Contains Non-Binding Recommendations 
 
# 136 
                   
 
 
 
Guidance for Industry 
 
Protocols for the Conduct of Method Transfer Studies for 
Type C Medicated Feed Assay Methods 
 
Final Guidance 
 
 
Comments and suggestions regarding this guidance should be sent to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, Rockville, MD  20852.  Comments may also be submitted electronically on 
the Internet at http://www.regulations.gov.  All comments should be identified with the 
Docket No. 2006D-0441. 
 
For questions regarding this guidance document, contact Rebecca L. Owen, Center for 
Veterinary Medicine (HFV-141), Food and Drug Administration, 7500 Standish Place, 
Rockville, MD  20855, 240-276-9842, E-mail: rebecca.owen@fda.hhs.gov. 
 
Additional copies of this guidance document may be requested from the Communications 
Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 
Standish Place, Rockville, MD  20855, and may be viewed on the Internet at 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIn
dustry/default.htm.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
April 26, 2007  Contains Non-Binding Recommendations 
 
 
TABLE OF CONTENTS 
 
  Page No. 
 
I.  Introduction   4 
 
II.  Discussion  5 
 
Table  Recommended Flow of Activities  12 
 
Appendix I  Example Sponsor Protocol  13 
 
1.  Objective  13 
 
2.  Scope  13 
 
3.  Quality Audit  13 
 
4.  Responsibilities  13 
 
5.  Definitions  14 
 
6.  Assay Method  14 
 
7.  Reagents & Chemicals  14 
 
8.  Feed Preparation, Determination of Reference Concentration,  
  Storage and Shipment  15 
 
9.  Transfer Study Sample Set  15 
 
10.  Conduct of the Feed Assay Transfer Study  15 
 
11.  Amendments to or Deviations from the Protocol  15 
 
12.  Reference Laboratory and/or Summary Report(s)  15 
 
- 2 -  Contains Non-Binding Recommendations 
 
Appendix II  Example Participating Laboratory Protocol  16 
 
1.  Objective  16 
 
2.  Scope  16 
 
3.  Quality Audit  16 
 
4.  Responsibilities  16 
 
5.  Definitions  17 
 
6.  Assay Method  17 
 
7.  Reagents & Chemicals  17 
 
8.  Transfer Study Feed Samples  17 
 
9.  Laboratory Transfer of the Medicated Feed Assay Method  17 
 
10.  Amendments to or Deviations from the Protocol  18 
 
11.  Participating Laboratory Report  18 
- 3 -  Contains Non-Binding Recommendations 
 
Guidance for Industry1 
 
Protocols for the Conduct of Method Transfer Studies for Type C 
Medicated Feed Assay Methods 
 
Final Guidance 
 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current 
thinking on this topic.  It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public.  You can use an alternative 
approach if the approach satisfies the requirements of applicable statutes and 
regulations. If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing this guidance.  If you cannot identify the appropriate 
FDA staff, call the telephone number listed on the title page of this guidance. 
 
 
 
I.  INTRODUCTION 
 
Section 512(b) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360b) 
establishes the requirements for a new animal drug approval.  FDA regulations specify 
the information you (the sponsor) must submit as part of your new animal drug 
application (NADA) and the proper format for the NADA submission.  21 CFR 514.1.  
As part of your NADA submission, you must describe analytical procedures capable of 
determining the active component(s) of the new animal drug within a reasonable degree 
of accuracy and of assuring the identity of such components.  21 CFR 514.1(b)(5)(vii).  
This includes a description of practicable methods of analysis (assay methods) that have 
adequate sensitivity to determine the amount of the new animal drug in the final dosage 
form.  21 CFR 514.1(b)(5)(vii)(a).  In the case of a Type A medicated article, the Type 
C medicated feed is a final dosage form used to treat the animal.  Thus as part of the 
NADA review process, FDA looks at assay methods for determining the amount of a new 
animal drug in Type C medicated feed. 
 
