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

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3,514 rows where document_type = "Other" and posted_year = 2009 sorted by posted_date descending

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agency_id 5

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  • 2009 · 3,514 ✖

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  • Other · 3,514 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
EPA-HQ-OPP-2008-0749-0004 EPA EPA-HQ-OPP-2008-0749 Draft Rule -Trichoderma gamsii strain ICC 080 Tolerance Exemption Other   2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z 2010-01-30T04:59:59Z 2009-12-31T17:10:27Z   0 0 0900006480a71750
EPA-HQ-OPP-2008-0750-0004 EPA EPA-HQ-OPP-2008-0750 Draft Rule- Trichoderma asperellum strain ICC 012; Tolerance Exemption Other   2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z 2010-01-30T04:59:59Z 2009-12-31T17:12:22Z   0 0 0900006480a71754
FDA-2009-P-0272-0003 FDA FDA-2009-P-0272 FDA/CDER Response to Sanofi-aventis, U.S., LLC - Petition Partial Approval and Denial Other PPAD-Petition Partial Approval and Denial 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2013-07-27T23:02:09Z   0 0 0900006480a68fe7
FDA-1995-S-0036-0109 FDA Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 FDA-1995-S-0036 Report 38 - Baylor College of Medicine Public Disclosure on IND 100,681 Other RPT-Report 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2013-07-27T23:02:32Z   0 0 0900006480a6b5ec
FDA-2009-P-0598-0001 FDA FDA-2009-P-0598 James Matthew Weber - Citizen Petition Other CP-Citizen Petition 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2012-03-06T19:35:08Z   0 0 0900006480a74a4d
FDA-2009-P-0298-0007 FDA FDA-2009-P-0298 FDA/CFSAN Interim Response to OVOS Natural Health, Inc. (Ullman, Shapiro & Ullman, LLP) - Letter Other LET-Letter 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2013-08-11T04:36:59Z   0 0 0900006480a69fe6
FDA-2009-P-0598-0002 FDA FDA-2009-P-0598 Acknowledgement Letter to James Matthew Weber Other ACK-Acknowledgement Letter 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2013-08-11T01:31:47Z   0 0 0900006480a74a4e
FDA-2008-D-0525-0013 FDA FDA-2008-D-0525 New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for Industry Other Guidance 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2024-11-07T22:12:12Z   1 0 0900006480a77652
EPA-HQ-OPP-2009-1004-0002 EPA EPA-HQ-OPP-2009-1004 Trichoderma Asperellum Strain ICC 0112 Other NA 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z 2010-01-30T04:59:59Z 2010-08-27T14:40:53Z   0 0 0900006480a73f69
EPA-HQ-OPP-2009-1003-0002 EPA EPA-HQ-OPP-2009-1003 Trichoderma Gamsii Strain ICC 080 Other NA 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z 2010-01-30T04:59:59Z 2010-08-27T14:50:23Z   0 0 0900006480a73f9a
EPA-HQ-SFUND-2009-1002-0001 EPA EPA-HQ-SFUND-2009-1002 Memorandum to the Docket from Lois Gartner, USEPA/OSWER/Community Involvement and Program Initiatives Branch through Elizabeth Southerland, Director, USEPA/OSWER/Assessment and Remediation Division Other   2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2010-06-16T14:22:05Z   0 0 0900006480a72fd3
FDA-2009-P-0282-0003 FDA FDA-2009-P-0282 FDA/CDRH to Mr. David S. Smith (Pepper Hamilton, LLP) Other LET-Letter 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2013-07-27T23:03:28Z   0 0 0900006480a7444f
EPA-HQ-RCRA-2009-0315-0259 EPA EPA-HQ-RCRA-2009-0315 Memorandum to Docket from Kathy Lett, USEPA/OSWER/ORCR/MRWMD through Robert Dellinger, Division Director, USEPA/OSWER/ORCR/MRWMD Other   2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z 2010-03-16T03:59:59Z 2010-06-16T14:23:34Z   0 0 0900006480a736e8
