| Monday | Tuesday | Wednesday | Thursday | Friday |
| 10/26 | 10/27 | 10/28 | 10/29 (Updated 10/30) | 10/30 |
| 10/19 | 10/20 | 10/21 | 10/22 | 10/23 |
| N/A | 10/13 | 10/14 (Updated 10/19) | 10/15 (Updated 10/19) | 10/16 |
| 10/5 | 10/6 | 10/7 | 10/8 | 10/9 |
| 10/1 | 10/2 |
| 10/30/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 103098co.pdf | 103098co.txt | ||||
| 98N-0331 | Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; FDAMA Third-Party Review | OC | Notice | 58397 | 103098a.pdf | 103098a.txt |
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
|---|---|---|---|---|---|---|
| Table of Contents | 102998co.pdf | 102998co.txt | ||||
| 98N-0877 | Medical Devices; Performance Standards for Dental and Mammographic X-Ray Devices; Amendment | CDRH | Proposed Rule | 57957 | 102998a.pdf | 102998a.txt |
| 98N-0718 76N-0377 | Eli Lilly & Co. And Bristol-Myers Squibb Co.; Withdrawal of Approval of Three New Drug Applications for Estrogen-Androgen Combination Drugs | CDER | Notice | 58053 | 102998b.pdf | 102998b.txt |
| Biological Response Modifiers Advisory Committee; Notice of Meeting | CBER | Notice | 58053 | 102998b.pdf | 102998c.txt | |
| Oncologic Drugs Advisory Committee; Notice of Meeting | CDER | Notice | 58054 | 102998c.pdf | 102998d.txt | |
| Product and Clinical Development of Tumor Vaccines; Public Workshop | CBER | Notice | 58054 | 102998c.pdf | 102998e.txt | |
| Vaccines and Related Biological Products Advisory Committee; Notice of Meeting | CBER | Notice | 58055 | 102998d.pdf | 102998f.txt | |
| 97N-0451 | Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Frutis and Vegetables; Availability | CFSAN | Notice | 58055 | 102998d.pdf | 102998g.txt |
| Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Frutis and Vegetables | Guidance for Industry | 970451gd.pdf | ||||
| 97N-0217 | Proposals to Increase the Legal Availability of Animal Drugs for Minor Species and Minor Uses; Availability | CVM | Notice | 58056 | 102998e.pdf | 102998h.txt |
| PROPOSALS TO INCREASE THE LEGAL AVAILABILITY OF ANIMAL DRUGS FOR MINOR SPECIES AND MINOR USESADAA Minor Use/Minor Species Working Group Report 19 August 1998 | Working Group Report | di1020co.pdf |
| 10/28/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 102898co.pdf | 102898co.txt | ||||
| 97F-0388 | Food Additives Permitted For Direct Addition to Food For Human Consumption; Polydextrose | CFSAN | Final rule | 57596 | 102898a.pdf | 102898a.txt |
| 97N-0524 | Food Labeling: Warning and Notice Statement; Labeling of Juice Products; Technical Scientific Workshops; Requests for Additional Time to Achieve the Pathogen Reduction Standard | CFSAN | Technical scientific workshops | 57594 | 102898b.pdf | 102898b.txt |
| Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | CDRH | Notice | 57696 | 102898c.pdf | 102898c.txt | |
| 98D-0878 | Global Harmonization Task Force: Essential Principles of Safety and Performance of Medical Devices on a Global Basis; Final Working Draft; Availability | CDRH | Notice. | 57697 | 102898d.pdf | 102898d.txt |
| Global Harmonization Task Force: Essential Principles of Safety and Performance of Medical Devices on a Global Basis; ; | Final Working Draft | 980878gd.pdf | ||||
| 10/27/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 102798co.pdf | 102798co.txt | ||||
| NADA 48-761 | New Animal Drugs for Use in Animal Feeds; Chlortetracycline | CVM | Final Rule | 57245 | 102798a.pdf | 102798a.txt |
| NADA 140-947 | New Animal Drugs for Use in Animal Feeds; Narasin and Nicarbazin With Lincomycin | CVM | Final Rule | 57248 | 102798b.pdf | 102798b.txt |
| 10/26/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 102698co.pdf | 102698co.txt | ||||
| 97N-0199 | General and Plastic Surgery Devices: Reclassification of the Tweezer-Type Epilator | CDRH | Final Rule | 57059 | 102698a.pdf | 102698a.txt |
| 97N-0022 | Agency Information Collection Activities; Submission for OMB Review; Comment Request; Hearing Aid Devices: Professional and Patient Package Labeling and Conditions for Sale | OC | Notice | 57127 | 102698b.pdf | 102698b.txt |
| 10/23/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 102398co.pdf | 102398co.txt | ||||
