#282 
 
Informed Consent Forms for Studies 
that Enroll Client-Owned Companion 
Animals 
 
Guidance for Industry 
 
Draft Guidance 
 
This guidance document is being distributed for comment purposes only. 
 
Submit comments on this draft guidance by the dated provided in the Federal Register notice 
announcing the availability of the draft guidance.  Submit electronic comments to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD  
20852.  All comments should be identified with docket number FDA-2023-D-2654. 
 
For further information regarding this document, contact Steven Fleischer, Center for Veterinary 
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Place, Rockville MD 
20855, 240-402-0809, email: steven.fleischer@fda.hhs.gov. 
 
Additional copies of this draft guidance document may be requested from the Policy and 
Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 
7500 Standish Place, Rockville MD 20855, and may be viewed on the Internet at 
https://www.fda.gov/animal-veterinary, https://www.fda.gov/regulatory-information/search-fda-
guidance-documents, or http://www.regulations.gov. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine (CVM) 
September 2023  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Table of Contents 
 
I.  Introduction .......................................................................................................................... 1 
II.  Background .......................................................................................................................... 1 
III.  Scope...................................................................................................................................... 2 
IV.  Terminology.......................................................................................................................... 2 
V.  General Considerations ....................................................................................................... 3 
A.  Use of plain language ..................................................................................................... 3 
B.  Coercion and undue influence ...................................................................................... 4 
C.  Exculpatory language .................................................................................................... 5 
VI.  Basic Elements of an Informed Consent Form ................................................................. 5 
A.  Description of the clinical investigation ....................................................................... 5 
B.  Description of benefits and compensation ................................................................... 8 
C.  Statements regarding voluntary participation, involuntary termination of   
owners participation, and consequences of owners decision to withdraw ............. 8 
D.  Description of procedures, treatments, and potential discomforts ........................... 9 
E.  Description of the risks associated with participation in the study ........................... 9 
F.  Providing significant new findings to owners ............................................................ 11 
G.  Statements on confidentiality ...................................................................................... 11 
H.  Signature on the Informed Consent Form ................................................................. 11 
I.  List of contacts.............................................................................................................. 12 
VII.  Informed Consent Form discussions with CVM ............................................................. 12 
 
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Informed Consent Forms for Studies that Enroll Client-Owned 
Companion Animals 
 
Draft Guidance for Industry 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or Agency) on this topic.  It does not establish any rights for any person 
and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page. 
 
I.  Introduction  
The FDAs Center for Veterinary Medicine (CVM) is issuing this guidance to provide 
recommendations on informed consent forms (ICF) used for studies that enroll client-owned 
companion animals (dogs, cats, and horses).  CVM recommends all studies conducted with 
client-owned companion animals use an ICF and be conducted in accordance with Good Clinical 
Practice (GCP) guidelines.  
 
In general, FDAs guidance documents 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  
As defined in Guidance for Industry (GFI) #85 (VICH1 GL9), Good Clinical Practice2 and for 
the purposes of this guidance, informed consent is a documented process by which an owner or 
owners agent voluntarily confirms the owners willingness to allow their animal(s) to participate 
in a particular study, after having been informed of all aspects of the study that may be relevant 
to the owners decision to participate.  The sponsor or investigator should ensure the owner is 
provided with adequate information and time to allow for an informed decision about voluntary 
participation in a clinical investigation.  CVM recommends an investigator, whenever possible, 
provide an owner with a copy of the ICF at least 12-24 hours prior to enrollment in the study (for 
example, at the time of screening) to allow sufficient time for the owner to review the 
information, formulate any questions, and consider whether to participate.   
 
 
1 International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal 
Products 
2 https://www.fda.gov/media/70333/download 
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CVM recommends animal drug sponsors consider the components of the ICF as described in this 
ICF guidance early during the development of their drug.  Discussions regarding the ICF may be 
particularly important for novel drug classes, novel dosage forms of new animal drugs, or 
previously unapproved uses or new conditions of use of an approved animal drug (for example, 
novel routes of administration or target animal species).  Additional discussions may be 
warranted as new information pertaining to safety or effectiveness becomes available during 
product development.  Sponsors are encouraged to contact CVM to discuss the ICF or any 
questions they may have about the ICF. 
 
