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September 1998 Federal Register Documents

Monday Tuesday Wednesday Thursday Friday
9/28 9/29 9/30
9/21 9/22 9/23 9/24 9/25
9/14 9/15 9/16 9/17 N/A
N/A 9/8 N/A 9/10 9/11
9/1 9/2 9/3 9/4
9/30/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


093098co.pdf 093098co.txt
NADA 113–232 Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection CVM Final rule 52157 093098a.pdf 093098a.txt
78G-0195 Valley Forest Resources, inc.; Withdrawal of GRAS Affirmation Petition CVM Notice 52274 093098b.pdf 093098b.txt
98P-0425 98P-0506 98P-0621 Medical Devices; Exemptions From Premarket Notification; Class II Devices CDRH Notice 52275 093098c.pdf 093098c.txt

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting CDRH Notice 52276 093098d.pdf 093098d.txt
98D-0777 Draft Guidance for Industry on Investigating Out of Specification (00S) Test Results for Pharmaceutical Production; Availability CDER Notice 52276 093098d.pdf 093098e.txt

Draft Guidance for Industry on Investigating Out of Specification (00S) Test Results for Pharmaceutical Production
Draft Guidance
980777gd.pdf
9/29/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


092998co.pdf 092998co.txt
NADA 141–102 New Animal Drugs for Use In Animal Feeds; Bacitracin Methylene Disalicylate and Decoquinate CVM Final rule 51824 092998a.pdf 092998a.txt
ANADA 200-055 Implantation or Injectable Dosage Form New Animal Drugs; Ketamine Hydrochloride Injection CVM Final rule 51822 092998b.pdf 092998b.txt
NADA 140-852 New Animal Drugs For Use In Animal Feeds; Narasin and Bacitracin Methylene Disalicylate with Roxarsone CVM Final rule 51823 092998c.pdf 092998c.txt
ANADA 200-197 Oral Dosage Form New Animal Drugs; Streptomycin Oral Solution CVM Final rule 51820 092998d.pdf 092998d.txt
NADA 100-840 New Animal Drugs; Change of Sponsor CVM Final rule 51821 092998 e.pdf 092998e.txt
98N-0520 Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices CDRH Direct final rule 51825 092998f.pdf 092998f.txt
98N-0520 Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Companion to Direct Final Rule CDRH Proposed rule 51874 092998g.pdf 092998g.txt
98N-0751 Biosera Inc.; Revocation of U.S. License No. 1059 CBER Notice 51938 092998h.pdf 092998h.txt
97-0294 Determination of Regulatory Review Period for Purposes of PatentExtension; Silvacote K OC Notice 51939 092998i.pdf 092998i.txt
80G-0360 James Flett Organization, !nc.; Withdrawal of GRAS Affirmation Petition CVM Notice 51939 092998j.pdf 092998j.txt
98N-0473 98P-0215 98P-0216 98P-0275 98P-0338 Medical Devices; Exemptions From Premarket Notification; Class II Devices CDRH Notice 51940 092998k.pdf 092998k.txt

Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting CDER Notice 51941 092998l.pdf 092998l.txt

Good Manufacturing Practices for Dietary Supplements Working Group of the Food Advisory Committee; Notice of Meeting CFSAN Notice 51942 092998m.pdf 092998m.txt
97N-0074 President's National Food Safety Initiative; Strategic plan development; meetings CFSAN Notice 52119 092998n.pdf 092998n.txt
98D-0746 Guidance for Industry: Donor Screening for Antibodies to HTLV-II; Availability CBER Notice 51942 092998o.pdf 092998o.txt

Guidance for Industry: Donor Screening for Antibodies to HTLV-II


980746gd.pdf
9/28/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


092898co.pdf 092898co.txt
98F-0183 Indirect Food Additives: Adhesives and Components of Coatings CFSAN Final rule 51527 092898a.pdf 092898a.txt

Food Safety Risk Assessment Clearinghouse; Postponement of Open Technical Workshop CFSAN Notice 51584 092898b.pdf 092898b.txt