| 98F-0433 | Indirect Food Additives: Adhesives and Components of Coatings | CFSAN | Final rule | 56786 | 102398a.pdf | 102398a.txt |
| 98F-0164 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers; Technical Amendment | CFSAN | Final rule; technical amendment | 56789 | 102398b.pdf | 102398b.txt |
| 77N-094A | Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-The-Counter Human Use; Final Rule for Professional Labeling of Aspirin, Buffered Aspirin, and Aspirin in Combination With Antacid Drug Products | CDER | Final rule | 56802 | 102398c.pdf | 102398c.txt |
| 77N-094W | Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use; Required Alcohol Warning | CDER | Final rule | 56789 | 102398d.pdf | 102398d.txt |
| 10/22/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 102298co.pdf | 102298co.txt | ||||
| 95N-0192 | Quality Mammography Standards; Correcting Amendment | CDRH | Final rule; correcting amendment. | 56555 | 102298a.pdf | 102298a.txt |
| 78N-0038 | Sunscreen Drug Products for Over-the-Counter Human Use; Amendment to the Tentative Final Monograph; Enforcement Policy | CDER | Notice of proposed rulemaking | 56584 | 102298b.pdf | 102298b.txt |
| 10/21/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 102198co.pdf | 102198co.txt | ||||
| 98D-0143 | Agency Emergency Processing Request Under OMB Review | OC | Notice | 56192 | 102198a.pdf | 102198a.txt |
| 98N-0811 | Agency Emergency Processing Request Under OMB Review | OC | Notice | 56195 | 102198b.pdf | 102198b.txt |
| 98F-0893 | Great Lakes Chemical Corp. ; Filing of Food Additive Petition | CFSAN | Notice | 56197 | 102198c.pdf | 102198c.txt |
| 98N-0194 | Agency Information Collection Activities; Announcement of OMB Approval; Registration of Cosmetic Product Establishment | OC | Notice | 56197 | 102198c.pdf | 102198d.txt |
| Antibody to Human T–Cell Lymphotropic Virus Type II (HTLV-11) Reference Panel 1; Availability | CBER | Notice | 56197 | 102198c.pdf | 102198e.txt | |
| 98D-0814 | “Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Test for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV; ” Availability | CBER | Notice | 56198 | 102198d.pdf | 102198f.txt |
| “Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Test for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV; ” | Guidance for Industry | 980814GD.PDF | ||||
| 10/20/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 102098co.pdf | 102098co.txt | ||||
| 98F-0390 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | CFSAN | Final rule | 55945 | 102098a.pdf | 102098a.txt |
| 98F-0292 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | CFSAN | Final rule | 55944 | 102098b.pdf | 102098b.txt |
| 96F-0107 | Indirect Food Additives: Polymers | CFSAN | Final rule | 55942 | 102098c.pdf | 102098c.txt |
| 98F-0894 | Ecolab Inc.; Filing of Food Additive Petition | CFSAN | Notice | 56035 | 102098d.pdf | 102098d.txt |
| 96G-0413 | Vulcan Chemical Technologies, Inc.; Withdrawal of GRAS Affirmation Petition | CFSAN | Notice | 56035 | 102098d.pdf | 102098e.txt |
| 97-0269 | Determination of Regulatory Review Period for Purposes of PatentExtension; Aldara (5,238,944) | OC | Notice | 56035 | 102098d.pdf | 102098f.txt |
| 10/19/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 101998co.pdf | 101998co.txt | ||||
| 98P-0086 | Determination That Sutilains Ointment USP Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | CDER | Notice | 55873 | 101998a.pdf | 101998a.txt |
| 98N-0864 | Privacy Act of 1974; Altered System of Records, Including Addition of Routine Use(s) to an Existing System of Records | ORA | Notice | 55873 | 101998a.pdf | 101998b.txt |
| 97N-0135 | Agency Information Collection Activities; Announcement of OMB Approval; OTC Test Sample Collection Systems for Drugs of Abuse Testing | OC | Notice | 55876 | 101998b.pdf | 101998c.txt |
| 98D-0514 | Draft Guidance for Industry on ANDA’s: Impurities in Drug Substances; Availability; Reopening of Comment Period | CDER | Notice; reopening of comment period. | 55876 | 101998b.pdf | 101998d.txt |
| 10/16/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 101698co.pdf | 101698co.txt | ||||
