#263 
 
Recommendations for Sponsors of 
Medically Important Antimicrobial 
Drugs Approved for Use in Animals to 
Voluntarily Bring Under Veterinary 
Oversight All Products That Continue to 
be Available Over-the-Counter 
 
Guidance for Industry 
 
 
For further information regarding this document, contact AskCVM@fda.hhs.gov. 
 
Additional copies of this 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 either 
https://www.fda.gov/animal-veterinary or https://www.regulations.gov. 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine (CVM) 
 
June 2021   
 
Table of Contents 
 
I.  Introduction ...................................................................................................................... 3 
II.  Background ....................................................................................................................... 3 
III.  Medically Important Antimicrobial Drugs .................................................................... 4 
IV.  Voluntary Adoption of Judicious Use Principles........................................................... 4 
V.  Veterinary Oversight of Medically Important Antimicrobials .................................... 5 
VI.  Timeline for Voluntarily Implementing Changes ......................................................... 5 
VII.  Supplemental New Animal Drug Applications (Pioneer Drugs) ................................. 6 
A.  Changing Marketing Status ................................................................................... 6 
B.  Voluntary Withdrawal of Approval of the Entire New Animal Drug 
Application ............................................................................................................... 9 
VIII. Supplemental Abbreviated New Animal Drug Applications (Generic Drugs) .......... 9 
A.  Changing Marketing Status ................................................................................. 10 
B.  Voluntary Withdrawal of Approval of the Entire Abbreviated New Animal 
Drug Application ................................................................................................... 12 
IX.  References ....................................................................................................................... 12 
 
   
  2   
Recommendations for Sponsors of Medically Important 
Antimicrobial Drugs Approved for Use in Animals to Voluntarily 
Bring Under Veterinary Oversight All Products That Continue to 
be Available Over-the-Counter 
 
Guidance for Industry 
 
This guidance represents 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 
 
This guidance is intended for sponsors of approved applications and abbreviated applications for 
new animal drugs containing medically important antimicrobials for use in non-food 
(companion), food-producing animals, or both, that are currently approved with over-the-counter 
marketing status.  The guidance contains information for sponsors of such new animal drugs to 
facilitate voluntary changes to the approved conditions of use of these drugs to prescription 
marketing status.  
 
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 
 
On April 13, 2012, FDA finalized a guidance document entitled The Judicious Use of 
Medically Important Antimicrobial Drugs in Food-Producing Animals (GFI #209).  In GFI 
#209, FDA stated that the development of resistance to antimicrobial drugs of importance to 
human medicine (medically important antimicrobial drugs), and the resulting loss of their 
effectiveness as antimicrobial therapies, poses a serious public health threat.  To further address 
this issue, FDA recommended the following two principles to help ensure the appropriate or 
judicious use of medically important antimicrobial drugs in animals: 
 
(1) Limit medically important antimicrobial drugs to uses in animals that are considered 
necessary for assuring animal health, and 
(2) Limit medically important antimicrobial drugs to uses in animals that include veterinary 
oversight or consultation. 
 
In December 2013, FDA finalized a guidance document entitled New Animal Drugs and New 
Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of 
  3  Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning 
Product Use Conditions with GFI #209 (GFI #213).  Based on recommendations in that final 
guidance, sponsors of medically important antimicrobial drugs approved for use in or on the feed 
or drinking water of food-producing animals worked with FDA to voluntarily withdraw approval 
of indications that were not considered necessary for assuring animal health (production 
indications), and voluntarily change all remaining approved uses of such new animal drugs from 
over-the-counter (OTC) to either Veterinary Feed Directive (VFD) or prescription (Rx) 
marketing status, as applicable.  FDA, working in conjunction with sponsors of the affected 
animal drug products, successfully completed implementation of GFI #213 in December 2016.  
https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-implementation-gfi-213-
outlines-continuing-efforts-address-antimicrobial-resistance. 
 
