81_FR_63365 81 FR 63187 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Request for Comments

81 FR 63187 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 178 (September 14, 2016)

Page Range63187-63191
FR Document2016-21972

The Food and Drug Administration (FDA, the Agency, we) is soliciting comments regarding the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes. This activity is consistent with previous efforts by FDA to protect public health by promoting the judicious use of these drugs in food-producing animals.

Federal Register, Volume 81 Issue 178 (Wednesday, September 14, 2016)
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Pages 63187-63191]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21972]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2635]


The Judicious Use of Medically Important Antimicrobial Drugs in 
Food-Producing Animals; Establishing Appropriate Durations of 
Therapeutic Administration; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, we) is 
soliciting comments regarding the establishment of appropriately 
targeted durations of use of antimicrobial drugs of importance to human 
medicine (i.e., medically important antimicrobial drugs) when they are 
administered in the feed or water of food-producing animals for 
therapeutic purposes. This activity is consistent with previous efforts 
by FDA to protect public health by promoting the judicious use of these 
drugs in food-producing animals.

DATES: Submit either electronic or written comments by December 13, 
2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-2635 for ``Establishing Appropriate Durations of Therapeutic 
Administration.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cindy Burnsteel, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0817, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On September 18, 2014, the President issued Executive Order 13676 
on ``Combating Antibiotic-Resistant Bacteria'' (https://www.thefederalregister.org/fdsys/pkg/FR-2014-09-23/pdf/2014-22805.pdf), underscoring the urgent 
need to address the global threat of antimicrobial resistance. The 
National Action Plan for Combating Antibiotic-Resistant Bacteria 
(National Action Plan) (March 2015, https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf) was developed in response to this Executive 
order, and presents a strategy for collaborative action by the U.S. 
Government in coordination with individuals and organizations within 
the human and animal health sectors. The plan establishes specific 
goals and objectives within a 5-year timeframe, outlines steps for 
implementing certain measures, and informs national policy development 
in order to combat the emergence of antimicrobial-resistant bacteria.
    FDA is actively engaged in several ongoing efforts to address 
antimicrobial resistance originating from the use of antimicrobial 
drugs that are important in human medicine (medically important 
antimicrobials) in food-

[[Page 63188]]

producing animals. These efforts have supported and continue to support 
the initiatives of the National Action Plan. Judicious use of medically 
important antimicrobials, which includes implementation of 
interventions (e.g., good husbandry practices) that can reduce the 
spread of antimicrobial resistance, is the cornerstone of Goal 1 in the 
National Action Plan, to ``Slow the Emergence of Resistant Bacteria and 
Prevent the Spread of Resistant Infections.'' FDA's approach to 
ensuring the judicious use of medically important antimicrobial drugs 
in food-producing animals has been presented in two Guidance for 
Industry (GFI) documents, GFI #209, ``The Judicious Use of Medically 
Important Antimicrobial Drugs in Food-Producing Animals'' \1\ (GFI 
#209) and GFI #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'' \2\ (GFI 
#213).
---------------------------------------------------------------------------

    \1\ http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf.
    \2\ http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf.
---------------------------------------------------------------------------

    GFI #209, published in April 2012, outlines FDA's fundamental 
principles of judicious use. These are: (1) Limiting medically 
important antimicrobial drugs to uses in food-producing animals that 
are considered necessary for assuring animal health and (2) limiting 
such drugs to uses that include veterinary oversight or consultation. 
In GFI #209, FDA stated that it generally considers uses that are 
associated with the treatment, control, or prevention of specific 
diseases to be uses that are necessary for assuring the health of food-
producing animals, in contrast to uses for production purposes (e.g., 
for growth promotion or improved feed efficiency) to enhance the 
production of animal-derived products.
    As discussed in GFI #209, FDA's current methodology for assessing 
antimicrobial risks associated with the use of antimicrobial new animal 
drugs in food-producing animals is premised on the concept that 
increasing the exposure of bacterial populations to antimicrobial drugs 
increases the risk of generating resistance to those antimicrobial 
drugs. Because feed or water use antimicrobial drugs are typically 
administered to entire herds or flocks of food-producing animals, such 
uses pose higher risk to public health than the administration of such 
drugs to individual animals or targeted groups of animals, as is done 
with dosage form drugs (e.g., injectables, tablets, etc.). Therefore, 
FDA is more concerned with medically important antimicrobial new animal 
drugs and combination new animal drug products intended for use in feed 
or water of food-producing animals.
    GFI #213, published in December 2013, is based on the two 
fundamental principles of judicious use described in GFI #209 and 
provides specific recommendations for drug sponsors. These 
recommendations for sponsors of approved medically important 
antimicrobial drugs administered in feed or water to food-producing 
animals include: (1) Removing production indications \3\ (e.g., 
increased rate of weight gain and improved feed efficiency) and (2) 
incorporating veterinary oversight for the remaining therapeutic 
indications.
---------------------------------------------------------------------------

    \3\ Production uses are also referred to as ``nontherapeutic'' 
or ``subtherapeutic'' uses, terms that we believe lack sufficient 
clarity (GFI #209).
---------------------------------------------------------------------------