This guidance provides our (the Office of New Animal Drug Evaluation or ONADE) 
recommendations for protocols for conducting the transfer study of a single-laboratory 
validated Type C medicated feed assay method to laboratories that have no experience 
with the test method.  Many testing laboratories, including state feed laboratories and 
contract laboratories, use Type C medicated feed assay methods to determine whether the 
drug in a medicated feed is within the assay limits.  The term assay limits refers to the 
                                                 
1 The Office of New Animal Drug Evaluation within the Food and Drug Administrations Center for 
Veterinary Medicine prepared this guidance document.   
- 4 -  Contains Non-Binding Recommendations 
 
amount of the drug detected when a Type B/C feed is assayed.  The limit is a range that is 
published at 21 CFR 558.4(d).  When feed assay values fall within this range, it 
indicates that the feed has been prepared with the correct amount of Type A medicated 
article.  Because many different laboratories use medicated feed assays, it is important 
that the assay methods are reproducible.  Sponsors should conduct method transfer 
studies to evaluate reproducibility.  A method transfer study is part of the evaluation 
process for a Type C medicated feed assay method and demonstrates the transferability of 
the feed assay method among different laboratories by comparing the results each 
laboratory obtains when using the method to analyze a specific set of feed samples.  
Sponsors may expand the method transfer study to include other medicated feed 
products, such as Top Dress Type C, Free-Choice Type C, and Type B medicated feeds.    
 
FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, guidances describe the Agencys current 
thinking on a topic and should be viewed only as recommendations, unless specific 
regulatory or statutory requirements are cited.  The use of the word "should" in 
Agency guidances means that something is suggested or recommended, but not 
required. 
 
II.  DISCUSSION 
 
There are several steps involved in the development of a medicated feed assay method.  
First, you should write the feed assay method description and conduct a single-laboratory 
validation.  The validation may be performed by a laboratory within your company or by 
an outside laboratory that you contract for this purpose.  For additional information 
regarding the preparation and validation of a suitable medicated feed assay method, we 
recommend you consult the Center for Veterinary Medicine (CVM) guidance documents 
Guidance for Industry #135:  Validation of Analytical Procedures for Type C Medicated 
Feeds, and Guidance for Industry #137:  Analytical Method Description for Type C 
Medicated Feeds.    
 
You should next evaluate the reproducibility of the feed assay method by conducting a 
method transfer study, where you compare results obtained by your reference laboratory2 
for fortified and medicated feed samples with results from participating laboratories3 not 
familiar with the test method.  Before beginning the method transfer study, you may wish 
to hold a method demonstration, where personnel from your reference laboratory 
demonstrate the assay method and you discuss the method and transfer study protocol 
with representatives from each of the participating laboratories.  The transfer study itself 
should be conducted in two phases.  The first phase is a method familiarization, during 
                                                 
2 The sponsors own expert laboratory or a contract testing laboratory retained by the sponsor.  The 
reference laboratory should have experience performing the assay method. 
3 Laboratory conducting the analytical phase of the transfer study.  Usually there are three participating 
laboratories including contract testing laboratories and at least one state feed laboratory; however, federal 
government and foreign laboratories may also participate. 
- 5 -  Contains Non-Binding Recommendations 
 
which the participating laboratories should assay control (unmedicated) and fortified feed 
samples to ensure that they understand the method and can perform the analysis.  The 
second phase is the assay of the control, fortified, and medicated feed samples that 
comprise the sample set for the transfer study.  Each participating laboratory should 
provide a report documenting their data and results from the transfer study.  The 
reference laboratory may also provide a separate report.  The sponsor's study director 
should compile the results from the reference and participating laboratories to prepare a 
transfer study summary report.  ONADE will use the report and data, along with the 
method description and single-laboratory validation, to evaluate the feed assay method.        
 
This guidance includes recommendations to help you write a protocol for the transfer 
study of your validated feed assay method.  You are not required to submit a method 
transfer study protocol to us for our review; however, our review and concurrence make 
it more likely that the study detailed in the protocol will generate information you can use 
to demonstrate that the assay method can be successfully implemented in laboratories 
with no previous experience performing the method.  Therefore, we recommend that you 
submit the protocol to us, and that we agree on the format and content of the feed assay 
method transfer study before you begin the study.  This document provides example 
protocol formats for the sponsor (App. I) and a participating laboratory (App. II).  You 
may use these example protocol formats as they are presented, combine the example 
formats into one protocol for both the sponsor and the participating laboratories, or 
develop your own protocol format.  Instructions for the reference laboratory are typically 
included in the sponsor protocol, but you may also choose to prepare a separate reference 
laboratory protocol.  Your protocol(s) should include detailed instructions for all the 
procedures, operational steps, and documentation of the transfer study, including: 
 
  identification of the participating laboratories and personnel;   
  preparation of feed samples for analysis; 
  analysis of the feed samples by your reference laboratory to provide the 
reference concentrations; 
  method familiarization and analysis of the transfer study sample set by the 
participating laboratories, including the number and type of feed samples each 
laboratory will assay and the sample analysis sequence; and  
  data reporting, data analysis techniques, and report formats.   
 
