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withdrawn,object_id FDA-2008-N-0650-0001,FDA,FDA-2008-N-0650,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,N-Notice,2008-12-30T05:00:00Z,2008,12,2008-12-30T05:00:00Z,2009-03-03T04:59:59Z,2024-11-12T04:27:47Z,E8-31058,1,0,09000064808079b5 FDA-2007-N-0451-0005,FDA,FDA-2007-N-0451,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,N-Notice,2008-12-30T05:00:00Z,2008,12,2008-12-30T05:00:00Z,,2008-12-30T13:05:40Z,E8-31057,0,0,09000064808079a6 FDA-2008-N-0637-0001,FDA,FDA-2008-N-0637,Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators,Notice,N-Notice,2008-12-29T05:00:00Z,2008,12,2008-12-29T05:00:00Z,2009-02-28T04:59:59Z,2024-11-12T04:27:44Z,E8-30837,1,0,0900006480805ec3 FDA-2008-N-0652-0001,FDA,FDA-2008-N-0652,Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation,Notice,N-Notice,2008-12-29T05:00:00Z,2008,12,2008-12-29T05:00:00Z,2009-02-28T04:59:59Z,2024-11-12T04:27:11Z,E8-30839,1,0,0900006480805e3a FDA-2008-N-0045-0008,FDA,FDA-2008-N-0045,"Regulatory Site Visit Training Program; December 24, 2008",Notice,N-Notice,2008-12-24T05:00:00Z,2008,12,2008-12-24T05:00:00Z,2009-01-24T04:59:59Z,2010-03-26T22:43:43Z,E8-30659,0,0,09000064807f8e05 FDA-2004-D-0375-0019,FDA,FDA-2004-D-0375,Guidance for Industry and Food and Drug Administration Staff; ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300; Availability,Notice,NAD-Notice of Availability of Data,2008-12-23T05:00:00Z,2008,12,2008-12-23T05:00:00Z,,2008-12-23T12:40:16Z,E8-30586,0,0,09000064807eda05 FDA-2008-N-0644-0001,FDA,FDA-2008-N-0644,SEQC--The Sequencing Quality Control Project,Notice,N-Notice,2008-12-23T05:00:00Z,2008,12,2008-12-23T05:00:00Z,,2008-12-23T12:54:12Z,E8-30410,0,0,09000064807eda32 FDA-2008-N-0648-0001,FDA,FDA-2008-N-0648,Agency Information Collection Activities; Proposed Collection; Comment Request; PDUFA Pilot Project Proprietary Name Review,Notice,N-Notice,2008-12-23T05:00:00Z,2008,12,2008-12-23T05:00:00Z,2009-02-24T04:59:59Z,2008-12-23T12:59:23Z,E8-30587,0,0,09000064807eda6f FDA-1994-N-0182-0001,FDA,FDA-1994-N-0182,Proposed Switch of Acyclovir from Prescription to Over-the-Counter Status; Public Hearing - Notice of Hearing Before the Commissioner,Notice,NHC-Notice of Hearing Before Commissioner,2008-12-23T05:00:00Z,2008,12,2008-12-23T05:00:00Z,1994-06-21T03:59:59Z,2008-12-23T21:00:51Z,,0,0,0900006480507142 FDA-1994-N-0182-0002,FDA,FDA-1994-N-0182,Joint Meeting of the Antiviral Drugs and Nonprescription Drugs Advisory Committees - Notice of Meeting,Notice,NM-Notice of Meeting,2008-12-23T05:00:00Z,2008,12,2008-12-23T05:00:00Z,,2008-12-23T21:00:52Z,,0,0,0900006480507143 FDA-2008-D-0603-0001,FDA,FDA-2008-D-0603,Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Expander; Availability,Notice,NAD-Notice of Availability of Data,2008-12-22T05:00:00Z,2008,12,2008-12-22T05:00:00Z,2009-03-24T03:59:59Z,2008-12-22T13:00:05Z,E8-30440,0,0,09000064807e6888 FDA-2004-D-0298-0004,FDA,FDA-2004-D-0298,Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date,Notice,NEC-Notice of Extension,2008-12-22T05:00:00Z,2008,12,2008-12-22T05:00:00Z,,2008-12-22T12:52:04Z,E8-30297,0,0,09000064807e6876 