[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Rules and Regulations]
[Pages 29129-29141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11082]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2012-N-0447]
RIN 0910-AG45


Antimicrobial Animal Drug Sales and Distribution Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is issuing a 
final rule to require that the sponsor of each approved or 
conditionally approved new animal drug product that contains an 
antimicrobial active ingredient submit an annual report to us on the 
amount of each such ingredient in the drug product that is sold or 
distributed for use in food-producing animals, including information on 
any distributor-labeled product. This final rule codifies the reporting 
requirements established in section 105 of the Animal Drug User Fee 
Amendments of 2008 (ADUFA). The final rule also includes an additional 
reporting provision intended to enhance our understanding of 
antimicrobial new animal drug sales intended for use in specific food-
producing animal species and the relationship between such sales and 
antimicrobial resistance.

DATES: This rule is effective July 11, 2016. For the applicable 
compliance dates, please see section V, ``Effective and Compliance 
Dates'' in SUPPLEMENTARY INFORMATION.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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: With regard to the final rule: Neal 
Bataller, Center for Veterinary Medicine (HFV-210), Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5745, 
[email protected].
    With regard to the information collection: FDA PRA Staff, Office of 
Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-
14526, Silver Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation/History of the Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of the Final Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Comments on our Legal Authority and FDA Response
    D. Specific Comments and FDA Response
V. Effective and Compliance Dates
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. References

I. Executive Summary

A. Purpose of the Final Rule

    The purpose of this rulemaking is to change the way we collect and 
report information related to the distribution and sale of approved or 
conditionally approved antimicrobial new animal drug products for use 
in food-producing animals.
    Sponsors of approved or conditionally approved applications for new 
animal drugs containing an antimicrobial active ingredient are required 
by section 512 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 360b), as amended by section 105 of ADUFA (ADUFA 105) 
(Title I of Pub. L. 110-316), to submit to us an annual report on the 
amount of each such ingredient in the drug that is sold or distributed 
for use in food-producing animals. We are also required by ADUFA 105 to 
publish annual summary reports of the data we receive from animal drug 
sponsors. In accordance with the law, sponsors of the affected 
antimicrobial new animal drug products began submitting their sales and 
distribution data to us on an annual basis, and we have published 
summaries of such data for each calendar year beginning with 2009. 
Since that time, we have published two documents inviting public input 
on potential changes to our regulations relating to records and reports 
for approved new animal drugs, including an advance notice of proposed 
rulemaking (77 FR 44177, July 27, 2012) and a proposed rule (80 FR 
28863, May 20, 2015). This final rule amends our existing records and 
reports regulation in part 514 (21 CFR part 514) to incorporate the 
sales and distribution data reporting requirements specific to 
antimicrobial new animal drugs that were added to the FD&C Act by ADUFA 
105. ADUFA 105 was enacted to assist us in our continuing analysis of 
the interactions (including drug resistance), efficacy, and safety of 
antimicrobials approved for use in both humans and food-producing 
animals for the purpose of mitigating the public health risk associated 
with antimicrobial resistance. This rule includes an additional 
reporting provision intended to improve our understanding of 
antimicrobial animal drug sales intended for use in specific food-
producing animal species. This additional provision assists us in 
assessing antimicrobial sales trends in the major food-producing animal 
species and examining how such trends may relate to antimicrobial 
resistance.
    Finalizing this rule will assist us in assessing the rate at which 
sponsors are voluntarily revising their FDA-approved labeled use 
conditions to promote the judicious use of medically important 
antimicrobial drugs in food-producing animals. In December 2013, we 
published guidance for industry (GFI) #213 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), a guidance that calls on sponsors 
of approved medically important antimicrobial new animal drugs 
administered through medicated feed or water to voluntarily make 
changes to remove production uses (growth promotion and feed 
efficiency) from their product labels and bring the remaining 
therapeutic uses of these products (to treat, control, or prevent 
disease) under the oversight of a veterinarian by the end of December 
2016. All affected drug sponsors committed to implementing the changes 
described in guidance for industry (GFI) #213 by the December 2016 
target date. Once the changes are fully implemented, it will be illegal 
to use these medically important antibiotics for production purposes, 
and animal producers will first need to obtain authorization from a 
licensed veterinarian to use them for therapeutic

