| Monday | Tuesday | Wednesday | Thursday | Friday |
| 8/31 | ||||
| 8/24 | 8/25 | 8/26 | 8/27 | 8/28 |
| 8/17 | 8/18 | 8/19 | 8/20 | N/A |
| N/A | 8/11 | N/A | 8/13 | N/A |
| 8/3 | 8/4 | 8/5 | 8/6 | 8/7 |
| 8/31/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 083198co.pdf | 083198co.txt | ||||
| 96N-0119 | Natural Rubber-Containing Medical Devices; User Labeling; Cold Seal Adhesives Partial Stay | CDRH | Final rule | 46174 | 083198a.pdf | 083198a.txt |
| 96N-0119 | Amended Economic Impact Analysis of Final Rule Requiring Use of Labeling on Natural Rubber Containing Devices | Final rule; amended economic analysis statement. | 46171 | 083198b.pdf | 083198b.txt | |
| 98F-0714 | Asahi Denka Kogyo K,K.; Filing of Food Additive Petition | CFSAN | Notice | 46226 | 083198c.pdf | 083198c.txt |
| 98F-0716 | Dainippon Ink and Chemicals, Inc. ; Filing of Food Additive Petition | CFSAN | Notice | 46226 | 083198d.pdf | 083198d.txt |
| General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | CDRH | Notice | 46227 | 083198e.pdf | 083198e.txt | |
| 98D-0646 | Global Harmonization Task Force: Draft Documents on Adverse Event and Vigilance Reporting of Medical Device Events; Availability | CDRH | Notice | 46227 | 083198f.pdf | 083198f.txt |
| “Comparison of Device Adverse Report Systems” (SG2–N6) | 98646gd.pdf | |||||
| “Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices” (SG2–N8) | 98646gda.pdf | |||||
| “Global Medical Devices Vigilance Report (Form and Instructions)” (S(32-N9) | 98646gdb.pdf | |||||
| ‘Precis” (Vigilance and Postmarked Surveillance) (SG2-N1 2) | 98646gdc.pdf | |||||
| “Adverse Event Reporting Guidelines for Manufacturers” (SG–N21) | 98646gdd.pdf | |||||
| 8/28/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 082898co.pdf | 082898co.txt | ||||
| ANADA 200-118 | Oral Dosage Form New Animal Drugs; Neomycin Sulfate Soluble Powder and Oral Solution | CVM | Final rule | 45944 | 082898a.pdf | 082898a.txt |
| NADA 9-576 | Implantation or Injectable Dosage Form New Animal Drugs; Progesterone and Estradiol Benzoate | CVM | Final rule | 45945 | 082898b.pdf | 082898b.txt |
| ANADA 200–248 | Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Suspension | CVM | Final rule | 45944 | 082898c.pdf | 082898c.txt |
| 95C-0399 | Listing of Color Additives for Coloring Sutures; D&C Violet No. 2; Confirmation of Effective Date | CFSAN | Final rule; confirmation of effective date. | 45943 | 082898d.pdf | 082898d.txt |
| 97F-0213 | Asahi Denka Kogyo K.K.; Filing of Food Additive Petition;Amendment | CFSAN | Notice | 46053 | 082898e.pdf | 082898e.txt |
| 96F-0248 | Life Technologies, Inc.; Filing of Food Additive Petition;Amendment | CFSAN | Notice | 46053 | 082898f.pdf | 082898f.txt |
| Advisory Committee Meeting; Amendment of Notice | CDRH | Notice | 46054 | 082898g.pdf | 082898g.txt | |
| 97N-0424 | Agency Information Collection Activities; Announcement of OMB Approval; Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | OC | Notice | 46054 | 082898g.pdf | 082898h.txt |
| 8/27/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 082798co.pdf | 082798co.txt | ||||
| 98F-0057 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | CFSAN | Final rule | 45715 | 082798a.pdf | 082798a.txt |
| 98N-0170 | Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting | CDRH | Direct final rule; withdrawal | 45716 | 082798b.pdf | 082798b.txt |
| 98F-0706 | BASF Corp.; Filing of Food Additive Petition | CFSAN | Notice | 45820 | 082798c.pdf | 082798c.txt |
| 98F-0705 | Ciba Specialty Chemicals Corp.; Filing of Food Additive Petition | CFSAN | Notice | 45820 | 0892798d.pdf | 0892798d.txt |