FDA-2008-N-0617-0001,FDA,FDA-2008-N-0617,Determination That RUBRAMIN PC (Cyanocobalamin) Injection and Ten Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,Notice,N-Notice,2008-12-19T05:00:00Z,2008,12,,,2008-12-20T16:20:57Z,E8-30154,0,0,09000064807e2d1a FDA-2008-N-0641-0001,FDA,FDA-2008-N-0641,Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments,Notice,N-Notice,2008-12-19T05:00:00Z,2008,12,2008-12-19T05:00:00Z,2009-02-18T04:59:59Z,2008-12-20T16:20:55Z,E8-30278,0,0,09000064807e2d30 FDA-2008-N-0635-0001,FDA,FDA-2008-N-0635,"Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly ""Emergency Medical Device Shortages Program Survey"")",Notice,60 Day Proposed Information Collection,2008-12-19T05:00:00Z,2008,12,2008-12-19T05:00:00Z,2009-02-18T04:59:59Z,2015-03-11T19:11:55Z,E8-30155,0,0,09000064807e2d45 FDA-2008-N-0631-0001,FDA,FDA-2008-N-0631,Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority,Notice,N-Notice,2008-12-19T05:00:00Z,2008,12,2008-12-19T05:00:00Z,2009-02-18T04:59:59Z,2008-12-20T16:20:56Z,E8-30280,0,0,09000064807e2c80 FDA-2008-D-0118-0028,FDA,FDA-2008-D-0118,Guidance for Industry on Diabetes Mellitus--Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability,Notice,NAD-Notice of Availability of Data,2008-12-19T05:00:00Z,2008,12,2008-12-19T05:00:00Z,,2008-12-23T23:31:51Z,E8-30086,0,0,09000064807e2c7c FDA-2008-N-0613-0001,FDA,FDA-2008-N-0613,Clinical Studies of Safety and Effectiveness of Orphan Products,Notice,,2008-12-18T05:00:00Z,2008,12,2008-12-18T05:00:00Z,,2008-12-20T16:20:58Z,E8-30061,0,0,09000064807e0637 FDA-2008-N-0039-0088,FDA,FDA-2008-N-0039,New Animal Drugs; Tylosin,Notice,Notice of Final Rule,2008-12-18T05:00:00Z,2008,12,,,2013-07-11T14:42:33Z,E8-29861,0,0,09000064807e0691 FDA-2008-N-0606-0001,FDA,FDA-2008-N-0606,Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates,Notice,N-Notice,2008-12-17T05:00:00Z,2008,12,2008-12-17T05:00:00Z,2009-02-18T04:59:59Z,2008-12-20T16:20:59Z,E8-29897,0,0,09000064807def85 FDA-2008-D-0623-0001,FDA,FDA-2008-D-0623,Draft Guidance for Industry on Anesthetics for Companion Animals; Availability,Notice,NAD-Notice of Availability of Data,2008-12-17T05:00:00Z,2008,12,2008-12-17T05:00:00Z,2009-03-03T04:59:59Z,2008-12-20T16:30:41Z,E8-29953,0,0,09000064807defce FDA-2008-N-0439-0002,FDA,FDA-2008-N-0439,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Blood Establishment Registration and Product Listing, Form FDA 2830",Notice,N-Notice,2008-12-17T05:00:00Z,2008,12,,,2008-12-20T16:22:36Z,E8-29898,0,0,09000064807defa6 FDA-2008-N-0043-0016,FDA,FDA-2008-N-0043,"Memorandum of Understanding Between the Office of the Assistant Secretary of Defense (Health Affairs), the Veterans Health Administration, and the U.S. Food and Drug Administration",Notice,N-Notice,2008-12-17T05:00:00Z,2008,12,,,2008-12-20T16:29:25Z,E8-29952,0,0,09000064807df02f FDA-2007-D-0365-0004,FDA,FDA-2007-D-0365,Guidance for Industry on Orally Disintegrating Tablets; Availability,Notice,NAD-Notice of Availability of Data,2008-12-16T05:00:00Z,2008,12,2008-12-16T05:00:00Z,,2008-12-21T02:35:44Z,E8-29688,0,0,09000064807dd857 