[[Page 29130]]

purposes (i.e., prevention, control, or treatment of a specifically 
identified disease).
    Finalizing this rule also implements Sub-Objective 2.4.2 (``Enhance 
collection and reporting of data regarding antibiotic drugs sold and 
distributed for use in food-producing animals'') of the ``National 
Action Plan for Combating Antibiotic-Resistant Bacteria'' (National 
Action Plan) (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf). 
The National Action Plan, released by the White House on March 27, 
2015, was developed in response to Executive Order 13676: Combating 
Antibiotic-Resistant Bacteria, which was issued by President Barack 
Obama on September 18, 2014, in conjunction with the National Strategy 
for Combating Antibiotic-Resistant Bacteria. The National Action Plan 
is intended to guide the activities of the U.S. Government as well as 
the actions of public health, health care, and veterinary partners in a 
common effort to address the urgent and serious public health threat of 
drug-resistant bacterial infections. Objective 2.4 of the National 
Action Plan is to ``enhance monitoring of antibiotic-resistance 
patterns, as well as antibiotic sales, usage, and management practices, 
at multiple points in the production chain from food-animals on-farm, 
through processing, and retail meat.''
    The provisions included in this final rule take into account 
stakeholder input received in response to multiple opportunities for 
public comment, including the advance notice of proposed rulemaking and 
the proposed rule.

B. Summary of the Major Provisions of the Final Rule

    The rule amends the records and reports regulation in part 514 to 
include the following:
     Procedures relating to the submission to us of annual 
sales and distribution data reports by sponsors of approved or 
conditionally approved antimicrobial new animal drug products sold or 
distributed for use in food-producing animals. Sponsors are already 
submitting such reports as required by ADUFA 105.
     Procedures relating to the requirement for sponsors of 
approved or conditionally approved antimicrobial new animal drugs to 
begin submitting species-specific estimates of product sales as a 
percentage of their total sales. This new reporting requirement was 
included based on our authority under section 512(l)(1) of the FD&C 
Act.
     Procedures applicable to our preparation and publication 
of summary reports on an annual basis based on the sales and 
distribution data we receive from sponsors of approved or conditionally 
approved antimicrobial new animal drug products. The final rule 
includes specific parameters for the content of the annual summary 
reports as well as provisions intended to protect confidential business 
information and national security, consistent with ADUFA 105 and this 
Agency's regulations at Sec.  20.61 (21 CFR 20.61).
     Provisions that will give sponsors of approved or 
conditionally approved antimicrobial new animal drug products that are 
sold or distributed for use in food-producing animals the opportunity 
to avoid duplicative reporting of product sales and distribution data 
to us under part 514.

C. Legal Authority

    Our legal authority for issuing this final rule is provided by 
section 512(l) of the FD&C Act relating to records and reports 
concerning approved and conditionally approved new animal drugs. In 
addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives us 
general rulemaking authority to issue regulations for the efficient 
enforcement of the FD&C Act.

D. Costs and Benefits

    We estimate one-time costs to industry from this final rule at 
about $134,600. We estimate annual costs at about $57,300. These costs 
equate to an estimated total annualized cost of about $76,500 at a 7 
percent discount rate over 10 years and about $73,100 at a 3 percent 
discount rate over 10 years. The total annualized costs include the 
administrative cost to review the rule ($8,800), plus the cost to those 
sponsors who wish to avoid duplicative reporting requirements under 
part 514 ($4,900), plus the cost of providing the species-specific 
estimates of the percent of the drug product distributed domestically 
($62,700).
    The final rule provides some flexibility in terms of the manner in 
which new animal drug sponsors report sales and distribution data under 
both Sec.  514.80(b)(4) and Sec.  514.87, by allowing the sponsor the 
option to satisfy its obligations under both provisions by making only 
one set of report submissions under certain circumstances. We estimate 
this will reduce labor costs for new animal drug sponsors by $103,200 
annually.
    Another benefit of the final rule is the cost savings associated 
with sponsors reporting their monthly sales and distribution data to us 
in terms of product units rather than calculating the amount of 
antimicrobial active ingredients associated with these monthly product 
sales and distribution data, as is currently the case. We estimate the 
calculation reductions will amount to an annual benefit to animal drug 
sponsors of about $19,100. We estimate total annual benefits to 
industry at about $122,300.