    FDA is working collaboratively with the sponsors of affected 
applications to facilitate the revision of product labeling to reflect 
the voluntary withdrawal of approval of production indications. 
Incorporating veterinary oversight is accomplished by changing the 
marketing status from over-the-counter (OTC) use to use by either 
veterinary feed directive (VFD), in the case of drugs administered in 
feed, or by veterinary prescription (Rx), in the case of drugs 
administered in water.
    In Section III of GFI #213, FDA states, ``all antimicrobial drugs 
listed in Appendix A to GFI #152 \4\ (Appendix A) [are considered] to 
be `medically important' in the context of implementing the 
recommendations outlined in GFI #209 and further discussed in this 
guidance document (GFI #213). We believe that the policy in GFI #209 
and GFI #213 applies to all three tiers [``critically important,'' 
``highly important,'' or ``important''] of medically important 
antimicrobial drugs at this time because each tier (and thus all of the 
drugs listed in Appendix A) contains drugs that have been previously 
assessed through the public processes used to develop GFI #152 and 
determined to be important for treating bacterial infections in people. 
. . . The current list of medically important antimicrobial drug 
classes that are the subject of this guidance includes: 
Aminoglycosides, lincosamides, macrolides, penicillins, streptogramins, 
sulfonamides, and tetracyclines.''
---------------------------------------------------------------------------

    \4\ GFI #152, ``Evaluating the Safety of Antimicrobial New 
Animal Drugs with Regard to their Microbiological Effects on 
Bacteria of Human Health Concern.'' (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052519.pdf).
---------------------------------------------------------------------------

    The implementation of GFI #213 is a critical step toward improving 
judicious use in veterinary practice, thereby minimizing the selection 
of antimicrobial-resistant microorganisms to help preserve the 
therapeutic effectiveness of medically important antimicrobial drugs. 
As stated previously, incorporating veterinary oversight is 
accomplished by changing the existing OTC marketing status of these 
drugs to either VFD marketing status, in the case of drugs administered 
in feed, or to veterinary Rx status, in the case of drugs administered 
in water. In GFI #213 and outreach related to the 2015 revisions made 
to the VFD regulations (http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm449019.htm), FDA has stated that, in 
addition to veterinary oversight, use of these antimicrobials should be 
linked to a specific etiologic agent and that the antimicrobial should 
be administered for an appropriately targeted period of time, i.e., 
have a defined duration of use.
    As explained in GFI #213, we expect, among other things, that any 
new indications for medically important antimicrobials, including those 
used in feed or in drinking water, have defined durations of use. 
Consistent with this expectation, the recently revised VFD regulations 
in 21 CFR part 558 state that a lawful VFD, among other requirements, 
must document the duration of use of the VFD drug contained in the 
medicated feed (see 21 CFR 558.6(b)(3)(x)).
    Although GFI #213 sets out our expectation that new indications of 
medically important antimicrobial drugs used in or on feed and water 
will have defined durations of use, it does not address what to do with 
respect to some currently approved therapeutics that lack defined 
durations of use. Establishing defined durations of use for currently 
approved therapeutics will support FDA's efforts to foster stewardship 
of medically important antimicrobial drugs in food-producing animals 
and help preserve the effectiveness of these antimicrobials in animal 
and human medicine. Some examples of defined durations of use on the 
labeling of currently approved therapeutics are ``Feed continuously for 
5 days,'' ``Feed continuously for 5 days as the sole ration,'' ``Feed 
from weaning up to 120 pounds,'' and ``Do not feed to

[[Page 63189]]

chickens over 16 weeks (112 days) of age.''
    In section II, FDA invites comment on the establishment of 
appropriately targeted durations of use of medically important 
antimicrobial drugs administered to food-producing animals in feed or 
water for those therapeutics for which a defined durations of use is 
not included on currently approved labeling. Along with labeling that 
is silent on limits to the duration of use, some examples in which the 
duration of use is not defined on currently approved labeling are 
``Feed continuously'' and ``Feed continuously as the sole ration.''
    FDA will consider submitted comments as we develop a process by 
which sponsors of currently approved, medically important antimicrobial 
drugs, administered in feed or water to food-producing animals for 
therapeutic purposes, could establish appropriately targeted durations 
of use. We recognize that, in certain circumstances, some medically 
important antimicrobial drugs may have a range of safe and effective 
durations (see 21 CFR 514.4(b)(2)(i)). Approval of defined durations of 
use may be supported by existing effectiveness data, target animal 
safety data, human food safety studies, clinical pharmacology studies, 
disease pathophysiology, and/or other available information.
    Based on an April 2016 review, FDA identified six species (cattle, 
swine, chickens, turkeys, sheep, and honey bees) for which there are 
approved, medically important antimicrobials administered in medicated 
feed or drinking water for therapeutic purposes that do not currently 
have a defined duration of use included on labeling. We have 
summarized, in tabular form, the species and disease indications for 
which these drugs are approved without defined durations of use (see 
tables 1 through 6). Indications are summarized as disease conditions 
(see column entitled ``Indication/Disease'') and are listed with their 
associated antimicrobial drugs (see column titled ``Ingredient(s)''). 
These tables may assist members of the public who wish to comment on 
establishing appropriately targeted durations of use.

II. Issues for Consideration

    A key objective of FDA is to optimize the use of medically 
important antimicrobials by using a dosage strategy that maximizes drug 
effectiveness, minimizes target animal toxicity, and has an 
appropriately targeted duration of use to minimize the development of 
resistance to antimicrobial drugs of human medical importance. FDA 
invites comments on the questions below to assist in evaluating 
appropriately targeted durations of use for medically important 
antimicrobial drugs administered to food-producing animals in or on 
feed or in drinking water for those therapeutics for which a defined 
duration of use is not included on the currently approved labeling.
    For the species and disease indications listed in tables 1 through 
6, this request for comments is intended to: (1) Obtain additional 
information, especially from the animal agriculture, animal health, and 
veterinary communities, on the underlying diseases for these 
therapeutic indications, including periods when livestock or poultry 
are at risk of developing these diseases; (2) seek input on more-
targeted antimicrobial use regimens for these diseases, and husbandry 
practices that may help avoid the need for these antimicrobials, or 
that may help make more-targeted antimicrobial use regimens more 
effective; and (3) seek comment on strategies for updating affected 
product labeling, as appropriate, that does not currently include a 
defined duration of use.
    When commenting on an appropriately targeted duration of use for a 
medicated feed for use in a food-producing major species, please 
consider the target animal classes described in Appendix III of GFI 
#191, ``Changes to Approved NADAs--New ANDAs vs Category II 
Supplemental NADAs,'' \5\ and the periods when that class of animal is 
at risk of developing that disease. For the diseases/indications and 
antimicrobials listed in tables 1 through 6 for which the duration of 
use is undefined on labeling, please address the following questions 
based on your current practices:
---------------------------------------------------------------------------

