| Monday | Tuesday | Wednesday | Thursday | Friday |
| N/A | 5/26 | 5/27 | 5/28 | 5/29 |
| 5/18 | 5/19 | 5/20 | 5/21 | 5/22 |
| 5/11 | 5/12 | 5/13 | 5/14 | 5/15 |
| 5/4 | 5/5 | 5/6 | 5/7 | 5/8 |
| 5/1 |
| 5/29/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 052998co.pdf | |||
| ANADA 200-230 | Implantation or Injectable Dosage Form NewAnimal Drugs; Guaifenesin Injection | Final rule. | 29352 | 052998a.pdf |
| NADA 140-915 | Oral Dosage Form New Animal Drugs;Milbemycin Oxime Tablet | Final rule. | 29351 | 052998b.pdf |
| Quality System Inspection Technique Meeting | Notice of meeting. | 29364 | 052998c.pdf | |
| 5/28/98 | ||||
|---|---|---|---|---|
| Docket Number | TODAYS FR Document Name | Action | FRN Page | File Name |
| Table of Contents | 052898co.pdf | |||
| 97F-0283 | Secondary Direct Food Additives Permitted in Foodfor Human Consumption; Monester ofalpha-Hydro-omega-Hydroxy-Poly(Oxyethylene) Poly(Oxypropylene) PoIy(Oxyethylene) (15 Mole Minimum) Blocked Copolymer | Final rule. | 29133 | 052898a.pdf |
| 96F-0489 | Indirect Food Additives: Polymers | Final rule. | 29135 | 052898b.pdf |
| 97N-0135 | Medical Devices; Hematology and Pathology Devices;Reclassification; Restricted Devices; OTC Test SampleCollection Systems for Drugs of Abuse Testing; PublicHearing | Notification of public hearing on proposed rule. | 29174 | 052898c.pdf |
| 98 N-0304 | Agency Information Collection Activities: Proposed Collection; Comment Request (OMB Control Number 0910–0001)—Reinstatement | Notice. | 29229 | 052898d.pdf |
| 98N-0273 | Texas Vitamin Co., RSR Laboratories Inc.; Proposal toWithdraw Approval of New Animal Drug Applications;Opportunity for Hearing | Notice. | 29233 | 052898e.pdf |
| Joint Meeting of the Pulmonary-Allergy Drugs andEndocrinologic and Metabolic Drugs Advisory Committees;Notice of Meeting | Notice. | 29234 | 052898f.pdf | |
| 5/27/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 052798co.pdf | |||
| 88G-0288 | Direct Food Substances Affirmed asGenerally Recognized as Safe; Sheanut Oil | Finall Rule | 28893 | 052798a.pdf |
| Food Safety Research: Availability of CooperativeAgreements; Request for Applications | Notice | 29016 | 052798b.pdf | |
| Research Studies to Support Microbial Risk AssessmentModeling; Availability of Cooperative Agreements; Requestfor Applications; Correction | Notice; Correction | 29020 | 052798c.pdf | |
| 5/26/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents - no FDA documents | 052698co.pdf | |||
| 5/22/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 052298co.pdf | |||
| 98N-0040 | Regulations for In Vivo Radiopharmaceuticals Used forDiagnosis and Monitoring | Proposed Rule | 28301 | 052298a.pdf |
| 98P-0160 | Determination That Cimetidine 100mg Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | 9/19/77 | 052298b.pdf |
| 98N-0331 | Medical Devices; Implementation of Third Party Review UnderThe Food and Drug Administration Modernization Act of 1997;Emergency Processing Request Under OMB Review | Notice | 28388 | 052298c.pdf |
| 97N-0438 | Agency Information Collection Activities; Announcementof OMB Approval - (OMB Control Number 0910-0297) | Notice | 28391 | 052298d.pdf |
| 97N-0327 | Agency Information Collection Activities; Announcementof OMB Approval - (OMB Control Number 0910-0194) | Notice | 28391 | 052298d.pdf |
| 98D-0298 | Guidance for Industry on General/Specific Intended Use;Draft; Availability | Notice | 28392 | 052298e.pdf |
| Guidance for Industry on General/Specific Intended Use;Draft; | Guidance | 980298gd.pdf | ||