II. Background

A. Need for the Regulation/History of the Rulemaking

    Section 512(l)(1) of the FD&C Act, which was added by the Animal 
Drug Amendments of 1968 (Pub. L. 90-399), requires sponsors of approved 
or conditionally approved new animal drugs to establish and maintain 
records and make such reports of data relating to experience and other 
data or information received or obtained by the sponsor with respect to 
such drug as required by regulation or order. Part 514 of FDA's 
regulations implements section 512(l) of the FD&C Act and requires new 
animal drug sponsors to report various types of information to FDA 
relating to their approved drug products, including periodic drug 
experience reports under Sec.  514.80(b)(4). Such reports must contain 
detailed information as specified in the regulations, including 
information concerning the quantities of the animal drug product 
distributed under the sponsor's approved application. The requirement 
for periodic reports under Sec.  514.80(b)(4) applies to all sponsors 
of approved new animal drug products and is separate from the reporting 
requirements subsequently established under ADUFA 105 relating to 
antimicrobial new animal drugs.
    This continuous monitoring of approved new animal drug applications 
(NADAs) by collecting post-approval information from sponsors is 
important because data previously submitted to FDA as part of the 
approval process may no longer be adequate, as animal drug effects can 
change over time and less apparent effects including, for example, on 
antimicrobial resistance, can sometimes take years to become evident. 
For this reason, post-approval reports are one of the primary means by 
which FDA can obtain information regarding safety or effectiveness 
problems with marketed new animal drugs.
    In an effort to address mounting public health concerns about 
antimicrobial drug resistance, Congress, in 2008, enacted ADUFA 105 to 
enhance the reports collected by FDA concerning marketed new animal 
drug products that contain an antimicrobial

[[Page 29131]]

active ingredient. ADUFA 105 amended section 512(l) of the FD&C Act by 
adding section 512(l)(3). Under new section 512(l)(3) of the FD&C Act, 
sponsors of antimicrobial new animal drugs approved or conditionally 
approved for use in food-producing animals must submit to us on an 
annual basis a report specifying the amount of each antimicrobial 
active ingredient in the drug that is sold or distributed for use in 
food-producing animals. Specifically, sponsors are required to report 
the amount of each antimicrobial active ingredient as follows: (1) By 
container size, strength, and dosage form; (2) by quantities 
distributed domestically and quantities exported; and (3) for each 
dosage form, a listing of the target animals, indications, and 
production classes that are specified on the approved label of the 
product. The information must be reported for the preceding calendar 
year, include separate information for each month of the calendar year, 
and be submitted to us each year no later than March 31. The statute 
also requires FDA to publish summary reports of the antimicrobial drug 
sales and distribution data collected from the drug sponsors on an 
annual basis, and further requires that such data be reported by 
antimicrobial class (section 512(l)(3) of the FD&C Act). In accordance 
with the law, sponsors of the affected antimicrobial new animal drug 
products began submitting their sales and distribution data to us on an 
annual basis, and we have published summaries of such data for each 
calendar year beginning with 2009.
    In the Federal Register of May 20, 2015 (80 FR 28863), we proposed 
to amend our existing animal drug records and reports regulation in 
part 514 to incorporate the antimicrobial drug sales and distribution 
data reporting requirements established by ADUFA 105. We proposed (80 
FR 28863 at 28864) to amend part 514 to include administrative 
practices and procedures for sponsors of antimicrobial new animal drugs 
sold or distributed for use in food-producing animals who must report 
annually under section 512(l)(3) of the FD&C Act. We also proposed (80 
FR 28863 at 28864) to collect species-specific data to assist us in 
assessing antimicrobial sales trends in the major food-producing animal 
species and examining how such trends may relate to antimicrobial 
resistance. We set forth the rationale that having the improved data 
would support our ongoing efforts to encourage the judicious use of 
antimicrobials in food-producing animals to help ensure the continued 
availability of safe and effective antimicrobials for animals and 
humans (80 FR 28863 at 28864).
    We believe that on-farm use data also are needed to obtain 
additional information necessary to help gauge the success of 
antibiotic stewardship efforts and guide their continued evolution and 
optimization, and assess associations between antibiotic use practices 
and resistance. Shortly after we issued the proposed rule, in the 
Federal Register of August 20, 2015 (80 FR 50638), we published a 
notice announcing plans to hold a public meeting on September 30, 2015, 
which we jointly sponsored with the U.S. Department of Agriculture 
(USDA) and the Centers for Disease Control and Prevention (CDC) to 
obtain public input on possible approaches for collecting additional 
on-farm antimicrobial drug use and resistance data. Such additional 
data are intended to supplement existing information, including data on 
the quantity of antimicrobials sold or distributed for use in food-
producing animals and data on antimicrobial use and resistance, for 
example, data collected under the National Animal Health Monitoring 
System (NAHMS) and the National Antimicrobial Resistance Monitoring 
System (NARMS). In the notice of public meeting, we explained that data 
from multiple sources are needed to provide a comprehensive and 
science-based picture of antimicrobial drug use and resistance in 
animal agriculture (80 FR 50638 at 50639). Taking into account the 
comments received from this public meeting, we are continuing to work 
with the USDA and the CDC in developing this plan to help ensure the 
continued availability of safe and effective antimicrobials for use in 
humans and animals. The information that we will receive under this 
final rule is part of this coordinated, interagency effort to assess 
and minimize antimicrobial resistance to help ensure the continued 
availability of safe and effective antimicrobial drugs for use in 
treating infectious disease in animals and humans.