    \5\ http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm052460.
---------------------------------------------------------------------------

    1. When is the animal/class at risk of developing the disease?
    2. For how long do you administer X antimicrobial for Y indication 
if the labeling says ``feed continuously,'' or is silent on duration of 
use?
    3. What factors influence your decision when determining the 
duration of use?
    4. In addition to the drug labeling, what sources of information do 
you use in making a decision regarding duration of use?
    a. Past personal experience;
    b. drug industry representatives;
    c. extension agents;
    d. producer or veterinary medicine magazines;
    e. online resources;
    f. formularies; and
    g. other.
    5. What pros and cons do you see if durations of use are defined 
for all of these antimicrobials?
    6. What reasonable alternatives to medically important 
antimicrobials, including other pharmaceutical or non-pharmaceutical 
approaches, are available for managing the diseases listed in tables 1 
through 6?
    In the following tables, undefined durations of use means, for 
example, therapeutics that include the statement ``feed continuously,'' 
``feed continuously as the sole ration'' or other similar language on 
their labeling, or that have labeling that is silent on limits to the 
duration of use. Ingredient(s) means a medically important 
antimicrobial ingredient and any feed use combination approvals 
including that ingredient. When more than one ingredient is listed, 
that drug combination is only available in a fixed-ratio, combination 
drug Type A medicated article for use in complete Type C medicated 
feeds.

  Table 1--Antimicrobials With Approved Therapeutic (Treatment/Control/
    Prevention) Indications With Undefined Durations of Use in Cattle
------------------------------------------------------------------------
           Indication/disease                     Ingredient(s)
------------------------------------------------------------------------
Anaplasmosis...........................  Chlortetracycline.
Bacterial enteritis....................  Chlortetracycline.
                                         Oxytetracycline.

[[Page 63190]]

 
Liver Abscesses........................  Chlortetracycline.
                                         Tylosin.
                                         Oxytetracycline.
                                         Neomycin With Oxytetracycline.
                                         Virginiamycin.
Pneumonia..............................  Chlortetracycline.
------------------------------------------------------------------------



  Table 2--Antimicrobials With Approved Therapeutic (Treatment/Control/
    Prevention) Indications With Undefined Durations of Use in Swine
------------------------------------------------------------------------
           Indication/disease                     Ingredient(s)
------------------------------------------------------------------------
Atrophic rhinitis......................  Tylosin.
                                         Tylosin With Sulfamethazine.
                                         Chlortetracycline.
                                         Sulfamethazine.
Pneumonia..............................  Tylosin With Sulfamethazine.
                                         Oxytetracycline.
GI-Parasites \1\.......................  Hygromycin B.
GI-Bacterial \2\.......................  Tylosin With Sulfamethazine.
                                         Lincomycin.
                                         Chlortetracycline With
                                          Sulfamethazine.
                                         Chlortetracycline.
                                         Oxytetracycline.
Jowl abscesses.........................  Chlortetracycline.
------------------------------------------------------------------------
\1\ An example of Gastrointestinal (GI)-Parasite indication is ``Control
  of infestations of large roundworms (Ascaris suis), nodular worms
  (Oesophagostomum dentatum), and whipworms (Trichuris suis).''
\2\ Examples of Gastrointestinal (GI)-Bacterial indications are: ``For
  treatment of swine dysentery''; ``To help prevent bacterial swine
  enteritis''; and ``Treatment of bacterial swine enteritis
  (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis
  and vibrionic dysentery).''



  Table 3--Antimicrobials With Approved Therapeutic (Treatment/Control/
   Prevention) Indications With Undefined Durations of Use in Chickens
------------------------------------------------------------------------
           Indication/disease                     Ingredient(s)
------------------------------------------------------------------------
Infectious Coryza......................  Ormetoprim with
                                          Sulfadimethoxine.
Chronic Respiratory Disease............  Oxytetracycline.
                                         Oxytetracycline.
Necrotic Enteritis/Colibacillosis......  Ormetoprim with
                                          Sulfadimethoxine.
                                         Lincomycin.
                                         Virginiamycin.
Fowl Cholera...........................  Ormetoprim with
                                          Sulfadimethoxine.
Gastrointestinal (GI)-Parasites \1\....  Hygromycin B.
Coccidiosis............................  Ormetoprim with
                                          Sulfadimethoxine.
------------------------------------------------------------------------
\1\ An example of Gastrointestinal (GI)-Parasite indication is, ``As an
  aid in the control of infections of large roundworms (Ascaris galli),
  cecal worms (Heterakis gallinae), and capillary worms (Capillaria
  obsignata).''