| 98N-0645 | Medical Device Warning Letter Draft Pilot; Availability | ORA CDRH | Notice | 45821 | 082798e.pdf | 082798e.txt |
| Nonprescription Drugs Advisory Committee; Notice of Meeting | CDER | Notice | 45825 | 082798f.pdf | 082798f.txt | |
| 97N–0074 | President’s National Food Safety Initiative | CFSAN | Notice: public meeting;establishment of public dockets. | 45921 | 082798g.pdf | 082798g.txt |
| 97N-0488 | Agency Information Collection Activities; 1998 and Year 2000 Update of a National Survey of Prescription Drug Information Provided to Patients; Announcement of OMB Approval | OC | Notice | 45826 | 082798h.pdf | 082798h.txt |
| 98D-0693 | Draft "Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test"; Availalbility | CBER | Notice | 45826 | 082798i.pdf | 082798i.txt |
| Draft "Guidance for Industry: On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test" | Draft Guidance | 980693gd.pdf | ||||
| 98D-0307 | Draft Guidance for Industry; Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996; Extension of Comment Period | OC | Notice; extension of comment period. | 45827 | 082798j.pdf | 082798j.txt |
| 98D-0697 | Compliance Guidance: The Mammography Quality Standards Act Final Regulations Draft; Availability | CDRH | Notice | 45828 | 082798k.pdf | 082798k.txt |
| Compliance Guidance: The Mammography Quality Standards Act Final Regulations Draft | Compliance Guidance | 980697gd.pdf | ||||
| 8/26/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 082698co.pdf | 082698co.txt | ||||
| 98N-0044 | Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Extension of Comment Period | CFSAN | Proposed Rule; Extension of Comment Period | 45427 | 082698a.pdf | 082698a.txt |
| Bioresearch Monitoring: Public Workshop | ORA | Notice of public workshop. | 45511 | 082698b.pdf | 082898b.txt | |
| 8/25/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 082598co.pdf | 082598co.txt | ||||
| 98F-0707 | Dover Chemical Corp. ; Filing of Food Additive Petition | CFSAN | Notice | 45248 | 082598a.pdf | 082598a.txt |
| Current Science and Technology on Sprouts | CFSAN | Notice of Meeting | 45248 | 082598b.pdf | 082598b.txt | |
| 8/24/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 44998 | 082498co.pdf | 082498co.txt | |||
| 98N-0636 | Status of Certain Additional Over-the-Counter Drug Category II and III Active Iingredients | CDER | Final rule | 44996 | 082498a.pdf | 082498a.txt |
| 96N-0320 | Radiology Devices; Classifications for Five Medical Image Management Devices; Correction | CDRH | Final rule; correction | 44998 | 082498b.pdf | 082498b.txt |
| 98C-0676 | Warner-Jenkinson Co., Inc. ; Filing of Color Additive Petition | CFSAN | Notice | 45073 | 082498c.pdf | 082498c.txt |
| 98F-0675 | The Dow Chemical Co.; Filing of Food Additive Petition | CFSAN | Notice | 45073 | 082498d.pdf | 082498d.txt |
| Arthritis Advisory Committee; Notice of Meeting | CBER | Notice | 45073 | 082498e.pdf | 082498e.txt | |
| Blood Products Advisory Committee; Notice of Meeting | CBER | Notice | 45074 | 082498f.pdf | 082498f.txt | |
| Medical Gas; Notice of Public Workshop | ORA | Notice of Public Workshop | 45074 | 082498g.pdf | 082498g.txt | |
| 98D-0362 | Draft Guidance for industry on Stabiiity Testing of Drug Substances and Drug Products; Availability; Extension of Comment Period | CDER | Notice; extension of comment period. | 45075 | 082498h.pdf | 082498h.txt |
| 8/20/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 082098co.pdf | 082098co.txt | ||||
| FDA Cares About Consumers: A Conversation With America; District Consumer Forum | ORA | Notice of meeting | 44626 | 082098a.pdf | 082098a.txt | |
| 98N-0339 | Public Meeting on Section 406(b) of the FDA Modernization Act of 1997 | OC | Notice of meeting | 44627 | 082098b.pdf | 082098b.txt |
