| Monday | Tuesday | Wednesday | Thursday | Friday |
| 6/29 | 6/30 | |||
| 6/22 | 6/23 | 6/24 | 6/25 | 6/26 |
| 6/15 | 6/16 | 6/17 | 6/18 | 6/19 |
| 6/8 | 6/9 | 6/10 | 6/11 | 6/12 |
| 6/1 | 6/2 | 6/3 | 6/4 | 6/5 |
| 6/30/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 063098co.pdf | |||
| 94N-0418 | Medical Devices; Retention of Three Preamendment Class III Devices in Class III | Final Rule | 35516 | 063098a.pdf |
| Single Issue Focus Meeting | Notice | 35551 | 063098b.pdf | |
| 97N-0022 | Agency Information Collection Activities: Proposed Collection; Comment Request - (OMB 0910–O171—Extension) | Notice | 35601 | 063098c.pdf |
| 98F-0430 | Nalco Chemical Co.; Filing of Food Additive Petition | Notice | 35603 | 063098d.pdf |
| 98F-0433 | Servo Delden BV; Filing of Food Additive Petition | Notice | 35603 | 063098d.pdf |
| Center for Veterinary Medicine; Change of internet Address | Notice | 35603 | 063098d.pdf | |
| 6/29/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 062998co.pdf | |||
| 93N-0445 | Financial Disclosure by Clinical Investigators; Correction | Final rule; correction. | 35134 | 062998a.pdf |
| 97F-0440 | Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers | Final rule. | 35134 | 062998a.pdf |
| Antiviral Drugs Advisory Committee; Notice of Meeting | Notice. | 35238 | 062998b.pdf | |
| Biological Response Modifiers Advisory Committee; Notice of Meeting | Notice. | 35238 | 062998b.pdf | |
| 6/26/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 062698co.pdf | |||
| Cardiovascular and Renal Drugs Advisory Committee;Notice of Meeting | Notice | 34901 | 062698a.pdf | |
| Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | Notice | 34902 | 062698b.pdf | |
| Circulatory System Devices Panel of the MedicalDevices Advisory Committee Meeting; Correction | Notice | 34902 | 062698b.pdf | |
| Nonprescription Drugs Advisory Committee; Notice of Meeting | Notice | 34902 | 062698b.pdf | |
| 6/25/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 062598co.pdf | |||
| 92N-0429 | Constantine 1. Kostas; Denial of Hearing; Final Debarment Order | Notice | 34652 | 062598a.pdf |
| Anti-infective Drugs Advisory Committee; Notice of Meeting | Notice | 34655 | 062598b.pdf | |
| Arthritis Advisory Committee; Notice of Meeting | Notice | 34655 | 062598b.pdf | |
| Ophthalmic Drugs Subcommittee of the Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting | Notice | 34655 | 062598b.pdf | |
| 6/24/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 062498co.pdf | |||
| 98D-0376 | Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem | Notice | 34433 | 062498a.pdf |
| Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem | Guidance | 980376gd.pdf | ||
| 6/23/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 062398co.pdf | |||
| 98F-0436 | Asahi Denka Kogyo K.K.; Filing of Food Additive Petition | Notice | 34188 | 062398a.pdf |
| 77N-0240 | Erythrityl Tetranitrate; Revocation of Exemption; Drug Efficacy Study Implementation; Opportunity for a Hearing | Notice | 34188 | 062398a.pdf |
| 6/22/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 062298co.pdf | |||
| 98N-0428 | Food Labeling: Health Claims; Antioxidant Vitamin A and Beta-Carotene and the Risk in Aduits of Atherosclerosis, Coronary Heart Disease, and Certain Cancers | Interim final rule | 34092 | 062298a.pdf |
| 98N-0426 | Food Labeling: Health Claims; Antioxidant Vitamins C and E and the Risk in of Atherosclerosis, Coronary Heart Disease, Certain Cancers, and Cataracts Adults | Interim final rule | 34084 | 062298b.pdf |
| 98N-0427 | Food Labeling: Health Claims; B-Complex Vitamins, Lowered Homocysteine Levels, and the Risk in Adults of Cardiovascular Disease | Interim final rule | 34097 | 062298c.pdf |
| 98N-0423 | Food Labeling: Health Claims; Calcium Consumption by Adolescents and Adults, Bone Density and The Risk of Fractures | Interim final rule | 34101 | 062298d.pdf |
| 98N-0424 | Food Labeling: Health Claims; Chromium and the Risk in Adults of Hyperglycemia and the Effects of Glucose Intolerance | Interim final rule | 34104 | 062298e.pdf |
| 98N-0422 | Food Labeling: Health Claims; Garlic, Reduction of Serum Cholesterol, and the Risk of Cardiovascular Disease in Adults | Interim final rule | 34110 | 062298f.pdf |