FDA-2008-N-0628-0002,FDA,FDA-2008-N-0628,Microbiological Testing for Contact Lens Care Products; Public Workshop,Notice,NM-Notice of Meeting,2008-12-16T05:00:00Z,2008,12,,,2008-12-20T16:20:56Z,E8-29741,0,0,09000064807dd7ce FDA-2008-D-0626-0001,FDA,FDA-2008-D-0626,Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability,Notice,NAD-Notice of Availability of Data,2008-12-16T05:00:00Z,2008,12,2008-12-16T05:00:00Z,2009-02-18T04:59:59Z,2009-01-23T17:39:34Z,E8-29692,0,0,09000064807dd7fc FDA-2008-D-0614-0001,FDA,FDA-2008-D-0614,Draft Guidance for Industry on Changes to Approved New Animal Drug Applications--New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability,Notice,NAD-Notice of Availability of Data,2008-12-16T05:00:00Z,2008,12,2008-12-16T05:00:00Z,2009-02-18T04:59:59Z,2008-12-20T16:30:42Z,E8-29691,0,0,09000064807dd83e FDA-2008-D-0610-0001,FDA,FDA-2008-D-0610,Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability,Notice,NAD-Notice of Availability of Data,2008-12-16T05:00:00Z,2008,12,2008-12-16T05:00:00Z,2009-02-18T04:59:59Z,2009-02-19T17:59:49Z,,0,0,09000064807ddbf2 FDA-2008-N-0633-0001,FDA,FDA-2008-N-0633,Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting,Notice,N-Notice,2008-12-16T05:00:00Z,2008,12,2008-12-16T05:00:00Z,2009-02-18T04:59:59Z,2008-12-20T16:20:56Z,E8-29664,0,0,09000064807dd800 FDA-2008-N-0038-0092,FDA,FDA-2008-N-0038,Advisory Committees; Filing of Closed Meeting Reports,Notice,N-Notice,2008-12-16T05:00:00Z,2008,12,,,2008-12-20T16:29:57Z,E8-29679,0,0,09000064807dd802 FDA-2008-D-0629-0001,FDA,FDA-2008-D-0629,Draft Guidance for Industry on Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; Availability,Notice,NAD-Notice of Availability of Data,2008-12-16T05:00:00Z,2008,12,2008-02-15T05:00:00Z,2009-02-18T04:59:59Z,2009-02-13T13:25:56Z,E8-29674,0,0,09000064807dd829 FDA-2008-N-0490-0004,FDA,FDA-2008-N-0490,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program,Notice,N-Notice,2008-12-16T05:00:00Z,2008,12,2008-12-16T05:00:00Z,,2008-12-20T16:21:40Z,E8-29685,0,0,09000064807dd7c6 FDA-2008-N-0512-0003,FDA,FDA-2008-N-0512,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices,Notice,N-Notice,2008-12-16T05:00:00Z,2008,12,,,2008-12-20T16:21:39Z,E8-29672,0,0,09000064807dd87d FDA-2008-N-0602-0001,FDA,FDA-2008-N-0602,Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Perceptions of Product Risks and Benefits,Notice,N-Notice,2008-12-15T05:00:00Z,2008,12,2008-12-15T05:00:00Z,2009-02-14T04:59:59Z,2008-12-20T16:21:00Z,E8-29517,0,0,09000064807dc0c0 FDA-2008-D-0611-0001,FDA,FDA-2008-D-0611,Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability,Notice,NAD-Notice of Availability of Data,2008-12-12T05:00:00Z,2008,12,2008-12-12T05:00:00Z,2009-03-13T03:59:59Z,2009-03-19T21:37:24Z,E8-29413,0,0,09000064807d8787 FDA-2008-N-0622-0001,FDA,FDA-2008-N-0622,Withdrawal of Certain Proposed Rules and Other Proposed Actions,Notice,NWL-Notice of Withdrawl,2008-12-12T05:00:00Z,2008,12,,,2008-12-20T16:20:57Z,E8-29331,0,0,09000064807d8820 FDA-2008-N-0499-0002,FDA,FDA-2008-N-0499,"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007",Notice,N-Notice,2008-12-12T05:00:00Z,2008,12,,,2008-12-20T16:21:40Z,E8-29459,0,0,09000064807d87c4 