FDA-2009-P-0597-0031 FDA FDA-2009-P-0597 Acknowledgement Letter to GlaxoSmithKline Other ACK-Acknowledgement Letter 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z   2013-08-11T03:05:59Z   0 0 0900006480a6dd07
FDA-2009-D-0591-0002 FDA FDA-2009-D-0591 Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions Other GDL-Guidance (Supporting and Related Materials) 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z   2024-11-07T22:11:11Z   1 0 0900006480a73756
FDA-2009-P-0597-0001 FDA FDA-2009-P-0597 GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition Other CP-Citizen Petition 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z   2019-01-30T20:17:16Z   0 0 0900006480a6c85b
FDA-1996-P-0383-0001 FDA ANDA Suitability for Nuprin in a Spoon Dose Sachets-CLOSED FDA-1996-P-0383 Fuisz Technologies Ltd - Citizen Petition Other CP-Citizen Petition 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2009-12-28T20:30:15Z   0 0 0900006480506ffd
FDA-1996-P-0383-0002 FDA ANDA Suitability for Nuprin in a Spoon Dose Sachets-CLOSED FDA-1996-P-0383 Fuisz Technologies Ltd - Letter Other LET-Letter 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2009-12-28T20:30:17Z   0 0 0900006480507008
FDA-1984-P-0333-0001 FDA ANDA FOR IBUPROFEN 200 MG CONVENTIONAL CAPSULES-CLOSED FDA-1984-P-0333 Petition Approval from Center for Drugs and Biologics to Sterling Drug Inc Other Approval 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2022-05-17T20:03:37Z   0 0 09000064805a9401
FDA-1996-P-0383-0004 FDA ANDA Suitability for Nuprin in a Spoon Dose Sachets-CLOSED FDA-1996-P-0383 Acknowledgement Letter to Fuisz Technologies LTD Other ACK-Acknowledgement Letter 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2009-12-28T20:30:21Z   0 0 0900006480a72ac2
FDA-1996-P-0383-0003 FDA ANDA Suitability for Nuprin in a Spoon Dose Sachets-CLOSED FDA-1996-P-0383 Fuisz Technologies Ltd. - Withdrawal Other CP-Citizen Petition 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2013-07-27T21:20:27Z   0 0 090000648050700a
FDA-1984-P-0333-0002 FDA ANDA FOR IBUPROFEN 200 MG CONVENTIONAL CAPSULES-CLOSED FDA-1984-P-0333 Acknowledgement Letter from Dockets Management Branch to Sterling Drug Inc Other Acknowledgement Letter/Receipt 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2022-05-18T15:15:25Z   0 0 0900006480a72b74
FDA-2009-D-0600-0002 FDA FDA-2009-D-0600 Draft Guidance for Industry on Tobacco Health Document Submission - Guidance Other Guidance 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2024-11-07T22:13:38Z   1 0 0900006480a71ffb
FDA-2009-P-0297-0003 FDA FDA-2009-P-0297 AllerQuest LLC to FDA - Withdrawal of Petition Other WDL-Withdrawal 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2013-07-27T23:03:06Z   0 0 0900006480a7087b
FDA-2002-D-0223-0003 FDA Information for the use of Human Blood & Blood Components FDA-2002-D-0223 An Acceptable Circular of Information for the Use of Human Blood and Blood Components - Level 2 Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2024-11-07T22:12:43Z   1 0 0900006480a700ff
FDA-2009-P-0305-0001 FDA FDA-2009-P-0305 Hygeia II Medical Group Inc. - Citizen Petition Other CP-Citizen Petition 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2020-05-05T14:43:19Z   0 0 09000064809e79c6
FDA-2009-P-0305-0002 FDA FDA-2009-P-0305 Acknowledgement Letter to Hygeia II Medical Group Inc. Other ACK-Acknowledgement Letter 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2009-12-23T15:29:49Z   0 0 09000064809e79c9