B. Summary of Comments to the Proposed Rule

    We received approximately 440 individual comments on the proposed 
rule from veterinary, feed manufacturing, and livestock production 
associations, as well as consumer advocacy groups and individuals, and 
a member of Congress. Some comments support our rulemaking and our 
ongoing efforts to address the problem of antimicrobial resistance, 
while others express concern about the manner in which data are going 
to be collected, interpreted, and used. Some comments offer suggestions 
for specific changes for us to consider making to the subject 
regulations.

C. General Overview of the Final Rule

    This final rule amends our animal drug records and reports 
regulation at part 514 to include administrative practices and 
procedures for sponsors of antimicrobial new animal drugs sold or 
distributed for use in food-producing animals who must report annually 
under section 512(l)(3) of the FD&C Act. In addition, the rule includes 
a provision based on our broader authority under section 512(l)(1) that 
requires sponsors to report antimicrobial new animal drug sales 
intended for use in specific food-producing animal species. In this 
rulemaking, we finalize the provisions in the proposed rule.

III. Legal Authority

    Our legal authority for issuing this final rule is provided by 
section 512(l) of the FD&C Act relating to records and reports 
concerning approved new animal drugs and section 701(a) of the FD&C 
Act. Section 512(l) gives FDA broad authority to collect information 
from sponsors concerning their approved or conditionally approved new 
animal drug products. Specifically, under section 512(l)(1) of the FD&C 
Act, animal drug sponsors with approved or conditionally approved NADAs 
must ``make such reports to the Secretary, of data relating to 
experience, including experience with uses authorized under subsection 
(a)(4)(A) [relating to extralabel use], and other data or information, 
received or otherwise obtained by such applicant with respect to such 
drug, or with respect to animal feeds bearing or containing such drug, 
as the Secretary may by general regulation, or by order with respect to 
such application, prescribe on the basis of a finding that such records 
and reports are necessary in order to enable the Secretary to 
determine, or facilitate a determination, whether there is or may be 
ground for invoking subsection (e) or subsection (m)(4) of this section 
[authorizing FDA to withdraw approval of a new animal drug or revoke a 
license to manufacture medicated feed].'' The statute provides for 
withdrawal of approval if FDA finds that new information shows that the 
drug is no longer shown to be safe for use under the approved 
conditions of use or the drug is ineffective for uses prescribed or 
recommended in the drug's labeling (21 U.S.C. 360b(e)(1)).
    Pursuant to its authority under section 512(l)(1) of the FD&C Act, 
FDA issued recordkeeping and reporting

[[Page 29132]]