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting CDRH Notice 51584 092898b.pdf 092898c.txt

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9/25/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


092598co.pdf 092598co.txt
98N-0417 Amendment to Examination and Investigation Sample Requirements ORA Direct final rule 51297 092598a.pdf 092598a.txt
NADA 141–108 Oral Dosage Form New Animal Drugs; Etodolac Tablets CVM Final rule 51300 092598b.pdf 092598b.txt
93C-0248 Listing of Color Additives Exempt from Certification; Canthaxanthin; Confirmation of Effective Date; Correction CFSAN Final rule 51299 092598c.pdf 092598c.txt

Drug Evaluation and Research Center, Director et al.; NARA/GPO CFR correction 51299 092598c.pdf
98N-0417 General Administrative Rulings and Decisions; Amendment to the Examination and Investigation Sample Requirements; Companion Document to Direct Final Rule ORA Proposed rule 51322 092598d.pdf 092598d.txt
98N-0335 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Good Laboratory Practices (GLP) Regulations for Nonclinical Studies OC Notice 51357 092598e.pdf 092598e.txt
98C-0790 EM Industries, Inc.; Filing of Color Additive Petition CFSAN Notice 51359 092598f.pdf 092598f.txt
98N-0787 Parke-Davis Pharmaceutical Research et al.; Withdrawal ofApproval of 14 New Drug Applications and 13 Abbreviated New DrugApplications CDER Notice 51359 092598f.pdf 092598g.txt
97N-0503 Agency Information Collection Activities; Announcement of OMB Approval; New Animal Drug Application (NADA), Form FDA 356 V, 21 CFR Part 514
 OC Notice 51360 092598g.pdf 092598h.txt

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9/24/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


092498co.pdf 092498co.txt
84D-0141 Compliance Policy Guide; Revocation CVM Notice 51074 092498a.pdf 092498a.txt
98F-0797 Ciba Specialty Chemicals Corp.; Filing of Food Additive Petition CFSAN Notice 51074 092498a.pdf 092498b.txt
96D-0058 International Conference on Harmonisation; Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin; Availability CFSAN Notice 51074 092498a.pdf 092498c.txt

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9/23/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


092398co.pdf 092398co.txt
98N-0361 Administrative Practices and Procedures; Internal Agency Review of Decisions OC Direct final rule; withdrawal 50757 092398a.pdf 092398a.txt
98N-0361 Administrative Practices and Procedures; Internal Agency Review of Decisions; Companion Document to Direct Final Rule; Correction OC Proposed rule; correction 50815 092398b.pdf 092398b.txt

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting CDER Notice 50917 092398c.pdf 092398c.txt
97N-O510 Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Medicated Feeds OC Notice 50918 092398d.pdf 092398d.txt
97N-O515 Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice for Type A Medicated Articles OC Notice 50918 092398d.pdf 092398e.txt
98D-0727 Draft “Guidance for industry: interpretation of On-farm Feed Manufacturing and Mixing Operations”; Availability; Request for Comments CVM Notice 50918 092398d.pdf 092398f.txt

Draft “Guidance for industry: interpretation of On-farm Feed Manufacturing and Mixing Operations”
Draft Guidance
980727gd.pdf

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9/22/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


092298co.pdf 092298co.txt
96N-0119 Amended Economic Impact Analysis of Final Rule Requiring Use of Labeling on Natural Rubber Containing Devices CDRH Notice 50659 092298a.pdf 092298a.txt
9/21/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


092198co.pdf 092198co.txt
98N-0304 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Application for FDA Approval to Market a New Drug OC Notice 50241 092198a.pdf 092198a.txt
97D-0159 International Conference on Harmonisation; Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnologicai/Biological Products; Availability CBER Notice 50244 092198b.pdf 092198b.txt

Medical Gas Workshop ORA Notice of workshop 50249 092198c.pdf 092198c.txt

Advisory Committee for Pharmaceutical Science; Notice of Meeting CDER Notice 50250 092198d.pdf 092198d.txt