FDA-1987-P-0230-0002 FDA IBUPROFEN 200MG SOFT GELATIN CAPSULES ANDA SUITABILILTY-CLOSED FDA-1987-P-0230 FDA/Center for Drugs and Biologics - Petition Approval Other PAV-Petition Approval 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2013-07-27T20:47:57Z   0 0 090000648046d7d3
FDA-2009-P-0305-0003 FDA FDA-2009-P-0305 FDA/Center for Devices and Radiological Health Interim Response to Hygeia II Medical Group Inc. Other LET-Letter 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2013-08-11T01:31:35Z   0 0 0900006480a6b1c4
FDA-1987-P-0230-0003 FDA IBUPROFEN 200MG SOFT GELATIN CAPSULES ANDA SUITABILILTY-CLOSED FDA-1987-P-0230 Acknowledgement Letter to Sidmak Laboratories Inc Other ACK-Acknowledgement Letter 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2009-12-23T17:23:52Z   0 0 0900006480a707a1
FDA-2008-D-0399-0007 FDA FDA-2008-D-0399 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 5 Disintegration Test General Chapter - Guidance for Industry Other GDL-Guidance (Supporting and Related Materials) 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2024-11-12T04:49:00Z   1 0 0900006480a70857
FDA-1987-P-0230-0001 FDA IBUPROFEN 200MG SOFT GELATIN CAPSULES ANDA SUITABILILTY-CLOSED FDA-1987-P-0230 Sidmak Laboratories, Inc - Citizen Petition Other CP-Citizen Petition 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2013-07-27T20:47:57Z   0 0 090000648046d7d2
EPA-HQ-OPP-2009-0044-0002 EPA EPA-HQ-OPP-2009-0044 Lavandulyl Senecioate Bipesticides Other NA 2009-12-22T05:00:00Z 2009 12 2009-12-22T05:00:00Z 2010-01-21T04:59:59Z 2010-08-27T15:31:32Z   0 0 0900006480a6f8f2
FDA-2009-D-0588-0002 FDA FDA-2009-D-0588 Guidance for Industry on the Timeframe for Submission of Tobacco Health Documents - Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-22T05:00:00Z 2009 12 2009-12-22T05:00:00Z   2024-11-07T22:11:18Z   1 0 0900006480a6f5bc
FDA-2009-D-0013-0005 FDA FDA-2009-D-0013 International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions - Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-22T05:00:00Z 2009 12     2024-11-07T22:13:57Z   1 0 0900006480a6f8f1
FDA-2009-P-0405-0021 FDA FDA-2009-P-0405 Consumers Union and Food Animal Concerns Trust (FACT) [Multiple Names=37,170 Citizens] - Letter Other LET-Letter 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2010-01-05T22:42:57Z   0 0 0900006480a6e1f4
FDA-2003-M-0501-0003 FDA Express & Express2 Monorail & Over-the-Wire Coronary Stent FDA-2003-M-0501 DUPLICATE Other AAV-Approval of Application 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2025-04-01T19:30:11Z   0 0 09000064804a2b21
FDA-2003-M-0501-0002 FDA Express & Express2 Monorail & Over-the-Wire Coronary Stent FDA-2003-M-0501 Premarket Approval Response Letter from FDA CDRH to Boston Scientific Scimed, Inc. Other Approval 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2025-04-01T19:34:05Z   0 0 09000064804a2b1f
FDA-2003-M-0501-0004 FDA Express & Express2 Monorail & Over-the-Wire Coronary Stent FDA-2003-M-0501 Background Materials re: Premarket Approval Response Letter from FDA CDRH to Boston Scientific Scimed, Inc. Other Background Material 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2025-04-01T19:36:00Z   0 0 09000064804a2b22
EPA-HQ-OEI-2009-0453-0001 EPA TRI Metal Mining EPA-HQ-OEI-2009-0453 Docket EPA-HQ-OEI-2009-0453 Open for Public Access Other   2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2010-07-15T19:27:50Z   0 0 0900006480a6c417