regulations relating to experience with approved new animal drugs. 
These regulations, which are found at part 514, include the requirement 
at Sec.  514.80(b)(4) for animal drug sponsors to submit periodic drug 
experience reports to FDA every 6 months for the first 2 years 
following approval of their application and subsequently on an annual 
basis. The periodic reports that sponsors are required to submit under 
Sec.  514.80(b)(4) must include detailed information as specified in 
the regulations, including information concerning the quantities of the 
animal drug product distributed under the sponsor's approved 
application. The requirement for sponsors to submit distribution data 
to us under Sec.  514.80(b)(4) predates the enactment of ADUFA 105.
    In addition to the broad authority already granted to FDA under 
section 512(l)(1) of the FD&C Act, in 2008, Congress established 
additional reporting requirements under ADUFA 105 for sponsors of 
antimicrobial new animal drug products. These new reporting 
requirements, which are set out in section 512(l)(3) of the FD&C Act, 
did not require the Agency to issue implementing regulations first in 
order for them to take effect. With respect to approved or 
conditionally approved new animal drugs containing an antimicrobial 
active ingredient, section 512(l)(3)(A) through (C) of the FD&C Act 
requires sponsors of such products to submit an annual report to FDA on 
the ``amount of each antimicrobial active ingredient in the drug that 
is sold or distributed for use in food-producing animals, including 
information on any distributor labeled product'' by March 31 of each 
year with separate data included for each month of the preceding 
calendar year. In addition, section 512(l)(3)(E) of the FD&C Act 
requires FDA to prepare summaries of the information reported by drug 
sponsors concerning their antimicrobial new animal drugs and to make 
those summaries available to the public. In accordance with ADUFA 105, 
sponsors of the affected antimicrobial new animal drug products have 
submitted their sales and distribution data to us, and we have 
published summaries of such data, for each calendar year since 2009.
    In enacting ADUFA 105, Congress clarified that ``[t]he reports 
required [to be submitted by animal drug sponsors] under section 
512(l)(3) of the Federal Food, Drug, and Cosmetic Act, as added by 
subsection (a) [of ADUFA 105], shall be separate from periodic drug 
experience reports that are required under section 514.80(b)(4) of 
title 21, Code of Federal Regulations.'' (see subsection (c) of ADUFA 
105).
    Section 701(a) of the FD&C Act gives us general rulemaking 
authority to issue regulations for the efficient enforcement of the 
FD&C Act.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    This section summarizes comments we received in response to the 
proposed rule and our response to those comments. We received 
approximately 440 individual comments on the proposed rule by the close 
of the comment period, each addressing one or more topics. 
Approximately 400 of those comments resulted from write-in campaigns. 
Several of the comments were signed by more than one person or group. 
We received comments from veterinary, feed manufacturing, and livestock 
production associations, as well as consumer advocacy groups and 
individuals, and a member of Congress. Some comments support our 
rulemaking and our ongoing efforts to address the problem of 
antimicrobial resistance, while others express concern about the manner 
in which data are going to be collected, interpreted, and used. Some 
comments offer suggestions for specific changes for us to consider 
making to the subject regulations. We considered the comments we 
received in response to the proposed rule in preparing this final rule. 
After considering these comments, we are not making any changes to the 
codified language that was included in the proposed rule.
    In sections IV.B. through IV.D., we describe the comments received 
on the proposed rule and provide our responses. To make it easier to 
identify the comments and our responses, the word ``Comment,'' in 
parentheses, appears before the comment's description, and the word 
``Response,'' in parentheses, appears before our response. We have 
numbered each comment to help distinguish between different comments. 
We have grouped similar comments together under the same number and, in 
some cases, we have separated different subjects discussed in the same 
comment and designated them as distinct comments for purposes of our 
responses. The number assigned to each comment or comment topic is 
purely for organizational purposes and does not signify the comment's 
value or importance or the order in which comments were received.

B. Description of General Comments and FDA Response

    Many comments make general remarks supporting or opposing the 
proposed rule without focusing on a particular proposed provision. In 
the following paragraphs of this section, we discuss and respond to 
such general comments.
    (Comment 1) Many comments from a variety of stakeholders, including 
veterinary, feed manufacturing, and animal production associations, 
drug manufacturing firms, as well as consumer advocacy groups and 
individuals, generally support our efforts aimed at gathering reliable 
information on the use of antimicrobials in food-producing animals, 
improving the manner in which that information is reported, enhancing 
our understanding of antimicrobial animal drug sales intended for use 
in specific food-producing animal species, and working alongside our 
Federal partners to share data for the purpose of minimizing 
antimicrobial resistance.
    (Response 1) We appreciate the general support that the comments 
express. As noted in section II.A., this rulemaking is part of a larger 
effort to address the problem of antimicrobial resistance. The rule is 
expected to provide us with information on the sales of antimicrobials 
intended for use in food-producing animals, including information 
regarding the sales of these products among the various animal species 
for which they are intended. Having species-specific estimates of 
product sales and distribution in the four major food-producing 
categories of animal species (cattle, swine, chickens, turkeys) will be 
important in supporting efforts such as NARMS, the national 
surveillance program that tracks trends related to antimicrobial 
resistance in food-producing animals and humans, and complement data on 
antimicrobial use collected under NAHMS. The data will also complement 
the data collection plan with the USDA and the CDC to obtain additional 
on-farm use and resistance data. The collection of data from multiple 
sources, including enhanced sales data, is needed to provide a 
comprehensive and science-based picture of antimicrobial drug use and 
resistance in animal agriculture. Such information will further enhance 
our ongoing activities related to slowing the development of 
antimicrobial resistance to help ensure that safe and effective 
antimicrobial new animal drugs will remain available for use in human 
and animal medicine. We intend to continue working in collaboration 
with the USDA, the CDC, the

