-2013-N-1504-0001 FDA FDA-2013-N-1504 Independent Assessment of the Process for the Review of Device Submissions; High Priority Recommendations Notice General Notice 2013-12-12T05:00:00Z 2013 12 2013-12-12T05:00:00Z   2013-12-12T15:04:28Z 2013-29612 0 0 09000064814ba585
FDA-2013-D-0928-0003 FDA FDA-2013-D-0928 Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive Petitions; Reopening of the Comment Period Notice Notice of Availability 2013-12-10T05:00:00Z 2013 12 2013-12-10T05:00:00Z 2014-01-10T04:59:59Z 2014-01-10T02:01:50Z 2013-29392 0 0 09000064814b5b83
FDA-2013-D-1478-0001 FDA FDA-2013-D-1478 Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format Notice 60 Day Proposed Information Collection 2013-12-10T05:00:00Z 2013 12 2013-12-10T05:00:00Z 2014-02-11T04:59:59Z 2013-12-10T14:19:50Z 2013-29393 0 0 09000064814b5a80
FDA-2013-N-1434-0001 FDA FDA-2013-N-1434 Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Availability Notice Notice of Availability 2013-12-10T05:00:00Z 2013 12 2013-12-10T05:00:00Z 2014-03-11T03:59:59Z 2014-04-06T02:24:30Z 2013-29395 0 0 09000064814b5c63
FDA-2013-N-0853-0002 FDA FDA-2013-N-0853 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical DevicesCurrent Good Manufacturing Practice Quality System Regulation Notice 30 Day Proposed Information Collection 2013-12-10T05:00:00Z 2013 12 2013-12-10T05:00:00Z 2014-01-10T04:59:59Z 2013-12-10T15:23:32Z 2013-29394 0 0 09000064814b5b4b
FDA-2013-N-0823-0002 FDA FDA-2013-N-0823 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Over-the-Counter Drugs; Labeling Requirements Notice 30 Day Proposed Information Collection 2013-12-05T05:00:00Z 2013 12 2013-12-05T05:00:00Z 2014-01-07T04:59:59Z 2013-12-08T15:37:58Z 2013-29079 0 0 09000064814a9e18
FDA-2013-D-1464-0001 FDA FDA-2013-D-1464 Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability Notice Notice of Availability 2013-12-05T05:00:00Z 2013 12 2013-12-05T05:00:00Z 2014-03-06T04:59:59Z 2014-03-06T02:01:21Z 2013-29081 0 0 09000064814a9ea0
FDA-2007-D-0369-0277 FDA FDA-2007-D-0369 Draft Guidance for Industry; Availability: Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension Notice Notice of Availability 2013-12-05T05:00:00Z 2013 12 2013-12-05T05:00:00Z 2014-02-04T04:59:59Z 2014-02-13T02:02:08Z 2013-29080 0 0 09000064814a9e1e
FDA-2013-D-1444-0001 FDA FDA-2013-D-1444 Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances Notice Notice of Availability 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z 2014-02-04T04:59:59Z 2014-02-05T02:03:21Z 2013-28963 0 0 09000064814a6225
FDA-2013-N-0579-0002 FDA FDA-2013-N-0579 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A Notice 30 Day Proposed Information Collection 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z 2014-01-04T04:59:59Z 2013-12-30T02:01:45Z 2013-28990 0 0 09000064814a61ed
FDA-2013-N-0795-0002 FDA FDA-2013-N-0795 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act Notice 60 Day Proposed Information Collection 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z 2014-01-04T04:59:59Z 2013-12-04T17:27:21Z 2013-29010 0 0 09000064814a6173
FDA-2013-N-1429-0001 FDA FDA-2013-N-1429 Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability Notice Notice of Availability 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z 2014-02-04T04:59:59Z 2020-04-23T20:10:32Z 2013-28962 0 0 09000064814a62d0
FDA-2012-D-1083-0007 FDA FDA-2012-D-1083 Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability Notice Notice of Availability 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z   2015-03-24T19:07:23Z 2013-28961 0 0 09000064814a62d1
FDA-2013-N-1428-0001 FDA FDA-2013-N-1428 Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability Notice Notice of Availability 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z 2014-02-04T04:59:59Z 2019-07-17T12:21:27Z 2013-28960 0 0 09000064814a6172