  Table 4--Antimicrobials With Approved Therapeutic (Treatment/Control/
   Prevention) Indications With Undefined Durations of Use in Turkeys
------------------------------------------------------------------------
           Indication/disease                     Ingredient(s)
------------------------------------------------------------------------
Coccidiosis............................  Ormetoprim with
                                          Sulfadimethoxine.
Fowl Cholera...........................  Ormetoprim with
                                          Sulfadimethoxine.
------------------------------------------------------------------------



[[Page 63191]]



  Table 5--Antimicrobials With Approved Therapeutic (Treatment/Control/
    Prevention) Indications With Undefined Durations of Use in Sheep
------------------------------------------------------------------------
           Indication/disease                     Ingredient(s)
------------------------------------------------------------------------
Vibrionic Abortion.....................  Chlortetracycline.
Enterotoxemia..........................  Chlortetracycline.
------------------------------------------------------------------------



  Table 6--Antimicrobials With Approved Therapeutic (Treatment/Control/
  Prevention) Indications With Undefined Durations of Use in Honey Bees
------------------------------------------------------------------------
           Indication/disease                     Ingredient(s)
------------------------------------------------------------------------
Foulbrood..............................  Oxytetracycline.
------------------------------------------------------------------------


    Dated: September 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21972 Filed 9-12-16; 11:15 am]
 BILLING CODE 4164-01-P



                                                                             Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices                                         63187

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                                                                                                                Instructions: All submissions received             I. Background
                                                    SUMMARY:    The Food and Drug                            must include the Docket No. FDA–                         On September 18, 2014, the President
                                                    Administration (FDA, the Agency, we)                     2016–D–2635 for ‘‘Establishing                        issued Executive Order 13676 on
                                                    is soliciting comments regarding the                     Appropriate Durations of Therapeutic                  ‘‘Combating Antibiotic-Resistant
                                                    establishment of appropriately targeted                  Administration.’’ Received comments                   Bacteria’’ (https://www.gpo.gov/fdsys/
                                                    durations of use of antimicrobial drugs                  will be placed in the docket and, except              pkg/FR-2014-09-23/pdf/2014-
                                                    of importance to human medicine (i.e.,                   for those submitted as ‘‘Confidential                 22805.pdf), underscoring the urgent
                                                    medically important antimicrobial                        Submissions,’’ publicly viewable at                   need to address the global threat of
                                                    drugs) when they are administered in                     http://www.regulations.gov or at the                  antimicrobial resistance. The National
                                                    the feed or water of food-producing                      Division of Dockets Management                        Action Plan for Combating Antibiotic-
                                                    animals for therapeutic purposes. This                   between 9 a.m. and 4 p.m., Monday                     Resistant Bacteria (National Action
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                                                    DATES: Submit either electronic or                       made publicly available, submit your                  bacteria.pdf) was developed in response
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                                                    www.regulations.gov. Follow the                          its consideration of comments. The                    development in order to combat the
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    instructions for submitting comments.                    second copy, which will have the                      emergence of antimicrobial-resistant
                                                    Comments submitted electronically,                       claimed confidential information                      bacteria.
                                                    including attachments, to http://                        redacted/blacked out, will be available                  FDA is actively engaged in several
                                                    www.regulations.gov will be posted to                    for public viewing and posted on http://              ongoing efforts to address antimicrobial
                                                    the docket unchanged. Because your                       www.regulations.gov. Submit both                      resistance originating from the use of
                                                    comment will be made public, you are                     copies to the Division of Dockets                     antimicrobial drugs that are important
                                                    solely responsible for ensuring that your                Management. If you do not wish your                   in human medicine (medically
                                                    comment does not include any                             name and contact information to be                    important antimicrobials) in food-


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                                                    63188                   Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices

