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Guidance for Industry 
 
DISPUTE RESOLUTION PROCEDURES FOR SCIENCE-BASED 
DECISIONS ON PRODUCTS REGULATED BY THE 
 CENTER FOR VETERINARY MEDICINE (CVM) 
 
(Note:  Due to the November 22, 2013 Federal Register notice (78 FR 69991) disbanding  the 
Veterinary Medicine Advisory Committee (VMAC), this guidance document is revised to reflect 
updated procedures for handling  a request for an internal review of scientific controversies 
relating to a decision affecting animal drugs or other products that are regulated by CVM.) 
Submit comments on this guidance at any time.  Submit  written comments to the Division  of 
Dockets Management (HFA-305), Food and Drug Administration,  5630 Fishers Lane (Room 
1061), Rockville,  MD 20852.  All comments should be identified  with the Docket No. FDA-
2003-D-0307 (formerly docket number 2003D-0167).  Submit electronic comments on the 
guidance at http://www.regulations.gov. 
For further information  regarding this guidance document, contact Marcia Larkins, Center for 
Veterinary Medicine (HFV-1), Food and Drug Administration,  7519 Standish Place, Rockville, 
MD 20855, 240-276-9015.   Email: marcia.larkins@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 either 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/d
efault.htm  or http://www.regulations.gov. 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
May 2014  Contains Nonbinding Recommendations 
DISPUTE RESOLUTION PROCEDURES FOR SCIENCE-BASED 
DECISIONS ON PRODUCTS REGULATED BY THE 
CENTER FOR VETERINARY MEDICINE (CVM) 
 
This guidance represents the Food and Drug Administrations (FDAs) 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 the 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 appropriate 
number listed on the title page of this guidance. 
 
I.  INTRODUCTION 
This guidance document describes a recommended approach for resolution of disputes 
relating to scientific controversies.  A scientific controversy involves issues that arise within 
the context of the Centers regulation of a specific product and are related to matters of 
technical expertise that require some specialized education, training,  or experience in order to 
be understood and resolved.  The guidance document describes the dispute resolution 
procedures that we recommend be followed  by sponsors, applicants,  and manufacturers when 
requesting review of FDA decisions related to regulated products for animals.  (Hereafter in 
this document, the term applicant includes a sponsor, applicant,  or manufacturer.) 
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.  BACKGROUND 
On November 21, 1997, the President signed the Food and Drug Modernization  Act of 1997 
(FDAMA) into law (Public Law 105-115).  Section 404 of FDAMA amends the Federal 
Food, Drug, and Cosmetic Act (the act) by adding a provision  (Section 562, 21 U.S.C.  
360bbb-1) for dispute resolution.  If a procedure under which an applicant could request a 
review of a scientific controversy related to human drugs, animal drugs, human biologics,  or 
devices did not already exist, either as a provision  in the act or a regulation promulgated 
under the act, FDAMA required FDA to establish a procedure by regulation through which 
an applicant may request review of such scientific controversy, including  a review by an 
appropriate scientific advisory panel or advisory committee.  Prior to FDAMA, a procedure 
for review of such controversies was provided under 10.75 (21 CFR 10.75), Internal agency 
review of decisions.  10.75 provides for internal agency review of a decision through the 
established agency channels of supervision  or review. 
   