III.  Scope 
The purpose of this guidance is to provide recommendations on informed consent forms used in 
studies that enroll client-owned companion animals.  This guidance is not applicable to studies 
conducted in food-producing animals.  This guidance is directed at individuals who develop ICFs 
and conduct studies in client-owned companion animals.  
 
The guidance provides recommendations regarding the following items:  
  The use of plain language. 
  The avoidance of coercive, unduly influential, or exculpatory language. 
  The basic elements of an ICF, including: 
  A description of the clinical investigation. 
o
  A description of benefits and compensation. 
o
  Statements regarding participation, termination, and withdrawal. 
o
  A description of procedures, treatments, and potential discomforts. 
o
  A description of risks associated with participation in the study. 
o
  Providing significant new findings to owners. 
o
  Statements on confidentiality. 
o
  Signature(s). 
o
  Contacts. 
o
  Informed consent form discussion with CVM. 
IV.  Terminology 
Investigator: The investigator is an individual, qualified by training and experience, responsible 
for all aspects of the conduct of the study.  These responsibilities may include: the dispensing 
and administration of the investigational and control veterinary product(s), the implementation of 
the study protocol, the collection and reporting of the study data, and the protection of the health 
and welfare of the personnel involved in the study and the animals during the study.  
 
Study animal: An animal participating in a clinical study. 
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V.  General Considerations 
A.  Use of plain language 
The U.S. Department of Health and Human Services (HHS) defines health literacy3 as 
follows: 
 
  Personal health literacy: the degree to which individuals have the ability to 
find, understand, and use information and services to inform health-related 
decisions and actions for themselves and others. 
  Organizational health literacy: the degree to which organizations equitably 
enable individuals to find, understand, and use information and services to 
inform health-related decisions and actions for themselves and others. 
 
Health literacy incorporates a range of abilities: reading, comprehension, and analyzing 
information; decoding instructions, symbols, charts, diagrams; weighing risks and 
benefits; and, ultimately, making decisions and taking actions.  Everyone, no matter 
how educated, is at risk for misunderstanding health information if the topic is 
emotionally charged or complex.4  These general concepts are applicable to 
investigational new animal drug studies that enroll client-owned companion animals.  
 
CVM recommends the ICFs use language understandable to owners (i.e., plain 
language) of potential study animals.  The ICF should incorporate all the information 
into a single document to avoid the possibility that an owner does not receive all the 
relevant information.  The ICF should be in the owners primary language.  If an owner 
is not fluent in English, a translated document, in plain language, is preferred over ad 
hoc translation. 
 
Documents should avoid the use of technical, scientific, or medical terminology.  When 
such terms are necessary or unavoidable, the document should explain them in context 
and/or provide a definition using plain language.  All complex concepts, including risks 
and benefits, should be explained in plain language.  The owner should have the 
opportunity to ask questions and have those questions answered.  
 
The Agency for Healthcare Research and Quality5 makes some the following 
recommendations regarding ICFs for human subjects enrolled in research studies and 
they are generally applicable to the owner or agent of client-owned companion animals 
enrolled in investigational new animal drug studies: 
 
3 https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/clear-
communication/health-literacy 
4 https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/clear-
communication/health-literacy  
5 https://www.ahrq.gov/sites/default/files/publications2/files/ictoolkit.pdf 
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  Keep the reading grade level low.  It is recommended, where possible, for 
documents to be written at the 5th or 6th grade level.6 
  Do not use medical jargon.  
  Use the active voice. 
  Use short sentences with simple sentence structure. 
  Use easily legible fonts and font size. 
  Do not use all capital letters or italics. 
  Use wide margins and avoid fully justified alignment of text.  For example, a 
line length of 50 characters and spaces or fewer may be easier to read. 
  Break up text into manageable sections using headings and subheadings. 
  Documents that use large fonts, short lines, white space, bulleted lists, and 
headings to break the text into manageable pieces are easier to read than short, 
dense documents.  
 
Charts, tables, or graphics that outline what happens at each visit may simplify the ICF 
and assist owners in understanding what participation in the clinical investigation may 
entail. 
 