FDA-2007-D-0429-0014,FDA,FDA-2007-D-0429,Draft Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability,Notice,Notice of Availability,2008-12-11T05:00:00Z,2008,12,2008-12-11T05:00:00Z,,2019-08-20T11:52:24Z,E8-29301,0,0,09000064807d7084 FDA-2007-D-0209-0016,FDA,FDA-2007-D-0209,Draft Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1; Availability,Notice,NAD-Notice of Availability of Data,2008-12-11T05:00:00Z,2008,12,2008-12-11T13:05:15Z,,2008-12-21T02:36:15Z,E8-29303,0,0,09000064807d6fbe FDA-2008-N-0039-0086,FDA,FDA-2008-N-0039,New Animal Drugs for Use in Animal Feeds; Ractopamine,Notice,Notice of Final Rule,2008-12-11T05:00:00Z,2008,12,,,2013-07-09T20:00:14Z,E8-29177,0,0,09000064807d7057 FDA-2007-D-0025-0004,FDA,FDA-2007-D-0025,Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval--the Premarket Approval Supplement Decisionmaking Process; Availability,Notice,NAD-Notice of Availability of Data,2008-12-11T05:00:00Z,2008,12,2008-12-11T12:59:15Z,,2008-12-21T02:37:29Z,E8-29330,0,0,09000064807d702e FDA-2008-N-0038-0091,FDA,FDA-2008-N-0038,Blood Products Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2008-12-09T05:00:00Z,2008,12,2008-12-09T05:00:00Z,,2008-12-20T16:29:58Z,E8-29105,0,0,09000064807d3c31 FDA-2008-N-0038-0090,FDA,FDA-2008-N-0038,Risk Communication Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2008-12-08T05:00:00Z,2008,12,2008-12-08T05:00:00Z,2009-04-01T03:59:59Z,2009-02-24T19:58:08Z,E8-28887,0,0,09000064807d1f6f FDA-2008-N-0612-0001,FDA,FDA-2008-N-0612,"Sentinel Initiative: Structure, Function, and Scope; Public Workshop; Request for Comments",Notice,NM-Notice of Meeting,2008-12-05T05:00:00Z,2008,12,2008-12-05T16:46:01Z,2009-01-17T04:59:59Z,2008-12-20T16:20:58Z,E8-28797,0,0,09000064807ce0bf FDA-2008-N-0453-0002,FDA,FDA-2008-N-0453,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act,Notice,30 Day Proposed Information Collection,2008-12-04T05:00:00Z,2008,12,,,2015-03-16T20:38:23Z,E8-28692,0,0,09000064807cc81a FDA-2008-N-0043-0014,FDA,FDA-2008-N-0043,"Memorandum of Understanding Between the Food and Drug Administration and WebMD, LLC",Notice,N-Notice,2008-12-04T05:00:00Z,2008,12,,,2008-12-20T16:29:26Z,E8-28690,0,0,09000064807cc834 FDA-2008-N-0454-0002,FDA,FDA-2008-N-0454,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substances Notification System,Notice,N-Notice,2008-12-04T05:00:00Z,2008,12,,,2008-12-20T16:22:26Z,E8-28694,0,0,09000064807cc7f7 FDA-2008-N-0607-0001,FDA,FDA-2008-N-0607,Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices,Notice,N-Notice,2008-12-04T05:00:00Z,2008,12,2008-12-04T15:10:40Z,2009-02-03T04:59:59Z,2008-12-20T16:20:58Z,E8-28695,0,0,09000064807cc7e6 FDA-1999-D-0128-0007,FDA,FDA-1999-D-0128,Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics; Availability,Notice,NAD-Notice of Availability of Data,2008-12-04T05:00:00Z,2008,12,2008-12-04T15:06:23Z,,2008-12-23T01:30:04Z,E8-28693,0,0,09000064807cc7d2 FDA-2008-D-0609-0001,FDA,FDA-2008-D-0609,Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability,Notice,NAD-Notice of Availability of