                                                    producing animals. These efforts have                   than the administration of such drugs to               antimicrobial drug classes that are the
                                                    supported and continue to support the                   individual animals or targeted groups of               subject of this guidance includes:
                                                    initiatives of the National Action Plan.                animals, as is done with dosage form                   Aminoglycosides, lincosamides,
                                                    Judicious use of medically important                    drugs (e.g., injectables, tablets, etc.).              macrolides, penicillins, streptogramins,
                                                    antimicrobials, which includes                          Therefore, FDA is more concerned with                  sulfonamides, and tetracyclines.’’
                                                    implementation of interventions (e.g.,                  medically important antimicrobial new                     The implementation of GFI #213 is a
                                                    good husbandry practices) that can                      animal drugs and combination new                       critical step toward improving judicious
                                                    reduce the spread of antimicrobial                      animal drug products intended for use                  use in veterinary practice, thereby
                                                    resistance, is the cornerstone of Goal 1                in feed or water of food-producing                     minimizing the selection of
                                                    in the National Action Plan, to ‘‘Slow                  animals.                                               antimicrobial-resistant microorganisms
                                                    the Emergence of Resistant Bacteria and                    GFI #213, published in December                     to help preserve the therapeutic
                                                    Prevent the Spread of Resistant                         2013, is based on the two fundamental                  effectiveness of medically important
                                                    Infections.’’ FDA’s approach to ensuring                principles of judicious use described in               antimicrobial drugs. As stated
                                                    the judicious use of medically important                GFI #209 and provides specific                         previously, incorporating veterinary
                                                    antimicrobial drugs in food-producing                   recommendations for drug sponsors.                     oversight is accomplished by changing
                                                    animals has been presented in two                       These recommendations for sponsors of                  the existing OTC marketing status of
                                                    Guidance for Industry (GFI) documents,                  approved medically important                           these drugs to either VFD marketing
                                                    GFI #209, ‘‘The Judicious Use of                        antimicrobial drugs administered in                    status, in the case of drugs administered
                                                    Medically Important Antimicrobial                       feed or water to food-producing animals                in feed, or to veterinary Rx status, in the
                                                    Drugs in Food-Producing Animals’’ 1                     include: (1) Removing production                       case of drugs administered in water. In
                                                    (GFI #209) and GFI #213, ‘‘New Animal                   indications 3 (e.g., increased rate of                 GFI #213 and outreach related to the
                                                    Drugs and New Animal Drug                               weight gain and improved feed                          2015 revisions made to the VFD
                                                    Combination Products Administered in                    efficiency) and (2) incorporating                      regulations (http://www.fda.gov/
                                                    or on Medicated Feed or Drinking Water                  veterinary oversight for the remaining                 AnimalVeterinary/
                                                    of Food-Producing Animals:                              therapeutic indications.                               DevelopmentApprovalProcess/
                                                    Recommendations for Drug Sponsors for                      FDA is working collaboratively with                 ucm449019.htm), FDA has stated that,
                                                    Voluntarily Aligning Product Use                        the sponsors of affected applications to               in addition to veterinary oversight, use
                                                    Conditions with GFI #209’’ 2 (GFI #213).                facilitate the revision of product                     of these antimicrobials should be linked
                                                       GFI #209, published in April 2012,                   labeling to reflect the voluntary                      to a specific etiologic agent and that the
                                                    outlines FDA’s fundamental principles                   withdrawal of approval of production                   antimicrobial should be administered
                                                    of judicious use. These are: (1) Limiting               indications. Incorporating veterinary                  for an appropriately targeted period of
                                                    medically important antimicrobial drugs                 oversight is accomplished by changing                  time, i.e., have a defined duration of
                                                    to uses in food-producing animals that                  the marketing status from over-the-                    use.
                                                    are considered necessary for assuring                   counter (OTC) use to use by either                        As explained in GFI #213, we expect,
                                                    animal health and (2) limiting such                     veterinary feed directive (VFD), in the                among other things, that any new
                                                    drugs to uses that include veterinary                   case of drugs administered in feed, or by              indications for medically important
                                                    oversight or consultation. In GFI #209,                 veterinary prescription (Rx), in the case              antimicrobials, including those used in
                                                    FDA stated that it generally considers                  of drugs administered in water.                        feed or in drinking water, have defined
                                                    uses that are associated with the                          In Section III of GFI #213, FDA states,             durations of use. Consistent with this
                                                    treatment, control, or prevention of                    ‘‘all antimicrobial drugs listed in                    expectation, the recently revised VFD
                                                    specific diseases to be uses that are                   Appendix A to GFI #152 4 (Appendix A)                  regulations in 21 CFR part 558 state that
                                                    necessary for assuring the health of                    [are considered] to be ‘medically                      a lawful VFD, among other
                                                    food-producing animals, in contrast to                  important’ in the context of                           requirements, must document the
                                                    uses for production purposes (e.g., for                 implementing the recommendations                       duration of use of the VFD drug
                                                    growth promotion or improved feed                       outlined in GFI #209 and further                       contained in the medicated feed (see 21
                                                    efficiency) to enhance the production of                discussed in this guidance document                    CFR 558.6(b)(3)(x)).
                                                    animal-derived products.                                (GFI #213). We believe that the policy
                                                       As discussed in GFI #209, FDA’s                                                                                Although GFI #213 sets out our
                                                                                                            in GFI #209 and GFI #213 applies to all                expectation that new indications of
                                                    current methodology for assessing
                                                                                                            three tiers [‘‘critically important,’’                 medically important antimicrobial drugs
                                                    antimicrobial risks associated with the
                                                                                                            ‘‘highly important,’’ or ‘‘important’’] of             used in or on feed and water will have
                                                    use of antimicrobial new animal drugs
                                                                                                            medically important antimicrobial drugs                defined durations of use, it does not
                                                    in food-producing animals is premised
                                                                                                            at this time because each tier (and thus               address what to do with respect to some
                                                    on the concept that increasing the
                                                                                                            all of the drugs listed in Appendix A)                 currently approved therapeutics that
                                                    exposure of bacterial populations to
                                                                                                            contains drugs that have been                          lack defined durations of use.
                                                    antimicrobial drugs increases the risk of
                                                                                                            previously assessed through the public                 Establishing defined durations of use for
                                                    generating resistance to those
                                                                                                            processes used to develop GFI #152 and                 currently approved therapeutics will
                                                    antimicrobial drugs. Because feed or
                                                                                                            determined to be important for treating                support FDA’s efforts to foster
                                                    water use antimicrobial drugs are
                                                                                                            bacterial infections in people. . . . The              stewardship of medically important
                                                    typically administered to entire herds or
                                                                                                            current list of medically important                    antimicrobial drugs in food-producing
                                                    flocks of food-producing animals, such
                                                                                                                                                                   animals and help preserve the
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    uses pose higher risk to public health                     3 Production uses are also referred to as
                                                                                                                                                                   effectiveness of these antimicrobials in
                                                                                                            ‘‘nontherapeutic’’ or ‘‘subtherapeutic’’ uses, terms
                                                     1 http://www.fda.gov/downloads/                        that we believe lack sufficient clarity (GFI #209).    animal and human medicine. Some
                                                    AnimalVeterinary/                                          4 GFI #152, ‘‘Evaluating the Safety of              examples of defined durations of use on
                                                    GuidanceComplianceEnforcement/                          Antimicrobial New Animal Drugs with Regard to          the labeling of currently approved
                                                    GuidanceforIndustry/UCM216936.pdf.                      their Microbiological Effects on Bacteria of Human     therapeutics are ‘‘Feed continuously for
                                                     2 http://www.fda.gov/downloads/                        Health Concern.’’ (http://www.fda.gov/downloads/
                                                    AnimalVeterinary/                                       AnimalVeterinary/
                                                                                                                                                                   5 days,’’ ‘‘Feed continuously for 5 days
                                                    GuidanceComplianceEnforcement/                          GuidanceComplianceEnforcement/                         as the sole ration,’’ ‘‘Feed from weaning
                                                    GuidanceforIndustry/UCM299624.pdf.                      GuidanceforIndustry/UCM052519.pdf).                    up to 120 pounds,’’ and ‘‘Do not feed to