FDA-2013-N-0797-0003 FDA FDA-2013-N-0797 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation Notice 30 Day Proposed Information Collection 2013-12-04T05:00:00Z 2013 12 2013-12-04T05:00:00Z 2014-01-04T04:59:59Z 2014-01-05T02:56:10Z 2013-28989 0 0 09000064814a6316
FDA-2013-N-0719-0002 FDA FDA-2013-N-0719 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products Notice 30 Day Proposed Information Collection 2013-12-02T05:00:00Z 2013 12 2013-12-02T05:00:00Z 2014-01-03T04:59:59Z 2013-12-03T01:11:39Z 2013-28735 0 0 09000064814a2106
FDA-2013-N-0748-0002 FDA FDA-2013-N-0748 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration Notice 30 Day Proposed Information Collection 2013-12-02T05:00:00Z 2013 12 2013-12-02T05:00:00Z 2014-01-03T04:59:59Z 2013-12-03T01:04:57Z 2013-28736 0 0 09000064814a1fbf
FDA-2013-N-0716-0002 FDA FDA-2013-N-0716 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species Notice General Notice 2013-11-29T05:00:00Z 2013 11 2013-11-29T05:00:00Z 2013-12-31T04:59:59Z 2013-11-29T17:13:49Z 2013-28598 0 0 090000648149f1ca
FDA-2013-N-1439-0001 FDA FDA-2013-N-1439 Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Products Notice General Notice 2013-11-29T05:00:00Z 2013 11 2013-11-29T05:00:00Z 2014-01-29T04:59:59Z 2013-11-29T17:16:39Z 2013-28600 0 0 090000648149f214
FDA-2013-N-1422-0001 FDA FDA-2013-N-1422 Agency Information Collection Activities; Proposed Collection; Comment Request; Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing Notice General Notice 2013-11-29T05:00:00Z 2013 11 2013-11-29T05:00:00Z 2014-01-29T04:59:59Z 2014-09-04T17:41:07Z 2013-28599 0 0 090000648149f075
FDA-2012-D-0880-0009 FDA FDA-2012-D-0880 Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Reopening of the Comment Period Notice General Notice 2013-11-27T05:00:00Z 2013 11 2013-11-27T05:00:00Z 2013-12-12T04:59:59Z 2016-11-18T14:46:02Z 2013-28392 0 0 090000648149c2b6
FDA-2013-N-1424-0001 FDA FDA-2013-N-1424 Transport Format for the Submission of Regulatory Study Data; Notice of Pilot Project Notice General Notice 2013-11-27T05:00:00Z 2013 11 2013-11-27T05:00:00Z 2014-01-28T04:59:59Z 2024-11-12T05:23:15Z 2013-28391 1 0 090000648149c255
FDA-2013-N-0001-0110 FDA FDA-2013-N-0001 Risk Communications Advisory Committee; Notice of Meeting Notice Meeting 2013-11-27T05:00:00Z 2013 11 2013-11-27T05:00:00Z   2013-11-27T15:57:46Z 2013-28435 0 0 090000648149c214
FDA-2013-N-1423-0001 FDA FDA-2013-N-1423 Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice Notice General Notice 2013-11-27T05:00:00Z 2013 11 2013-11-27T05:00:00Z 2014-01-28T04:59:59Z 2024-11-12T05:23:18Z 2013-28438 1 0 090000648149c36a
FDA-2007-D-0369-0275 FDA FDA-2007-D-0369 Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Reopening of the Comment Period Notice Notice of Availability 2013-11-27T05:00:00Z 2013 11 2013-11-27T05:00:00Z 2013-12-12T04:59:59Z 2013-12-08T18:23:54Z 2013-28394 0 0 090000648149c332
FDA-2013-N-0002-0040 FDA FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Arsanilic Acid Notice General Notice 2013-11-26T05:00:00Z 2013 11 2013-11-26T05:00:00Z   2013-11-26T14:17:06Z 2013-28255 0 0 0900006481498795
FDA-2011-D-0305-0058 FDA FDA-2011-D-0305 Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and Food and Drug Administration Staff; Availability Notice Notice of Availability 2013-11-25T05:00:00Z 2013 11 2013-11-25T05:00:00Z   2013-11-26T13:37:08Z 2013-28084 0 0 0900006481495921
FDA-2012-D-1038-0017 FDA FDA-2012-D-1038 Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products; Availability Notice Notice of Availability 2013-11-25T05:00:00Z 2013 11 2013-11-25T05:00:00Z   2013-11-26T13:43:05Z 2013-28173 0 0 0900006481495aaa