| 98N-0339 | Public Meeting on Section 406(b) of the FDA Modernization Act of 1997 | OC | Notice of meeting | 44628 | 082098c.pdf | 082098c.txt |
| 8/19/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 081998co.pdf | 081998co.txt | ||||
| NADA 141-059 | New Animal Drugs For Use In Animal Feeds; Bacitracin Methylene Disalicylate and Chlortetracycline | CVM | Final rule. | 44385 | 081998a.pdf | 081998a.txt |
| NADA 141-034 | New Animal Drugs for Use in Animal Feeds; Bambermycins | CVM | Final rule. | 44386 | 081998b.pdf | 081998b.txt |
| NADA 141-107 | Implantation or Injectable Dosage Form New Animal Drugs; Beta-Aminopropionitrile Fumarate | CVM | Final rule. | 44381 | 081998c.pdf | 081998c.txt |
| NADA 141-044 | Implantation or Injectable Dosage Form New Animal Drugs; Deslorelin Acetate | CVM | Final rule. | 44382 | 081998d.pdf | 081998d.txt |
| ANADA 200-254 | Implantation or Injectable Dosage Form New Animal Drugs; Iron Hydrogenated Dextran Injection | CVM | Final rule. | 44384 | 081998e.pdf | 081998e.txt |
| ANADA 200-219 | Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution | CVM | Final rule. | 44384 | 081998f.pdf | 081998f.txt |
| NADA 8-622 | Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder | CVM | Final rule. | 44383 | 081998g.pdf | 081998g.txt |
| 98F-0674 | Dover Chemical Corp. ; Filing of Food Additive Petition | CFSAN | Notice | 44463 | 081998h.pdf | 081998h.txt |
| 8/18/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF File | TXT File |
| Table of Contents | 081898co.pdf | 081898co.txt | ||||
| 98N-0564 | Medical Devices; Effective Date of Requirement for Premarket Approval for Three Class Ill Preamendments Devices | CDRH | Proposed rule; opportunity to request a change in classification. | 44177 | 081898a.pdf | 081898a.txt |
| 8/17/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 081798co.pdf | 081798co.txt | ||||
| 98F-0055 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers. | CFSAN | Final Rule | 43874 | 081798a.pdf | 081798a.txt |
| 97F-0467 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers. | CFSAN | Final Rule | 43873 | 081798b.pdf | 081798b.txt |
| 98N-0392 | Irradiation in the Production, Processing and Handling of Food. | CFSAN | Final Rule | 43875 | 081798c.pdf | 081798c.txt |
| 94P-0110 95N-0245 | Agency Information Collection Activities; Announcement of OMB Approval. | OC | Notice | 43951 | 081798d.pdf | 081798d.txt |
| 98D-0565 | Off-the-Shelf Software Use in Medical Devices; Draft Guidance; Availability | CDRH | Notice | 43951 | 081798e.pdf | 081798e.txt |
| Off-the-Shelf Software Use in Medical Devices; Draft Guidance | Draft Guidance | 980565gd.pdf | ||||
| 8/13/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 081398co.pdf | 081398co.txt | ||||
| 81N-0201 | Pediculicide Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment | CDER | Final rule; technical amendment. | 43302 | 081398a.pdf | 081398a.txt |
| 98D-0389 | Agency Information Collection Activities: Proposed Collection; Comment Request; Notification of a Health Claim or a Nutrient Content Claim Based on an Authoritative Statement | OC | Notice | 43400 | 081398b.pdf | 081398b.txt |
| Joint Meeting of the Hematology and Pathology Devices Panel and the Immunology Devices Panel of the Medical Devices Advisory Committee; | CDRH | Notice of Meeting | 43401 | 081398c.pdf | 081398c.txt | |
| 97D-0153 | Guidance on Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies; Availability | CDRH | Notice | 43402 | 081398d.pdf | 081398d.txt |
| Guidance on Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies | Guidance | 970153gd.pdf | ||||