Joint Meeting of the Advisory Committee for Pharmaceutical Science and the Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting CDER Notice 50250 092198d.pdf 092198e.txt

Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee); Notice of Meeting NCTR Notice 50250 092198d.pdf 092198f.txt
98D-0656 Draft Guidance for Industry on Submission of Abbreviated Reports and Synopses in Support of Marketing Applications; Availability CDER Notice 50251 092198e.pdf 092198g.txt

Draft Guidance for Industry on Submission of Abbreviated Reports and Synopses in Support of Marketing Applications
Draft Guidance
980656gd.pdf
9/17/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


091798co.pdf 091798co.txt

Science Board to the Food and Drug Administration; Notice of Meeting OC Notice 49698 091798a.pdf 091798a.txt
9/16/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


091698co.pdf 091698co.txt
98N-0747 Agency Information Collection Activities: Proposed Collection; Comment Request; Customer/Partner Service Surveys OC Notice 49581 091698a.pdf 091698a.txt
98N-0748 Agency Emergency Processing Request Under OMB Review; Attitudinal and Behavioral Effects of Direct-To-Consumer Advertising of Prescription Drugs OC Notice 49582 091698b.pdf 091698b.txt
97D-0174 International Conference on Harmonisation; Guidance on Statistical Principles for Clinical Trials; Availability CDER Notice 49583 091698c.pdf 091698c.txt
9/15/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


091598co.pdf 091598co.txt

Indirect Food Additives: Adjuvants, Production aids, and Sanitizers
CFR Correction 49284 091598a.pdf 091598a.txt
98F-0749 Rohm and Haas Co.; Filing of Food Additive Petition CFSAN Notice 49360 091598b.pdf 091598b.txt
9/14/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


091498co.pdf 091498co.txt
NADA 141-068 Animal drugs, feeds, and related products: Enrofloxacin solution CVM Final Rule 49002 091498a.pdf 091498a.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; correction OC Notice; correction 49130 091498b.pdf 091498b.txt
98N-0373 Agency information collection activities: Submission for OMB review; comment request ; FDA Recall Regulations OC Notice 49130 091498b.pdf 091498c.txt
9/11/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


091198co.pdf 091198co.txt
98N-O21O Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin; Confirmation of Effective Date CDER Direct final rule; confirmation of effective date 48576 091198a.pdf 091198a.txt

New Animal Drugs For Use In Animal Feeds; Bacitracin Methylene Disalicylate, Decoquinate, and Roxarsone; Correction OC Final rule; correction 48576 091198a.pdf 091198b.txt
98N-O211 Removal of Regulations Regarding Certification of Antibiotic Drugs; Confirmation of Effective Date CDER Direct final rule; confirmation of effective date 48576 091198a.pdf 091198c.txt
93N-0253 Mark Perkal; Grant of Special Termination; Final Order Terminating Debarment CDER Notice 48733 091198b.pdf 091198d.txt
9/10/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


091098co.pdf 091098co.txt
98N-0426 98N-0428 98N-0427 98N-0423 98N-0424 98N-0419 98N-0422 98N-0421 98N-0420 Food Labeling: Health Claims; Reopening of Comment Period CFSAN Interim final rules; reopening of comment period. 48428 091098a.pdf 091098a.txt
97N-0335 Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro Fertilization and Related Assisted ReproductionProcedures CDRH Final rule 48428 091098a.pdf 091098b.txt

Antiviral Drugs Advisory Committee; Notice of Meeting CDER Notice 48515 091098b.pdf 091098c.txt
97N-0513 Agency Information Collection Activities; Announcement of OMB Approval; Orphan Drugs—21 CFR Part 316 OC Notice 48516 091098c.pdf 091098d.txt
98D-0670 Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft; Availability CDRH Notice 48516 091098c.pdf 091098e.txt

Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k) draft guidance

980670gd.pdf
9/8/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


090898co.pdf 090898co.txt
98F-0730 Keller and Heckman LLP; Filing of Food Additive Petition CFSAN Notice 47503 090898a.pdf 090898a.txt