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To implement  Section 562, FDA amended 21 CFR Part 10 (Administrative  Practices and 
Procedures) to add the following: 
A sponsor, applicant, or manufacturer of a drug or device regulated under the act or the Public Health 
Service Act (42 U.S.C. 262), may request review of a scientific controversy by an appropriate scientific 
advisory panel as described in section 505(n) of the act, or an advisory committee as described in section 
515(g)(2)(B) of the act.  The reason(s) for any denial of a request for such review shall be briefly set forth 
in writing to the requester.  Persons who receive a Center denial of their request under this section may 
submit a request for review of the denial.  The request should be sent to the Chief Mediator and 
Ombudsman. (21 CFR 10.75(b)(2), 63 FR 63982, November 18, 1998) 
There are significant  differences in the statutory provisions  that govern the regulation of the 
various products regulated by FDAs Centers, and similarly  in the existing appeal and dispute 
resolution  mechanisms and approaches to advisory committee management.  Therefore, FDA 
did not include in  10.75 specific procedures for requesting reviews of scientific 
controversies, but has instead adopted a Center-based approach to resolving  such disputes for 
drugs or devices.  Each affected Center is responsible for developing  and administering  its 
own processes for handling  requests for reviews of scientific controversies. This guidance 
sets forth CVMs recommended processes.  Section 404 of FDAMA only required the 
agency to establish dispute resolution  procedures for scientific controversies involving  drugs 
and devices and  10.75(b)(2) only applies to drugs and devices.  With the exception of 
Section IV.B. of this guidance, which describes the procedure for requesting advisory 
committee review of a scientific dispute concerning a drug, the procedure in Section IV.A. of 
this guidance may also be used by applicants for other products regulated by CVM. 
  III.  SCIENTIFIC CONTROVERSIES ELIGIBLE FOR DISPUTE RESOLUTION 
It is not CVMs intent for applicants to use the dispute resolution  procedure as their initial 
response to incomplete  letters that the Center sends to applicants when the Center needs 
more information  than contained in a submission  in order to make a decision issued as a 
result of Investigational  New Animal Drug, New Animal Drug Application (NADA), 
Abbreviated New Animal Drug Application,  Investigational  Food Additive,  or Food Additive 
Petition review.  A scientific controversy may be considered eligible  for dispute resolution 
when there is an unresolved disagreement between applicants and Division  Directors on 
scientific decisions made by CVM including,  but not limited  to, the following  examples: 
A. CVM requests specific studies from an applicant in order to meet minimum  pre-approval 
data requirements (e.g., a request for more than one field trial, or a request for 
antimicrobial  resistance studies, or a request based on a recently implemented 
regulation/guidance). 
B.  In compliance with the provisions  of section 512(b)(3) (21 U.S.C. 360b(b)(3)) of the act, 
CVM changes the data/protocol requirements that it had previously  agreed to with the 
applicant (e.g., based on new information  discovered after a pre-submission  conference). 
   
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C.  CVM determines that the information  submitted by an applicant is inadequate (e.g., 
because the description  of a particular aspect of a study in the protocol is inadequate, or 
because a study is not acceptable for or applicable to a particular indication  or assessment 
of safety, or because the inferential value of an efficacy study is insufficient  to support a 
claim). 
D. CVM and an applicant have different interpretations  of the results/data from a study. 
  IV.  DISPUTE RESOLUTION PROCEDURE 
We recommend the applicant follow the dispute resolution  procedure as explained below 
when requesting review of a written scientific decision.  The key features of the dispute 
resolution  procedure are also summarized in VII. CVM Decision Review Process. 
A.  Review by the Supervisory  Chain of Command 
The Code of Federal Regulations  at  10.75 states that any interested person may obtain 
review of any agency decision by raising the matter through established agency channels 
of supervision  or review.  CVM encourages applicants to begin the resolution of science-
based disputes with discussions with the review team/group, including  the Team Leader 
or Division  Director.  The Center prefers that differences of opinion  regarding science or 
science-based policy be resolved between the review team/group and the applicant.  If the 
matter is not resolved by that method, we recommend that the applicant follow the 
procedure below. 
1.  Office Level Appeals Procedure 
a)  When an applicant has a scientific disagreement with a written decision by FDA, 
the applicant may submit to the Division  Director, who is responsible for the 
team/group/individual  that communicated the decision,  a request for review of 
that decision.  The initial  appeal should identify the information  in the 
administrative  file (the file) upon which the request is based.  If the appeal 
contains new information,  not previously  contained in the administrative  file, the 
matter will,  in accordance with  10.75(d), be returned to the appropriate lower 
level in the agency for reevaluation based on the new information.   A 
reevaluation,  based on the new information,  is subject to the corresponding 
review times provided by statute or regulation (e.g., 180 days for a NADA). 
b)  The Division  Director should prepare a written response to the applicant's request 
within 30 calendar days of receiving the request for review.  The response should 
include the reasoning/rationale  for the decision. 
c)  If the applicant disagrees with the Division  Directors response, the applicant may 
appeal in writing to the Office Director.  The Office Director should prepare a 
written response to the applicants appeal within 40 calendar days of receiving the 
formal appeal. The response should include the reasoning/rationale  for the 
decision.  The following  options outlined  below are some but not all of the 
options available to the Office Director: 
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  i.  If the Office Director agrees with the applicant's position,  the Office Director 
should document his or her decision in writing and return the file to the 
Division  Director. The Division  Director should expeditiously  take 
appropriate action to implement  the Office Directors decision and after 
obtaining  the Office Directors concurrence on the response, communicate the 
action (including  the reasoning/rationale)  to the applicant. 
ii. If the Office Director disagrees in whole or in part with the applicants 
position,  he or she should document the decision in writing and return the file 
to the Division  Director.  The Division  Director should obtain the Office 
Directors concurrence on the response and notify the applicant of the 
decision (including  the reasoning/rationale  for the decision) and of the 
applicants right to have the issue forwarded to the CVM Ombudsman with a 
request for either 1) consideration  by a Deputy Center Director Ad Hoc 
Appeals Committee (Ad Hoc Appeals Committee) or 2) review by an 
advisory committee if the product is a drug as required by  10.75(b)(2).  
Applicants of other products regulated by CVM may only request review by 
the Ad Hoc Appeals Committee.  These two options for appeal are described 
below.  Either request should be sent in writing to the CVM Ombudsman with 
courtesy copies to the appropriate Division  and Office Directors.  It is the 
applicants responsibility  to decide whether to continue to pursue the review 
of a scientific decision.  If the applicant requests consideration  by the Ad Hoc 
Appeals Committee, the CVM Ombudsman should provide written 
acknowledgement to the applicant,  within 14 days, and forward the request to 
the CVM Deputy Director.  If the applicant requests consideration by an 
advisory committee, the CVM Ombudsman should provide similar 
acknowledgement and forward the request to the CVM Director. 
2.  Deputy Center Director Ad Hoc Appeals Committee Procedure: 
 