Data,2008-12-03T05:00:00Z,2008,12,2008-12-03T05:00:00Z,2009-02-03T04:59:59Z,2008-12-31T12:14:33Z,E8-28657,0,0,09000064807cac04 FDA-2008-D-0576-0001,FDA,FDA-2008-D-0576,"Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability",Notice,NAD-Notice of Availability of Data,2008-12-01T05:00:00Z,2008,12,2008-12-01T05:00:00Z,,2024-11-12T04:25:37Z,E8-28387,1,0,09000064807c7038 FDA-2008-N-0578-0004,FDA,FDA-2008-N-0578,Pediatric Ethics Subcommittee; Amendment of Notice,Notice,N-Notice,2008-11-28T05:00:00Z,2008,11,2008-11-28T05:00:00Z,,2008-12-20T16:21:02Z,E8-28382,0,0,09000064807c39f6 FDA-2008-N-0595-0001,FDA,FDA-2008-N-0595,Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study: Toll-Free Number for Consumer Reporting of Drug Product Side Effects in Direct-to-Consumer Television Advertisements for Prescription Drugs,Notice,N-Notice,2008-11-26T05:00:00Z,2008,11,2008-11-26T05:00:00Z,2009-01-27T04:59:59Z,2008-12-20T16:21:01Z,E8-28065,0,0,09000064807c1010 FDA-2008-D-0597-0001,FDA,FDA-2008-D-0597,Draft Guidance for Industry: Small Entities Compliance Guide for Renderers--Substances Prohibited From Use in Animal Food or Feed; Availability,Notice,NAD-Notice of Availability of Data,2008-11-26T05:00:00Z,2008,11,2008-11-26T05:00:00Z,2009-01-27T04:59:59Z,2008-12-20T16:30:45Z,E8-28189,0,0,09000064807c0fd7 FDA-2008-N-0162-0007,FDA,FDA-2008-N-0162,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements,Notice,N-Notice,2008-11-26T05:00:00Z,2008,11,2008-11-26T05:00:00Z,,2008-12-20T16:29:06Z,E8-28064,0,0,09000064807c10cd FDA-2008-N-0038-0089,FDA,FDA-2008-N-0038,Sex Differences in the Cardiovascular Device Trials; Public Workshop,Notice,NM-Notice of Meeting,2008-11-26T05:00:00Z,2008,11,2008-11-26T05:00:00Z,,2008-12-20T16:29:58Z,E8-28169,0,0,09000064807c0fed FDA-2008-D-0588-0001,FDA,FDA-2008-D-0588,Compliance Policy Guide Sec. 540.700 Processed and/or Blended Seafood Products (CPG 7108.16); Availability,Notice,NAD-Notice of Availability of Data,2008-11-25T05:00:00Z,2008,11,2008-11-25T05:00:00Z,,2020-05-14T17:56:30Z,E8-27969,0,0,09000064807bf098 FDA-1999-N-2439-0003,FDA,FDA-1999-N-2439,FDA,Notice,NCR-Notice of Correction,2008-11-24T05:00:00Z,2008,11,2008-11-24T05:00:00Z,,2008-11-24T20:55:54Z,,0,0,09000064804f0462 FDA-1999-N-2439-0001,FDA,FDA-1999-N-2439,FDA,Notice,NM-Notice of Meeting,2008-11-24T05:00:00Z,2008,11,2008-11-24T05:00:00Z,1999-05-12T03:59:59Z,2008-11-24T20:52:32Z,,0,0,09000064804f0461 FDA-2008-D-0592-0001,FDA,FDA-2008-D-0592,Draft Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability,Notice,NAD-Notice of Availability of Data,2008-11-24T05:00:00Z,2008,11,2008-11-24T05:00:00Z,2009-01-24T04:59:59Z,2009-01-27T18:39:41Z,E8-27896,0,0,09000064807bd57c FDA-2007-N-0474-0001,FDA,FDA-2007-N-0474,Debarment Orders: George Kindness,Notice,NFR-Notice of Final Rule,2008-11-24T05:00:00Z,2008,11,,,2008-12-21T02:07:01Z,E8-27802,0,0,09000064807bd6cd FDA-2007-N-0488-0001,FDA,FDA-2007-N-0488,"Debarment Orders: Roy Page, M.D.",Notice,NFR-Notice of Final Rule,2008-11-24T05:00:00Z,2008,11,,,2008-12-21T02:06:53Z,E8-27803,0,0,09000064807bd6b3 FDA-2008-N-0589-0001,FDA,FDA-2008-N-0589,"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Mental Models Study of Health Care