Anti-Infective Drugs Advisory Committee; Notice of Meeting CDER Notice 47504 090898b.pdf 090898b.txt

Dental Plaque Subcommittee of the Nonprescription Drugs Advisory Committee; Notice of Meeting CDER Notice 47504 090898b.pdf 090898c.txt
98D-0340 Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants; Report and Guidance for Industry; Availability CFSAN Notice 47505 090898c.pdf 090898d.txt

Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants; Report and Guidance for Industry
Draft Guidance
98340gdl.pdf

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9/4/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


090498co.pdf 090498co.txt
98N-0192 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Establishment and Product License Applications: Forms FDA 2599, 2599a, 2600, 2600b, 3066, 3086, 3096, 3098, 3098a, 3098b, 3098c, 3098d, 3098e, 3210, 3213, 3214, and 3314 OC Notice 47299 090498a.pdf 090498a.txt
92F-0397 Great Lakes Chemical Corp.; Withdrawal of Food Additive Petition CFSAN Notice 47300 090498b.pdf 090498b.txt

Pharmacy Compounding Advisory Committee; Notice of Meeting CDER Notice 47301 090498c.pdf 090498c.txt

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9/3/98
Docket Number Document Name Center Action FRN Page PDF file TXT file

Table of Contents


090398co.pdf 090398co.txt
98N-0698 Agency Information Collection Activities: Proposed Collection; Comment Request; Survey of Consumer Attitudes Toward Potential Changes in Food Standards of Identity OC Notice 47031 090398a.pdf 090398a.txt}

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9/2/98
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


090298co.pdf 090298co.txt

Implantation or Injectable Dosage Form New Animal Drugs; Ampicillin Trihydrate For Sterile Suspension; Correction OC Final rule; correction 46652 090298a.pdf 090298a.txt

Oral Dosage Form New Animal Drugs; Clenbuterol; Correction OC Final rule; correction 46652 090298a.pdf 090298b.txt
98N-0144 Biological Products Regulated Under Section 351 of the Public Health Services Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Correction OC Proposed rule; correction. 46718 090298b.pdf 090298c.txt
98N-0363 Agency Information Collection Activities: Proposed Collection; Comment Request; Correction OC Notice 46799 090298c.pdf 090298d.txt

Technical Electronic Products Radiation Safety Standards Committee; Notice of Meeting CDRH Notice 46799 090298c.pdf 090298e.txt
96N-0373 Agency Information Collection Activities; Announcement of OMB Approval; Request for Information From U.S. Processors that Export to the European Community OC Notice 46799 090298c.pdf 090298f.txt

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9/1/98 Display
Docket Number Document Name Center Action FRN Page PDF File TXT File

Table of Contents


090198co.pdf 090198co.txt

New Animal Drugs for Use in Animal Feeds; Melengestrol Acetate and Oxytetracycline; Correction OC Final rule; correction 46389 090198a.pdf 090198a.txt
98N-0392 Irradiation in the Production, Processing and Handling of Food; Correction OC Final rule; correction 46388 090198b.pdf 090198b.txt
81N-0201 Pediculicide Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment; Correction OC Final rule; technical amendment; correction. 46389 090198c.pdf 090198c.txt
98N-0378 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Color Additive Certification Requests and Recordkeeping OC Notice 46461 090198d.pdf 090198d.txt
98N-0336 Agency information Collection Activities; Submission for OMB Review; Comment Request; Premarket Notification Submission 510(k), Subpart E OC Notice 46462 090198e.pdf 090198e.txt
97N-0385 Agency Information Collection Activities; Submission for OMB Review; Comment Request OC Notice 46464 090198f.pdf 090198f.txt
98F-0717 Mitsubishi Chemical Corp.; Filing of Food Additive Petition CFSAN Notice 46465 090198g.pdf 090198g.txt
98N-0357 Agency Information Collection Activities; Announcement of OMB Approval; Medical Devices; Current Good Manufacturing Practice (CGMP) Quality System (QS) OC Notice 46463 090198h.pdf 090198h.txt

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