Animal & Veterinary
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Withdrawn / Replaced
Withdrawn/Replaced Guidances
No. | Title | Date |
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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2 | Anthelmintics | Withdrawn 12/22/2004 |
4 | Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle | Withdrawn 12/22/2004 |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9 | Preclearance Guidelines for Production Drugs | Withdrawn pending revisions |
10 | Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines | Withdrawn pending revisions |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for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing Animals | Withdrawn 12/22/2004 |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for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals | Withdrawn 12/22/2004 |
16 | FOI Summary Guideline | Withdrawn 02/24/2005 |
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18 | Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria | Withdrawn 12/22/2004 |
19 | Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria | Withdrawn 12/22/2004 |
20 | Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria | Withdrawn 12/22/2004 |
21 | Nutritional Ingredients in Animal Drugs and Feeds | Replaced by P&P 1240.3420 9/17/09 |
22 | Guideline Labeling of Arecoline Base Drugs Intended for Animal Use | Withdrawn 7/6/2011 |
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Safety, Effectiveness, Human Food Safety and Environmental Considerations for Minor Use of New Animal Drugs | 04/86 (superceded by Guidance 61) |
27 | New Animal Drug Determinations | Replaced by P&P 1240.3500 9/17/2009 |
28 | Animal Drug Applications Expedited Review Guideline | Replaced by P&P 1240.3135 10/14/2009 |
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 |
33 | Target Animal Safety Guidelines for New Animal Drugs | Replaced by #185 4/24/2009 |
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 03/2002 |
43 | Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug Substances | Withdrawn 05/24/2006 |
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 | 06/1994 --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 |
59 | How to Submit a Notice of Claimed Investigational Exemption in Electronic Format to CVM | Withdrawn 09/30/2011 |
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 | Withdrawn 01/30/2002 |
77 | Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCE | Withdrawn 06/12/2003 |
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 |
86 | How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to CVM | Withdrawn 09/30/2011 |
87 | How to Submit a Notice of Intent to Slaughter for Human Food Purpose in Electronic Format to CVM | Withdrawn 09/30/2011 |
88 | How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVM | Withdrawn 09/30/2011 |
107 | How to Submit a Protocol without Data in Electronic Format to CVM | Withdrawn 09/30/2011 |
121 | Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims | Withdrawn 05/24/2011 |
154 | Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records Withdrawn 02/25/03 | Withdrawn 02/25/2003 |
155 | Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic Records | Withdrawn 02/4/2003 |
172 | Guidance for Industry #172 - Use of unapproved hormone implants in veal calves, April 2, 2004 | Withdrawn 07/15/2004 |
174 | Guidance for Industry #174 - Use of Material from BSE-Positive Cattle in Animal Feed | Withdrawn 04/13/2011 |
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