[[Page 29133]]

pharmaceutical industry, veterinary organizations, animal producers, 
and other stakeholders to address this important public health issue.

C. Comments on Our Legal Authority and FDA Response

    (Comment 2) Some comments suggest that we lack the legal authority 
to require drug sponsors to report species-specific distribution 
estimates.
    Specifically, one comment suggests that we lack authority under 
section 512(l)(3) of the FD&C Act, as added by ADUFA 105, to require 
species-specific distribution estimates. The comment suggests that the 
lack of express authority in section 512(l)(3) of the FD&C Act to 
require species-specific distribution estimates thus limits our broader 
authority relating to the collection of records and reports concerning 
experiences and other information with respect to approved new animal 
drugs under 512(l)(1) of the FD&C Act, and precludes us from requiring 
the submission of species-specific distribution estimates under that 
provision as well.
    Three comments suggest that in addition to lacking authority to 
require species-specific distribution estimates under section 512(l)(3) 
of the FD&C Act, we also lack authority under section 512(l)(1) of the 
FD&C Act because we have not made a ``finding'' that species-specific 
distribution estimates are necessary in order to facilitate a 
determination of whether there may be grounds for invoking the 
withdrawal provisions of the FD&C Act.
    (Response 2) FDA acknowledges that section 512(l)(3) of the FD&C 
Act, as added by ADUFA 105, does not explicitly address species-
specific distribution estimates. In requiring such estimates, we rely 
not on section 512(l)(3) but rather on our broader authority under 
section 512(l)(1) of the FD&C to collect information concerning 
approved and conditionally approved new animal drugs under a regulation 
or order issued by FDA. (See Section III. Legal Authority.) Section 
512(l)(1) of the FD&C Act reads in relevant part, ``In the case of any 
new animal drug for which approval of an application filed pursuant to 
subsection (b) or section 571 is in effect, the applicant shall 
establish and maintain such records, and make such reports to the 
Secretary, of data relating to experience . . . and other data or 
information, received or otherwise obtained by such applicant with 
respect to such drug, or with respect to animal feeds bearing or 
containing such drug, as the Secretary may by general regulation, or by 
order with respect to such application, prescribe on the basis of a 
finding that such records and reports are necessary in order to enable 
the Secretary to determine, or facilitate a determination, whether 
there is or may be ground for'' withdrawal of approval of the new 
animal drug at issue. FDA therefore has the authority to establish 
reporting requirements applicable to approved or conditionally approved 
new animal drugs by regulation or order if it finds those requirements 
are necessary to enable it to determine, or facilitate a determination, 
as to whether the drugs are no longer shown to be safe, are 
ineffective, or are otherwise subject to withdrawal under section 
512(e) of the FD&C Act.
    Based on its authority under section 512(l)(1) of the FD&C Act, in 
March 2003, FDA issued regulations requiring recordkeeping and reports 
concerning experience with approved new animal drugs at Sec.  514.80. 
Under Sec.  514.80(b)(4), sponsors that have approved applications for 
new animal drugs, including sponsors of antimicrobial new animal drug 
products, must submit periodic drug experience reports to FDA every 6 
months for the first 2 years following approval and annually 
thereafter. These periodic drug experience reports must contain, among 
other things, various types of information about the distribution of 
the sponsor's drug, including data concerning the quantity of the drug 
distributed domestically and the quantity exported. The requirement in 
Sec.  514.80(b)(4) for sponsors to submit detailed distribution data 
concerning their approved new animal drugs predates the enactment of 
ADUFA 105. In enacting ADUFA 105, Congress left intact the periodic 
reporting requirements under Sec.  514.80(b)(4)--including the 
requirement for distribution data--stating at ADUFA section 105(c) that 
the reporting requirements established under section 512(l)(3) of the 
FD&C Act for antimicrobial new animal drugs did not relieve the 
sponsors of their separate obligation to provide periodic drug 
experience reports to FDA under Sec.  514.80(b)(4). In so doing, 
Congress clearly signaled that the reporting requirements relating to 
antimicrobial drugs in 512(l)(3) were intended to supplement rather 
than supplant FDA's existing authority under section 512(l)(1) to 
impose distribution data reporting requirements on the same parties 
covered by section 512(l)(3) of the FD&C Act.
    Further, the scant legislative history relating to ADUFA 105 that 
exists supports the conclusion that in establishing section 512(l)(3) 
Congress meant to enhance, not limit, our general authority under 
section 512(l)(1) of the FD&C Act to require information about marketed 
new animal drug products in order to ensure their continued safety and 
effectiveness. For example, in his remarks to other members of 
Congress, Chairman of the House Energy and Commerce Subcommittee on 
Health, Representative Frank Pallone, Jr., stated that the ADUFA 
legislation he had introduced earlier that year would ``improve the 
uniform collection and reporting of data to FDA on the sales about 
animal drugs that contain an antibiotic ingredient'' and that it 
``includes language that would enhance FDA's current data collection by 
creating a new antimicrobial animal drug use data report for all food-
producing animals. The report puts critical information in one place 
for FDA; otherwise, the agency would have to search through warehouses 
of multiple paper reports.'' 154 Congressional Record 17,287 
(2008)(statement of Rep. Pallone). In remarks Representative Waxman 
made concerning the legislation, he stated, ``The ADUFA bill we are 
considering includes a provision to increase the availability and 
accessibility of data on the amount of animal antibiotics being 
distributed'' and that the ``reauthorization [of ADUFA] has also given 
us an opportunity to look at providing FDA with new tools to address a 
related public health crisis, the problem of antibiotic resistance.'' 
154 Congressional Record 17,288 (2008) (statement of Rep. Waxman). 
These statements made by members of Congress strongly suggest that FDA 
was viewed as already having the requisite legal authority under 
section 512(l) and that the reason Congress established the requirement 
in section 512(l)(3) of the FD&C Act for an additional report relating 
to antimicrobial new animal drugs sold for use in food-producing 
animals was merely to improve the efficiency of the reporting process 
for such drugs so that we could more effectively address the problem of 
resistance associated with the use of antimicrobial drugs in food 
animal production. In addition to improving efficiency by establishing 
a more uniform process for the collection of important information 
about approved antimicrobial new animal drugs sold or distributed for 
use in food-producing animals, ADUFA 105 also streamlined the process 
for putting these reporting requirements in place by eliminating the 
need for the Agency to first engage in time-consuming rulemaking 
activities that otherwise would have been