| 8/11/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 081198co.pdf | 081198co.txt | ||||
| 98N-0168 | Medical Devices--30-day notices and 135-day PMA supplement review | CDRH | Direct Final Rule | 42699 | 081198a.pdf | 081198a.txt |
| 98N-0144 | Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Public Workshop | CBER | Proposed rule | 42773 | 081198b.pdf | 081198b.txt |
| 98F-0522 | Rumentek Industries Pty Ltd.; Filing of Food Additive Petition (Animal Use); Formaldehyde | CVM | Notice | 42856 | 081198c.pdf | 081198c.txt |
| 97E-0357 | Determination of Regulatory Review Period for Purposes of PatentExtension; Fareston | OC | Notice | 42857 | 081198d.pdf | 081198d.txt |
| 8/7/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN page | PDF file | TXT file |
| Table of Contents | 080798co.pdf | 080798co.txt | ||||
| 98N-0439 | Medical Devices; Reports of Corrections and Removals | CDRH | Direct final rule | 42229 | 080798a.pdf | 080798a.txt |
| 98N-0439 | Medical Devices; Reports of Corrections and Removals; Companion to Direct Final Rule | CDRH | Proposed rule | 42300 | 080798b.pdf | 080798b.txt |
| 98N-0515 | Agency Information Collection Activities; Submission for OMB Review; Comment Request | OC | Notice | 42404 | 080798c.pdf | 080798c.txt |
| 97-0290 | Determination of Regulatory Review Period for Purposes of Patent Extension;Aqueous Aryl Fluorophosphite Suspension | OC | Notice | 42405 | 080798d.pdf | 080798d.txt |
| 98P-0220 | Determination That Acyclovir 200-Milligram Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | CDER | Notice | 42406 | 080798e.pdf | 080798e.txt |
| 97E-0464 | Determination of Regulatory Review Period for Purposes of Patent Extension;Mirapex | OC | Notice | 42407 | 080798f.pdf | 080798f.txt |
| 97E-0461 | Determination of Regulatory Review Period for Purposes of Patent Extension; Cook GRII Coronary Stent | OC | Notice | 42408 | 080798g.pdf | 080798g.txt |
| 8/6/98 | ||||||
|---|---|---|---|---|---|---|
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 080698co.pdf | 080698co.txt | ||||
| 98N-0294 | Beverages: Bottled Water | CFSAN | Direct Final Rule | 42197 | 080698a.pdf | 080698a.txt |
| Delegations of Authority and Organization; Office of the Commissioner | OC | Final Rule | 41959 | 080698b.pdf | 080698b.txt | |
| 98N-0320 | Agency Emergency Processing Request Under OMB Review Correction | OC | Notice | 42052 | 080698c.pdf | 080698c.txt |
| 98N-0294 | Bottled Water: Monitoring Requirements | CFSAN | Notice | 42199 | 080698d.pdf | 080698d.txt |
| Biotechnology Manufacturing Grassroots Meeting | CBER | Notice of meeting | 42052 | 080698e.pdf | 080698e.txt | |
| 98D-0389 | Agency Information Collection Activities; Announcement of OMB Approval | OC | Notice | 42053 | 080698f.pdf | 080698f.txt |
| 98D-0519 | Draft Modifications To Devices Subject To Premarket Approval—The PMA Supplement Decision Making Process; Availability | CDRH | Notice | 42053 | 080698g.pdf | 080698g.txt |
| Draft Modifications To Devices Subject To Premarket Approval—The PMA Supplement Decision Making Process; | CDRH | Draft Guidance | 980519gd.pdf | |||
| 8/5/98 | ||||||
|---|---|---|---|---|---|---|
| Docket | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table Of Contents | 080598co.pdf | 080598.txt | ||||
| 97N-0449 | Revisions to the General Safety Test Requirements for Biological Products | CBER | Direct final rule | 41718 | 080598a.pdf | 080598a.txt |
| 98F-0635 | General Electric Co.; Filing of Food Additive Petition | CFSAN | Notice | 41855 | 080598b.pdf | 080598b.txt |
| Clinical Studies of Safety and Effectiveness of Orphan Products; Availability of Grants; Request for Applications | OC | Notice | 41855 | 080598c.pdf | 080598c.txt | |