Although there are no Federal laws that regulate the informed consent process for 
investigational new animal drug studies that enroll client-owned companion animals, 
for similar information on informed consent for studies that enroll human subjects, 
review 21 CFR 50.20, as well as FDA guidances, Informed Consent: Guidance for 
Institutional Review Boards, Clinical Investigators, and Sponsors,7 and A Guide to 
Informed Consent.8  These documents describe the law surrounding informed consent 
for human subjects and the FDAs interpretation of these laws.  
 
B.  Coercion and undue influence 
Coercion and undue influence are the use of pressure, either by promises of benefits or 
threats of harm, whether explicit or implied, to persuade the owner or agent of a 
potential study animal to participate in the study.  All efforts should be made to 
eliminate or minimize the possibility for undue influence or coercion, intentional or 
inadvertent, to play a role in the owners decision.  It is important to compose the ICF 
to avoid the possibility that the owner will feel coerced or unduly influenced, whether 
or not actually intended, because a valid consent depends on the owners ability to 
freely decide on their own whether or not to allow their animal to participate in the 
 
6 https://www.ahrq.gov/health-literacy/improve/precautions/tool11.html  
7 https://www.fda.gov/media/88915/download 
8 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guide-informed-consent 
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study.  The ICF should provide factual, relevant information and avoid persuasive 
language.   
 
The ICF should avoid statements that: 
  Could be false or misleading;  
  May cause owners to believe the investigation has the FDAs endorsement; or  
  Could give rise to overly optimistic expectations as to risks, prognosis, 
outcome, safety, effectiveness, or any matter that might influence the owner to 
participate. 
To help ensure the integrity of the study, CVM recommends avoiding the enrollment of 
animals owned by investigators, employees or relatives of investigators or the sponsor, 
or any person with any direct or indirect interest in the outcome of the study.  For 
example, an employee of an entity with an interest in a study may be vulnerable to 
influence or coercion.  Consider including a statement for signature that the owner does 
not have a direct or indirect interest in the study.  
 
The ICF should make clear that clients may remove their animals from the study at any 
time without penalty or loss of benefits to which the client is entitled.  The ICF should 
not pressure the owner to continue participation in the study by suggesting, implicitly 
or explicitly, that leaving the study would cause harm to the animal.  The ICF should be 
consistent with any oral information given to the owner.  
 
C.  Exculpatory language 
The ICF should not incorporate any language that waives or appears to waive any of the 
owners legal rights or releases the investigator, sponsor, institution, or other entity or 
its agents from any legal liability it may have or come to have. 
 
The ICF should not require the owner to affirm that they understand the information 
provided.  The owner should also not be asked or required to affirm that the ICF 
provides all relevant information.  Any language intended to limit the study 
investigators responsibilities or duty of care is inappropriate.  A signed statement by 
the client confirming receipt of the written information is more appropriate, as further 
discussed below. 
 