| 98N-0312 | Draft Guidance for Staff, Industry, and Third Parties:Implementation of Third Party Programs Under theFDA Moderniation Act of 1997; Availability | Notice | 28392 | 052298e.pdf |
| 5/21/98 | ||||
|---|---|---|---|---|
| Docket Number | TODAYS FR Document Name | Action | FRN Page | File Name |
| Table of Contents | 052198co.pdf | |||
| Animal Drugs,Feeds,and Related Products; Change of Sponsor Name | Final Rule | 27844 | 052198a.pdf | |
| Animal Drugs,Feeds,and Related Products; Change of Sponsor Name | Final Rule | 27844 | 052198a.pdf | |
| 90F-0310 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | Final Rule | 27835 | 052198b.pdf |
| 78N-036L | Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction Statements for Oral and RectalSodium Phosphates for Over-the-Counter Laxative Use | Final Rule | 27836 | 052198c.pdf |
| 78N-036L | Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph | Notice of proposed rulemaking. | 27886 | 052198d.pdf |
| 98P-0062 | Determination That Carbinoxamine Maleate 4-Milligram Immediate Release Tablets- Were Not Withdrawn From Sale forReasons of Safety or Effectiveness | Notice | 27986 | 052198e.pdf |
| 98N-0317 | Prompt Review of Supplemental Applications of Approved Devices | Notice | 27987 | 052198f.pdf |
| Draft Guidance for Staff, Industry, and Third Parties:Implementation of Third Party Programs Under theFDA Moderniation Act of 1997; | Draft Guidance | 980312gd.pdf | ||
| 98D-0333 | Guidance for Industry, Supplements to Approved Applicationsfor Class III Medical Devices: Use of Published Literature,Use of Previously Submitted Materials, and Priority Review; | Notice | 27988 | 052198g.pdf |
| Guidance for Industry, Supplements to Approved Applicationsfor Class III Medical Devices: Use of Published Literature,Use of Previously Submitted Materials, and Priority Review; | Guidance | 980333gd.pdf | ||
| 5/20/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 052098co.pdf | |||
| 98N-0056 | List of Drugs for Which Additional Pediatric Information May Produce Health Benefits in the Pediatric Population; Availability | Notice | 27733 | 052098a.pdf |
| 5/19/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 051998co.pdf | |||
| 97N–0322 | Salmonella Enteritidis in Eggs | Advance notice of proposed rulemaking; request for comments. | 27502 | 051998a.pdf |
| 98N-0194 | Agency Information Collection Activities: Proposed Collection; Comment Request; (OMB Control Number 0910–0216-extension) | Notice. | 27581 | 051998b.pdf |
| Open Meeting for Representatives of Health Professional Organizations; Notice of Public Meeting | Notice. | 27582 | 051998c.pdf | |
| First Part Audit Program; Notice of Meeting | Notice. | 27583 | 051998d.pdf | |
| Advisory Committee for Pharmaceutical Science; Notice of Meeting | Notice. | 27583 | 051998e.pdf | |
| 97N-0451 | Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards forFresh Fruits and Vegetables; Availability; | Notice; correction. | 27584 | 051998f.pdf |
| 5/18/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 051898co.pdf | |||
| Delegations of Authority and Organization; Center for Devices and Radiological Health | Final rule. | 27207 | 051898a.pdf | |
| 97N-0513 | Agency Information Collection Activities;Orphan Drugs: Submission for OMB Review;Comment Request (OMB No. 0910-O167 - Reinstatement) | Notice. | 27299 | 051898b.pdf |
| 98N-0286 | Environmental Assessments and Findings of No Significant Impact | Notice. | 27300 | 051898c.pdf |