FDA-2003-P-0127-0004 FDA To Request the Commissioner of FDA to Declare That the Drug Product Diclofenac Potassium Capsules 25 mg, is Suitable for Submission as a ANDA-CLOSED FDA-2003-P-0127 The Weinberg Group, Inc. - Petition Withdrawal re FDA-2003-P-0127-0003 Other WDL-Withdrawal 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2024-10-30T20:35:50Z   0 0 0900006480a6b578
FDA-2009-D-0574-0002 FDA FDA-2009-D-0574 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z 2010-02-17T04:59:59Z 2009-12-17T20:39:09Z   0 0 0900006480a6d53a
FDA-2003-P-0127-0003 FDA To Request the Commissioner of FDA to Declare That the Drug Product Diclofenac Potassium Capsules 25 mg, is Suitable for Submission as a ANDA-CLOSED FDA-2003-P-0127 Citizen Petition from The Weinberg Group, Inc. Other CP-Citizen Petition 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2024-10-30T20:56:47Z   0 0 0900006480486267
FDA-2009-P-0567-0003 FDA FDA-2009-P-0567 Arent Fox LLP - Withdrawal Other WDL-Withdrawal 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2013-07-27T23:02:39Z   0 0 0900006480a6ba1b
FDA-2009-P-0273-0004 FDA FDA-2009-P-0273 FDA/CDER Interim Response to Lachman Consultant Services, Inc. - Letter Other LET-Letter 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2013-07-27T23:02:16Z   0 0 0900006480a69fe3
FDA-2009-P-0595-0002 FDA FDA-2009-P-0595 Acknowledgement Letter to Public Citizen Health Research Group Other ACK-Acknowledgement Letter 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2009-12-17T23:10:44Z   0 0 0900006480a6b5a8
FDA-2009-D-0573-0002 FDA FDA-2009-D-0573 Addendum To ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1) - Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z 2010-02-02T04:59:59Z 2023-12-21T02:00:44Z   0 0 0900006480a6d52c
FDA-2009-P-0595-0001 FDA FDA-2009-P-0595 Public Citizen Health Research Group - Citizen Petition Other CP-Citizen Petition 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z   2011-01-05T16:57:05Z   0 0 0900006480a6b5a7
FDA-2009-D-0579-0002 FDA FDA-2009-D-0579 Q4B Evaluation and Recommenations of Pharmacopoeial Texts for Use in the ICH Regions - Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-17T05:00:00Z 2009 12 2009-12-17T05:00:00Z 2010-02-17T04:59:59Z 2009-12-17T19:31:20Z   0 0 0900006480a6cf78
FDA-2009-P-0593-0001 FDA FDA-2009-P-0593 Grove Medical LLC - Citizen Petition Other   2009-12-17T00:00:00Z 2009 12     2013-08-11T03:05:56Z   0 1 0900006480a6b102
FDA-2009-P-0593-0002 FDA FDA-2009-P-0593 Acknowledgement Letter to Grove Medical LLC Other   2009-12-17T00:00:00Z 2009 12     2013-08-11T03:05:56Z   0 1 0900006480a6b103
APHIS-2007-0044-0253 APHIS Regulatory Status of Alfalfa Genetically Engineered for Tolerance to the Herbicide Glyphosate APHIS-2007-0044 Glyphosate-Tolerant Alfalfa Events J101 and J163: Request for Nonregulated Status -- Draft Environmental Impact Statement(November 2009) Other EIS 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z 2010-03-04T04:59:59Z 2010-02-18T12:39:37Z   0 0 0900006480a6b7a1
FDA-2009-P-0589-0001 FDA FDA-2009-P-0589 Buchanan Ingersoll & Rooney PC - Citizen Petition Other CP-Citizen Petition 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2012-03-09T16:55:44Z   0 0 0900006480a62246
FDA-1975-N-0013-0025 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Request for Hearing from Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Other Request for Hearing 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2017-11-13T19:00:29Z   0 0 0900006480a4e166
FDA-2009-P-0185-0003 FDA FDA-2009-P-0185 Bioniche Pharma, LLC - Amendment Other AMD-Amendment 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2013-07-27T23:01:53Z   0 0 0900006480a6714d