| 98N-0419 | Food Labeiing: Health Claims; Omega-3 Fatty Acids and the Risk in Adults of Cardiovascular Disease | Interim final rule | 34107 | 062298g.pdf |
| 98N-0420 | Food Labeling: Health Claims; Vitamin K and Promotion of Proper Blood Clotting and Improvement in Bone Health in Adults | Interim final rule | 34115 | 062298h.pdf |
| 98N-0421 | Food Labeling: Health Claims; Zinc and the Body’s Ability to Fight Infection and Heal Wounds in Adults | Interim final rule | 34112 | 062298i.pdf |
| 98N-0364 | Agency Information Collection Activities: Proposed Collection; Comment Request - OMB 0910-0213 - Reinstatement | Notice | 33933 | 062298j.pdf |
| 98C-0431 | EM Industries, Inc.; Filing of Color Additive Petition | Notice | 33934 | 062298k.pdf |
| 98F-0432 | Ticona; Filing of Food Additive Petition | Notice | 33935 | 062298l.pdf |
| 6/19/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 061998co.pdf | |||
| 78 N-036L | Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph | Notice of proposed rulemaking. | 33592 | 061998a.pdf |
| Studies of Adverse Effects of Marketed Drugs; Availability of Grants (Cooperative Agreements); Request for Application | Notice | 33680 | 061998b.pdf | |
| 98N-0192 | Agency Information Collection Activities; Announcement of OMB Approval - OMB 0910–0124. | Notice | 33686 | 061998c.pdf |
| 97N-0529 | Agency Information Collection Activities; Announcement of OMB Approval - OMB 0910–0369. | Notice | 33686 | 061998c.pdf |
| 98D-0401 | Draft “Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product”; Availability | Notice | 33686 | 061998c.pdf |
| Draft “Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product”; | Draft Guidance | 980401gd.pdf | ||
| 97N-0384 | Knickerbocker Biological, Inc.; Revocation of U, S. License No. 458-001 | Notice | 33680 | 061998b.pdf |
| 6/18/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 061898co.pdf | |||
| 97D–0381 | Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—NDA’s; Reopening of Comment Period | Notice; reopening of comment period. | 33375 | 061898a.pdf |
| 98D–0388 | Draft Guidance for Industry on Topical Dermatological Drug Product NDA’s and ANDA’s—In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies; Availability | Notice | 33375 | 061898a.pdf |
| Draft Guidance for Industry on Topical Dermatological Drug Product NDA’s and ANDA’s—In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies | Draft Guidance | 980388gd.pdf | ||
| 6/17/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 061798co.pdf | |||
| 96 N-0007 | Labeling of Drugs for Use in Milk-Producing Animals | Final rule | 32978 | 061798a.pdf |
| 6/16/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 061698co.pdf | |||
| 98N-0361 | Administrative Practices and Procedures; Internal Review of Agency Decisions | Direct Final Rule | 32733 | 061698a.pdf |
| 98N-0361 | Administrative Practices and Procedures; Internal Review of Agency Decisions | Proposed Rule | 32772 | 061698b.pdf |
| Relocation of the Dockets Management Branch | Notice | 32888 | 061698c.pdf | |
| 6/15/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 061598co.pdf | |||
| 98N-0378 | Agency Information Collection Activities: Proposed Collection; Comment Request; Correction | Notice; Correction | 32667 | 061598a.pdf |
| 98N-0357 | Agency Information Collection Activities: Proposed Collection; Comment Request - (OMB 0910-O073-Reinstatement) | Notice | 32667 | 061598a.pdf |
| 98F-0390 | BASF Corp.; Filing of Food Additive Petition (FAP 8B4596) | Notice | 32672 | 061598b.pdf |
| 98F-0391 | BASF Corp.; Filing of Food Additive Petition (FAP 8B4595) | Notice | 32672 | 061598b.pdf |
| 91F–0392] | Phoenix Medical Technology, Inc.; Withdrawal of Food Additive Petition (FAP 1B4273) | Notice | 32673 | 061598c.pdf |
| 97N-0487 | Agency Information Collection Activities; Announcement of OMB Approval (OMB 0910-O305) | Notice | 32673 | 061598c.pdf |
| 89N-0474 | Agency Information Collection Activities; Announcement of OMB Approval (OMB 0910-O370) | Notice | 32673 | 061598c.pdf |
| 98D–0365 | Revised Guidance for Industry and Reviewers on Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act | Notice | 32673 | 061598c.pdf |
| Revised Guidance for Industry and Reviewers on Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act | Guidance | 98365agd.pdf | ||
| 6/12/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 061298co.pdf | |||
