Guidance for Industry #79 - Dispute Resolution Procedures

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#79
Guidance for Industry
DISPUTE RESOLUTION PROCEDURES FOR
SCIENCE-BASED DECISIONS ON PRODUCTS REGULATED
BY THE CENTER FOR VETERINARY MEDICINE (CVM)
This guidance document describes the 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. Guide 1240.3130 (Center Appeals Procedure Guide) of
the CVM Program Policy and Procedures (P&P) Manual describes CVM’s appeals
procedure. Because this Guide predates the Food and Drug Administration Modernization
Act (FDAMA), CVM is revising its procedures. This guidance supersedes Guide 1240.3130,
which has been deleted from the P&P Manual.
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.fda.gov/dockets/ecomments. Once on this Internet site, select "[03D0167][Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by
the Center for Veterinary Medicine]" and follow the directions. All written comments should
be identified with Docket No.03D-0167.
For questions regarding this guidance document, contact Marcia Larkins, Center for
Veterinary Medicine (HFV- 7), Food and Drug Administration, 7519 Standish Place,
Rockville, MD 20855, 301-827-4535. E-mail: [email protected]
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/cvm.
Paperwork Reduction Act (PRA) Public Burden Statement
According to the Paperwork Reduction Act of 1995, a collection of information should
display a valid OMB control number. The valid OMB control number for this information
collection is 0910-0566. (Expires 06/30/08).

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
July, 2005
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DISPUTE RESOLUTION PROCEDURES FOR SCIENCE-BASED
DECISIONS ON PRODUCTS REGULATED BY CVM
This guidance represents the Food and Drug Administration’s current
thinking on resolving scientific disputes concerning the products regulated
by CVM. 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 appropriate number listed on the title
page of this guidance.
I. INTRODUCTION
FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, guidances describe the Agency’s 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.
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 Center’s 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.)
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
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review of a decision through “the established agency channels of supervision or review.”
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 FDA’s 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 CVM’s recommended processes. Although
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, the procedure in this guidance may also be used by
applicants for other products regulated by CVM.
III. SCIENTIFIC CONTROVERSIES ELIGIBLE FOR DISPUTE RESOLUTION
It is not CVM’s 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 INAD (Investigational New Animal Drug), NADA (New
Animal Drug Application), ANADA (Abbreviated New Animal Drug Application), IFA
(Investigational Feed Additive), or FAP (Feed 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 preapproval 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 APPENDIX I, 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 Director’s response, the applicant
may appeal in writing to the Office Director. The Office Director should
prepare a written response to the applicant’s appeal within 40 calendar days of
receiving the formal appeal. The response should include the
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reasoning/rationale for the decision. The following options outlined below
are some but not all of the options available to the Office Director:
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 Director’s decision and after
obtaining the Office Director’s 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 applicant’s
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 Director’s concurrence on the response and notify the applicant of
the decision (including the reasoning/rationale for the decision) and of the
applicant’s 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
the Veterinary Medicine Advisory Committee (VMAC) if the product is a
drug or device as required by § 10.75(b)(2). Applicants of other products
regulated by CVM may also request review by VMAC. 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 applicant’s 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 VMAC, 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 Center’s 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.

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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 the meeting, the Chair and the
Committee members should deliberate without the applicant, the applicant’s
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 applicant’s 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 applicant’s 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 applicant’s 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. Veterinary Medicine Advisory Committee Procedure
CVM has one standing advisory committee, the VMAC. The committee consists of
13 members representing a wide spectrum of disciplines and interests associated with
veterinary medicine. The committee meets once or twice a year to give advice on
broad scientific issues identified by CVM and the agency. 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 VMAC. A request for review by VMAC from an applicant
should relate to agency action on the applicant’s own product.
1. Upon the applicant's request, the Center may refer a scientific controversy to
VMAC 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 VMAC to the CVM
Ombudsman for consideration by the Center Director. CVM recommends that
applicants filing a request for review by VMAC 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
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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 VMAC 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.
2. The Center should send a written response to the applicant's request for VMAC
review within 30 calendar days of receiving the request. If the CVM Director
denies a request for VMAC review, the reasons for the denial must be briefly set
forth in writing to the applicant, if the product is a drug or device, as required by
§10.75 (b)(2). The reasons for the denial should also be briefly set forth in writing
to applicants of other products regulated by CVM. 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 a VMAC review should be
granted, but should work informally with the Center and the person denied VMAC
review to develop a mutually acceptable approach, taking into account all relevant
factors (63 FR 63978 at 63979).
3. If the Center Director grants a request for VMAC review of the scientific
controversy, VMAC 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 VMAC 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 VMAC meeting. If the Center Director
disagrees with the applicant’s 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
CVM’s 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 FDA’s
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 Commissioner’s Office to resolve inter-center
disputes, hear appeals of decisions of the Center Directors, and to resolve other disputes
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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 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 Center’s 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 (see IV. A. above). 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. 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 FDA’s Office of the Ombudsman to become
involved. 21 CFR 10.115(o).

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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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CVM DECISION REVIEW PROCESS

Discuss w ith
TEAM
LEADER
AGREE

DISAGREE

Appeal to DIVISION
DIRECTOR
( 30 ca lendar days )

DECISION
DISAGREE

AGREE

Appeal to
OFFICE
DIRECTOR
(40 ca lendar
days)

DECISION

Dec ision Communicated to
Applicant by DIVISION
DIRECTOR
AGREE

Im plemented
by DIVISION
DIRECTOR
( Immediate)

DISAGREE

App licant Chooses Appeal
O ption through CVM
OMBUDSMAN

DECISION

Request Ad
Hoc Appea ls
Committee
Review

Request VMAC
Rev iew

OMBUDSMAN
Forwards
Request to
DEPUTY
CENTER
DIRECTOR

OMBUDSMAN Forwards
Request to CENTER
DIRECTOR
( 30 calendar days )

Hold Ad Hoc
Appeals
Committee
Meeting

DEPUTY CENTER
DIRECTOR Provides
Status Report
( 60 calendar days after
Comm ittee meeting)

W ritten
Acknow ledgem ent
(14 days)

DENY

Applicant
Subm i ts to
FDA
OMBUDSMAN
for Rev iew

DISAGREE

DECISION

AGREE

AGREE

Appea l to the CENTER
DIRECTOR
( 40 calendar days )
AGREE

Ho ld VMAC
Meeting

CENTER
DIRECTOR
W rites Decis ion
(60 calendar
days after
VM AC meet ing

DEPUTY CENTER
DIRECTOR Prov ides
W ritten D ec ision
( 60 ca lendar days after
Comm ittee meet ing )
DISAGR EE

GRANT

DECISION

DIS AG REE

Appeal to the FDA
COMMISSIONER

DECISION