| 97N-0486 | Agency Information Collection Activities;Announcement of OMB Approval (OMB controf number 0910-0045) | Notice. | 27303 | 051898d.pdf |
| 5/15/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 051598co.pdf | |||
| Implanatation or Injectable Dosage Form New Animal Drugs; -- Florfenicol solution | Final rule. | 26981 | 051598a.pdf | |
| Animal drugs, feeds, and related products: Sponsor name and address change | Final rule. | 26981 | 051598a.pdf | |
| 98N-0283 | Food Labeling; Nutrient Content Claims—General Provisions | Final rule. | 26978 | 051598b.pdf |
| 97N–0524 | Food Labeling: Warning and Notice Statements; Labeling of Juice Products; Correction | Proposed rule; correction. | 27016 | 051598c.pdf |
| 98N-0268 | Agency Information Collection Activities: Proposed Collection; Comment Request (OMB control number 0910-0233-Extension) | Notice. | 27090 | 051598d.pdf |
| 98N-0456 | Agency Information Collection Activities: Announcement of OMB Approval (OMB control number 0910-0140) | Notice. | 27092 | 051598e.pdf |
| 98D-0287 | Guidance for Industry on Buspirone Hydrochloride Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing; Availability | Notice. | 27092 | 051598e.pdf |
| Guidance for Industry on Buspirone Hydrochloride Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing; | Guidance | 98287gdl.pdf | ||
| 98D-0276 | Guidance for Industry on Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements; Availability | Notice. | 27092 | 051598f.pdf |
| Guidance for Industry on Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy Supplements | Guidance | 98276gdl.pdf | ||
| 97D-O1OO | Guidance for Industry on Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products; Availability | Notice. | 27093 | 051598g.pdf |
| Guidance for Industry on Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products | Guidance | 971OOgdl.pdf | ||
| 97D-0214 | Guidance for industry on Pharmacokinetics in Patients with impaired Renai Function - Study Design, Data Anaiysis, and impact on Dosing and Labeiing; Avaiiabiiity | Notice. | 27094 | 051598h.pdf |
| Guidance for industry on Pharmacokinetics in Patients with impaired Renai Function - Study Design, Data Anaiysis, and impact on Dosing and Labeiing | Guidance | 97214gdl.pdf | ||
| 5/14/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 051498co.pdf | |||
| 98N–0274 | Food Labeling; Petitions for Nutrient Content and Health Claims, General Provisions | Final rule. | 26717 | 051498a.pdf |
| 97N–484R | Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products | Proposed rule. | 26744 | 051498b.pdf |
| Oncologic Drugs Advisory Committee; Notice of Meeting | Notice. | 26808 | 051498c.pdf | |
| 98D–0284 | Guidance for Industry on Classifying Resubmissions in Response to Action Letters; Availability | Notice. | 26808 | 051498c.pdf |
| Guidance for Industry on Classifying Resubmissions in Response to Action Letters | Guidance | 98284gd.pdf | ||
| 98D–0282 | Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds; Availability | Notice. | 26809 | 051498d.pdf |
| Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds; | Guidance | 98282gd.pdf | ||
| 5/13/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 051398co.pdf | |||
| 98N-O21O | Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin;. | Direct final rule | 26694 | 051398a.pdf |
| 98N-O21O | Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin;. | Proposed rule | 26690 | 051398b.pdf |
