2001

Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora.    (27DEC01)
Click here for
txt or pdf
Prepublication display
The Draft Guidance

New Animal Drugs; Change of Sponsor's Address.  (27DEC01)
Click here for
txt or pdf
Prepublication display

International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on "Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSU's)" (VICH GL29); Request for Comments; Availability.    (13DEC01)
Click here for
txt or pdf
Prepublication display
The Draft Guidance

Import Tolerances; Extension of Comment Period.    (07DEC01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor.    (07DEC01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs for Use in Animal Feeds; Monensin.    (07DEC01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Oral Dosage Form New Animal Drugs; Ivermectin Liquid.    (05DEC01)
Click here for
txt or pdf
Prepublication display
 
Freedom of Information Summary

New Animal Drugs; Change of Sponsor's Address.    (05DEC01)
Click here for
txt or pdf
Prepublication display

Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Pour-On.    (05DEC01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Oral Dosage Form New Animal Drugs; Carprofen.    (05DEC01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

New Animal Drugs for Use in Animal Feeds; Diclazuril.    (04DEC01)
Click here for
txt or pdf
Prepublication display
 
Freedom of Information Summary                                                                                                       Finding of No Significant Impact

Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder; Technical Amendment.    (26NOV01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

New Animal Drugs for Use in Animal Feeds; Fenbendazole; Technical Amendment.    (26NOV01)
Click here for
txt or pdf
Prepublication display

Veterinary Medicine Advisory Committee; Notice of Meeting.    (21NOV01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs for Use in Animal Feeds; Arsanilic Acid; Technical Amendment.    (19NOV01)
Click here for
txt or pdf
Prepublication display

Oxytetracycline in Fish; Availability of Data.    (16NOV01)
Click here for
txt or pdf
Prepublication display

Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds; Availability.   (09NOV01)
Click here for
txt or pdf
Prepublication display                                                                                                                                   The Guidance

Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor.  (06NOV01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor's Name.    (06NOV01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.  (05NOV01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use.  (16OCT01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Announcement of OMB Approval; Current Good Manufacturing Practice Regulations for Medicated Feeds.    (15OCT01)
Click here for
txt or pdf
Prepublication display
Supporting Statement

Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed; Public Hearing; Request for Comments.    (05OCT01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor; Technical Amendment.    (17SEP01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor; Technical Amendment.    (17SEP01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor.     (17SEP01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs for Use in Animal Feeds; Lasalocid (Final rule).    (11SEP01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

New Animal Drugs; Change of Sponsor.     (07SEP01)
Click here for
txt or pdf
Prepublication display

Animal Drugs, Feeds, and Related Products; Technical Amendments.    (06SEP01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor's Name and Address.    (05SEP01)
Click here for
txt or pdf
Prepublication display

Ophthalmic and Topical Dosage Form New Animal Drugs; Change of Sponsor.    (05SEP01)
Click here for
txt or pdf
Prepublication display

Oral Dosage Form New Animal Drugs; Marbofloxacin Tablets.    (05SEP01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Ophthalmic and Topical Dosage Form New Animal Drugs; Moxidectin.    (05SEP01)
Click here for
txt or pdf
Prepublication display

Tolerances for Residues of New Animal Drugs in Food; Oxytetracycline; Technical Amendment.    (05SEP01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs for Use in Animal Feeds; Lasalocid and Bacitracin Methylene Disalicylate.   (05SEP01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Alpharma, Inc; Withdrawal of Approval of NADA.    (03AUG01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report; Reopening of Comment Period.    (31AUG01)
Click here for
txt or pdf
Prepublication display

International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing (VICH GL28); Request for Comments; Availability.    (28AUG01)
Click here for
txt or pdf
Prepublication display
The Draft Guidance

New Animal Drugs for Use in Animal Feeds; Nequinate; Oxytetracycline; Technical Amendment.    (28AUG01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor's Name and Address.   (21AUG01)
Click here for
txt or pdf
Prepublication display

Oral Dosage Form New Animal Drugs; Ponazuril.    (21AUG01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

EVSCO Pharmaceuticals, an Affiliate of IGI, Inc.; Withdrawal of Approval of NADAs.    (15AUG01)
Click here for
txt or pdf
Prepublication display

CVM 2000119.  Ophthalmic and Topical Dosage Form New Animal Drugs; Chloramphenicol, etc.; Withdrawal of Approval of NADAs.     (15AUG01)
Click here for
txt or pdf
Prepublication display

CVM 1998109.  Import Tolerances.  (10AUG01)
Click here for
txt or pdf
Prepublication display

Veterinary Medicine Advisory Committee; Notice of Meeting.   (10AUG01)
Click here for
txt or pdf
Prepublication display