On September 14, 2018, FDA unveiled a 5-year action plan for supporting antimicrobial 
stewardship in veterinary settings.1  This plan builds upon the important steps the Center for 
Veterinary Medicine (CVM) has already taken to support the judicious use of antimicrobials in 
animals,2 and is driven by the concept that medically important antimicrobial drugs should only 
be used in animals when necessary for the treatment, control, or prevention of specific diseases.  
One action item included in this plan is to ensure that any medically important antimicrobial new 
animal drugs that continue to remain available as OTC products are brought under the oversight 
of licensed veterinarians.  The purpose of this guidance is to provide sponsors with specific 
recommendations on how to facilitate voluntary changes to the approved conditions of use of 
these drugs to prescription marketing status.  The voluntary process outlined in this guidance will 
help to ensure all new animal drugs containing antimicrobials of human importance are 
administered only under veterinary oversight and only for therapeutic uses. 
  
III.  Medically Important Antimicrobial Drugs 
 
In 2003, FDA issued Guidance for Industry (GFI) #152, entitled Evaluating the Safety of 
Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of 
Human Health Concern.  GFI #152 contains an appendix in which FDA ranked antimicrobial 
drugs according to their relative importance to human medicine: critically important, highly 
important, or important.  At this time, FDA considers all antimicrobial drugs listed in 
Appendix A to GFI #152 (Appendix A) to be medically important.  The scope of this guidance 
(GFI #263) encompasses all antimicrobial new animal drugs that are considered medically 
important and that currently remain approved with an OTC marketing status.  
 
FDA recognizes that the list of medically important antimicrobial drugs in Appendix A is not 
static and will periodically reassess and update this list.  The Agencys reassessment will take 
into consideration such factors as the development of new antimicrobials for human therapy, the 
emergence of diseases in humans, and changes in prescribing practices in the United States.  
Therefore, the antimicrobial products affected by this guidance may change in the future if this 
reassessment process results in a change to the list of antimicrobial drugs that are considered 
medically important. 
 
IV.  Voluntary Adoption of Judicious Use Principles 
 
 
1 https://www.fda.gov/media/115776/download 
2 https://www.fda.gov/animal-veterinary/safety-health/antimicrobial-resistance 
  4  FDA intends to work with affected drug sponsors to help them to voluntarily change the 
marketing status of their medically important antimicrobial new animal drug products from OTC 
to Rx.  Based on the positive feedback received regarding the approach taken to successfully 
implement the recommendations outlined in GFI #209 and GFI #213, FDA believes a voluntary 
approach is an effective and efficient way to achieve the common goal of judicious use of 
medically important antimicrobials in animals. 
 
V.  Veterinary Oversight of Medically Important Antimicrobials 
 
While the principles for judicious use of medically important antimicrobials recommended in 
GFI #209 are nominally specific to the use of such drugs in food-producing animals, FDA 
believes it is appropriate to apply these same judicious use principles to the use of medically 
important antimicrobial drugs in all animals.  Based on the available scientific evidence 
concerning antimicrobial resistance, including information about resistance trends associated 
with the use of medically important antimicrobial drugs, FDA believes the judicious use of 
medically important antimicrobial drugs intended for use in animals should involve the scientific 
and clinical training of a licensed veterinarian.  The involvement of a veterinarian is needed 
because judicious use of antimicrobial drugs requires an accurate diagnosis of the bacterial 
disease that is present, or likely to be present, and the selection of a suitable antimicrobial drug to 
address that disease. 
 