FDA-2013-N-0002-0038 FDA FDA-2013-N-0002 Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone Notice General Notice 2013-11-22T05:00:00Z 2013 11 2013-11-22T05:00:00Z   2013-11-22T14:37:17Z 2013-27916 0 0 09000064814910b5
FDA-2013-D-0269-0003 FDA FDA-2013-D-0269 Guidance for Industry: Purchasing Reef Fish Species Associated with the Hazard of Ciguatera Fish Poisoning; Availability Notice Notice of Availability 2013-11-22T05:00:00Z 2013 11 2013-11-22T05:00:00Z   2013-11-22T15:33:10Z 2013-27913 0 0 090000648149122c
FDA-2013-P-0573-0003 FDA FDA-2013-P-0573 Determination That BANZEL (Rufinamide) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice General Notice 2013-11-21T05:00:00Z 2013 11 2013-11-21T05:00:00Z   2013-11-21T14:54:32Z 2013-27874 0 0 090000648148e297
FDA-2013-N-1432-0001 FDA FDA-2013-N-1432 Agency Information Collection Activities; Proposed Collection; Comment Request; Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables Notice General Notice 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z 2014-01-22T04:59:59Z 2014-01-22T02:01:42Z 2013-27782 0 0 090000648148bb1a
FDA-2013-N-0001-0108 FDA FDA-2013-N-0001 Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation; Public Workshop Notice Meeting 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z   2013-11-20T15:29:32Z 2013-27771 0 0 090000648148bb54
FDA-1999-D-4079-0004 FDA Product Name Placement,Size, & Prominence in Advertising FDA-1999-D-4079 Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling; Availability Notice Notice of Availability 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z 2014-01-25T04:59:59Z 2014-01-17T02:02:42Z 2013-27770 0 0 090000648148bad1
FDA-2013-D-1358-0001 FDA FDA-2013-D-1358 Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Availability Notice Notice of Availability 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z 2014-02-19T04:59:59Z 2015-07-13T17:54:08Z 2013-27774 0 0 090000648148bc0a
FDA-2013-D-0576-0003 FDA FDA-2013-D-0576 Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period Notice Notice of Availability 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z 2014-05-10T03:59:59Z 2014-05-13T14:34:04Z 2013-27769 0 0 090000648148ba3d
FDA-2013-N-0879-0002 FDA FDA-2013-N-0879 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products Notice 30 Day Proposed Information Collection 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z 2013-12-21T04:59:59Z 2016-12-08T13:41:55Z 2013-27775 0 0 090000648148ba3c
FDA-2013-N-1427-0001 FDA FDA-2013-N-1427 Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice Notice 60 Day Proposed Information Collection 2013-11-20T05:00:00Z 2013 11 2013-11-20T05:00:00Z 2014-01-22T04:59:59Z 2016-08-09T18:09:39Z 2013-27811 0 0 090000648148bb55
FDA-2013-N-0878-0002 FDA FDA-2013-N-0878 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient Notice General Notice 2013-11-18T05:00:00Z 2013 11 2013-11-18T05:00:00Z 2013-12-19T04:59:59Z 2015-02-11T23:13:29Z 2013-27536 0 0 0900006481486d8c
FDA-2013-N-1119-0002 FDA FDA-2013-N-1119 Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers; Extension of Comment Period Notice Extension of Comment Period 2013-11-18T05:00:00Z 2013 11 2013-11-18T05:00:00Z   2024-11-12T05:23:33Z 2013-27537 1 0 0900006481486d8d
FDA-2013-N-1394-0001 FDA FDA-2013-N-1394 Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment Notice General Notice 2013-11-18T05:00:00Z 2013 11 2013-11-18T05:00:00Z 2014-01-18T04:59:59Z 2014-01-14T19:56:34Z 2013-27503 0 0 0900006481486bba
FDA-2013-D-0715-0001 FDA FDA-2013-D-0715 Draft Guidance for Industry on Acrylamide in Foods; Availability Notice Notice of Availability 2013-11-15T05:00:00Z 2013 11 2013-11-15T05:00:00Z 2014-01-15T04:59:59Z 2014-01-15T02:03:26Z 2013-27362 0 0 0900006481481e8f