| 98D–0307 | Draft Guidance for Industry; Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 | Notice | 32219 | 061298a.pdf |
| 6/11/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 061198co.pdf | |||
| ANADA 200-229. | Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, and Clotrimazole Ointment | Final rule | 31931 | 061198a.pdf |
| 98N-0320 | Agency Emergency Processing Request Under OMB Review | Notice | 32102 | 061198b.pdf |
| 96N-0003 | Dulal C. Chatterji; Grant of Special Termination; Final Order Terminating Debarment | Notice | 32103 | 061198c.pdf |
| Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | Notice | 32014 | 061198d.pdf | |
| 97N-0489 | Agency Information Collection Activities; Announcement of OMB Approval - OMB 0910-0192. | Notice | 32014 | 061198d.pdf |
| 98D-0389 | Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an AuthoritativeStatement of a Scientific Body; Availability | Notice | 32102 | 061198e.pdf |
| Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an AuthoritativeStatement of a Scientific Body | Guidance | 980389.pdf | ||
| 6/10/98 | ||||
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 061098co.pdf | |||
| NADA 160-248 | Oral Dosage Form New Animal Drugs; Fenbendazole Paste | Final Rule | 31624 | 061098a.pdf |
| Animal Drugs, Feeds, and Related Products Change of Sponsor | Final Rule | 31623 | 061098b.pdf | |
| 98N-0335 | Agency Information Collection Activities; Proposed Collection; Comment Request - (OMB 0910 - O119 - Extension) | Notice | 31786 | 061098c.pdf |
| 98N-0308 | Agency Information Collection Activities; Proposed Collection; Comment Request - (OMB 0910 - O012 - Reinstatement | Notice. | 31788 | 061098d.pdf |
| 98N–0131 | Scott Feuer; Final Debarment Order | Notice. | 31789 | 061098e.pdf |
| 97D-0299 | International Conference on Harmonization:Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data; Availability | Notice. | 31790 | 061098f.pdf |
| 6/9/98 | ||||
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 060998co.pdf | |||
| 98N-0373 | Agency Information Collection Activities; Proposed Collection; Comment Request - (OMB 0910 - O249 - Extension | Notice. | 31502 | 060998a.pdf |
| 97N-0424 | Agency Information Collection Activities; Submission for OMB Review; Comment Request - (FDA Form 2253) | Notice. | 31503 | 060998b.pdf |
| 97N-0503 | Agency information Coiiection Activities; Submission for OMB Review; Comment Request - (OMB 0910 - O032 - Reinstatement) | Notice. | 31505 | 060998c.pdf |
| Request for Nominations for Members on Public Advisory Committees; Veterinary Medicine Advisory Committee | Notice. | 31506 | 060998d.pdf | |
| 98D-0374 | International Conference on Harmonization: Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products | Notice. | 31506 | 060998d.pdf |
| 98N-0285 | Sanofi Pharmaceuticals, Inc., et. Al.; Withdrawal of Approval of 21 New Drug Applications and 62 Abbreviated New Drug Applications; Correction | Notice. | 31513 | 060998e.pdf |
| 97N-0532 | Agency Information Collection Activities; Announcement of OMB Approval (OMB - 0910-0053) | Notice. | 31513 | 060998e.pdf |
| 6/8/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 060898co.pdf | |||
| 98N-0222 | Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices | Proposed Rule | 31143 | 060898a.pdf |
| 98D-0362 | Draft Guidance for Industry on Stability Testing of Drug Substances and Drug Products Availability | Notice | 31224 | 060898b.pdf |
| Draft Guidance for Industry on Stability Testing of Drug Substances and Drug Products | Draft Guidance | 980362gd.pdf | ||
| 6/5/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 060598co.pdf | |||
| 98N-0294 | Beverages: Bottled Water; Correction | Direct final rule; correction. | 30620 | 060598a.pdf |
| 94P-0110 95N-0245 | Food Labeling; Statementof Identity,NutritionLabeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide, Revocation | Final rule; action on petitions for reconsideration. | 30615 | 060598b.pdf |
| 98N-0192 | Agency Information Collection Activities: Proposed Collection; Comment Request -(OMB 0910–0124 - Reinstatement) | Notice. | 30762 | 060598c.pdf |
| 98N-0336 | Agency Information Collection Activities: Proposed Collection; Comment Request -(OMB 0910–0120 -Reinstatement) | Notice. | 30763 | 060598d.pdf |