The decision by the veterinarian to use a specific approved drug is generally based on multiple 
factors, such as the mode of antibacterial action, drug distribution in specific tissues, the duration 
of effective drug levels at the site of infection, past treatment outcomes, local burden of illness 
information, and concurrent animal health issues.  Other important factors veterinarians consider 
when determining the appropriateness of a given antimicrobial use include whether: (1) there is 
evidence of effectiveness, (2) such use is consistent with accepted veterinary practice, (3) the use 
is linked to a specific etiologic agent, (4) the use is appropriately targeted to animals with or at 
risk of developing a specific disease, and (5) no reasonable alternatives for intervention exist.  
FDA believes that veterinarians are uniquely qualified to make these decisions and to determine 
appropriately timed administration of the antimicrobial to treat, control, or prevent disease in 
animals. 
 
Accordingly, FDA recommends that sponsors of medically important antimicrobial new animal 
drugs that are currently approved with OTC marketing status voluntarily revise the conditions of 
use of these drug products to reflect the need for professional oversight of a licensed veterinarian 
(i.e., change the drug from OTC to Rx marketing status).  
 
VI.  Timeline for Voluntarily Implementing Changes 
 
FDA encourages all sponsors of affected new animal drugs (i.e., medically important 
antimicrobial new animal drugs that are currently approved with OTC marketing status) to 
initiate steps to change the product labeling and approved conditions of use for such products 
through the voluntary process outlined in this guidance. 
 
To ensure continued progress under the cooperative framework outlined in this guidance and 
provide for an orderly implementation process, FDA will monitor progress to assess whether 
these changes are being adopted along the timelines discussed below.  FDA is confident that the 
objective of phasing in these changes can be met through the cooperative process discussed in 
this guidance, which is why we are initially pursuing this voluntary approach.  To assist FDA in 
  5  effectively monitoring the rates of participation in the industry, we request that sponsors of 
affected products notify the Agency3 of their intentions to engage in the voluntary process to 
modify their product labeling within 3 months from the date of publication of the final version of 
this guidance.  
 
FDA anticipates that sponsors of affected products should be able to have revised labeling 
approved that incorporates the changes discussed in this guidance within 2 years from the date of 
publication of the final version of this guidance.  The 2-year timeframe for voluntary 
implementation is intended to provide a sufficient amount of time for animal drug sponsors to 
make these changes across all affected new animal drug applications in an efficient and practical 
manner, and for other stakeholders (e.g., veterinarians, animal producers and owners, and 
distributors of animal health products) to prepare for the resulting changes in 
management/business practices that may occur.  If we determine that adequate progress has not 
been made by the end of the 2-year timeframe, we will consider whether further action under the 
existing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for addressing 
matters related to the safety of approved new animal drugs may be appropriate. 
 
Concurrent with the publication of this guidance, FDA is making public on its website a listing 
of all medically important antimicrobial new animal drugs that currently have OTC marketing 
status.  FDA considers all drugs that appear in this listing to be covered by this guidance.4   
 
VII.  Supplemental New Animal Drug Applications (Pioneer Drugs) 
 
Sponsors of new animal drug application(s) (NADAs) affected by this guidance should either (1) 
propose to change the marketing status to Rx, or (2) request to voluntarily withdraw the approval 
of the application. These two options apply even if the affected OTC product is not currently 
marketed. 
 
A. Changing Marketing Status 
 
The procedures in this section (VII.A.) apply to the situation where no new indications, or other 
substantive changes to the application are being proposed.5  The recommendations in this section 
describe how sponsors may submit supplemental new animal drug applications to voluntarily 
change the approved marketing status of their affected drugs from OTC to Rx. 
 