VI.  Basic Elements of an Informed Consent Form 
A.  Description of the clinical investigation 
1.  Identifying the clinical investigation as investigational.  The ICF should contain a 
brief introductory paragraph that: 
a.  States the product is investigational, and safety and effectiveness have not 
been demonstrated or evaluated for the indicated investigational use.  If the 
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product has been approved for other uses under a new animal drug 
application (NADA), the ICF should include that information.  
b.  States the purpose of the study is for the investigational use of the veterinary 
product rather than to provide medical treatment to the study participants.  
c.  Describes the objective of the clinical investigation (for example, to evaluate 
the safety and effectiveness of the test article or to evaluate a different dose 
or route of administration of an approved drug).  
If the ICF contains multiple pages or sections, repeating this information in other 
parts of the ICF may aid the owner in understanding the nature of the clinical 
investigation. 
The ICF should not include statements that suggest the investigational veterinary 
product (IVP) is safe or effective under the proposed conditions of use.  The 
ICF may incorporate factual information that accurately reflects data from 
completed studies.  
2.  Identify the treatment groups and number of study animals.  The ICF should include 
the following: 
a.  The approximate number of study animals intended to be enrolled in the 
study. 
b.  A description of the treatment groups, including control groups (placebo, 
active control, or no treatment), presented in plain language. 
c.  The likelihood of the animal being assigned to a control group versus a 
treatment group (for example, the animals have a 33% chance of being 
enrolled in the control group in a field study with a 2:1 treated:control 
enrollment ratio). 
3.  Alternative procedures or treatments: 
The ICF should include information about appropriate alternatives, if any, to 
entering the study that may be advantageous to the study animal.  The ICF should 
identify: 
a.  Procedures or treatments, if any, that animals with the condition(s) would 
likely receive if they choose not to participate in the study, including 
alternatives such as approved drugs (for example, an approved oncology 
drug) for the study animals condition, or other forms of therapy (for 
example, surgery).  This should include identifying any procedures and 
treatments that will not be performed or allowed during the study (for 
example, a requirement to not receive insulin during a study investigating a 
novel drug to treat diabetes mellitus).  CVM recommends the ICF briefly 
describe these procedures or treatments, if any, first and then provide the 
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information about the study.  This sequence allows the owner to understand 
how the study differs from the care their animal might otherwise receive. 
b.  Potential consequences of these differences in care, if known (for example, 
a worsening of the disease or clinical condition than would be expected with 
an approved drug). 
4.  Owners responsibilities to comply with the protocol: 
The ICF should state the owners responsibilities while participating in the clinical 
investigation.  Examples of responsibilities include, but are not limited to, the 
following: 
a.  To maintain masking, only discuss treatment information with pre-specified 
study personnel involved in the conduct of the investigational study.  
Depending on treatment, masking, and other study requirements and 
circumstances, do not disclose treatment information to investigators, staff, 
other owners, or others.  
b.  Complete an owner diary, questionnaire, or other means of recording events 
and data.  Owners should be provided with the means to use sound 
documentation practices that are attributable, legible, contemporaneous, 
original, and accurate (ALCOA). 
c.  Comply with medical, dietary, or other restrictions for the animal during the 
study. 
d.  Know when to contact the Investigator regarding any clinical concerns (for 
example, whether to contact the Investigator regarding any vomiting, 
diarrhea, anorexia, or clinical concerns prior to the next scheduled visit). 
e.  Know when to return for study visits.  If the study is complex or the 
duration is long, consider including a study schedule or calendar.  
If a detailed description of every responsibility would make the ICF too lengthy, 
CVM recommends generally listing the responsibilities and describing additional 
details of all owner responsibilities in an addendum.  
Charts, tables, or graphics that outline what happens at each visit may simplify the 
ICF and assist owners in understanding what participation in the clinical 
investigation will involve. 
5.  Additional costs to the owners: 
The ICF should include the following: 
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a.  Whether owners will be responsible for the cost of any treatments or 
diagnostics that may be necessary for the health of the animal should any 
adverse events occur as a result of the investigational study. 
b.  Other potential costs to the owner.  
c.  Where further information regarding costs may be obtained. 
B.  Description of benefits and compensation 
The ICF should include: 
1.  Reasonably expected benefits to the animal derived from reliable information.  The 
ICF can provide a clear and balanced description of potential benefits not only to 
the individual animal, but also to others.  For example, the animals participation 
in the study may not benefit the animal but may benefit future patients with the 
same disease or condition. 
2.  A statement that a beneficial outcome for the study animal cannot be guaranteed. 
3.  A clear statement when there is no intended clinical benefit to the study animal.  
4.  A clear statement that, because the purpose of the study may be to determine the 
safety and/or effectiveness of the drug compared to a control or placebo, it is not yet 
known whether the drug may or may not provide a benefit and the study animal 
may be in a control or placebo group. 
5.  Avoidance of overly optimistic statements of the clinical investigation that may be 
misleading or represent the new animal drug as safe or effective for the purpose for 
which it is under investigation, which would violate FDA regulation (21 CFR 
511.1(b)(8)(iv)). 
6.  A statement of whether any compensation will or will not be provided to the owner.   
7.  A description of any compensation, which may include, but is not limited to, things 
such as medical care, procedures, reduction of costs (for example, no charge for 
physical examinations), or cash payments.  CVM considers payment to owners for 
participation in clinical investigations to be compensation for expenses and 
inconveniences, not a benefit of participation in the study.  If payments are 
provided, the consent process should not identify them as benefits; however, the 
requirements to qualify for payments should be clearly delineated in the ICF.  
Compensation should not be contingent on completion of the study. 
C.  Statements regarding voluntary participation, involuntary termination of owners 
participation, and consequences of owners decision to withdraw 
The ICF should include: 
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1.  A clear statement that study animal participation is voluntary and that refusal to 
participate, or the owners decision to terminate participation at any time, will not 
impact the care of the animal or involve a penalty or loss of benefits to which the 
owner is otherwise entitled.  
2.  A statement indicating the study animal may be removed from the study at the 
discretion of the investigator with or without the owners consent.  For example, the 
investigator may remove the animal from the study if the owner is unable to comply 
with procedures required by the protocol, if the animal no longer meets eligibility 
criteria for continuing in the study, or if the site at which the animal is enrolled 
withdraws from the study.  
3.  A description of any special procedures for study animal withdrawal from the study, 
including an explanation of any withdrawal procedures or follow-up care that are 
recommended to ensure the animals safety. 
4.  A statement informing the owner of the requirement for study animal medical 
record retention when their animal is withdrawn from the study. 
5.  The potential consequences resulting from an owners decision to withdraw from 
the study.  For example, potential side effects, additional costs not compensated, or 
loss of veterinary medical oversight provided by participation in the study. 
D.  Description of procedures, treatments, and potential discomforts 
The ICF should briefly discuss, in plain language, the procedures, treatments, and 
potential discomforts the study animal may experience, for example, imaging 
(radiographs, ultrasound, etc.), blood and/or urine sample collection, injections, and 
drug administration or application.  The ICF should identify study procedures and tests 
that would not be part of their animals care (for example, drawing blood samples for 
pharmacokinetic data). 
 