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                                                                                    Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices                                                            63189

                                                    chickens over 16 weeks (112 days) of                                    members of the public who wish to                             class of animal is at risk of developing
                                                    age.’’                                                                  comment on establishing appropriately                         that disease. For the diseases/
                                                       In section II, FDA invites comment on                                targeted durations of use.                                    indications and antimicrobials listed in
                                                    the establishment of appropriately                                                                                                    tables 1 through 6 for which the
                                                    targeted durations of use of medically                                  II. Issues for Consideration
                                                                                                                                                                                          duration of use is undefined on labeling,
                                                    important antimicrobial drugs                                              A key objective of FDA is to optimize                      please address the following questions
                                                    administered to food-producing animals                                  the use of medically important                                based on your current practices:
                                                    in feed or water for those therapeutics                                 antimicrobials by using a dosage                                 1. When is the animal/class at risk of
                                                    for which a defined durations of use is                                 strategy that maximizes drug                                  developing the disease?
                                                    not included on currently approved                                      effectiveness, minimizes target animal                           2. For how long do you administer X
                                                    labeling. Along with labeling that is                                   toxicity, and has an appropriately                            antimicrobial for Y indication if the
                                                    silent on limits to the duration of use,                                targeted duration of use to minimize the                      labeling says ‘‘feed continuously,’’ or is
                                                    some examples in which the duration of                                  development of resistance to                                  silent on duration of use?
                                                    use is not defined on currently                                         antimicrobial drugs of human medical                             3. What factors influence your
                                                    approved labeling are ‘‘Feed                                            importance. FDA invites comments on                           decision when determining the duration
                                                    continuously’’ and ‘‘Feed continuously                                  the questions below to assist in                              of use?
                                                    as the sole ration.’’                                                   evaluating appropriately targeted                                4. In addition to the drug labeling,
                                                       FDA will consider submitted                                          durations of use for medically important                      what sources of information do you use
                                                    comments as we develop a process by                                     antimicrobial drugs administered to                           in making a decision regarding duration
                                                    which sponsors of currently approved,                                   food-producing animals in or on feed or                       of use?
                                                    medically important antimicrobial                                       in drinking water for those therapeutics
                                                                                                                                                                                             a. Past personal experience;
                                                    drugs, administered in feed or water to                                 for which a defined duration of use is
                                                    food-producing animals for therapeutic                                                                                                   b. drug industry representatives;
                                                                                                                            not included on the currently approved
                                                    purposes, could establish appropriately                                 labeling.                                                        c. extension agents;
                                                    targeted durations of use. We recognize                                    For the species and disease                                   d. producer or veterinary medicine
                                                    that, in certain circumstances, some                                    indications listed in tables 1 through 6,                     magazines;
                                                    medically important antimicrobial drugs                                 this request for comments is intended                            e. online resources;
                                                    may have a range of safe and effective                                  to: (1) Obtain additional information,                           f. formularies; and
                                                    durations (see 21 CFR 514.4(b)(2)(i)).                                  especially from the animal agriculture,                          g. other.
                                                    Approval of defined durations of use                                    animal health, and veterinary                                    5. What pros and cons do you see if
                                                    may be supported by existing                                            communities, on the underlying                                durations of use are defined for all of
                                                    effectiveness data, target animal safety                                diseases for these therapeutic                                these antimicrobials?
                                                    data, human food safety studies, clinical                               indications, including periods when                              6. What reasonable alternatives to
                                                    pharmacology studies, disease                                           livestock or poultry are at risk of                           medically important antimicrobials,
                                                    pathophysiology, and/or other available                                 developing these diseases; (2) seek input                     including other pharmaceutical or non-
                                                    information.                                                            on more-targeted antimicrobial use                            pharmaceutical approaches, are
                                                       Based on an April 2016 review, FDA                                   regimens for these diseases, and                              available for managing the diseases
                                                    identified six species (cattle, swine,                                  husbandry practices that may help                             listed in tables 1 through 6?
                                                    chickens, turkeys, sheep, and honey                                     avoid the need for these antimicrobials,                         In the following tables, undefined
                                                    bees) for which there are approved,                                     or that may help make more-targeted                           durations of use means, for example,
                                                    medically important antimicrobials                                      antimicrobial use regimens more                               therapeutics that include the statement
                                                    administered in medicated feed or                                       effective; and (3) seek comment on                            ‘‘feed continuously,’’ ‘‘feed
                                                    drinking water for therapeutic purposes                                 strategies for updating affected product                      continuously as the sole ration’’ or other
                                                    that do not currently have a defined                                    labeling, as appropriate, that does not                       similar language on their labeling, or
                                                    duration of use included on labeling.                                   currently include a defined duration of                       that have labeling that is silent on limits
                                                    We have summarized, in tabular form,                                    use.                                                          to the duration of use. Ingredient(s)
                                                    the species and disease indications for                                    When commenting on an                                      means a medically important
                                                    which these drugs are approved without                                  appropriately targeted duration of use                        antimicrobial ingredient and any feed
                                                    defined durations of use (see tables 1                                  for a medicated feed for use in a food-                       use combination approvals including
                                                    through 6). Indications are summarized                                  producing major species, please                               that ingredient. When more than one
                                                    as disease conditions (see column                                       consider the target animal classes                            ingredient is listed, that drug
                                                    entitled ‘‘Indication/Disease’’) and are                                described in Appendix III of GFI #191,                        combination is only available in a fixed-
                                                    listed with their associated                                            ‘‘Changes to Approved NADAs—New                               ratio, combination drug Type A
                                                    antimicrobial drugs (see column titled                                  ANDAs vs Category II Supplemental                             medicated article for use in complete
                                                    ‘‘Ingredient(s)’’). These tables may assist                             NADAs,’’ 5 and the periods when that                          Type C medicated feeds.