[[Page 29134]]

required under section 512(l)(1) of the FD&C Act prior to collecting 
such data.
    In light of what we consider to be clear evidence that Congress 
intended section 512(l)(3) of the FD&C Act to bolster rather than limit 
our existing authority to require information to be reported concerning 
approved new animal drugs, we conclude that the comment's assertion, 
that by establishing section 512(l)(3) Congress has somehow curtailed 
our ability to exercise authority we would otherwise have under section 
512(l)(1), is without merit.
    We now respond to the comments asserting that we may not rely on 
section 512(l)(1) of the FD&C Act absent a finding that species-
specific distribution estimates are necessary in order to facilitate a 
determination of whether there may be grounds for invoking the 
withdrawal provisions of the FD&C Act. Although we stated in the 
proposed rule that collection of species-specific sales and 
distribution estimates would help to ensure ``the continued 
availability of safe and effective antimicrobials for animals and 
humans,'' we agree that language more clearly stating our finding is 
appropriate. Accordingly, we find that the collection of species-
specific sales and distribution estimates, in addition to other 
information about antimicrobial use in food-producing animals and drug 
resistance, is necessary to enable us to determine, or to facilitate a 
determination, as to whether there may be grounds for additional 
measures short of and, where appropriate, including withdrawal of 
approval or specific portions of the approval in certain instances in 
the future to minimize antimicrobial resistance and ensure the 
continued availability of safe and effective antimicrobials for use in 
treating animals and humans. In particular, such information is needed, 
among other reasons, to support ongoing efforts to promote the 
judicious use of antimicrobials in food-producing animals and evaluate 
the success of those efforts; to aid in our assessment of antimicrobial 
sales trends in the major food-producing animal species and our 
examination of how these species-specific sales trends may relate to 
antimicrobial resistance; and to help inform microbial food safety risk 
assessments. In addition, because many antimicrobial drugs are approved 
for use in multiple species, in those instances where we believe 
appropriate grounds may exist to withdraw approval, having species-
specific information also will be necessary to help us determine which 
specific portions of the approval may need to be withdrawn.

