New Animal Drugs for Use in Animal Feeds; Decoquinate and Monensin. (29DEC00) Click here for txt
or
pdf Prepublication display
Freedom of Information Summary |
Veterinary Antimicrobial Decision Support System. (29DEC00) Click here for txt
or
pdf Prepublication display |
Use of Antimicrobial Drugs in Food Animals and Establishment of Regulatory Thresholds on Antimicrobial Resistance;
Amendment. (29DEC00) Click here for txt or pdf
Prepublication display |
Agency Information Collection Activities; Announcement of OMB Approval; Medicated Feed Mill License. (21DEC00)
Click here for txt or pdf
Prepublication display Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; 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. (21DEC00) Click here for txt
or pdf Prepublication display Supporting Statement |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidance on Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (VICH GL22); Availability; Request for Comments. (19DEC00) Click here for txt
or
pdf Prepublication display Draft Guidance
|
International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Safety Studies for Veterinary Drug Residues in Human Food: Genotoxicity Studies (VICH GL23); Availability; Request for Comments. (18DEC00) Click here for txt
or
pdf Prepublication display Draft Guidance
|
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidance on Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AER's) (VICH GL24); Availability; Request of Comments. (18DEC00) Click here for txt
or
pdf Prepublication displayDraft Guidance
|
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidances for Industry on Effectiveness of Anthelmintics: Specific Recommendations for Feline (VICH GL20) and Effectiveness of Anthelmintics: Specific Recommendations for Poultry (VICH GL21); Availability;
Request for Comments. (18DEC00) Click here for
txt or pdf
Prepublication display Draft Guidance VICH GL20 Recommendations for Feline Draft Guidance VICH GL21 Recommendations for Poultry |
Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry on How to Use E-Mail to
Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter. (11DEC00) Click here for txt or pdf Prepublication display Supporting Statement |
Tolerances for Residues of New Animal Drugs in Food; Moxidectin. (08DEC00) Click here for txt
or
pdf Prepublication display |
Animal Drug Availability Act; Veterinary Feed Directive. (08DEC00) Click here for txt
or
pdf Prepublication display |
Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry on How to Use E-Mail to
Submit Information to the Center for Veterinary Medicine. (07DEC00) Click here for txt or pdf Prepublication display |
New Animal Drugs for Use in Animal Feeds; Salinomycin and Bacitracin Methylene Disalicylate. (28NOV00) Click here for
txt or pdf
Prepublication display
Freedom of Information Summary |
2001 National Antimicrobial Resistance Monitoring System (NARMS) Scientific Meeting; Public Meeting. (28NOV00)
Click here for txt or pdf
Prepublication display |
Oral Dosage Form New Animal Drugs; Nitenpyram Tablets. (27NOV00) Click here for txt
or
pdf Prepublication display
Freedom of Information Summary |
Oral Dosage Form New Animal Drugs; Ivermectin Paste. (27NOV00) Click here for txt
or
pdf Prepublication display
Freedom of Information Summary |
Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol. (27NOV00) Click here for txt
or
pdf Prepublication display
Freedom of Information Summary |
New Animal Drugs; Change of Sponsor's Address. (21NOV00) Click here for txt
or
pdf Prepublication display |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Substantial Evidence of
Effectiveness of New Animal Drugs. (16NOV00) Click here for
txt or pdf
Prepublication display |
New Animal Drugs for Use in Animal Feeds; Pyrantel Tartrate. (07NOV00) Click here for txt
or
pdf Prepublication display
Freedom of Information Summary |
Ophthalmic and Topical Dosage Form New Animal Drugs; Enrofloxacin, Silver Sulfadiazine Emulsion. (07NOV00)
Click here for txt or pdf
Prepublication display Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Decoquinate and Chlortetracycline. (07NOV00) Click here for txt
or
pdf Prepublication display
Freedom of Information Summary |
Final Guidance for Industry: The Use of Published Literature in Support of New Animal Drug Approval; Availability.