                                                          TABLE 1—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
                                                                                        UNDEFINED DURATIONS OF USE IN CATTLE
                                                                                           Indication/disease                                                                                  Ingredient(s)
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Anaplasmosis ...........................................................................................     Chlortetracycline.
                                                    Bacterial enteritis ......................................................................................   Chlortetracycline.
                                                                                                                                                                 Oxytetracycline.




                                                      5 http://www.fda.gov/downloads/

                                                    animalveterinary/guidancecomplianceenforcement/
                                                    guidanceforindustry/ucm052460.

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                                                    63190                            Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices

                                                          TABLE 1—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
                                                                                  UNDEFINED DURATIONS OF USE IN CATTLE—Continued
                                                                                            Indication/disease                                                                                   Ingredient(s)

                                                    Liver Abscesses .......................................................................................        Chlortetracycline.
                                                                                                                                                                   Tylosin.
                                                                                                                                                                   Oxytetracycline.
                                                                                                                                                                   Neomycin With Oxytetracycline.
                                                                                                                                                                   Virginiamycin.
                                                    Pneumonia ................................................................................................     Chlortetracycline.




                                                          TABLE 2—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
                                                                                        UNDEFINED DURATIONS OF USE IN SWINE
                                                                                            Indication/disease                                                                                   Ingredient(s)

                                                    Atrophic rhinitis .........................................................................................    Tylosin.
                                                                                                                                                                   Tylosin With Sulfamethazine.
                                                                                                                                                                   Chlortetracycline.
                                                                                                                                                                   Sulfamethazine.
                                                    Pneumonia ................................................................................................     Tylosin With Sulfamethazine.
                                                                                                                                                                   Oxytetracycline.
                                                    GI-Parasites 1 ............................................................................................    Hygromycin B.
                                                    GI-Bacterial 2 .............................................................................................   Tylosin With Sulfamethazine.
                                                                                                                                                                   Lincomycin.
                                                                                                                                                                   Chlortetracycline With Sulfamethazine.
                                                                                                                                                                   Chlortetracycline.
                                                                                                                                                                   Oxytetracycline.
                                                    Jowl abscesses ........................................................................................        Chlortetracycline.
                                                      1 An example of Gastrointestinal (GI)-Parasite indication is ‘‘Control of infestations of large roundworms (Ascaris suis), nodular worms
                                                    (Oesophagostomum dentatum), and whipworms (Trichuris suis).’’
                                                      2 Examples of Gastrointestinal (GI)-Bacterial indications are: ‘‘For treatment of swine dysentery’’; ‘‘To help prevent bacterial swine enteritis’’;
                                                    and ‘‘Treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery).’’




                                                          TABLE 3—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
                                                                                       UNDEFINED DURATIONS OF USE IN CHICKENS
                                                                                            Indication/disease                                                                                   Ingredient(s)

                                                    Infectious Coryza ......................................................................................       Ormetoprim with    Sulfadimethoxine.
                                                    Chronic Respiratory Disease ....................................................................               Oxytetracycline.
                                                                                                                                                                   Oxytetracycline.
                                                    Necrotic Enteritis/Colibacillosis .................................................................            Ormetoprim with    Sulfadimethoxine.
                                                                                                                                                                   Lincomycin.
                                                                                                                                                                   Virginiamycin.
                                                    Fowl Cholera ............................................................................................      Ormetoprim with    Sulfadimethoxine.
                                                    Gastrointestinal (GI)-Parasites 1 ...............................................................              Hygromycin B.
                                                    Coccidiosis ................................................................................................   Ormetoprim with    Sulfadimethoxine.
                                                       1 An
                                                          example of Gastrointestinal (GI)-Parasite indication is, ‘‘As an aid in the control of infections of large roundworms (Ascaris galli), cecal
                                                    worms (Heterakis gallinae), and capillary worms (Capillaria obsignata).’’




                                                          TABLE 4—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
                                                                                       UNDEFINED DURATIONS OF USE IN TURKEYS
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                            Indication/disease                                                                                   Ingredient(s)

                                                    Coccidiosis ................................................................................................   Ormetoprim with Sulfadimethoxine.
                                                    Fowl Cholera ............................................................................................      Ormetoprim with Sulfadimethoxine.




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                                                                                     Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Notices                                                                  63191

                                                          TABLE 5—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
                                                                                        UNDEFINED DURATIONS OF USE IN SHEEP
                                                                                            Indication/disease                                                                                   Ingredient(s)

                                                    Vibrionic Abortion .....................................................................................       Chlortetracycline.
                                                    Enterotoxemia ...........................................................................................      Chlortetracycline.




                                                          TABLE 6—ANTIMICROBIALS WITH APPROVED THERAPEUTIC (TREATMENT/CONTROL/PREVENTION) INDICATIONS WITH
                                                                                      UNDEFINED DURATIONS OF USE IN HONEY BEES
                                                                                            Indication/disease                                                                                   Ingredient(s)

                                                    Foulbrood ..................................................................................................   Oxytetracycline.