We also recommend that you wait for us to conduct a technical evaluation of the Type C 
medicated feed assay method description and the single-laboratory validation report 
before you begin your method transfer study.   
 
Selecting Participating Laboratories 
We usually recommend that a sponsor conduct a three-laboratory transfer study for a new 
Type C medicated feed assay method associated with a new animal drug application for a 
new Type A medicated article.  These laboratories should not be familiar with the test 
method.  We recommend that at least one of the laboratories be a state feed laboratory.  
We usually recommend a one-laboratory transfer study for an updated or new feed assay 
method for an already approved Type A medicated article, and for Type A medicated 
- 6 -  Contains Non-Binding Recommendations 
 
articles intended for minor uses or minor species.  If you perform a one-laboratory 
transfer study in a laboratory within your company, we strongly recommend that the 
laboratory not be involved in the development of the method.  
  
Method Demonstration 
We recommend that you hold a training session at which personnel from your reference 
laboratory demonstrate the method for representatives from the participating laboratories, 
to highlight or clarify practical details of the assay method.  During the training session, 
you should also discuss all aspects of the protocol(s) to ensure everyone understands the 
procedures and objectives.  This can help you identify key points that may cause 
difficulties in the transfer study, perhaps as a result of differences in laboratory 
procedures and equipment, or facility limitations.  If the method demonstration shows the 
need for changes to the protocol(s) or method description, you should make the 
appropriate revisions before proceeding with the method transfer study.  If you make 
changes, we recommend that you submit the revised method and protocol(s) to us for 
concurrence before you begin the laboratory phase of your method transfer study. 
 
Feed Samples for the Transfer Study 
We recommend that you prepare the medicated feeds used in the transfer study in at least 
pilot scale equipment using manufacturing processes comparable to the commercial 
manufacturing processes.  We recommend at least a 1,000 pound batch size, and you 
should prepare at least two (2) batches of medicated feed, preferably in different mixer 
types.  The drug concentration(s) in the medicated feed samples should be within a range 
of 0.5-1.5X the proposed label claim(s).  You should include a description of the 
procedures for feed mixing, sampling, and homogeneity testing in the sponsor protocol.  
You should also state in the protocol that you will provide the specific feed formulas and 
batch records as appendices in your transfer study summary report.   
 
You should prepare and distribute the test materials to the participating laboratories, 
including the analytical standards and control and medicated feeds that have been 
manufactured in typical feed mixing equipment.  For each batch of feed you include in 
the transfer study, you should prepare five (5) feed samples, identified only by a sample 
identification number, that you will distribute to each of the participating laboratories.  
The sponsor usually grinds and sub-divides the medicated and control feeds before 
shipment to the participating laboratories; however, you may choose to include the feed 
grinding and sampling procedures in the transfer study.  If a feed is already a fine or 
coarse powder, you may not need to grind this type of feed prior to sub-sampling.  You 
should provide medicated feed samples of sufficient size to allow for at least duplicate 
analysis.  For example, for an analysis that requires 150 grams of feed, each individual 
bag of medicated feed sample should contain over 300 grams of feed to allow for 
preparation of two (2) samples for analysis.  You should also provide control feeds to the 
participating laboratories in single large samples sufficient to assay the method 
familiarization samples and the control and fortified samples included in the transfer 
study sample set.  We recommend that you provide control feed sample amounts large 
enough to allow the participating laboratory to repeat the entire analysis at least three (3) 
- 7 -  Contains Non-Binding Recommendations 
 
times.  You should specify in the sponsor protocol the number and weights of the sample 
bags that you will provide to each participating laboratory.   
 
We recommend that you describe the shipment and storage of feed samples and the 
documentation procedures in both the sponsor and participating laboratory protocols.  
You should include expiration dates for the control and medicated feed samples, which 
should be consistent with the known storage stability of the drug in the feed.  You should 
ship the samples at a time that will allow for the completion of the transfer study, in the 
absence of unreasonable delays, before the samples expire.  If high moisture feed samples 
(e.g., a cattle finisher feed) are used, each participating laboratory should perform a loss 
on drying (LOD) test as close as possible to the time they prepare the feed samples for 
drug analysis, to determine the amount of  moisture in the feed.  You should monitor the 
moisture results to check for variability between samples due to shipping and/or storage.  
If you expect the participating laboratories to perform an LOD test, you should provide 
the LOD test method as an appendix to the sponsor and participating laboratory 
protocol(s).  Your feed assay method description may include a calculation to adjust the 
concentration of the drug substance to a specific moisture level, if appropriate. 
 