(07NOV00) Click here for txt or pdf
Prepublication display The Guidance |
New Animal Drugs for Use in Animal Feeds; Narasin and Tylosin Phosphate. (01NOV00) Click here for txt
or
pdf Prepublication display
Finding of No Significant Impact |
Enrofloxacin for Poultry; Opportunity For Hearing. (31OCT00) Click here for txt
or
pdf Prepublication display |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidances for Industry on ``Effectiveness of Anthelmintics: Specific Recommendations for Equine'' (VICH GL15), ``Effectiveness of Anthelmintics: Specific Recommendations for Porcine'' (VICH GL16), and
``Effectiveness of Anthelmintics: Specific Recommendations for Canine'' (VICH GL19); Availability; Request for Comments. (19OCT00) Click here for txt or pdf Prepublication display
Draft Guidance Specific Recommendations for Equine VICH GL15
Draft Guidance Specific Recommendations for Porcine VICH GL16 Draft Guidance Specific Recommendations for Canine VICH GL19 |
Implantation or Injectable Dosage Form New Animal Drugs; Levamisole Phosphate Injection. (16OCT00) Click here for
txt or pdf
Prepublication display
Freedom of Information Summary |
Intramammary Dosage Form New Animal Drugs; Pirlimycin Hydrochloride. (16OCT00) Click here for txt
or
pdf Prepublication display
Freedom of Information Summary |
New Animal Drugs; Change of Sponsor's Name. (12OCT00) Click here for txt
or
pdf Prepublication display |
New Animal Drugs; Change of Sponsor Name and Address. (10OCT00) Click here for txt or pdf Prepublication display |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medicated Feed Mill License.
(06OCT00) Click here for txt or pdf
Prepublication display |
Nutrient Requirements of Domestic Animals and Critical Roles of Animal Nutrition. (04OCT00) Click here for txt
or
pdf Prepublication display |
Establishment of Resistance and Monitoring Thresholds in Food-Producing Animals; Public Meeting; Amendment of Notice (26SEP00) Click here for txt or pdf Prepublication document |
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail
to Submit Information to the Center for Veterinary Medicine. (21SEP00) Click here for txt or pdf Prepublication document |
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail
to Submit a Notice of Intent to Slaughter for Human Food Purposes. (21SEP00) Click here for txt or pdf Prepublication document |
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail
to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter. (21SEP00) Click here for txt or pdf Prepublication document |
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail
to Submit a Notice of Intent to Slaughter for Human Food Purposes. (21SEP00) Click here for txt or pdf Prepublication document |
Food Labeling; Use of the Term ``Fresh'' for Foods Processed With Alternative Nonthermal Technologies. (20SEP00)
Click here for txt or pdf
Prepublication document |
New Animal Drugs for Use in Animal Feeds; Narasin and Bacitracin Zinc. (15SEP00) Click here for txt
or
pdf Prepublication document
Freedom of Information Summary |
New Animal Drugs; Change of Sponsor's Address. (14SEP00) Click here for txt
or
pdf Prepublication document |
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Bacitracin Methylene Disalicylate. (08SEP00)
Click here for txt or pdf
Prepublication document
Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Monensin and Roxarsone. (08SEP00) Click here for txt
or
pdf Prepublication document Freedom of Information Summary |
Animal Drugs, Feeds, and Related Products; Technical Amendment. (07SEP00) Click here for txt
or
pdf Prepublication document |
Oral Dosage Form New Animal Drugs; Neomycin Sulfate Oral Solution. (05SEP00) Click here for txt
or
pdf Prepublication document Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin Phosphate. (05SEP00) Click here for txt
or
pdf Prepublication document Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Monensin and Bambermycins. (05SEP00) Click here for txt
or
pdf Prepublication document Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Monensin, Bacitracin Methylene Disalicylate, and Roxarsone. (05SEP00)
Click here for txt or pdf
Prepublication document
Freedom of Information Summary |
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium Yeast; Correction. (01SEP00) Click here for
txt or pdf
Prepublication document |
Ophthalmic and Topical Dosage Form New Animal Drugs; 209Mercaptobenzothiazole Solution. (22AUG00) Click here for txt
or
pdf Prepublication document |
New Animal Drugs for Use in Animal Feeds; Fenbendazole. (22AUG00) Click here for txt
or
pdf Prepublication document Environmental Assessment
Finding of No Significant Impact Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate, Robenidine Hydrochloride, and Roxarsone.
(22AUG00) Click here for txt or pdf
Prepublication document Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Diciazuril, Bacitracin Methylene Disalicylate, Bambermycins, and Virginiamycin.