| 98N-0182 | List of Bulk Drug Substances That May Be Used in Pharmacy Compounding;Preliminary Draft Proposed Rule; Availability | CDER | Draft Proposed rule | 55564 | 101698a.pdf | 101698a.txt |
| List of Bulk Drug Substances That May Be Used in Pharmacy Compounding;Preliminary Draft Proposed Rule; | 980182np.pdf | |||||
| 77N-0240 | Erythrityl Tetranitrate; Drug Efficacy Study Implementation; Withdrawal of Approval of Abbreviated New Drug Applications | CDER | Notice | 55616 | 101698b.pdf | 101698b.txt |
| 97D-0530 | FDA Modernization Act of 1997: Modifications to the List of Recognized Standards; Availability; Withdrawal of Draft Guidance “Use of lEC 60601 Standards; Medical Electrical Equipment” | CDRH | Notice | 55617 | 101698c.pdf | 101698c.txt |
| 10/15/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 101598co.pdf | 101598co.txt | ||||
| 97 E-0270 | Determination of Regulatory Review Period for Purposes of PatentExtension; Aldara (4,689,338) | OC | Notice | 55398 | 101598a.pdf | 101598a.txt |
| 98 D-0834 | Draft Guidance for Industry on Non-Contraceptive Estrogen Class Labeling; Availability | CDER | Notice | 5539 | 101598b.pdf | 101598b.txt |
| 98 D-0834 | Draft Guidance for Industry on Non-Contraceptive Estrogen Class Labeling | Draft Guidance | 980834gd.pdf | |||
| 10/14/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 101498co.pdf | 101498co.txt | ||||
| 98N-0040 | Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring; Extension of Comment Period | CBER CDER | Proposed rule | 55067 | 101498a.pdf | 101498a.txt |
| 98D-0785 | Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics; Availability | CBER CDER | Notice | 55067 | 101498a.pdf | 101498b.txt |
| 98D-0785 | Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics | Draft Guidance | 980785gd.pdf | |||
| 98N-0494 | Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Device Registration and Listing | OC | Notice | 55132 | 101498b.pdf | 101498c.txt |
| 98N-0147 | Agency Information Collection Activities; Announcement of OMB Approval; Access to Mammography Services Survey | OC | Notice | 55133 | 101498c.pdf | 101498d.txt |
| 10/13/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT file |
| Table of Contents | 101398co.pdf | 101398co.txt | ||||
| 97-0012 | Determination of Regulatory Review Period for Purposes of PatentExtension; Rimadyl | OC | Notice | 54716 | 101398a.pdf | 101398a.txt |
| 98F-0871 | Servo Deldon BV; Filing of Food Additive Petition | CFSAN | Notice | 54717 | 101398b.pdf | 101398b.txt |
| 98E-0489 | Determination of Regulatory Review Period for Purposes of PatentExtension; Corlopam | OC | Notice | 54718 | 101398c.pdf | 101398c.txt |
| 97E-0367 | Determination of Regulatory Review Period for Purposes of PatentExtension; Normiflo | OC | Notice | 54717 | 101398b.pdf | 101398d.txt |
| 97-0087 | Determination of Regulatory Review Period for Purposes of PatentExtension; Ray Threaded Fusion Cage | OC | Notice | 54719 | 101398d.pdf | 101398e.txt |
| 98-0230 | Determination of Regulatory Review Period for Purposes of PatentExtension; Wiktor Prime Coronary Stent System | OC | Notice | 54720 | 101398e.pdf | 101398f.txt |
| 10/9/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT file |
| Table of Contents | 100998co.pdf | 100998CO.TXT | ||||
| NADA 140-974 | New Animal Drugs For Use In Animal Feeds; Ivermectin | CVM | Final rule | 54352 | 100998a.pdf | 100998a.txt |
| 98N-0867 | Federal Food, Drug, and Cosmetic Act; implementation: Antimicrobial substances use; legal and policy interpretation | CFSAN | Notice | 54532 | 100998b.pdf | 100998b.txt |
| 97-0293 | Determination of Regulatory Review Period for Purposes of PatentExtension; Skelid | OC | Notice | 54481 | 100998c.pdf | 100998c.txt |
| Antiviral Drugs Advisory Committee; Notice of Meeting | CDER | Notice | 54481 | 100998c.pdf | 100998d.txt | |
| 1998 FDA Science Forum on Biotechnology: Advances, Applications, and Regulatory Challenges | OC | Notice | 54482 | 100998d.pdf | 100998e.txt | |
| National Consumer Forum; Notice of Meeting | OC | Notice | 54482 | 100998d.pdf | 100998f.txt | |