Providers Understanding of Prescription Drug Effectiveness",Notice,N-Notice,2008-11-24T05:00:00Z,2008,11,2008-11-24T05:00:00Z,2009-01-24T04:59:59Z,2008-12-20T16:21:01Z,E8-27801,0,0,09000064807bd65b FDA-2008-P-0029-0004,FDA,FDA-2008-P-0029,"Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,N-Notice,2008-11-21T05:00:00Z,2008,11,,,2008-12-20T16:20:55Z,E8-27714,0,0,09000064807b6f10 FDA-2008-N-0038-0088,FDA,FDA-2008-N-0038,Oncologic Drugs Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2008-11-21T05:00:00Z,2008,11,,,2008-12-20T16:29:58Z,E8-27713,0,0,09000064807b6edc FDA-1998-D-0560-0001,FDA,FDA-1998-D-0560,Food and Drug Administration Modernization Act of 1997; Establishment of Public Dockets; Section 112 Fast Track Products,Notice,N-Notice,2008-11-19T05:00:00Z,2008,11,2008-11-19T05:00:00Z,,2008-11-20T00:17:45Z,,0,0,090000648059b701 FDA-1998-D-0147-0001,FDA,FDA-1998-D-0147,Food and Drug Administration Modernization Act of 1997; Establishment of Public Dockets; Section 118 Data Requirements for Drugs & Biologics,Notice,N-Notice,2008-11-19T05:00:00Z,2008,11,2008-11-19T05:00:00Z,,2008-11-19T23:21:40Z,,0,0,090000648058a9ba FDA-1998-D-0869-0001,FDA,FDA-1998-D-0869,Food and Drug Administration Modernization Act of 1997; Establishment of Public Dockets; Section 122 Radiopharmaceuticals,Notice,N-Notice,2008-11-19T05:00:00Z,2008,11,2008-11-19T05:00:00Z,,2008-11-19T23:37:36Z,,0,0,09000064805a1078 FDA-2008-N-0526-0001,FDA,FDA-2008-N-0526,"Global Harmonization Task Force, Study Group 1; Proposed Document Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer",Notice,NAD-Notice of Availability of Data,2008-11-19T05:00:00Z,2008,11,2008-11-19T05:00:00Z,2009-02-18T04:59:59Z,2009-02-19T14:23:14Z,E8-27466,0,0,09000064807b1539 FDA-2008-N-0571-0001,FDA,FDA-2008-N-0571,"Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicous Mark of Manufacturers on Single-Use Devices (formerly ""Reprocessed Single-Use Device Labeling"")",Notice,N-Notice,2008-11-18T05:00:00Z,2008,11,2008-11-18T05:00:00Z,2009-01-17T04:59:59Z,2024-11-12T04:25:39Z,,1,0,09000064807b0083 FDA-2008-N-0038-0087,FDA,FDA-2008-N-0038,Meetings: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee,Notice,NM-Notice of Meeting,2008-11-18T05:00:00Z,2008,11,2008-11-18T05:00:00Z,,2008-12-20T16:29:59Z,E8-27255,0,0,09000064807af8df FDA-2008-N-0397-0003,FDA,FDA-2008-N-0397,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,N-Notice,2008-11-18T05:00:00Z,2008,11,2008-11-18T05:00:00Z,,2008-12-20T16:25:34Z,E8-27258,0,0,09000064807af963 FDA-2008-D-0559-0001,FDA,FDA-2008-D-0559,"Industry on Process Validation, Draft Guidance; Availability: General Principles and Practices",Notice,NAD-Notice of Availability of Data,2008-11-18T05:00:00Z,2008,11,2008-11-18T05:00:00Z,2009-01-22T04:59:59Z,2009-01-27T19:14:18Z,E8-27321,0,0,09000064807af91e FDA-2008-E-0111-0006,FDA,FDA-2008-E-0111,Determination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT,Notice,N-Notice,2008-11-18T05:00:00Z,2008,11,2008-11-18T05:00:00Z,2009-01-17T04:59:59Z,2024-11-07T22:00:28Z,,1,0,09000064807b01d3 FDA-1978-N-1542-0043,FDA,FDA-1978-N-1542,"GRAS Status of Whey, Whey Products & Hydrogen