E.  Description of the risks associated with participation in the study 
The ICF should briefly discuss of the following: 
1.  Potential risks or side effects of the use of the IVP or active pharmaceutical 
ingredient(s) (API) to study animals.  These risks may include any safety 
information or relevant findings identified in pilot data, the target animal safety 
technical section, published literature, or publicly available reports (for example, 
European Medicines Agency reports).  If safety information about the IVP is 
limited, the ICF may include safety information about the API(s), drugs in the same 
drug class, approved drugs containing the same API(s), or other relevant 
information.  
2.  Potential risks of the study procedures to study animals (for example, anesthesia, 
sedation, or surgery).  
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3.  Potential risks of any active control products to study animals.  Client Information 
Sheets for FDA-approved products used as an active control product are acceptable 
to provide to owners.  Providing the owner with a copy of the package insert as the 
sole description of potential risks or side effects is not appropriate, as the package 
insert is not written in plain language.  
4.  Human User Safety: 
Human user safety should be considered a component of the ICF, and should 
include the following: 
a.  A clear description of how to handle and dispose of the IVP, active control 
product, and any associated delivery devices, as well as any procedures to 
mitigate the risk to owners, if applicable.  
b.  Risks from exposure before and during the administration of the test 
article(s), if known. 
c.  A clear description of how to handle and dispose of animal bodily fluids, 
particularly if the IVP is to be administered at home or if special mitigations 
are necessary (for example, use of gloves, disposing of vomitus or waste in 
plastic bags).  This may be especially applicable to oncology drugs, or other 
IVPs that maintain a high-risk profile after administration. 
d.  Information regarding no contact or petting times for treated animals, if 
applicable.  Contact between treated animals and humans or other animals is 
a common potential risk for dermal or topically applied products. 
e.  Risks to household members from accidental exposure. 
f.  A clear description of the occupational and residential risks to humans, 
including children and pregnant or nursing women, if applicable.  
g.  Risks to human users as a result of IVP lack of effectiveness, including any 
zoonotic concerns (for example, ascariasis should an anti-parasiticide 
demonstrate a lack of effectiveness). 
h.  Procedures following accidental human exposure, including directions on 
medical assistance, for removing the product from the eyes or skin (for 
example, wash contacted skin or rinse eyes), or counteragent (for example, 
naloxone). 
i.  A statement that any reported accidental human exposure is required to be 
reported to the FDA by the sponsor (as defined in 21 CFR 511.1(8)(ii)). 
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For more information regarding Human User Safety, see draft GFI #278, Human 
User Safety in New and Abbreviated New Animal Drug Applications.9 
F.  Providing significant new findings to owners 
The ICF should state that significant new findings will be provided to the owner in a 
timely manner.  It is particularly important to include this information for investigations 
that are complex or involve significant risk and when knowledge of potential risks is 
limited (for example, studies using novel therapies and new molecular entities). 
Examples of significant new findings that should be provided to the owner include, but 
are not limited to, the following: 
1.  New risk information that may relate to the study animals continued 
participation in the study. 
2.  Unexpected adverse events. 
3.  Adverse events occurring at greater frequency or severity than previously stated 
in the consent process. 
4.  Lack of effectiveness when it may impact the survival or well-being of the study 
animal. 
G. Statements on confidentiality 
Confidentiality is a critical element of any ICF.  The ICF should clearly describe: 
1.  The extent, if any, to which confidentiality of records identifying the owner and 
animal will be maintained.  
2.  That there is a possibility that the FDA may inspect the records. 
3.  How the data generated from the study will be used by the sponsor/investigator 
(for example, published, reported to the FDA, etc.). 
4.  That the confidentiality provisions described will not be affected by the owners 
decision to remove their animal from the study or by any other action, save by 
operation of law. 
H. Signature on the Informed Consent Form 
Each owner participating in the study should be required to sign an ICF.  The space for 
the owners signature should be preceded by an explanation in plain language of what 
 