Determination of Reference Concentrations 
Your reference laboratory should assay the same transfer study sample set you provide to 
the participating laboratories.  The reference laboratorys analysis of the medicated feed 
samples determines the reference concentrations, to which you will compare the results 
obtained by the participating laboratories.  If you retain a contract testing laboratory to 
determine the reference concentrations, you may prepare a separate reference laboratory 
protocol detailing this procedure and include it as an appendix to your sponsor protocol.  
You should provide the results of the reference laboratory analysis of the transfer study 
sample set to CVM at the initiation of the transfer study.     
 
Transfer Study of the Assay Method 
We recommend that the transfer study of the medicated feed assay method include two 
phases:  a method familiarization, and the analysis of the transfer study sample set.  In the 
method familiarization phase, participating laboratories assay control and fortified feed 
samples. This phase ensures that the participating laboratories understand the method and 
have the equipment and expertise to perform the analysis.  You should provide 
instructions in the participating laboratory protocol to analyze a set of control and 
fortified feed samples and to evaluate the results against defined non-interference, 
recovery, and linearity criteria.  Each participating laboratory should provide the method 
familiarization results to the sponsors study director and wait for sponsor agreement 
before proceeding with the transfer study.  We strongly urge you to include a method 
familiarization step in your transfer study protocol, particularly if you do not hold a 
method demonstration for the participating laboratories.   
 
The participating laboratories may suggest modifications to the feed assay method before 
they begin the transfer study.  The participating laboratory protocol should describe the 
process by which a participating laboratory should propose any feed assay method 
modifications to the sponsors study director.  The sponsors study director should 
- 8 -  Contains Non-Binding Recommendations 
 
approve any modifications to the feed assay method before the participating laboratory 
conducts the transfer study.   
 
The second phase of the transfer study is the analysis of the transfer study sample set.  
The reference laboratory and participating laboratories should each assay the following 
samples: 
 
  Five (5) replicates of control feed samples. 
  Five (5) replicates of control feed samples fortified at 0.5X the lowest label 
claim. 
  Five (5) replicates of control feed samples fortified at 1X the label claim (if a 
range of concentrations is being transferred, fortify control feeds at both 100% 
of the lowest concentration level and 100% of the highest concentration 
level). 
  Five (5) replicates of control feed samples fortified at 1.5X the highest label 
claim. 
  Five (5) replicate samples of each batch of medicated feed.  You should 
prepare at least two (2) batches of medicated feed, and you should provide 
five (5) individual portions of each batch; thus, each participating laboratory 
receives at least ten (10) blinded medicated feed samples. 
 
The sponsor protocol should describe the samples included in the transfer study sample 
set.  The participating laboratory protocol should include all information the participating 
laboratory needs to assay the transfer study sample set.  You should state the transfer 
characteristics that the participating laboratory will investigate and how these 
characteristics are to be investigated (e.g., the number of analyses the participating 
laboratory will conduct, the number of replicates of individual standards they will use to 
prepare standard curves, etc.).  You should provide the criteria for acceptability of the 
data, as well as the criteria for re-analysis.  The protocol should state that the 
participating laboratory should explain any re-analysis it performs with a scientifically 
supportable justification.   
 
We recommend you instruct the participating laboratories to analyze the transfer study 
sample set over several days, in sub-sets that include all of the sample types, to 
demonstrate that the method will provide the same results on different days.  You may 
wish to provide the participating laboratories with a specific sample analysis sequence, to 
ensure that they assay each sample type over multiple days.  In addition, specified sample 
sets allow for easier auditing and data analysis. 
 
Reports 
The participating laboratories and the sponsors study director should prepare reports.  
The reference laboratory may also prepare a report. 
 