| 95N-0182 | KV Pharmaceutical Co.; Withdrawal of Approval of Two Abbreviated New Drug Applications and OneAbbreviated Anitbiotic Application | Notice. | 30765 | 060598e.pdf |
| Food Advisory Committee; Amendment of Notice | Notice | 30765 | 060598e.pdf | |
| 6/4/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | |
060498co.pdf | ||
| 98F–0342 | Alcide Corp.; Filing of Food Additive Petition | Notice. | 30498 | 060498a.pdf |
| |
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting | Notice. | 30498 | 060498a.pdf |
| 6/3/98 | ||||
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 060398co.pdf | |||
| 94P-0341 | Medical Devices; Classification/Reclassification of Immunohistochemistry Reagents and Kits | Final Rule | 30132 | 060398a.pdf |
| 79N-0043 92N-0334 | Permanent Listing of Color Additive Lakes; Additions to the Administrative Record; Reopening of Comment Period | Proposed rule; reopening of comment period | 30160 | 060398b.pdf |
| 96N-0393 | Agency Information Collection Activities; Submission for OMB Review; Comment Request | Notice | 30239 | 060398c.pdf |
| 98N-0359 | Program Priorities in the Center for Food Safety and Applied Nutrition; Public Meeting | Notice | 30241 | 060398d.pdf |
| Blood Products Advisory Committee; Notice of Meeting | Notice | 30242 | 060398e.pdf | |
| 6/2/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 060298co.pdf | |||
| |
Good Clinical Practices In InvestigationalProduct Research Meeting | Notice of meeting. | 30001 | 060298a.pdf |
| Memorandum of Understanding Between the Foodand Drug Administration and the National Institutesof Health's National Institute of Dental Research | Notice | 30002 | 060298b.pdf | |
| 6/1/98 | ||||
|---|---|---|---|---|
| Docket Number | Document Name | Action | FRN Page | File Name |
| Table of Contents | 060198co.pdf | |||
| NADA 141-105 | Implantation or Injectable Dosage Form New Animal Drugs; Lufenuron Suspension | Final rule. | 29551 | 060198a.pdf |
| NADA 141-080 | Animal Drugs, Feeds, and Related Products; Changeof Sponsor | Final rule. | 29551 | 060198a.pdf |
| 97N-0418 | Revocation of Lather Brushes Regulation; Correction | Final rule; correction. | 29591 | 060198b.pdf |
| 87F-0162 | Indirect Food Additive: Adjuvants, Production Aids, and Sanitizers (FAP 6B3908) | Final rule. | 29548 | 060198c.pdf |
| 96N-0119 | Amended Economic Analysis of Final Rule Requiring Use of Labeling on Natural Rubber Containing Devices | Final rule; amended economic analysis statement. | 060198d.pdf | |
| 96N-0373 | Agency Information Collection Activities; Submission for OMB Review (OMB 0910-0320—Reinstatement) | Notice. | 29738 | 060198e.pdf |
| 98D-0314 | Draft Guidance for Industry: Pilot Program for Electronic Investigational New Drug (eIND) Applications forBiological Products; Availability | Notice. | 29740 | 060198f.pdf |
| |
Draft Guidance for Industry: Pilot Program for Electronic Investigational New Drug (eIND) Applications forBiological Products; | Draft Guidance | 980314gd.pdf | |
| 98D-0317 | Draft "Guidance for Industry: Electronic Submissions of Case Report Forms (CRF's), Case Report Tabulations(CRT's) and Data to the Center for Biologic Evaluationand Research," Availability | Notice. | 29739 | 060198g.pdf |
| |
Draft "Guidance for Industry: Electronic Submissions of Case Report Forms (CRF's), Case Report Tabulations(CRT's) and Data to the Center for Biologic Evaluationand Research," | Draft Guidance | 980317gd.pdf | |
| 98D-0315 | Draft "Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research;" Availability | Notice. | 29742 | 060198h.pdf |
| |
Draft "Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research;" | Draft Guidance | |
980315gd.pdf |
| 98D-0316 | Draft "Guidance for Industry: Electronic Submissions of a Biologics License Application (BLA) or Product LicenseApplication (PLA)/Establishment License Application (ELA)to the Center for Biologics Evaluation and Research;" Availability | Notice. | 29741 | 060198i.pdf |
| |
Draft "Guidance for Industry: Electronic Submissions of a Biologics License Application (BLA) or Product LicenseApplication (PLA)/Establishment License Application (ELA)to the Center for Biologics Evaluation and Research;" | Draft Guidance | 980316gd.pdf | |
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