FDA-1975-N-0013-0024 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Citizen Petition from Amuchina International, Inc. Other Citizen Petition 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2017-11-16T14:57:17Z   0 0 09000064805c1daa
FDA-1977-P-0193-0002 FDA Solid Contents Statement on Canned Fruit & Vegetable Product FDA-1977-P-0193 National Food Processors Association - Supplement Other Supplement (SUP) 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2013-08-13T15:53:38Z   0 0 09000064805db3dd
FDA-2009-P-0589-0003 FDA FDA-2009-P-0589 Acknowledgement Letter to Buchanan Ingersoll & Rooney PC Other Acknowledgement Letter/Receipt 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2013-07-27T23:02:15Z   0 0 0900006480a69569
EPA-HQ-OPP-2009-0125-0001 EPA EPA-HQ-OPP-2009-0125 Public Acess for Application Containing New Active Ingredients, 2-Methyl-1 butanol and Calcium Acetate Other   2009-12-15T05:00:00Z 2009 12 2009-12-15T05:00:00Z 2010-01-16T04:59:59Z 2009-12-15T20:42:41Z   0 0 0900006480a6b5ed
FDA-2009-P-0266-0005 FDA FDA-2009-P-0266 FDA/CDER Interim Response to Dr. Reddy's Laboratories, Inc. - Letter Other LET-Letter 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-08-11T01:31:24Z   0 0 0900006480a661cd
FDA-1995-D-0298-0011 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 Alaska Seafood Marketing Institute - Request for Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-08-11T02:46:21Z   0 0 09000064805998f7
FDA-2009-P-0587-0001 FDA FDA-2009-P-0587 Buchanan Ingersoll & Rooney PC - Citizen Petition Other CP-Citizen Petition 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-07-27T23:01:55Z   0 0 0900006480a6777c
FDA-2009-P-0362-0011 FDA FDA-2009-P-0362 Ryszard Rokicki - Supplement Citizen Petition Other SUP-Supplement 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-07-27T23:01:31Z   0 0 0900006480a63846
FDA-1995-D-0298-0003 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 NFPA, National Food Processors Assn. - Request for Extension Comments Other EXT-Request for Extension Comment Due Date 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-07-27T21:45:00Z   0 0 09000064805998f2
FDA-1995-D-0298-0006 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 FDA/CFSAN Between MaryLynn Datoc, and Robert L. Collette, and Allen W. Matthys - Memorandum of Telephone Conversations Other MT-Memorandum of Telephone Conversation 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2009-12-14T18:03:00Z   0 0 09000064805998f9
FDA-1995-D-0298-0009 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 Pacific Seafood Processors Assn. - Request for Comment Due Data Other EXT-Request for Extension Comment Due Date 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-07-27T21:45:00Z   0 0 09000064805998f5
FDA-2008-P-0330-0005 FDA FDA-2008-P-0330 FDA/CDER Response to Rakoczy Molino Mazzochi Siwik, LLP - Letter Other LET-Letter 2009-12-14T05:00:00Z 2009 12     2013-08-11T04:36:53Z   0 0 0900006480a661d0
FDA-2009-N-0374-0016 FDA FDA-2009-N-0374 Ellen Frank, Director Division of Public Affairs - "Educating the Public On the Phase-Out of Epinephrine CFC Inhalers" [Public Workshop, September 25, 2009] - Testimony Other TS-Testimony 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-07-27T23:01:22Z   0 0 0900006480a62271
FDA-2009-P-0586-0002 FDA FDA-2009-P-0586 Acknowledgement Letter to Canada Ice Enterprises Other ACK-Acknowledgement Letter 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-08-11T04:36:55Z   0 0 0900006480a67288
FDA-1981-D-0064-0003 FDA DEFECT ACTION LEVELS FOR HISTAMINE IN TUNA FDA-1981-D-0064 References for Memorandum of March 2, 1979 Other References (External) (REF) 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2026-01-30T22:37:16Z   0 0 0900006480a6a243