Each participating laboratory should prepare a report documenting its results for the 
method transfer study.  The participating laboratory protocol should specify the items 
- 9 -  Contains Non-Binding Recommendations 
 
that the participating laboratory should include in the report.  The following are some 
examples of items you may want to ask the participating laboratory to provide: 
 
  A summary of the method familiarization results (without copies of the 
chromatograms and raw data). 
  Individual and summary results for the transfer study sample set in tabular  
form.   
  A discussion of the laboratory study and a description of any difficulties or 
problems and their resolution. 
  A description of any deviations from the test method and recommendations 
for clarifying operational steps that were not clearly described in the method. 
  Signatures of the individuals responsible for the conduct of the transfer study.  
   
The participating laboratory protocol should also provide a format for the report.  You 
may wish to provide the following types of instructions and forms in the protocol, to 
ensure results from each laboratory are reported in an appropriate format:  
 
  Instructions for rounding the numerical results. 
  Templates for reporting analytical data in a standard format.  
  Instructions to append copies of all the chromatograms for the transfer study 
sample set, system suitability test results, and standard curves.   
 
If you retain a contract testing laboratory as your reference laboratory, that laboratory 
should prepare a report documenting its results for determination of the reference 
concentrations.  You should provide the reference laboratory report as an appendix to 
your study director's transfer study summary report (described below).  If the reference 
laboratory is your own expert laboratory, you may choose to provide the reference 
laboratory results as a section of the study director's transfer study summary report, rather 
than preparing a separate report.  You should document in the sponsor protocol and/or 
reference laboratory protocol how you will report the reference laboratory results.  You 
should present the raw data and results for the reference laboratory analysis of the 
transfer study sample set using the same forms and format as the participating 
laboratories. 
 
The sponsors study director should prepare a transfer study summary report.  Normally, 
this report includes a comparison of the reference and participating laboratory results for 
the transfer study sample set and a discussion of the participating laboratory reports, 
specifically addressing any problems or comments from the participants.  The sponsor 
protocol should describe the structure of the summary report and specify the items that 
you will include in the report.  The following list provides examples of items you may 
want to include in your summary report:   
 
  Copies of the reference and participating laboratory reports, including copies 
of the chromatograms for the transfer study sample set. 
  The key to the blinded medicated feed samples.  
- 10 -  Contains Non-Binding Recommendations 
 
  A tabular summary of the individual and average results the participating and 
reference laboratories reported for the transfer study sample set.  
  A discussion and comparison of the results and observations included in the 
reference and participating laboratory reports. 
  An assessment of the transfer study results and documentation of any issues or 
changes made to the results based on the data audit. 
  A copy of the feed assay method that ONADE evaluated.   
  If appropriate, a summary of proposed changes to the feed assay method and 
the revised method description. 
  Copies of the signed protocol(s).  Note:  If you have a single transfer study 
protocol that covers both the sponsor and the participating laboratories, the 
protocol should include signature blocks for both the sponsor and 
participating laboratories personnel. 
  Signatures of the individuals responsible for the conduct of the transfer study.   
 
ONADEs evaluation of the method description, the single-laboratory method validation, 
and the results from the method transfer study will be the basis for acceptance of the feed 
assay method.   
 
The Table on the following page illustrates the flow of activities we recommend for 
conduct of the transfer study. 
 
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Table 
 
Recommended Flow of Activities 
 
PHASE OF THE  ACTIVITY  PARTICIPANTS 
TRANSFER STUDY 
  Medicated feed assay description  Sponsor 
Method Description   and single-laboratory validation 
&  Technical review  ONADE 
Single-Laboratory  Modification of feed assay and/or  Sponsor based on 
Method Validation  additional supporting data   ONADE comments 
&  Technical review  ONADE 
Transfer Protocol  
Method transfer study protocol(s)  Sponsor 
Protocol(s) review and concurrence  ONADE 
  Method demonstration  Sponsor, ONADE, 
   (optional)   Reference Laboratory, 
  Participating 
  Laboratories  
  Submission of any revisions to the  Sponsor, ONADE 
  protocol for review and concurrence 
Laboratory   (optional) 
Preparation and distribution of the  Sponsor  
control and medicated feed samples   
Determination of the reference  Reference Laboratory 
concentrations 
Method familiarization   Participating 
Laboratories with 
Sponsor oversight 
Analysis of the transfer   Participating 
study sample set   Laboratories  
  Data audit and   Participating 
  preparation of the study report   Laboratories 
  Analysis of the participating  Sponsor,  
  laboratory reports, data audit,  Reference Laboratory 
Reporting  method revision and preparation of 
the reference laboratory and sponsor 
study director's transfer study 
summary reports  
Submission of summary   Sponsor 
report to ONADE 
Evaluation of the   Method and data evaluation  ONADE 
Type C Medicated Feed 
Assay Method 
- 12 -  Contains Non-Binding Recommendations 
 
Appendix I 
 
Example Sponsor Protocol 
 
1.  Objective 
 
This section should clearly state the objective of the study and identify the drug and 
animal species and number of participating laboratories. 
 