  Administrative Procedures and Submission Content 
 
3 Sponsors of pioneer or generic applications should mail these notifications of intent to the attention of the Division 
of Therapeutic Drugs for Food Animals in the Office of New Animal Drug Evaluation, CVM (HFV-130), at the 
following address: MPN 2, Room E150, 12225 Wilkins Avenue, Rockville, MD 20852.  Future labeling 
supplements should be submitted to the appropriate target animal review division for each application. 
4 This listing also includes the small number of combination drugs currently approved for OTC use in animals that 
include one or more medically important antimicrobials as a component of the combination drug. 
5 To facilitate orderly implementation of this guidance, sponsors wishing to propose new indications or make other 
substantive changes to the application (including changes to the labeling other than those described in this guidance) 
are encouraged to do so under a separate supplemental application, submitted after approval of the marketing status 
change, that includes all applicable technical sections following established procedures.  These procedures are 
described elsewhere and are beyond the scope of this Guidance.  Sponsors wishing to implement all labeling 
changes at a single future printing may submit the subsequent supplement at any time (e.g., immediately) after the 
Rx marketing status change supplement is submitted. 
  6   
FDA anticipates that the labeling changes needed to voluntarily implement the recommendations 
in this guidance will be straightforward.  Therefore, a presubmission conference or other advance 
communication with FDA to discuss planned labeling changes typically should not be necessary.  
However, as always, sponsors may contact FDA with any specific questions in advance of 
submitting their labeling supplement.  
 
Sponsors should use eSubmitter to submit a labeling supplement (NF subclass code, 180-day 
review clock6) to the applicable target animal review division in CVMs Office of New Animal 
Drug Evaluation (ONADE) and indicate that their supplemental application is being submitted in 
accordance with GFI #263.  The submission should include: 
 
  A request to change the marketing status of the product from OTC to prescription (Rx) 
o
to align with the recommendations of this guidance document. 
 
  A single copy of clean color facsimile labeling7 or final printed labeling (electronic 
o
FPL, eFPL) for each affected labeling component revised as follows:8 
 
  The Rx statement, "Caution: Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.", found in section 503(f)(4) of the FD&C Act (21 U.S.C. 
353(f)(4)) must be appropriately added to the label.  At minimum, this statement 
must appear on the immediate container label.  It is recommended that the statement 
also be included on the outer carton and package insert, if any.  In the case of an 
immediate container label too small to accommodate the full statement, but which is 
packaged within an outer container, the statement may be placed on the outer 
container.  See 21 CFR 201.105(b). 
 
  The Caution statement should be placed immediately below the drug product 
o
identification area of the labeling.  The drug product identification information 
normally appears near the top or beginning of a labeling component and 
includes the proprietary name, established name, route of administration, dosage 
form, strength or concentration, pharmacologic class, and controlled substance 
symbol, if applicable. 
  Any other labeling changes previously required by the Agency that have not yet 
been implemented (e.g., storage statement updates). 
 
6 Sponsors should not check yes for the question on the eSubmitter template that asks if they are submitting a 
Qualifying Labeling Supplement (QLS) because these supplements will not qualify for a 60-day review 
timeframe.  If this option is inadvertently selected, ONADE will change the submission review time from 60 to 180 
days. 
7 For products that are not currently marketed, and for which there are no plans to begin marketing them in the 
foreseeable future, FDA may accept marked up facsimile labeling for approval of these supplements if the sponsor 
is not able to provide clean color facsimile labeling.  Such labeling, while not preferred, would take the form of a 
copy of the most recently approved label, marked with clear indicators (arrows or similar) showing the exact text to 
be inserted or deleted and the exact location such changes will appear, presented in a way that does not obscure any 
existing information on the labeling. 
8 With the exception of minor formatting or layout adjustments necessary to add the Rx statement, updates to the 
component version date or number, and any other changes described in this guidance, sponsors should not propose 
other changes to the labeling in the context of this supplemental application.  As previously noted, requests to 
approve other substantive changes may be submitted in a separate supplement. 
  7   
  If not previously implemented, FDA strongly recommends that sponsors revise or 
add the Approved by FDA under NADA # XXX-XXX statement, as required in 
section 502(w)(3) of the FD&C Act.9  If this change is made at this time, it should 
be implemented as follows: 
 
  The statement must read as follows, using the exact format and spacing shown. 
o
Replace XXX-XXX with the specific application number (including leading 
zeros): 
 
Approved by FDA under NADA # XXX-XXX 
 
  Present the statement on a single straight line, unless there is insufficient space, 
o
in which case two straight lines are recommended. 
 
