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U.S. Department of Health and Human Services

Animal & Veterinary

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Withdrawn / Replaced

Withdrawn/Replaced Guidances

 

No.TitleDate
   
1Anticoccidial Guidelines Replaced by Guideline 40
2Anthelmintics  Withdrawn 12/22/2004
4Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for Cattle Withdrawn 12/22/2004
8Guidelines for Toxicological Investigations 
 		Replaced by Guideline 3
9Preclearance Guidelines for Production Drugs 
  		 Withdrawn pending revisions
10 Amendment of Section II(G)(1)(b)(4) of the Preclearance Guidelines Withdrawn pending revisions
14Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Food Producing Animals  Withdrawn 12/22/2004
15Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing Animals   Withdrawn 12/22/2004
16FOI Summary GuidelineWithdrawn  02/24/2005
17Working Guidelines for Assigning Residue Tolerances Replaced by Guideline 3
18 Antibacterial Drugs in Animal Feeds: Human Health Safety Criteria   Withdrawn 12/22/2004
19Antibacterial Drugs in Animal Feeds: Animal Health Safety Criteria   Withdrawn 12/22/2004
20Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness Criteria  Withdrawn 12/22/2004
21Nutritional Ingredients in Animal Drugs and Feeds

Replaced by P&P 1240.3420 9/17/09

22Guideline Labeling of Arecoline Base Drugs Intended for Animal UseWithdrawn 7/6/2011
25Guidelines for the Efficacy Evaluation of Equine Anthelmintics  Replaced by Guidance 109
26Guidelines 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Safety, Effectiveness, Human Food Safety and Environmental Considerations for Minor Use of New Animal Drugs  04/86 (superceded by Guidance 61) 
27New Animal Drug Determinations

Replaced by P&P 1240.3500 9/17/2009

28Animal Drug Applications Expedited Review GuidelineReplaced by P&P 1240.3135 10/14/2009
29Guidelines for the Effectiveness Evaluation of Swine Anthelmintics  Replaced by Guidance 110
30Guidelines for Anti-infective Bovine Mastitis Product Development  Replaced by Guideline 49
31Guideline for the Evaluation of Bovine Anthelmintics  Replaced by Guideline 95
32Guideline for Threshold Assessment  Replaced by Guideline  3
33Target Animal Safety Guidelines for New Animal Drugs Replaced by #185 4/24/2009
34Biomass Guideline - Guideline for New Animal Drugs and Food Additives Derived From a Fermentation; Human Food Safety Evaluation Replaced by Guideline 3
36Guidelines for Efficacy Evaluation of Canine/Feline Anthelmintics   Replaced by Guidance 111
39Guideline on the Conduct of Clinical Investigations: Responsibilities of Clinical Investigators and Monitors for Investigational New Animal Drug Studies  Replaced by Guidance 85
41Draft Guideline:  Formatting, Assembling, and Submitting New Animal Drug Applications   Withdrawn 03/2002
43Draft Guideline for Generic Animal Drug Products Containing Fermentation-Derived Drug Substances  Withdrawn 05/24/2006
51Points to Consider Guideline - Development of a Pharmacokinetic Guideline Enabling Flexible Labeling of Therapeutic Antimicrobials See Guidance 66 for updated information
52Assessment of the Effects of Antimicrobial Drug Residues from Food of Animal Origin on the Human Intestinal Flora, February 18, 2004  Replaced by Guidance 159
54Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds  06/1994 --See Final Guidance 80
58Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and Monitors Withdrawn 12/22/2004; superseded by guidance 85
59How to Submit a Notice of Claimed Investigational  Exemption in Electronic Format to CVMWithdrawn 09/30/2011
60Guidance For Industry: Animal Proteins Prohibited From Animal Feed; Small Entity Compliance GuideReplaced by Guidance 67, 68, 69, and 70
66Withdrawal of Guidance Document on Professional Flexible Labeling of Antimicrobial Drugs Withdrawn 01/30/2002
77Guidance for Industry: Interpretation of On-Farm Feed Manufacturing and Mixing Operations: DRAFT GUIDANCEWithdrawn 06/12/2003
78Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing AnimalsReplaced by Guidance 152
86How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format to CVMWithdrawn 09/30/2011
87How to Submit a Notice of Intent to Slaughter for Human Food Purpose in Electronic Format to CVMWithdrawn 09/30/2011
88How to Submit a Request for a Meeting or Teleconference in Electronic Format to CVMWithdrawn 09/30/2011
107How to Submit a Protocol without Data in Electronic Format to CVMWithdrawn 09/30/2011
121Expedited Review for New Animal Drug Applications for Human Pathogen Reduction ClaimsWithdrawn 05/24/2011
154Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic Records Withdrawn 02/25/03Withdrawn 02/25/2003
155 Draft Guidance for Industry: 21 CFR Part 11: Electronic Records; Electronic Signatures; Electronic Copies of Electronic RecordsWithdrawn 02/4/2003
172 Guidance for Industry #172 - Use of unapproved hormone implants in veal calves, April 2, 2004 Withdrawn 07/15/2004
174Guidance for Industry #174 - Use of Material from BSE-Positive Cattle in Animal FeedWithdrawn 04/13/2011

 

 

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