Peroxide",Notice,Notice of Final Rule,2008-11-17T05:00:00Z,2008,11,2008-11-17T05:00:00Z,,2020-02-06T13:14:57Z,81-25547,0,0,090000648059bcd2 FDA-1978-N-1542-0047,FDA,FDA-1978-N-1542,"GRAS Status of Whey, Whey Products & Hydrogen Peroxide; Correction",Notice,Correction,2008-11-17T05:00:00Z,2008,11,2008-11-17T05:00:00Z,,2020-02-06T13:19:18Z,82-4294,0,0,090000648059bcd4 FDA-1978-N-1542-0029,FDA,FDA-1978-N-1542,"Whey, Whey Products and Hydrogen Peroxide Affirmation of GRAS Status as Direct Human Food Ingredients; Extension of Comment Period",Notice,Notice of Extension,2008-11-16T05:00:00Z,2008,11,2008-11-16T05:00:00Z,1979-09-21T03:59:59Z,2020-04-08T16:31:10Z,79-28788,0,0,090000648059bcc5 FDA-1997-N-0398-0006,FDA,FDA-1997-N-0398,"Medical Devices; Reconditioners, Rebuilder of Medical Devices; Revocation of Compliance Policy Guide; Request for Comments",Notice,N-Notice,2008-11-15T05:00:00Z,2008,11,2008-11-15T05:00:00Z,,2008-11-15T22:07:17Z,,0,0,09000064805d41ac FDA-1998-P-0074-0007,FDA,FDA-1998-P-0074,Grated Parmesan Cheese Deviating From Identity Standard; Temporary Permit for Market Testing; Extension of Temporary Permit,Notice,NEC-Notice of Extension,2008-11-15T05:00:00Z,2008,11,2008-11-15T05:00:00Z,,2011-08-01T17:25:04Z,,0,0,0900006480583fae FDA-1999-N-0083-0002,FDA,FDA-1999-N-0083,FDA,Notice,NM-Notice of Meeting,2008-11-15T05:00:00Z,2008,11,2008-11-15T05:00:00Z,,2008-11-15T19:48:37Z,,0,0,09000064804a6983 FDA-1998-P-0074-0006,FDA,FDA-1998-P-0074,Grated Parmesan Cheese Deviating From Identity Standard; Temporary Permit for Market Testing,Notice,NTP-Notice of Temporary Permit,2008-11-15T05:00:00Z,2008,11,2008-11-15T05:00:00Z,1999-07-07T03:59:59Z,2008-11-15T18:59:08Z,,0,0,0900006480583f64 FDA-2008-N-0578-0001,FDA,FDA-2008-N-0578,Pediatric Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2008-11-14T05:00:00Z,2008,11,2008-11-14T05:00:00Z,2008-12-03T04:59:59Z,2008-11-14T13:23:05Z,E8-27117,0,0,09000064807a8f23 FDA-2008-N-0578-0002,FDA,FDA-2008-N-0578,Pediatric Ethics Subcommittee; Notice of Meeting,Notice,NM-Notice of Meeting,2008-11-14T05:00:00Z,2008,11,2008-11-14T05:00:00Z,2008-12-03T04:59:59Z,2008-11-28T12:54:30Z,E8-27118,0,0,09000064807a8f45 FDA-2008-N-0038-0086,FDA,FDA-2008-N-0038,Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2008-11-13T05:00:00Z,2008,11,,,2008-11-13T13:09:39Z,E8-26965,0,0,09000064807a6f2b FDA-2008-N-0556-0001,FDA,FDA-2008-N-0556,Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products,Notice,60 Day Proposed Information Collection,2008-11-13T05:00:00Z,2008,11,2008-11-13T05:00:00Z,2009-01-13T04:59:59Z,2015-02-20T23:02:32Z,E8-27008,0,0,09000064807a6e8c FDA-2008-N-0574-0001,FDA,FDA-2008-N-0574,Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans; Availability,Notice,NAD-Notice of Availability of Data,2008-11-13T05:00:00Z,2008,11,2008-11-13T05:00:00Z,2009-01-13T04:59:59Z,2008-11-13T12:49:04Z,E8-26869,0,0,09000064807a6ebe FDA-2008-N-0581-0001,FDA,FDA-2008-N-0581,Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representative on Public Advisory Committees,Notice,N-Notice,2008-11-13T05:00:00Z,2008,11,,,2008-11-13T13:04:42Z,E8-26963,0,0,09000064807a6f13 