  If a labeling component currently has an older version of the statement, place 
o
the revised version in the same location. 
 
  If a labeling component does not currently have such a statement, add the 
o
statement as follows for each component of the labeling: 
 
  Package inserts and single-panel labeling components: place the statement 
near the bottom of the labeling component. 
 
  Multiple-panel labeling components: place the statement at the bottom of the 
front panel. 
 
  A claim of categorical exclusion (CE) from the need to prepare an environmental 
o
assessment (EA) or an environmental impact statement (EIS) pursuant to 21 CFR 
25.33(a).  Other citations should not be used.  With this claim of CE, pursuant to 21 
CFR 25.15 sponsors must also include a statement that to the sponsors knowledge, no 
extraordinary circumstances exist that may significantly affect the quality of the human 
environment as discussed under 21 CFR 25.21.  Sponsors unable to provide this 
statement should contact the ONADE Environmental Safety Team before submitting 
their supplemental application. 
 
  Permission for CVM to contact sponsors of any affected generic copies of the drug to 
o
discuss changes being made to the pioneer drugs labeling, in advance of FDAs 
approval of the pioneer sponsors labeling supplement. 
 
  If applicable, a statement that the product (or specific product(s)/formulation(s) within 
o
the application) is not currently marketed and that includes any plans and time frames 
for marketing the product(s) or formulation(s) in the future. 
 
   Other technical sections/information 
o
 
 
9 This requirement was added by section 303 of the Animal Drug and Animal Generic Drug User Fee Amendments 
of 2018, Public Law 115-234, and requires the addition (or revision) of this statement on the labeling (except 
representative medicated feed labeling) of approved new animal drugs by September 30, 2023. 
  8    Supplemental applications to change the marketing status generally do not need to 
include additional safety or effectiveness data.  Except in rare cases, it is not 
expected that sponsors will need to address any other technical sections for approval 
of these labeling supplements. 
 
B. Voluntary Withdrawal of Approval of the Entire New Animal Drug Application 
 
The procedures in this section (VII.B.) apply to the situation where the sponsor requests to 
voluntarily withdraw approval of the entire new animal drug application(s).  As always, sponsors 
may contact FDA with any specific questions in advance of submitting such requests.  The 
recommendations below apply when sponsors who wish to voluntarily pursue judicious use 
changes submit requests to voluntarily withdraw the approval of their application(s) without 
prejudice under 21 CFR 514.115(d). 
 
  Administrative Procedures and Submission Content 
 
Sponsors should submit a request for withdrawal of approval of their application without 
prejudice, citing 21 CFR 514.115(d), to the CVM Office of Surveillance and Compliance, 
Marketed Product Information Team (HFV-212).  The request should include the following: 
 
  The sponsors acknowledgement that the request waives the sponsors right to a notice 
o
of opportunity for a hearing in relation to the withdrawal of approval. 
 
  Written permission for CVM to contact the sponsors of affected generic copies of the 
o
drug (if applicable) in advance of publication of notice of the withdrawal of approval in 
the Federal Register (FR).  The sponsor should use the following language for this 
request: 
 
<Sponsor Name> grants CVM permission to contact the sponsor(s) of affected 
generic copies (if applicable) in advance of Federal Register (FR) publication. 
 
  A claim of CE from the requirement to prepare an EA or an EIS pursuant to 21 CFR 
o
25.33(g).  Other citations should not be used.  With this claim of CE, pursuant to 21 
CFR 25.15 sponsors must also include a statement that to the sponsors knowledge, no 
extraordinary circumstances exist that may significantly affect the quality of the human 
environment as discussed under 21 CFR 25.21.  Sponsors unable to provide this 
statement should contact the ONADE Environmental Safety Team before submitting 
their request to voluntarily withdraw approval of the application. 
 
