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  1. Guidance for Industry

Withdrawn/Replaced Guidances

No. Title Date
  CPG Sec. 170.100 Turtles - Ban on Interstate and Intrastate Sales and Distribution Withdrawn 03/03/2015
  CPG Sec. 665.200 Checklist Labeling for Custom Mixed Medicated Feeds Withdrawn 7/23/2019
  CPG Sec. 675.400 Rendered Animal Feed Ingredients Withdrawn 4/30/2019
  CPG Sec. 690.300  Canned Pet Food Withdrawn 4/30/2019
  CPG Sec. 690.500  Uncooked Meat for Animal Food Withdrawn 4/30/2019
  Draft Guidance for Industry: Use of Antibiotic Resistance Marker Genes in Transgenic Plants
Withdrawn 05/06/2015; For questions, contact Division of Animal Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine at (240) 402-7077.
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2 Anthelmintics Withdrawn 12/22/2004
4 Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle Withdrawn 12/22/2004
6 Submitting NADA's for Generic Drugs Reviewed by NAS/NR Withdrawn 8/23/2018
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9 Preclearance Guidelines for Production Drugs Withdrawn pending revisions
10 Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines Withdrawn pending revisions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Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing Animals Withdrawn 12/22/2004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for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals Withdrawn 12/22/2004
16 FOI Summary Guideline Withdrawn  02/24/2005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18 Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria Withdrawn 12/22/2004
19 Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria Withdrawn 12/22/2004
20 Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria Withdrawn 12/22/2004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22 Guideline Labeling of Arecoline Base Drugs Intended for Animal Use Withdrawn 7/6/2011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
40 Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drug Combinations in Poultry Superseded by Guidance for Industry #217 11/20/2012
41 Draft Guideline:  Formatting, Assembling, and Submitting New Animal Drug Applications Withdrawn 03/2002
42 Animal Drug Manufacturing Guidelines- Series of Four Guidelines Withdrawn 10/30/2019 pending revision
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
153 Draft Guidance for Industry #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals Withdrawn 05/06/2015
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
182 VICH GL42 - Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports Withdrawn 01/17/2014; harmonized under Guidance 188
230 Draft GFI #230 – Compounding Animal Drugs from Bulk Drug Substances Withdrawn 11/7/2017; Replaced by Draft Guidance 256