| 5/12/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 051298co.pdf | |||
| 97P–0418 | Revocation of Lather Brushes Regulation | Final rule. | 26077 | 051298a.pdf |
| 98N-0211 | Removal of Regulations Regarding Certification of Antibiotic Drugs | Direct Final Rule | 26066 | 051298b.pdf |
| 98N-0170 | Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting | Direct Final Rule | 26069 | 051298c.pdf |
| 98N-0211 | Removal of Regulations Regarding Certification of Antibiotic Drugs; Companion Document to Direct Final Rule | Proposed Rule | 26127 | 051298d.pdf |
| 98N-0170 | Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting: Companion Document to Direct Final Rule | Proposed Rule | 26129 | 051298e.pdf |
| Pfizer, Inc.; Withdrawal of Approval of NADA's | Notice. | 26191 | 051298f.pdf | |
| 98F-0196 | Alltech Biotechnology Center; Filing of Food Additive Petition (FAP 2238) (Animal Use) - Selenium Yeast | Notice. | 26193 | 051298g.pdf |
| 96F-0341 | MacMillan Bloedel, Ltr., Withdrawal of Food Additive Petition (FAP 6B4517) | Notice. | 26193 | 051298g.pdf |
| 98F-0195 | Vanetta S.p.A.; Filing of Food Additive Petition (FAP 2239) | Notice. | 26194 | 051298h.pdf |
| 98N-0285 | Sanofi Pharmaceuticals, Inc., et. Al.; Withdrawal of Approval of 21 New Drug Applications and 62 Abbreviated New Drug Applications | Notice. | 26191 | 051298f.pdf |
| Food Advisory Committee; Notice of Meeting | Notice. | 26194 | 051298h.pdf | |
| 5/11/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 051198co.pdf | |||
| 98N-0294 | Beverages: Bottled Water | Direct final rule. | 25764 | 051198a.pdf |
| 98N-0294 | Beverages: Bottled Water; Companion Document to Direct Final Rule | Proposed rule. | 25789 | 051198b.pdf |
| 98N-0249 | Ear, Nose, and Throat Devices; Classification of the Nasal Dilator, the Intranasal Splint, and the Bone Particle Collector | Proposed rule. | 25794 | 051198c.pdf |
| 98F-0292 | Ciba Specialty Chemicals Corp.; Filing of Food Additive Petition (FAP 8B4594) | Notice. | 25864 | 051198d.pdf |
| 98F-0289 | UBE Industries, Ltd. ; Filing of Food Additive Petition (FAP 8B4569) | Notice. | 25864 | 051198d.pdf |
| 97N-0362 | The New 510(k) Paradigm; Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Availability | Notice. | 25865 | 051198e.pdf |
| The New 510(k) Paradigm; Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; | guidance | 97N0362.pdf | ||
| 5/8/98 | ||||
|---|---|---|---|---|
| Document Number | Document Name | Action | FRN Page | File Name |
| Table of Contents - No FDA Documents | 050898co.pdf | |||
| 5/7/98 | ||||
|---|---|---|---|---|
| Document Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 050798co.pdf | |||
| Certain Other Dosage Form New Animal Drugs; Competitive Exclusion Culture | Final rule. | 25163 | 050798a.pdf | |
| 98F–0291 | Asahi Denka Kogyo K.K.; Filing of Food Additive Petition (FAP 8B4592) | Notice. | 25212 | 050798b.pdf |
| 98F–0290 | The Dow Chemical Company; Filing of Food Additive Petition (FAP 8B4586) | Notice. | 25212 | 050798b.pdf |
| 98 F-0288 | Mitsui Chemicals, Inc. ; Filing of Food Additive Petition (FAP 8B4590 | Notice. | 25213 | 050798c.pdf |
| 81G–0035 | Dairy Crest Food, Ltd.; Withdrawal of GRAS Affirmation Petition | Notice. | 25213 | 050798c.pdf |
| Ophthalmic Devices Panel of theMedical Devices Advisory Committee; Notice of Meeting | Notice of Meeting | 25214 | 050798d.pdf | |
| 5/6/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 050698co.pdf | |||
| 96N–0119 | Natural Rubber-Containing Medical Devices; User Labeling | Final rule; interpretation. | 24934 | 050698a.pdf |