FDA-2013-N-1038-0003 FDA FDA-2013-N-1038 Over-the-Counter Ophthalmic Drug Products--Emergency Use Eyewash Products; Rescheduling of Public Hearing Notice Public Meetings 2013-11-15T05:00:00Z 2013 11 2013-11-15T05:00:00Z 2014-06-07T03:59:59Z 2014-06-07T01:06:55Z 2013-27359 0 0 0900006481481db2
FDA-2013-N-1306-0001 FDA FDA-2013-N-1306 International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability Notice Announcement 2013-11-15T05:00:00Z 2013 11 2013-11-15T05:00:00Z   2024-11-12T05:24:37Z 2013-27358 1 0 0900006481481dfb
FDA-1994-D-0007-0003 FDA Utility Study Anti-Salmonella Chemical Food Adds in Feeds FDA-1994-D-0007 Guidance for Industry; Availability: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds Notice Request for Comments 2013-11-14T05:00:00Z 2013 11 2013-11-14T05:00:00Z 2014-01-14T04:59:59Z 2014-01-18T02:04:25Z 2013-27194 0 0 090000648147d87c
FDA-2013-N-1393-0001 FDA FDA-2013-N-1393 Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Notice 60 Day Proposed Information Collection 2013-11-14T05:00:00Z 2013 11 2013-11-14T05:00:00Z 2014-01-14T04:59:59Z 2016-10-24T13:43:28Z 2013-27226 0 0 090000648147d67b
FDA-2000-N-0110-0008 FDA Proposal to Debar Bruce I Diamond PhD, Opportunity for Heari FDA-2000-N-0110 Debarment Orders: Bruce I. Diamond; Denial of Hearing Notice General Notice 2013-11-14T05:00:00Z 2013 11 2013-11-14T05:00:00Z   2013-11-14T15:45:07Z 2013-27186 0 0 090000648147d79f
FDA-2013-D-1279-0001 FDA FDA-2013-D-1279 Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability Notice Notice of Availability 2013-11-14T05:00:00Z 2013 11 2013-11-14T05:00:00Z   2013-11-14T16:39:29Z 2013-27233 0 0 090000648147d82e
FDA-2013-D-0880-0006 FDA FDA-2013-D-0880 Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period Notice General Notice 2013-11-14T05:00:00Z 2013 11 2013-11-14T05:00:00Z 2013-12-17T04:59:59Z 2016-03-18T18:15:07Z 2013-27213 0 0 090000648147d709
FDA-2013-N-1152-0001 FDA FDA-2013-N-1152 Agency Information Collection Activities; Proposed Collection; Comment Request; Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Notice General Notice 2013-11-14T05:00:00Z 2013 11 2013-11-14T05:00:00Z 2014-01-14T04:59:59Z 2014-01-14T16:41:07Z 2013-27222 0 0 090000648147d67d
FDA-2013-N-0001-0106 FDA FDA-2013-N-0001 Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Notice Meeting 2013-11-12T05:00:00Z 2013 11 2013-11-12T05:00:00Z   2013-11-12T19:54:30Z 2013-26891 0 0 090000648147745b
FDA-2013-N-0001-0105 FDA FDA-2013-N-0001 Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting Notice Meeting 2013-11-12T05:00:00Z 2013 11 2013-11-12T05:00:00Z   2013-11-12T19:51:02Z 2013-26868 0 0 0900006481477329
FDA-2013-N-1361-0001 FDA FDA-2013-N-1361 Determination That ADDERALL (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) Tablet and 13 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice General Notice 2013-11-12T05:00:00Z 2013 11 2013-11-12T05:00:00Z   2013-11-12T19:58:09Z 2013-26856 0 0 09000064814774f2
FDA-2013-N-0764-0005 FDA FDA-2013-N-0764 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Animal Feed Regulatory Program Standards Notice 30 Day Proposed Information Collection 2013-11-08T05:00:00Z 2013 11 2013-11-08T05:00:00Z 2013-12-10T04:59:59Z 2016-04-04T11:10:30Z 2013-26778 0 0 090000648147379d
FDA-2013-N-0001-0107 FDA FDA-2013-N-0001 Sixth Annual Sentinel Initiative; Public Workshop Notice Meeting 2013-11-08T05:00:00Z 2013 11 2013-11-08T05:00:00Z   2013-11-12T20:11:03Z 2013-26855 0 0 09000064814737a3
FDA-2013-N-1317-0001 FDA FDA-2013-N-1317 Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information Notice Request for Comments 2013-11-08T05:00:00Z 2013 11 2013-11-08T05:00:00Z 2014-01-08T04:59:59Z 2014-12-14T02:23:47Z 2013-26854 0 0 090000648147367f

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