a)  The Committee should generally consist of the CVM Deputy Director (or on rare 
occasions, an alternate senior level Center manager), who acts as the Chair, and a 
minimum  of three members from the Centers management and other experts 
from the federal government appointed by the Chair.  Selection of these 
individuals  should be on an ad hoc basis, depending on the issue involved.   It is 
expected that the Committee may also seek expert advice by consulting  on an 
individual,  as-needed basis with others inside the Agency as well as outside the 
Agency or the government, who possess expertise on the matter under 
consideration. 
b)  The Chair should provide, in writing, an opportunity  for the applicant to submit 
written arguments and to meet with the Committee.  If the applicant decides to 
meet with the Committee,  the applicant may bring as many consultants as the 
applicant wishes. The meeting is to provide an opportunity  for the full exchange 
of information  and views between the Committee and the applicant.  The meeting 
should be structured to allow for presentation by the applicant, input by the 
appropriate CVM reviewing Division,  and appropriate discussion.  Finally,  after 
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the meeting, the Chair and the Committee members should deliberate without the 
applicant, the applicants consultants, or personnel from the CVM reviewing 
Division. 
c)  Following  the deliberations,  the Chair, with the advice of the Committee, should 
make a decision on the issue and take appropriate action to implement  the 
decision.  The Chair should provide the decision or a status report on the appeal to 
the applicant in writing within 60 calendar days following  the Committee 
meeting.  The response should include the reasoning/rationale  for the decision. 
d)  If the Chair disagrees with the applicants position,  and the applicant is not 
satisfied with the decision,  the applicant may appeal the Committee decision to 
the Center Director by letter.  The Center Director should respond in writing to 
the applicants appeal within 40 calendar days of receipt.  The response should 
include the reasoning/rationale  for the decision.  If the Center Director also 
disagrees with the applicants position,  the applicant may submit an appeal by 
letter to the Office of the Commissioner  either directly or through the Office of 
the FDA Ombudsman. 
B.   Advisory Committee Procedure 
In cases involving  broad scientific matters having a general impact on the veterinary drug 
industry,  and if time and budgetary constraints permit, the Center may refer a request for 
the review of a scientific controversy to an advisory committee. A request for review by 
an advisory committee from an applicant should relate to agency action on the applicants 
own product. 
1. Upon the applicant's request, the Center may refer a scientific controversy involving  a 
veterinary drug product to an advisory committee for review after the applicant has 
requested review by the supervisory chain of command through the level of the Office 
Director, as described in IV.A.  The applicant may submit a written request for review 
by an advisory committee to the CVM Ombudsman for consideration  by the Center 
Director.  CVM recommends that applicants filing  a request for review by an advisory 
committee provide the CVM Ombudsman with a concise summary of the scientific 
issue in dispute, including  a summary of the particular FDA action or decision to which 
the applicant objects, the results of all efforts that have been made to resolve the dispute 
to date, and a clear articulated summary of the arguments and relevant data and 
information.   The information  collected will form the basis for resolving the dispute 
between the applicant and FDA.  The Center Director should determine whether review 
by an advisory committee is appropriate or, depending on the scientific issue involved, 
whether the Ad Hoc Appeals Committee review procedure might provide a more 
efficient means of resolving  the scientific controversy. 
   