FDA-1981-D-0064-0002 FDA DEFECT ACTION LEVELS FOR HISTAMINE IN TUNA FDA-1981-D-0064 Guidance - GDL Other GDL-Guidance 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2009-12-14T17:00:25Z   0 0 0900006480a6a241
FDA-2007-P-0181-0013 FDA FDA-2007-P-0181 The Lillie Center, Inc. to FDA - Letter Other LET-Letter 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-07-27T23:01:56Z   0 0 0900006480a67903
FDA-1995-D-0298-0013 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 Ocean Beauty Seafoods, Inc. - Request fo Extension Comment Due Date Other EXT-Request for Extension Comment Due Date 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2009-12-14T19:28:24Z   0 0 0900006480a6a5a4
FDA-1995-D-0298-0002 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 National Fisheries Institute, Inc. - Request for Extension Comment Due Data Other EXT-Request for Extension Comment Due Date 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-07-27T21:45:00Z   0 0 09000064805998f1
FDA-1995-D-0298-0005 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 FDA/CFSAN Between MaryLynn Datoc, and Jim Yonker and Vincent A. Curry and Kevin O'Sullivan - Memorandum of Telephone Conversations Other MT-Memorandum of Telephone Conversation 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2009-12-14T18:02:20Z   0 0 09000064805998fa
FDA-2004-P-0279-0007 FDA Petition for Rulemaking to Revoke the Authority for Industry to Use Partially Hydrogenated Vegetable Oils in Foods FDA-2004-P-0279 Letter from the Center for Science in the Public Interest Other Letter(s) 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2025-01-30T00:29:49Z   0 0 0900006480a637bc
FDA-1995-D-0298-0007 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 FDA/CFSAN to Christopher E. Rezendes, Seafood Team Leader Other M-Memorandum 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2009-12-14T18:06:30Z   0 0 09000064805998fb
FDA-1995-D-0298-0014 FDA Decomposition & Histamine-Raw,Frozen Tuna & Mahi-Mahi; Avail FDA-1995-D-0298 Compliance Policy Guide - Guidance Other GDL-Guidance 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2009-12-14T19:32:50Z   0 0 0900006480a6a5f9
FDA-1981-D-0064-0004 FDA DEFECT ACTION LEVELS FOR HISTAMINE IN TUNA FDA-1981-D-0064 Reference 1 - Westgate Foods - F.D.C. #57693, summarized in FDA Consumer, Oct 1. 1974- [ Background Material - BKG] Other BKG-Background Material 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2009-12-14T17:00:28Z   0 0 0900006480a6a248
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FDA-2009-P-0587-0004 FDA FDA-2009-P-0587 Acknowledgement Letter to Buchanan Ingersoll & Rooney PC Other ACK-Acknowledgement Letter 2009-12-14T05:00:00Z 2009 12 2009-12-14T05:00:00Z   2013-08-11T03:05:50Z   0 0 0900006480a67922
FDA-2006-P-0518-0005 FDA FDA-2006-P-0518 George Washington University Medical Center to FDA, December 3, 2009 - Letter re FDA-2006-P-0518-0001 Other LET-Letter 2009-12-13T05:00:00Z 2009 12 2009-12-13T05:00:00Z   2013-07-27T23:02:07Z   0 0 0900006480a68b1b
FDA-2008-P-0560-0005 FDA FDA-2008-P-0560 FDA/CDER Response to Schiff & Company - Letter Other LET-Letter 2009-12-13T05:00:00Z 2009 12 2009-12-13T05:00:00Z   2013-07-27T23:01:53Z   0 0 0900006480a6714e
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FDA-2009-P-0471-0007 FDA FDA-2009-P-0471 Mark Antell, et al - Supplement Other SUP-Supplement 2009-12-11T05:00:00Z 2009 12 2009-12-11T05:00:00Z   2013-07-27T23:00:42Z   0 0 0900006480a5dd84