(17AUG00) Click here for txt or pdf
Prepublication document Freedom of Information Summary Freedom of Information Summary Freedom of Information Summary |
Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Evidence of Effectiveness of
New Animal Drugs. (16AUG00) Click here for txt or pdf
Prepublication document |
Tilmicosin Phosphate Injection for Sheep; Availability of Data. (04AUG00) Click here for txt
or
pdf Prepublication document
Freedom of Information Summary |
New Animal Drug Applications; Sheep as a Minor Species. (03AUG00) Click here for txt
or
pdf Prepublication document |
Establishment of Resistance and Monitoring Thresholds in Food-Producing Animals; Public Meeting. (28JUL00)
Click here for txt or pdf Prepublication document |
New Animal Drugs; Change of Sponsor Address. (26JUL00) Click here for txt
or pdf Prepublication document |
Oral Dosage Form New Animal Drugs; Ivermectin Sustained-Release Bolus. (26JUL00) Click here for txt
or pdf Prepublication document Freedom of Information Summary |
New Animal Drugs; Change of Sponsor. (26JUL00) Click here for txt
or pdf Prepublication document |
Implantation or Injectable Dosage Form New Animal Drugs; Ketamine hydrochloride Injection. (26JUL00) Click here for
txt
or pdf Prepublication document Freedom of Information Summary
|
Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradio. (26JUL00) Click here for txt
or pdf Prepublication document Freedom of Information Summary |
Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor. (26JUL00) Click here for txt
or pdf Prepublication document |
New Animal Drugs for Use in Animal Feeds; Monensin. (26JUL00) Click here for txt
or pdf Prepublication document Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Neomycin Sulfate. (26JUL00) Click here for txt
or pdf Prepublication document |
New Animal Drugs for Use in Animal Feeds; Penicillin; Technical Amendment. (26JUL00) Click here for txt
or pdf Prepublication document |
New Animal Drugs for Use in Animal Feeds; Chlortetracycline. (26JUL00) Click here for txt
or pdf Prepublication document Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Halofuginone and Roxarsone. (25JUL00) Click here for txt
or pdf Prepublication document |
New Animal Drugs for Use in Animal Feeds; Salinomycin and Roxarsone. (24JUL00) Click here for txt
or pdf Prepublication document Freedom of Information Summary
|
Ophthalmic and Topical Dosage Form New Animal Drugs; Selamectin. (21JUL00) Click here for txt
or pdf Prepublication document Freedom of Information Summary |
New Animal Drugs for Use in Animal Feeds; Salinomycin, Bacitracin Methylene Disalicylate, and Roxarsone. (07JUL00)
Click here for txt or pdf Prepublication document Freedom of Information Summary
|
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Final Guidance on ``Impurities in New Veterinary Medicinal Products'' (VICH GL11); Availability. (07JUL00) Click here for txt or pdf Prepublication document
The Guidance |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Final Guidance on ``Impurities in New Veterinary Drug Substances'' (VICH GL10); Availability. (07JUL00) Click here for txt or pdf Prepublication document The Guidance |
Ophthalmic and Topical Dosage Form New Animal Drugs; Furazolidone Aerosol Powder. (06JUL00) Click here for txt
or pdf Prepublication document Freedom of Information Summary
|
Tolerances for Residues of New Animal Drugs in Food; Fenbendazole. (06JUL00) Click here for txt
or pdf Prepublication document |
New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Fenbendazole. (06JUL00) Click here for
txt
or pdf Prepublication document Freedom of Information Summary
|
Draft Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for
Immediate Slaughter; Availability. (29JUN00) Click here for
txt or pdf Prepublication document The Draft Guidance |
Draft Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes;
Availability. (29JUN00) Click here for txt or pdf Prepublication document The Draft Guidance |
Draft 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. (29JUN00) Click here for txt or pdf Prepublication document The Draft Guidance |
Draft Guidance for Industry on How to Use E-Mail to Submit Information to the Center for Veterinary Medicine;
Availability. (29JUN00) Click here for txt or pdf Prepublication document The Draft Guidance |
Ceftiofur Sodium Injection for Goats; Availability of Data. (28JUN00) Click here for txt
or pdf Prepublication document Freedom of Information Summary |
Antimicrobial resistance, public health action plan to combat; availability and comment request. (22JUN00)
Click here for txt or pdf |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Substances Prohibited From Use in
Animal Food or Feed; Animal Protein Prohibited in Ruminant Feed. (20JUN00) Click here for txt or pdf Prepublication document |
New Animal Drugs; Change of Sponsor's Address. (12JUN00) Click here for txt
or pdf Prepublication document |
New Animal Drugs; Change of Sponsor's Address. (09JUN00) Click here for txt
|