Alpharma, Inc; Withdrawal of Approval of NADA.    (03AUG01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Announcement of OMB Approval; New Animal Drug Application, Form FDA 356 V.     (23JUL01)
Click here for
txt or pdf
Prepublication display
Supporting Statement

Novus International, Inc.; Filing of Food Additive Petition (Animal Use)- Ethoxyquin phosphate.  (13JUL01)
Click here for
txt or pdf
Prepublication display

Heinold Feeds, Inc.; Withdrawal of Approval of New Animal Drug Applications.    (11JUL01)
Click here for
txt or pdf
Prepublication display

Animal Drugs, Feeds, and Related Products; Tylosin; Withdrawal of Approval of NADAs.   (11JUL01)
Click here for
txt or pdf
Prepublication display

Oral Dosage Form New Animal Drugs; Chlortetracycline Powder.    (10JUL01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Oral Dosage Form New Animal Drugs; Ivermectin and Pyrantel Pamoate Chewable Tablets.    (09JUL01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Implantation or Injectable Dosage Form New Animal Drugs; Moxidectin.    (09JUL01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Tolerances for Residues of New Animal Drugs in Food; Clorsulon.    (06JUL01)
Click here for
txt or pdf
Prepublication display
  Freedom of Information Summary

New Animal Drugs; Change of Sponsor.  (18JUN01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds.   (15JUN01)
Click here for
txt or pdf
Prepublication display

Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Sterile Powder for Injection;   (15JUN01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Draft Guidance for Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues; Availability.     (13JUN01)
Click here for
txt or pdf
Prepublication display
The Draft Guidance

Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (29MAY01)
Click here for
txt or pdf
Prepublication display

Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder.   (29MAY01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

New Animal Drugs for Use in Animal Feeds; Lasalocid and Bacitracin Zinc.    (29MAY01)
Click here for
txt or pdf
Prepublication display
 
Freedom of Information Summary

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry on "Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients" (VICH GL18); Availability.    (22MAY01)
Click here for
txt or pdf
Prepublication display
The Guidance

New Animal Drugs For Use in Animal Feeds; Naracin, Nicarbazin, and Bambermycins.    (16MAY01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry entitled Good Clinical Practice (VICH GL9); Availability   (15MAY01)
Click here for
txt or pdf
Prepublication display
The Guidance

Purina Mills, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications.    (09MAY01)
Click here for
txt or pdf
Prepublication display

Animal Drugs, Feeds, and Related Products; Trichlorfonm etc.; Withdrawal of Approval of NADAs;.    (09MAY01)
Click here for
txt or pdf
Prepublication display

Tolerances for Residues of New Animal Drugs in Food; Narasin.   (09MAY01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Agency Information Collection Activities; Submission for OMB Review; Comment Request; New Animal Drug Application, Form 356 V.  (06MAY01)
Click here for
txt or pdf
Prepublication display

Elanco Animal Health, A Div. of Eli Lilly & Co. et al.; Withdrawal of Approval of NADAs.   (03MAY01)
Click here for
txt or pdf
Prepublication display

Animal Drugs, Feeds, and Related Products; Tylosin Tartrate for Injection, etc.; Withdrawal of Approval of NADAs.     (03MAY01)
Click here for
txt or pdf
Prepublication display

Animal Drugs, Feeds, and Related Products; Technical Amendments.    (03MAY01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs for Use in Animal Feeds; Monensin, Sulfadimethoxine, and Ormetoprim; Technical Amendment.  (02MAY01)
Click here for
txt or pdf
Prepublication display

Abbott Laboratories' Sarafloxacin for Poultry; Withdrawal of Approval of NADAs.  (30APR01)
Click here for
txt or pdf
Prepublication display

Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder.    (30APR01)
Click here for
txt or pdf
Prepublication display

Animal Drugs, Feeds, and Related Products; Sarafloxacin for Poultry; Withdrawal of Approval of NADAs.    (30APR01)
Click here for
txt or pdf
Prepublication display

Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Sterile Powder for Injection.    (30APR01)
Click here for
txt or pdf
Prepublication display
 
Freedom of Information Summary

New Animal Drugs for Use in Animal Feeds; Ractopamine and Tylosin.   (30APR01)
Click here for
txt or pdf
Prepublication display

Extra-Label Use of Medicated Feeds for Minor Species; Compliance Policy Guide; Availability.    (23APR01)
Click here for
txt or pdf
Prepublication display                                                                                                                        The Guidance

New Animal Drugs for Use in Animal Feeds; Amprolium, Bacitracin Methylene Disalicylate, and Roxarsone.  (23APR01)
Click here for
txt or pdf
Prepublication display                                                                                                                Freedom of Information Summary