9 https://www.fda.gov/media/166696/download (April 2023).   When final, this guidance will represent FDAs 
current thinking on this topic.  
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the owners signature represents.  
The ICF should describe the signature as an acknowledgement that the owner has been 
provided the information discussed in the form.  It may describe the signature as 
affirming the investigator has explained that: 
1.  Participation in the study does not guarantee that the study animal will 
experience any improvement in health. 
2.  The drug product being studied is not FDA-approved for the use under 
investigation. 
3.  The owner wishes to participate in the study and that such participation is 
undertaken voluntarily. 
4.  A confirmation that the owner is the owner of the study animal.  In cases of 
authorized agents, the agents identity and scope of authority should be set forth 
in writing, signed by the owner, and attached to the ICF upon the agents 
signing on behalf of the owner. 
Consider having a neutral witness present for the signing of the ICF by the owner or 
their agent.  Consider providing a space for the witness to sign, confirming that they 
witnessed the owner signing the ICF. 
I.  List of contacts 
The ICF should provide an explanation to the owner of whom to contact: 
1.  For answers to general questions or concerns. 
2.  With concerns regarding clinical signs their study animal may be experiencing.  
3.  In the event of a study-related injury to a study animal or owner. 
4.  For further explanation of the owners rights. 
VII. Informed Consent Form discussions with CVM 
Informed consent may be discussed with CVM at any point in the development process, although 
ideally, conversations would occur before studies are conducted using an informed consent form.  
The sponsors decision regarding when to start the conversation with CVM may be affected by 
where the project is in the development process and the information available, among other 
factors.  CVM recommends the sponsor consider any concerns regarding animal and/or human 
user safety or conditions of use that may impact the ICF as early in the drug approval process as 
possible.  CVM recommends sponsors use the initial presubmission conference process to 
discuss plans to address unique aspects of the new animal drug or conditions of use that may 
impact the ICF.  
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If the sponsor is seeking review and concurrence on an ICF, the ICF should be submitted at the 
time the applicable study protocol is submitted for review (E-submission).  To allow CVM to 
review the ICF and provide appropriate feedback, if necessary, CVM recommends the sponsor 
assess the ICF for inclusion of the recommendations discussed in this GFI, as applicable, prior to 
submission.  
CVMs Office of New Animal Drug Evaluation (ONADE) project managers (PMs) serve as a 
central point of contact for pioneer drug sponsors and can provide information about the new 
animal drug review process and ONADEs regulatory procedures.  If sponsors have questions 
and do not have an ONADE PM assigned to their company, sponsors can contact the PMs 
through the CVM mailbox CVM.ONADE.PM@fda.hhs.gov. 
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