FDA-2004-P-0278-0007 FDA Petition to Require Restaurants to Indicate That the Food they Serve Contains Trans Fat From Partially Hydrogenated Vegetable Oils-CLOSED FDA-2004-P-0278 Center for Science in the Public Interest to FDA - Letter Other LET-Letter 2009-12-10T05:00:00Z 2009 12 2009-12-10T05:00:00Z   2025-02-19T16:43:59Z   0 0 0900006480a6305a
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FDA-1977-N-0049-0002 FDA O. T. C. Internal Analgesic, Antipyretic & Antirhematic Drugs - OPEN FDA-1977-N-0049 Internal Memorandum from William E. Gilbertson (HFD-210) to Dockets Management Branch (HFA-305) December 24, 1991 Other Memorandum 2009-12-10T05:00:00Z 2009 12 2009-12-10T05:00:00Z   2019-02-07T14:57:56Z   0 0 0900006480a68e9d
FDA-1995-S-0039-0224 FDA 75-Day Premarket Notifications for New Dietary Ingredients FDA-1995-S-0039 NDI 586 - Oxaloacetic Acid from Terra Biological LLC Other 75 Day PreMarket Notification 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2016-09-30T14:23:36Z   0 0 0900006480a2eb6f
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FDA-2008-P-0542-0008 FDA FDA-2008-P-0542 FDA/CFSAN Response to Coburn & Coffman PLLC - Petition Denial Other PDN-Petition Denial 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2013-07-27T23:01:55Z   0 0 0900006480a67862
FDA-1995-S-0039-0233 FDA 75-Day Premarket Notifications for New Dietary Ingredients FDA-1995-S-0039 Letter from FDA/CFSAN to Shannon Minerals Ltd. re NDI 305 - Extract of Garcinia Cambogia (Burren Spring Trim) Other Supplement (SUP) 2009-12-09T05:00:00Z 2009 12     2016-09-30T14:23:38Z   0 0 0900006480a6272c
FDA-1995-S-0039-0230 FDA 75-Day Premarket Notifications for New Dietary Ingredients FDA-1995-S-0039 NDI 587 - Androsta-1,4,6-triene-3,17-dione from Proprietary Wellness Other 75 Day PreMarket Notification 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2016-09-30T14:23:37Z   0 0 0900006480a2bc6d
FDA-2009-P-0581-0015 FDA FDA-2009-P-0581 Acknowledgement Letter to Bayer HealthCare LLC (Ropes & Gray, LLP) Other ACK-Acknowledgement Letter 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2013-08-11T04:36:50Z   0 0 0900006480a6357c
FDA-1995-S-0039-0232 FDA 75-Day Premarket Notifications for New Dietary Ingredients FDA-1995-S-0039 Letter from FDA/CFSAN to Shannon Minerals Ltd. re NDI 304 - Extract of Garcinia Cambogia (Coolwater Trim) Other Supplement (SUP) 2009-12-09T05:00:00Z 2009 12     2016-09-30T14:23:38Z   0 0 0900006480a6272b
FDA-2009-P-0259-0003 FDA FDA-2009-P-0259 FDA/CDER Interim Response to Akorn, Inc. - Letter Other LET-Letter 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2013-08-11T01:31:21Z   0 0 0900006480a62241
FDA-2009-P-0581-0001 FDA FDA-2009-P-0581 Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition Other CP-Citizen Petition 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2013-12-08T02:21:43Z   0 0 0900006480a63509
FDA-2020-D-1381-0001 FDA FDA-2020-D-1381 Guidance PET Drugs — Current Good Manufacturing Practice (CGMP) Other Guidance 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2024-11-06T23:36:02Z   1 0 09000064845e6c9d
FDA-2009-E-0175-0008 FDA FDA-2009-E-0175 U.S. Patent and Trademark Office to FDA/CDER - Letter Other LET-Letter 2009-12-08T05:00:00Z 2009 12 2009-12-08T05:00:00Z   2013-07-27T23:01:42Z   0 0 0900006480a666a0
FDA-1984-P-0033-0016 FDA Labeling Restrictions for Ibuprofen on an Over-the-Counter (OTC) Basis-CLOSED FDA-1984-P-0033 FDA/CDER and Upjohn Company, March 21, 1984 - Memorandum of Telephone Conversation Other MT-Memorandum of Telephone Conversation 2009-12-08T05:00:00Z 2009 12     2013-07-27T21:48:42Z   0 0 09000064805a8227

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