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2. The Center should send a written response to the applicant's request for advisory 
committee review within 30 calendar days of receiving the request. If the CVM 
Director denies a request for advisory committee review, the reasons for the denial 
must be briefly set forth in writing to the applicant, if the product is a drug, as required 
by 10.75 (b)(2). The applicant may submit to the FDA Ombudsman a request for 
review of the denial.  The FDA Ombudsman should not make an independent 
determination  of whether an advisory committee review should be granted, but should 
work informally  with the Center and the person denied advisory committee review to 
develop a mutually  acceptable approach, taking into account all relevant factors (see 63 
FR 63978). 
3. If the Center Director grants a request for advisory committee review of the scientific 
controversy, the reviewing advisory committee should make a recommendation  to the 
Center Director who should consider it in making a decision.  While the purpose of an 
advisory committee is to provide expert scientific advice and recommendations,  the 
conclusions  of the advisory committee are not binding  on the agency.  The Center 
Director should issue a written decision, including  the reasoning/rationale  for that 
decision within 60 calendar days following  the advisory committee meeting.  If the 
Center Director disagrees with the applicants position,  and the applicant is not satisfied 
with the decision,  the applicant may choose to request further review by the Office of 
the Commissioner. 
Unless otherwise provided by law, the resolution of a scientific dispute by CVM is not final 
agency action for purposes of judicial  review. 
  V.  THE ROLE OF THE OMBUDSMAN 
CVMs Ombudsman plays an important  role in the dispute resolution  process.  This person is 
committed to handling  disputes in a neutral and confidential  manner and to helping  achieve 
equitable solutions.  The Ombudsman can help ensure that the process proceeds as smoothly 
and fairly as possible. 
A May 1, 1998, Presidential memorandum directs each federal agency to promote greater 
use of mediation,  arbitration,  early neutral evaluation,  agency ombudsman and other ADR 
[alternative dispute resolution]  techniques (Ref. 1).  In addition to FDAs formal processes, 
several ombudsman offices, including  one in CVM, have been established to facilitate the 
resolution  of disputes informally.   FDA has established the Office of the Ombudsman within 
the Commissioners  Office to resolve inter-center disputes, hear appeals of decisions of the 
Center Directors, and to resolve other disputes where the complainant  has concerns about 
raising the issue with a Center (see 63 FR 63978). 
In a memo dated June 29, 1995, the Commissioner  of Food and Drugs (the Commissioner) 
reminded all FDA employees that companies are free to vigorously  challenge agency 
positions  and requirements, and to freely voice their views (Ref. 2).  By letter of the same 
date, the Commissioner  assured members of Congress that any act or threat of retaliation  by 
any FDA employee is totally unacceptable and will  not be tolerated.  Anyone who believes 
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retaliation  has occurred, or is likely  to occur, is urged to contact the CVM Ombudsman, 
Center management, or the Office of the FDA Ombudsman. 
The function of the CVM Ombudsman is to help resolve disputes at the Center level, 
typically  in accordance with the procedures described in this guidance.  The CVM 
Ombudsman facilitates the resolution of disputes by operating in a neutral role, to help 
achieve equitable solutions.   The Ombudsman is also the Centers point of contact for 
information  on the dispute resolution  process (see 63 FR 63978) and is also responsible for 
assuring the effective implementation  of the process.  An applicant may contact the 
Ombudsman when the applicant does not know where or how to begin an appeal, little 
progress is being made going up the chain of command, or a matter is not resolved in the 
supervisory chain of command procedure (IV.A.).  The Ombudsman helps to facilitate 
administratively  the formal appeals process above the Office level.  The Ombudsman serves 
as a neutral and may suggest alternatives to the procedures described in this guidance for 
resolving  disputes during the appeals process, subject to mutual agreement by the applicant 
and CVM as described in the Administrative  Dispute Resolution  Act (ADRA) of 1996 (see 5 
U.S.C. 571 (3) and (9), 573 (b)). 
Additionally,  anyone who believes that an employee has not followed proper good guidance 
practices or has treated this or any guidance document as a binding  document may also ask 
the CVM Ombudsman for assistance.  If the issue is not resolved at the Center level the 
complainant  may ask FDAs Office of the Ombudsman to become involved  (see 21 CFR 
10.115(o)). 
VI.  REFERENCES 
1.  President William  J. Clinton.  Memorandum for Heads of Executive Departments and 
Agencies.  Designation of Interagency Committees to Facilitate and Encourage Agency 
Use of Alternate Means of Dispute Resolution  and Negotiated Rulemaking.   May 1, 
1998. 
2.  Commissioner  David A. Kessler.  Memorandum to All FDA Employees.  Allegations  of 
Retaliation.  June 29, 1995. 
   
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VII.  CVM Decision Review Process 
 
 
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