New Animal Drugs for Use in Animal Feeds; Amprolium and Bacitracin Methylene Disalicylate.  (19APR01)
Click here for
txt or pdf
Prepublication display                                                                                                              Freedom of Information Summary

Tolerances for Residues of New Animal Drugs in Food; Lasalocid.  (18APR01)
Click here for
txt or pdf
Prepublication display                                                                                                               Freedom of Information Summary 

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry Entitled "Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products" (13APR01)
Click here for
txt or pdf
Prepublication display                                                                                                                            The Guidance

Irradiation in the Production, Processing, and Handling of Animal Feed and Pet Food; Irradiation.  (10APR01)
Click here for
txt or pdf
Prepublication display

International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Final Guidances entitled "Effectiveness of Anthelmintics: General Recommendations" (VICH GL7), "Effectiveness of Anthelmintics: Specific Recommendations for Bovine"  (VICH GL12), "Effectiveness of Anthelmintics: Specific Recommendations for Ovine"  (VICH GL13), and "Effectiveness of Anthelmintics: Specific Recommendations for Caprine"  (VICH GL14); Availability (06APR01)
Click here for
txt or pdf
Prepublication display                                                                                                                        The Guidance                                                                                                                                       The Guidance                                                                                                                                       The Guidance                                                                                                                                       The Guidance

New Animal Drugs; Change of Sponsor.  (02APR01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin.  (23MAR01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor.  (19MAR01)
Click here for
txt or pdf
Prepublication display

International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Final Guidance on "Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)-Phase I" (VICH GL6); Availability.  (13MAR01)
Click here for
txt or pdf
Prepublication display
The Guidance

Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and Boluses.  (12MAR01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Guidance for Industry: Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims; Availability.  (09MAR01)
Click here for
txt or pdf
Prepublication display
The Guidance

New Animal Drugs; Change of Sponsor.   (09MAR01)
Click here for
txt or pdf
Prepublication display

New Animal Drugs; Change of Sponsor Name and Address.   (08MAR01)
Click here for
txt or pdf
Prepublication display

Oral Dosage Form New Animal Drugs; Clindamycin Hydrochloride Liquid,.   (08MAR01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Ophthalmic and Topical Dosage Form New Animal Drugs; Milbemycin Oxime Solution.   (08MAR01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

New Animal Drugs; Change of Sponsor.   (06MAR01)
Click here for
txt or pdf
Prepublication display

Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin.   (05MAR01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection.  (05MAR01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

New Animal Drugs for Use in Animal Feeds; Monesin, Bacitracin Methylene Disalicylate, and Roxarsone.   (05MAR01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Pour-On.  (05MAR01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin;.   (05MAR01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Announcement of OMB Approval; Emergency Health Surveys.  (02MAR01)
Click here for
txt or pdf
Prepublication display

Agency Information Collection Activities; Announcement of OMB Approval; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Phohibited in Ruminant Feed.  (02MAR01)
Click here for
txt or pdf
Prepublication display
Supporting Statement

Agency Information Collection Activities; Announcement of OMB Approval; Substantial Evidence of Effectiveness of New Animal Drugs  (01MAR01)
Click here for
txt or pdf
Prepublication display
Supporting Statement

Guidance for Industry on How to Use E-Mail to Submit Information to the Center for Veterinary Medicine; Availability.  (22FEB01)
Click here for
txt or pdf
Prepublication display
The Guidance

Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes; Availability.  (22FEB01)
Click here for
txt or pdf
Prepublication display
The Guidance

Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter; Availability  (16FEB01)
Click here for
txt or pdf
Prepublication display
The Guidance

Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation; Availability  (16FEB01)
Click here for
txt or pdf
Prepublication display
The Guidance

Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds.  (09FEB01)
Click here for
txt or pdf
Prepublication display

Oral Dosage Form New Animal Drugs; Pyrantel Pamoate Chewable Tablets.  (09FEB01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Suspension.  (24JAN01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Oral Dosage Form New Animal Drugs; Ivermectin Liquid.  (24JAN01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Application, Form FDA 356 V, 21 CFR Part 514  (23JAN01)
Click here for
txt or pdf
Prepublication display

Enrofloxacin for Poultry; Opportunity for Hearing; Correction.  (22JAN01)
Click here for
txt or pdf
Prepublication display
Revised Risk Assessment

New Animal Drugs for Use in Animal Feeds; Decoquinate, Monensin, and Tylosin.  (10JAN01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary

Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor.   (04JAN01)
Click here for
txt or pdf
Prepublication display

CV Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Mometasone Furoate, Clotrimazole Otic Suspension.  (04JAN01)
Click here for
txt or pdf
Prepublication display
Freedom of Information Summary