VIII. Supplemental Abbreviated New Animal Drug Applications (Generic Drugs)  
 
Consistent with current practice, if the marketing status or other conditions of use for a new 
animal drug application for a medically important antimicrobial is changed, we expect that the 
approved labeling for any currently approved abbreviated new animal drug application(s) 
(ANADA) that references the original new animal drug application would be revised in a similar 
fashion.  FDA intends to work expeditiously with the sponsors of affected generic new animal 
drug applications to align their products with the revised conditions of use specified in the 
referenced (i.e., pioneer) applications.  Sponsors of generic applications affected by this guidance 
should either (1) align their labeling with the revised labeling of the referenced listed new animal 
drug (RLNAD) application, or (2) request to voluntarily withdraw the approval of the generic 
  9  application.  These two options apply even if the affected OTC generic product is not currently 
marketed. 
 
A. Changing Marketing Status 
 
FDA will contact sponsors of affected generic new animal drug applications after it receives a 
supplemental application to revise the labeling of the RLNAD. As is currently the practice, we 
expect that the generic sponsor will submit a supplemental application to make changes to the 
generic products labeling consistent with the revised labeling of the RLNAD within 60 days 
after FDA notifies the generic sponsor that the approved conditions of use for the RLNAD have 
been or are being revised.  In addition, any future generic sponsor that wants to use a pioneer 
drug as its RLNAD for which the labeling has been revised as recommended in this guidance 
must submit labeling that is the same as the labeling approved for the RLNAD with a few 
exceptions not relevant here.  See section 512(c)(2)(A)(vii) of the FD&C Act (21 U.S.C. 
360b(c)(2)(A)(vii)). 
 
Administrative Procedures and Submission Content 
 
Sponsors should use eSubmitter to submit a labeling supplement (NF subclass code, 240-day 
review clock) to the Division of Generic Animal Drugs in ONADE and indicate that their 
supplemental application is being submitted in accordance with GFI #263.  Sponsors should not 
propose labeling changes in this supplement other than those described in this guidance, except 
for any additional changes that may be required by the Agency.  The submission should include: 
 
  A single copy of clean color facsimile labeling10 or final printed labeling (electronic 
o
FPL, eFPL) for each affected labeling component revised as follows:11 
 
  The Rx statement, "Caution: Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.", found in section 503(f)(4) of the FD&C Act (21 U.S.C. 
353(f)(4)) must be appropriately added to the label.  At minimum, this statement 
must appear on the immediate container label.  It is recommended that the statement 
also be included on the outer carton and package insert, if any.  In the case of an 
immediate container label too small to accommodate the full statement, but which is 
packaged within an outer container, the statement may be placed on the outer 
container.  See 21 CFR 201.105(b). 
 
  The Caution statement should be placed immediately below the drug product 
o
identification area of the labeling.  The drug product identification information 
normally appears near the top or beginning of a labeling component and 
 
10 For products that are not currently marketed, and for which there are no plans to begin marketing them in the 
foreseeable future, FDA may accept marked up facsimile labeling for approval of these supplements if the sponsor 
is not able to provide clean color facsimile labeling.  Such labeling, while not preferred, would take the form of a 
copy of the most recently approved label, marked with clear indicators (arrows or similar) showing the exact text to 
be inserted or deleted and the exact location such changes will appear, presented in a way that does not obscure any 
existing information on the labeling. 
11 With the exception of minor formatting or layout adjustments necessary to add the Rx statement, updates to the 
component version date or number, and any other changes described in this guidance, sponsors should not propose 
other changes to the labeling in the context of this supplemental application.  As previously noted, requests to 
approve other substantive changes may be submitted in a separate supplement. 
  10  includes proprietary name, established name, route of administration, dosage 
form, strength or concentration, pharmacologic class, and controlled substance 
symbol, if applicable.  
  Any other labeling changes necessary to align with the revised RLNAD labeling. 
 