                                                      Dated: September 7, 2016.                                               procaine penicillin, and sulfamethazine)                      DEPARTMENT OF HEALTH AND
                                                    Leslie Kux,                                                               Type A medicated article that pertain to                      HUMAN SERVICES
                                                    Associate Commissioner for Policy.                                        use of the procaine penicillin
                                                    [FR Doc. 2016–21972 Filed 9–12–16; 11:15 am]                              component for the production                                  Food and Drug Administration
                                                    BILLING CODE 4164–01–P                                                    indications of growth promotion and
                                                                                                                              increased feed efficiency in swine.                           [Docket No. FDA–2016–N–0001]
                                                                                                                              Pharmgate requested voluntary
                                                    DEPARTMENT OF HEALTH AND                                                  withdrawal of approval of these                               Vaccines and Related Biological
                                                    HUMAN SERVICES                                                            indications for use because                                   Products Advisory Committee;
                                                                                                                              PENNCHLOR SP 500 Type A medicated                             Cancellation
                                                    Food and Drug Administration                                              article is no longer manufactured.
                                                    [Docket No. FDA–2016–N–0002]                                                 Therefore, under authority delegated                       AGENCY:    Food and Drug Administration,
                                                                                                                              to the Commissioner of Food and Drugs                         HHS.
                                                    Withdrawal of Approval of Part of a                                       and redelegated to the Director of the                        ACTION:   Notice.
                                                    New Animal Drug Application;                                              Center for Veterinary Medicine, and in
                                                    Chlortetracycline, Procaine Penicillin,                                   accordance with § 514.116 Notice of
                                                    and Sulfamethazine                                                                                                                      SUMMARY:  The meeting of the Vaccines
                                                                                                                              withdrawal of approval of application                         and Related Biological Products
                                                    AGENCY:        Food and Drug Administration,                              (21 CFR 514.116), notice is given that                        Advisory Committee scheduled for
                                                    HHS.                                                                      approval of those parts of NADA 138–                          November 16, 2016, is cancelled. This
                                                    ACTION:Notification of withdrawal of                                      934 that pertain to use of procaine                           meeting was announced in the Federal
                                                    approval.                                                                 penicillin for the production indications                     Register of August 30, 2016 (81 FR
                                                                                                                              of growth promotion and increased feed
                                                                                                                                                                                            59634).
                                                    SUMMARY:   The Food and Drug                                              efficiency in swine are hereby
                                                    Administration (FDA) is withdrawing                                       withdrawn, effective September 14,                            FOR FURTHER INFORMATION CONTACT:
                                                    approval of those parts of a new animal                                   2016.                                                         Sujata Vijh, Center for Biologics
                                                    drug application (NADA) for a 3-way,                                         NADA 138–934 was identified as                             Evaluation and Research, Food and
                                                    fixed-ratio, combination drug Type A                                      being affected by guidance for industry                       Drug Administration, 10903 New
                                                    medicated article that pertain to use of                                  (GFI) #213 ‘‘New Animal Drugs and                             Hampshire Ave., Bldg. 71, Rm. 6128,
                                                    the procaine penicillin component for                                     New Animal Drug Combination                                   Silver Spring, MD 20993–0002, 240–
                                                    production indications in swine. This                                     Products Administered in or on                                402–7107, sujata.vijh@fda.hhs.gov; or
                                                    action is being taken at the sponsor’s                                    Medicated Feed or Drinking Water of                           FDA Advisory Committee Information
                                                    request because the 3-way Type A                                          Food-Producing Animals:                                       Line, 1–800–741–8138 (301–443–0572
                                                    medicated article is no longer                                            Recommendations for Drug Sponsors for                         in the Washington, DC area), and follow
                                                    manufactured.                                                             Voluntarily Aligning Product Use                              the prompts to the desired center or
                                                    DATES:  Withdrawal of approval is                                         Conditions with GFI #209,’’ December                          product area. Please call the Information
                                                    effective September 14, 2016.                                             2013.                                                         Line for up-to-date information on this
                                                    FOR FURTHER INFORMATION CONTACT:                                             Elsewhere in this issue of the Federal                     meeting.
                                                    Cindy L. Burnsteel, Center for                                            Register, FDA is amending the animal                            Dated: September 8, 2016.
                                                    Veterinary Medicine (HFV–130), Food                                       drug regulations to reflect the
                                                    and Drug Administration, 7500 Standish                                                                                                  Janice M. Soreth,
                                                                                                                              withdrawal of approval of these parts of
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Pl., Rockville, MD 20855, 240–402–                                        NADA 138–934.                                                 Acting Associate Commissioner, Special
                                                    0817, cindy.burnsteel@fda.hhs.gov.                                                                                                      Medical Programs.
                                                                                                                               Dated: September 6, 2016.                                    [FR Doc. 2016–22051 Filed 9–13–16; 8:45 am]
                                                    SUPPLEMENTARY INFORMATION: Pharmgate
                                                    LLC (Pharmgate), 1015 Ashes Dr., Suite                                    William T. Flynn,                                             BILLING CODE 4164–01–P
                                                    102, Wilmington, NC 28405 has                                             Acting Director, Center for Veterinary
                                                    requested that FDA withdraw approval                                      Medicine.
                                                    of those parts of NADA 138–934 for                                        [FR Doc. 2016–21984 Filed 9–13–16; 8:45 am]
                                                    PENNCHLOR SP 500 (chlortetracycline,                                      BILLING CODE 4164–01–P




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Document Created: 2016-09-14 02:27:25
Document Modified: 2016-09-14 02:27:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comments.
DatesSubmit either electronic or written comments by December 13, 2016.
ContactCindy Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0817, [email protected]
FR Citation81 FR 63187 

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