| 97N–0451 | Microbial Safety of Produce; Notice of Public Meetings | Notice. | 25059 | 050698b.pdf |
| Surveillance Updates and Trends; Notice of Workshops | Notice of Workshops | 25060 | 050698c.pdf | |
| 5/5/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 050598co.pdf | |||
| 96F-0348 | MacMillan Bloedel, Ltd.: withdrawal of Food Additive Petititon [FAP 6B4520] | Notice of Withdrawal | 24812 | 050598a.pdf |
| Vaccines and Related Biological Producst Advisory Committee; Notice of Meeting | Notice of Meeting | 24812 | 050598a.pdf | |
| 98D-0149 | Guidance for Industry on National Uniformity for Nonprescription Drugs--Ingredient Listing for OTC Drugs; Availability; Clarification | Notice; Clarification | 24183 | 050598b.pdf |
| National Uniformity for Nonprescription Drugs--Ingredient Listing for OTC Drugs | guidance | |||
| 5/4/98 | ||||
|---|---|---|---|---|
| Document Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 050498co.pdf | |||
| Implantation or Injectable Dosage Form New Animal Drugs; Propofol | Final rule. | 24420 | 050498a.pdf | |
| New Animal Drugs For Use In Animal Feeds; Monensin | Final rule. | 24420 | 050498a.pdf | |
| 90G–0412 | Lipase Enzyme Preparation From Rhizopus Niveus; Affirmation of GRAS Status as a Direct Food Ingredient | Final rule. | 24416 | 050498b.pdf |
| 98N-0044 | Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body | Correction | 24593 | 050498c.pdf |
| Research Studies to Support Microbial Risk Assessment Modeling; Availability of Cooperative Agreements; Request for Applications | Notice- | 24553 | 050498d.pdf | |
| 96P–0090 | Determination That Testosterone Propionate 2% Ointment Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Amendment | Notice | 24556 | 050498e.pdf |
| 96E–0189 | Determination of Regulatory Review Period for Purposes of Patent Extension; LIPOSORBERÒ LA–15 System | Notice | 24557 | 050498f.pdf |
| Dental Plaque Subcommittee of the Nonprescription Drugs Advisory Committee; Notice | Notice | 24558 | 050498g.pdf | |
| 98D–0191 | Testing for Skin Sensitization to Chemicals in Latex Products; Draft Guidance; Availability | Notice. | 24559 | 050498h.pdf |
| Testing for Skin Sensitization to Chemicals in Latex Products; Draft Guidance | Draft Guidance | 98D0191.pdf | ||
| 5/1/98 | ||||
|---|---|---|---|---|
| Document Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 050198co.pdf | |||
| ANADA 200-187 | Certain Other Dosage Form New Animal Drugs; Isoflurane | Final rule. | 24105 | 050198a.pdf |
| NADA 141-077 | Implantation or Injectable Dosage Form New Animal Drugs Spectinomycin solution | Final rule. | 24106 | 050198b.pdf |
| 93N-0325 and 97N-0296 | Preliminary Regulatory Impact Analysis and Initial Regulatory Flexibility Analysisof the Proposed Rules to Ensure the Safety of Juice and Juice Products; Proposed Rule (Pages 24254 - 24302) | Proposed Rule | 24254 | 050198c.pdf |
| 93N-0325 and 97N-0296 | Preliminary Regulatory Impact Analysis and Initial Regulatory Flexibility Analysisof the Proposed Rules to Ensure the Safety of Juice and Juice Products; Proposed Rule (Pages 24303 - 24352) | Proposed Rule | 24303 | 050198c1.pdf |
| 93N-0325 and 97N-0296 | Preliminary Regulatory Impact Analysis and Initial Regulatory Flexibility Analysisof the Proposed Rules to Ensure the Safety of Juice and Juice Products; Proposed Rule (Pages 24353 - 24378) | Proposed Rule | 24353 | 050198c2.pd |
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