  Any other labeling changes previously required by the Agency that have not yet 
been implemented. 
 
  If not previously implemented, FDA strongly recommends that sponsors revise or 
add the Approved by FDA under ANADA # XXX-XXX statement, as required in 
section 502(w)(3) of the FD&C Act.12  If this change is made at this time, it should 
be implemented as follows: 
 
  The statement must read as follows, using the exact format and spacing shown. 
o
Replace XXX-XXX with the specific application number (including leading 
zeros): 
 
Approved by FDA under ANADA # XXX-XXX 
 
  Present the statement on a single straight line, unless there is insufficient space, 
o
in which case two straight lines are recommended. 
 
  If a labeling component currently has an older version of the statement, place 
o
the revised version in the same location. 
 
  If a labeling component does not currently have such a statement, add the 
o
statement as follows for each component of the labeling: 
 
  Package inserts and single-panel labeling components: place the statement 
near the bottom of the labeling component. 
 
  Multiple-panel labeling components: place the statement at the bottom of the 
front panel. 
 
  A claim of CE from the need to prepare an EA or an EIS pursuant to 21 CFR 25.33(a). 
o
Other citations should not be used.  With this claim of CE, pursuant to 21 CFR 25.15 
sponsors must also include a statement that to the sponsors knowledge, no 
extraordinary circumstances exist that may significantly affect the quality of the human 
environment as discussed under 21 CFR 25.21.  Sponsors unable to provide this 
statement should contact the ONADE Environmental Safety Team before submitting 
their supplemental application. 
 
  If applicable, a statement that the product (or specific product(s)/formulation(s) within 
o
the application) is not currently marketed and that includes any plans and time frames 
for marketing the products(s) or formulations(s) in the future.  
 
12 This requirement was added by section 303 of the Animal Drug and Animal Generic Drug User Fee Amendments 
of 2018 and requires the addition (or revision) of this statement on the labeling (except representative medicated 
feed labeling) of approved new animal drugs by September 30, 2023. 
  11   
  Other technical sections/information 
o
 
  Except in rare cases, it is not expected that sponsors of generic applications will 
need to address any other technical sections for approval of these labeling 
supplements. 
 
B. Voluntary Withdrawal of Approval of the Entire Abbreviated New Animal Drug 
Application 
 
The procedures in this section (VIII.B.) apply to the situation where the sponsor requests to 
voluntarily withdraw approval of the entire abbreviated new animal drug application(s).  As 
always, sponsors may contact FDA with any specific questions in advance of submitting such 
requests.  The recommendations below apply when sponsors who wish to voluntarily pursue 
judicious use changes are submitting requests to voluntarily withdraw the approval of their 
application(s) without prejudice under 21 CFR 514.115(d). 
 
  Administrative Procedures and Submission Content 
 
Sponsors of abbreviated new animal drug applications who do not wish to make their product 
labeling consistent with the revised labeling of the RLNAD should request to voluntarily 
withdraw approval of the ANADA, following the procedures described for NADAs above in 
section VII.B.  Voluntary Withdrawal of Approval of the Entire New Animal Drug Application, 
except that there would be no need to provide permission for CVM to contact sponsors of 
affected generic copies. 
 
IX.  References 
 
1.  FDA 2003. Guidance for Industry #152, Evaluating the Safety of Antimicrobial New 
Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health 
Concern, Appendix A.  https://www.fda.gov/media/69949/download 
2.  FDA 2012. Guidance for Industry #209, The Judicious Use of Medically Important 
Antimicrobial Drugs in Food-Producing Animals.  
https://www.fda.gov/media/79140/download 
3.  FDA 2013. Guidance for Industry #213, New Animal Drugs and New Animal Drug 
Combination Products Administered in or on Medicated Feed or Drinking Water of Food-
Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product 
Use Conditions with GFI #209.  https://www.fda.gov/media/83488/download 
  12