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Table of Contents

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Withdrawn/Replaced Guidance Documents

 

 NO.

 TITLE

DATE

 1 Anticoccidial Guidelines  Replaced by Guideline 40
 2 Anthelmintics   Withdrawn 12/22/2004
 4 Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle  Withdrawn 12/22/2004
 8 Guidelines for Toxicological Investigations 
 
Replaced by Guideline 3
 9 Preclearance Guidelines for Production Drugs 
  
 Withdrawn pending revisions
 10  Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines
 Withdrawn pending revisions
 14 Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing Animals   Withdrawn 12/22/2004
 15 Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals (2277)   Withdrawn 12/22/2004
 17

Working Guidelines for Assigning Residue Tolerances

 Replaced by Guideline 3
 18  Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria    Withdrawn 12/22/2004
 19 Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria    Withdrawn 12/22/2004
 20 Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria   Withdrawn 12/22/2004
 25 Guidelines for the Efficacy Evaluation of Equine Anthelmintics   Replaced by Guidance 109
 26

Guidelines for the Preparation of Data to Satisfy the Requirements of Section 512 of the Act Regarding Animal Safety, Effectiveness, Human Food Safety and Environmental Considerations for Minor Use of New Animal Drugs 

 04/86 (superceded by Guidance 61) 
 29 Guidelines for the Effectiveness Evaluation of Swine Anthelmintics   Replaced by Guidance 110
 30 Guidelines for Anti-infective Bovine Mastitis Product Development   Replaced by Guideline 49
 31 Guideline for the Evaluation of Bovine Anthelmintics   Replaced by Guideline 95
 32 Guideline for Threshold Assessment   Replaced by Guideline  3
 34 Biomass Guideline - Guideline for New Animal Drugs and Food Additives Derived From a Fermentation; Human Food Safety Evaluation  Replaced by Guideline  3
 36 Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics    Replaced by Guidance  111
 39 Guideline on the Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies   Replaced by Guidance 85
 41 Draft Guideline:  Formatting, Assembling, and Submitting New Animal Drug Applications    Withdrawn 3/2002
 43 Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug Substances   Withdrawn 05/24/06
 51 Points to Consider Guideline - Development of a Pharmacokinetic Guideline Enabling Flexible Labeling of Therapeutic Antimicrobials  See Guidance 66 for updated information
 52 Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora, February 18, 2004   Replaced by Guidance 159
 54 Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds   06/94 --See Final Guidance 80
 58 Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and Monitors  Withdrawn 12/22/2004;  superseded by guidance 85
 60 Guidance For Industry: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance Guide Replaced by Guidance 67, 68, 69, and 70
 66 Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs  | html | | pdf | Withdrawn 01/30/2002
 77 Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCE | html | | pdf | Withdrawn 06/12/03
 78 Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals Replaced by Guidance 152
 154  Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records | html | | pdf | Withdrawn 02/25/03
 155

 Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic Records | html | | pdf |

Withdrawn 02/4/03
 172  Guidance for Industry #172 - Use of unapproved hormone implants in veal calves, April 2, 2004 | html |  Withdrawn 07/15/04


Web Page Updated by jmo - January 15, 2009, 8:00 am




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