FDA-2004-P-0205-0016,FDA,FDA-2004-P-0205,"Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis",Notice,NCR-Notice of Correction,2008-11-12T05:00:00Z,2008,11,,,2008-11-12T12:40:52Z,E8-26868,0,0,09000064807a4d66 FDA-2008-N-0345-0004,FDA,FDA-2008-N-0345,"Agency Information Collection Activities; Proposals, Submissions, and Approvals",Notice,N-Notice,2008-11-12T05:00:00Z,2008,11,,,2008-11-12T13:34:49Z,E8-26863,0,0,09000064807a4e21 FDA-2008-N-0039-0079,FDA,FDA-2008-N-0039,Approval of Original Abbreviated New Animal Drug Application; Phenylbutazone Tablets,Notice,Notice of Approval,2008-11-12T05:00:00Z,2008,11,,,2013-07-09T19:53:18Z,E8-26793,0,0,09000064807a4da6 FDA-2004-D-0375-0018,FDA,FDA-2004-D-0375,Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff; ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300,Notice,N-Notice,2008-11-10T05:00:00Z,2008,11,2008-11-10T05:00:00Z,,2008-11-10T13:10:18Z,E8-26828,0,0,09000064807a13df FDA-2007-E-0229-0006,FDA,FDA-2007-E-0229,Determination of Regulatory Review Period for Purposes of Patent Extension; TYKERB,Notice,N-Notice,2008-11-10T05:00:00Z,2008,11,2008-11-10T05:00:00Z,2009-01-10T04:59:59Z,2008-11-12T17:20:22Z,E8-26679,0,0,09000064807a13a5 FDA-2008-E-0093-0006,FDA,FDA-2008-E-0093,Determination of Regulatory Review Period for Purposes of Patent Extension; IXEMPRA,Notice,N-Notice,2008-11-10T05:00:00Z,2008,11,2008-11-10T05:00:00Z,2009-01-10T04:59:59Z,2008-11-10T13:02:42Z,E8-26678,0,0,09000064807a13b2 FDA-2007-D-0487-0001,FDA,FDA-2007-D-0487,Draft Compliance Policy Guide; ``Sec. 110.310 Prior Notice of Availability,Notice,NAD-Notice of Availability of Data,2008-11-07T05:00:00Z,2008,11,2008-11-07T05:00:00Z,2008-12-09T04:59:59Z,2008-11-10T20:55:06Z,E8-26281,0,0,090000648079c492 FDA-2003-D-0435-0023,FDA,FDA-2003-D-0435,See FDA-2007-0487,Notice,,2008-11-07T00:00:00Z,2008,11,,,2009-03-10T20:58:34Z,,0,1,090000648079ca0a FDA-2008-N-0567-0001,FDA,FDA-2008-N-0567,Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing,Notice,NHC-Notice of Hearing Before Commissioner,2008-11-06T05:00:00Z,2008,11,2008-11-06T13:23:36Z,2009-02-07T04:59:59Z,2008-11-06T13:41:34Z,E8-26528,0,0,0900006480797b39 FDA-2004-E-0081-0007,FDA,FDA-2004-E-0081,Determination of Regulatory Review Period for Purposes of Patent Extension; S8 OVER-THE WIRE SYSTEM - Federal Register Notice,Notice,N-Notice,2008-11-06T05:00:00Z,2008,11,2008-11-06T05:00:00Z,2007-04-25T03:59:59Z,2008-11-06T12:58:48Z,,0,0,090000648046edc8 FDA-1997-E-0063-0006,FDA,FDA-1997-E-0063,Determination of Review Period for Purposes of Patent Extenison - RETEVASE - Federal Register Notice,Notice,General Notice,2008-11-05T05:00:00Z,2008,11,2008-11-05T05:00:00Z,2007-05-30T03:59:59Z,2024-09-23T19:28:26Z,,0,0,09000064805d033e FDA-2008-N-0038-0083,FDA,FDA-2008-N-0038,Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2008-11-04T05:00:00Z,2008,11,2008-11-04T05:00:00Z,,2008-11-04T13:45:13Z,E8-26230,0,0,090000648079396e FDA-2008-N-0038-0085,FDA,FDA-2008-N-0038,Antiviral Drugs Advisory Committee; Notice of Meeting,Notice,NM-Notice of Meeting,2008-11-04T05:00:00Z,2008,11,2008-11-04T05:00:00Z,,2008-11-04T13:55:29Z,E8-26244,0,0,0900006480793998