| 96-0270 | Determination of Regulatory Review Period for Purposes of Patent Extension; ETOPOPHOS | OC | Notice | 41859 | 080598d.pdf | 080598d.txt |
| 8/4/98 | ||||||
| Docket | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 080498co.pdf | 080498co.txt | ||||
| ANADA 200-180 | Implantation or Injectable Dosage Form New Animal Drugs; Ampicillin Trihydrate for Sterile Suspension | CVM | Final Rule | 41419 | 080498a.pdf | 080498a.txt |
| NADA 140-973 | Oral Dosage Form New Animal Drugs; Clenbuterol | CVM | Final Rule | 41419 | 080498b.pdf | 080498b.txt |
| 98N-0453 | Agency Information Collection Activities; Announcement of OMB Approval | OC | Notice | 41583 | 080498c.pdf | 080498c.txt |
| 98N-0331 | Agency Information Collection Activities; Proposed Collection; Comment Request | CDRH | Notice | 41575 | 080498d.pdf | 080498d.txt |
| 98N-0268 | Agency Information Collection Activities; Submission for OMB Review; Comment Request | OC | Notice | 41576 | 080498e.pdf | 080498e.txt |
| 97N-0535 | Agency Information Collection Activities; Submission for OMB Review; Comment Request | OC | Notice | 41577 | 080498f.pdf | 080498f.txt |
| 97E-0338 | Determination of Regulatory Review Period for Purposes of Patent Extension: Anipry1 | OC | Notice | 41578 | 080498g.pdf | 080498g.txt |
| 97-168 | Determination of Regulatory Review Period for Purposes of Patent Extension; BeneFIX | OC | Notice | 41579 | 080498h.pdf | 080498h.txt |
| 97-292 | Determination of Regulatory Review Period for Purposes of Patent Extension; AQUEOUS ARYL FLUOROPHOSPHITE SUSPENSION | OC | Notice | 41580 | 080498i.pdf | 080498i.txt |
| 97-152 | Determination of Regulatory Review Period for Purposes of Patent Extension; Dostinex Tablets | OC | Notice | 41581 | 080498j.pdf | 080498j.txt |
| 97E-0462 | Determination of Regulatory Review Period for Purposes of Patent Extension; Posicor | OC | Notice | 41582 | 080498k.pdf | 080498k.txt |
| 98N-0453 | Agency Information Collection Activities; Proposed Collection; Comment Request | OC | Notice | 41573 | 080498l.pdf | 080498l.txt |
| 98N-0331 | Agency Information Collection Activities; Announcement of OMB Approval | OC | Notice | 41583 | 080498m.pdf | 080498m.txt |
| 8/3/98 | ||||||
| Docket Number | Document Name | Center | Action | FRN Page | PDF file | TXT file |
| Table of Contents | 080398co.pdf | 080398co.txt | ||||
| NADA 141-063 | Animal Drugs, Feeds, and Related Products; Florfenicol Solution | CVM | Final rule | 41190 | 080398a.pdf | 080398a.txt |
| NADA 46-718 NADA 46-719 | New Animal Drugs For Use In Animal Feeds; Melengestrol Acetate and Oxytetracycline | CVM | Final rule | 41191 | 080398b.pdf | 080398b.txt |
| NADA 141-084 | Oral Dosage Form New Animal Drugs; Milbemycin Oxime/Lufenuron Tablets | CVM | Final rule | 41189 | 080398c.pdf | 080398c.txt |
| NADA 140-915 | Oral Dosage Form New Animal Drugs; Milbemycin Oxime Tablets | CVM | Final rule | 41188 | 080398d.pdf | 080398d.txt |
| NADA 135–773 | Animal Drugs, Feeds, and Related Products; Change of Sponsor | CVM | Final rule | 41188 | 080398e.pdf | 080398e.txt |
| Animal Drugs, Feeds, and Related Products; Change of Sponsor | CVM | Final rule | 41188 | 080398f.pdf | 080398f.txt | |
| 98 N-0040 | Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring; Extension of Comment Period | CBER | Proposed rule; extension of comment period. | 41219 | 080398g.pdf | 080398g.txt |
| 96E-0314 | Determination of Regulatory Review Period for Purposes of Patent Extension; GEMZAR | OC | Notice | 41263 | 080398h.pdf | 080398h.txt |
| District Consumer Forum; Notice of Meeting | ORA | Notice | 41225 | 080398i.pdf | 080398i.txt | |
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