2.  Scope 
 
This section should state that the transfer study is designed to evaluate an official method 
of analysis for a drug for use at specified concentrations in the preparation of medicated 
animal feeds for specific species.   
 
3.  Quality Audit 
 
We recommend that a qualified person not involved with the transfer study perform a 
100% data audit of the reference and participating laboratory reports.  The quality audit 
section of the protocol should state that this will occur and should also include specific 
information, such as the name of the person performing the audit and his or her 
affiliation.   
 
4.  Responsibilities 
 
This section should list the sponsor personnel conducting the transfer study and 
evaluating the results and it should identify their responsibilities.  You should include 
contact information.  The following chart provides examples of the personnel you should 
include in this section: 
 
Sponsors Study Director:  Name 
Affiliation 
Address and Contact Information  
Description of Responsibilities 
 
Investigators:  For each investigator: 
Name 
Affiliation 
Address and Contact Information 
Description of Responsibilities 
 
 
 
- 13 -  Contains Non-Binding Recommendations 
 
ONADE Representative4:  Name 
Affiliation 
Address and Contact Information 
Description of Responsibilities 
 
5.  Definitions 
 
This section should provide definitions for terms used in the protocol.  As much as 
possible, you should use terms consistently in the sponsor and participating laboratory 
protocols.  The following chart provides examples of definitions you may wish to include 
in this section: 
 
Reference Laboratory:  The sponsors own expert laboratory, or a contract testing 
laboratory retained by the sponsor that has experience 
performing the assay method.   
 
Reference Concentration:  The concentration of the drug substance in the medicated 
feed samples as determined by the reference laboratory.   
 
Participating Laboratory:  Laboratory conducting the analytical phase of the transfer 
study. 
 
Investigators:  The scientists who will prepare the samples for distribution 
to the participating laboratories and/or analyze the feed 
samples using the proposed feed assay method. 
 
ONADE Representative:  The person designated by ONADE to review the protocol(s) 
and summary report, oversee the project, and provide 
guidance on issues as they may arise during conduct of the 
study.  
 
6.  Assay Method 
 
This section should identify the feed assay method you propose.  You should include the 
feed assay method as an appendix. 
 
7.  Reagents & Chemicals  
 
This section should identify any specific equipment, reagents or chemicals, such as 
analytical standards, you will supply to the participating laboratories.  This section of the 
protocol should state that you will provide appropriate information, such as Certificate of 
Analyses, lot numbers, expiration dates, and material safety data sheets. 
 
                                                 
4 ONADE assigns this representative.  You should contact ONADE to determine the representative for 
your method transfer study and include the representatives contact information in your protocol(s). 
- 14 -  Contains Non-Binding Recommendations 
 
8.  Feed Preparation, Determination of Reference Concentrations, Storage and  
Shipment 
 
This section should describe the procedures you will use to prepare the control and 
medicated feed samples, and to determine and document the reference concentrations for 
the medicated feeds.  You should also describe the preparation and shipment of the 
control and medicated feeds to the various laboratories involved in the transfer study.  
You should include how the participating laboratories will document receipt of the feed 
samples, and provide appropriate storage conditions and expiration dates. 
 
9.  Transfer Study Sample Set  
 
This section should describe the number and types of samples the reference and 
participating laboratories will assay during the transfer study. 
 
10.  Conduct of the Feed Assay Transfer Study  
 
This section should reference the participating laboratory protocol for a description of the 
analysis of the samples and should include a list of the names, addresses, telephone and 
fax numbers, and other relevant information for the participating laboratory personnel 
involved in the transfer study.  You may specify time frames for the conduct of the 
transfer study and for reporting the data from the study.   
 
This section should also define the kind of written and verbal communication you expect 
to occur between the sponsor study director and the participating laboratory personnel, as 
well as procedures for documenting such communication. 
 