| 98N-0546 | Agency Information Collection Activities; Announcement of OMB Approval; Food Labeling Regulations | OC | Notice | 54482 | 100998d.pdf | 100998g.txt |
| 10/8/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT file |
| Table of Contents | 100898co.pdf | 100898co.txt | ||||
| 98N-0168 | Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review | CDRH | Final rule | 54042 | 100898a.pdf | 100898a.txt |
| 98N-0655 | List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | CDER | Proposed Rule | 54082 | 100898b.pdf | 100898b.txt |
| Active Pharmaceutical Ingredients (API) Seminar | ORA | Notice of meeting | 54142 | 100898c.pdf | 100898c.txt | |
| 10/7/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 100798co.pdf | 100798co.txt | ||||
| 98N-0753 | Dental Products Devices; Reclassification of Endosseous Dental Implant Accessories | CDRH | Proposed rule | 53859 | 100798a.pdf | 100798a.txt |
| 10/6/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 100698co.pdf | 100698co.txt | ||||
| NADA 140-890 | Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Hydrochloride Sterile Suspension | CVM | Final rule | 53578 | 100698a.pdf | 100698a.txt |
| 97F-0522 | Food Additives Permitted in Feed and Drinking Water of Animals; Formaldehyde | CVM | Final rule | 53579 | 100698b.pdf | 100698b.txt |
| ANADA 200–256 | Implantation or Injectable Dosage Form New Animal Drugs; Iron Dextran Injection | CVM | Final rule | 53577 | 100698c.pdf | 100698c.txt |
| 98N-0721 | Agency Information Collection Activities: Proposed Collection; Comment Request; Premarket Approval of Medical Devices | OC | Notice | 53675 | 100698d.pdf | 100698d.txt |
| 98N-0364 | Agency Information Collection Activities; Submission for OMB Review; comment Request; Reporting and Recordkeeping for Electronic Products: Specific Product Requirements | OC | Notice | 53677 | 100698e.pdf | 100698e.txt |
| 98F-0824 | BASF Corp.; Filing of Food Additive Petition | CFSAN | Notice | 53679 | 100698f.pdf | 100698f.txt |
| 98F-0825 | Dover Chemical Corp. ; Filing of Food Additive Petition | CFSAN | Notice | 53679 | 100698f.pdf | 100698g.txt |
| 98F-0823 | The Dow Chemical Co. ; Filing of Food Additive Petition | CFSAN | Notice | 53679 | 100698f.pdf | 100698h.txt |
| National Mammography Quality Assurance Advisory Committee; Notice of Meeting | CDRH | Notice | 53680 | 100698g.pdf | 100698i.txt | |
| 10/5/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 100598co.pdf | 100598co.txt | ||||
| 96N-0512 | Hoechst Marion Roussel, Inc., and Baker Norton Pharmaceuticals, Inc.; Terfenadine; Withdrawal of Approval of Two New Drug Applications and One Abbreviated New Drug Application | CDER | Notice | 53444 | 100598a.pdf | 100598a.txt |
| Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | CDRH | Notice | 53445 | 100598b.pdf | 100598b.txt | |
| Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | CDRH | Notice | 53445 | 100598b.pdf | 100598c.txt | |
| 10/2/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 100298co.pdf | 100298co.txt | ||||
| NADA 141-035 | Oral Dosage Form New Animal Drugs; Lufenuron Tablets | CVM | Final rule | 52968 | 100298a.pdf | 100298a.txt |
| NADA 140-937 | New Animal Drugs For Use In Animal Feeds; Monensin and Bacitracin Methylene Disalicylate | CVM | Final rule | 52969 | 100298b.pdf | 100298b.txt |
| NADA 141-011 | New Animal Drugs For Use In Animal Feeds; Tiamulin and Chlortetracycline | CVM | Final rule | 52968 | 100298a.pdf | 100298c.txt |
| Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | CDRH | Notice | 53060 | 100298c.pdf | 100298d.txt | |
| 98D-0713 | Draft Guidance for Industry on Submitting Debarment Certification Statements; Availability | CDER | Notice | 53060 | 100298c.pdf | 100298e.txt |
| Draft Guidance for Industry on Submitting Debarment Certification Statements | Draft Guidance | 980713gd.pdf | ||||
| 10/1/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 100198co.pdf | 100198co.txt | ||||
| 98N-0776 | Food and Drug Administration Modernization Act of 1997; Allergenic Patch Test Kits; Request for Comments or Data | CBER | Notice | 52740 | 100198a.pdf | 100198a.txt |
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