11.  Amendments to or Deviations from the Protocol 
 
This section should describe the process by which the sponsor may amend the protocol(s) 
and the mechanism for recording deviations from the protocol(s), and identify the 
individuals responsible for approving such amendments or deviations.  This section 
should also specify the mechanism by which the participating laboratories may propose 
changes to the feed assay method and report any deviations or problems encountered in 
the conduct of the feed assay method. 
 
12.  Reference Laboratory and/or Summary Report(s) 
 
This section should describe the structure of the reports the sponsor and the reference 
laboratory will prepare and specify the items that you will include in your transfer study 
summary report.   
 
 
 
 
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Appendix II 
 
Participating Laboratory Protocol 
1.  Objective 
 
This section should clearly state the objective of the study and identify the drug and 
animal species.   
 
2.  Scope 
 
This section should state that the transfer study is designed to evaluate an official method 
of analysis for a drug for use at specified concentrations in the preparation of medicated 
animal feeds for specific species.   
 
3.  Quality Audit 
 
We recommend that a qualified person not involved with the transfer study perform a 
100% data audit of the participating laboratory report.  The quality audit section of the 
protocol should state that this will occur and should also include specific information, 
such as the name of the person performing the audit and his or her affiliation.   
 
4.  Responsibilities 
 
This section should list the participating laboratory personnel conducting the transfer 
study and evaluating the results and their responsibilities.  You should include complete 
contact information.  The following chart provides examples of the personnel you should 
include in this section:  
 
Participating Laboratory Study Coordinator:  Name 
Affiliation 
Address and Contact Information 
Description of Responsibilities 
 
Investigators:  For each investigator: 
Name 
Affiliation 
Address and Contact Information 
Description of Responsibilities 
 
ONADE Representative5:  Name 
Affiliation 
Address and Contact Information 
Description of Responsibilities 
                                                 
5 ONADE assigns this representative.  You should contact ONADE to determine the representative for 
your method transfer study and include the representatives contact information in your protocol(s). 
- 16 -  Contains Non-Binding Recommendations 
 
 
5.  Definitions 
 
This section should provide definitions for terms used in the protocol.  As much as 
possible, you should use terms consistently in the sponsor and participating laboratory 
protocols.  The following chart provides examples of definitions you may wish to include 
in this section: 
 
Participating Laboratory:  Laboratory conducting the analytical phase of the transfer 
study. 
Investigators:  The scientists at the participating laboratory who will 
analyze the feed samples using the proposed feed assay 
method. 
 
ONADE Representative:  The person designated by ONADE to review the protocol(s) 
and summary report, oversee the project, and provide 
guidance on issues as they may arise during conduct of the 
study.  
 
6.  Assay Method 
 
This section should identify the feed assay method you propose.  You should include the 
feed assay method as an appendix. 
 
7.  Reagents & Chemicals  
 
This section should identify the specific equipment, reagents and chemicals the 
participating laboratory will use in the laboratory phase of the study, such as analytical 
standards, HPLC system, and analytical reagents.  This section should also identify 
which of these materials you will supply to the participating laboratory. 
 
8.  Transfer Study Feed Samples 
 
This section should include information for documentation of sample arrival and use at 
the participating laboratory, storage conditions and expiration dates for the samples, and 
instructions for disposal of materials at the end of the study.  You should reference and 
append any documentation forms.  This section should also state that the participating 
laboratory will not assay any feed samples outside the expiration dating periods.   
 
9.  Laboratory Transfer of the Medicated Feed Assay Method 
 
This section provides instructions for the method familiarization and the analysis of the 
transfer study sample set.  The information in Section 9 of the sponsor protocol 
describing the transfer study sample set should be repeated here. 
 
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This section should include the time frames for the participating laboratories to conduct 
and report the interim and final data to the sponsor.  If appropriate, this section should 
state how and where the participating laboratories will archive the raw data. 
 
This section should also define the kind of written and verbal communication you expect 
to occur between the sponsor study director and the participating laboratory personnel, as 
well as procedures for documenting such communication. 
 
10.  Amendments to or Deviations from the Protocol 
 
This section should describe the process by which the sponsor may amend the protocol(s) 
and the mechanism for recording deviations from the protocol(s), and identify the 
individuals responsible for approving such amendments or deviations.  This section 
should also specify the mechanism by which the participating laboratories may propose 
changes to the feed assay method and report any deviations or problems encountered in 
the conduct of the feed assay method. 
 
11.  Participating Laboratory Report 
 
This section should provide a format for the participating laboratory report and specify 
the items that the participating laboratory should include in the report.   
 
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