D. Specific Comments and FDA Response

    Many comments make specific remarks supporting or opposing a 
particular proposed provision. In this section, we discuss and respond 
to such comments. The order of the discussion reflects the order in the 
regulatory text.
    (Comment 3) Several comments support our effort to eliminate 
duplicative reporting of sales and distribution data by sponsors of 
antimicrobial new animal drugs.
    (Response 3) We agree with the comments and therefore, in this 
final rule, we are keeping language as proposed at Sec.  
514.80(b)(4)(i)(B). As described in the proposed rule (80 FR 28863 at 
28871), we are providing an opportunity for sponsors of antimicrobial 
new animal drugs to modify the reporting period for these drug products 
in order to eliminate duplicative reporting of quantity marketed under 
current Sec.  514.80(b)(4) and new Sec.  514.87.
    (Comment 4) Several comments support reporting of sales and 
distribution data but suggest modification of the proposed requirement 
in Sec.  514.87(a) and (b)(1) to report the antimicrobial active 
ingredient. One comment suggests that we reduce the scope of what we 
require to be reported so that we only collect data for what it 
characterizes as ``medically important antimicrobials.'' Another 
comment suggests that we expand the scope of what we require to be 
reported to include data on what the comment characterizes as live 
cultures and complex products ``intentionally developed and marketed 
for antimicrobial production.''
    (Response 4) We have carefully considered the comments' suggested 
changes to the scope of reporting of the antimicrobial active 
ingredient. The requirement to report the antimicrobial active 
ingredient under Sec.  514.87(a) reflects the requirement, under 
section 512(l)(3) of the FD&C Act, for each sponsor of a new animal 
drug product that is approved or conditionally approved and contains an 
antimicrobial active ingredient, to report to us on an annual basis the 
amount of each antimicrobial active ingredient in the drug product that 
is sold or distributed for use in food-producing animals. This includes 
products that are the subject of an approved NADA or abbreviated NADA, 
as well as products that are conditionally approved under section 571 
of the FD&C Act (21 U.S.C. 360ccc). The requirement in Sec.  514.87(a) 
also incorporates the requirement from section 512(l)(3) of the FD&C 
Act for animal drug sponsors to capture in their sales and distribution 
data reports information regarding any distributor labeled products 
(see section 512(l)(3)(A) of the FD&C Act). We decline to implement the 
suggestion to limit the reporting to ``medically important 
antimicrobials'' due to the statutory reporting requirements under 
section 512(l)(3) of the FD&C Act, which apply to a new animal drug 
product that is approved or conditionally approved and contains an 
antimicrobial active ingredient without limitation.
    With regard to the comment about live cultures and complex 
products, we understand the comment to be referring to products that 
contain one or more microorganisms. We carefully considered the issues 
the comment raises and are finalizing the proposed rule without change. 
Currently, there are no approved new animal drug products that contain 
microorganisms and such products do not appear in Appendix A, GFI #152 
as being important in human clinical medicine (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052519.pdf). A live culture or complex product 
could potentially be the subject of a NADA if because of its intended 
use the particular product at issue meets the statutory definition of a 
drug in section 201(g) of the FD&C Act (21 U.S.C. 321(g)) (an article 
intended for use in the diagnosis, cure, mitigation, treatment, or 
prevention of disease or an article (other than food) intended to 
affect the structure or any function of the body) and the statutory 
definition of a new animal drug in section 201(v) of the FD&C Act. 
Furthermore, should a live culture or complex product be approved as a 
new animal drug, and should any of the active ingredients of that 
product be approved specifically for an antimicrobial use or be known 
to have antimicrobial properties, then sponsors of such an approved 
product would be required to submit data to us on the amount of each 
such ingredient in this drug product sold or distributed for use in 
food-producing animals.
    (Comment 5) Comments on the proposed rule generally support our 
effort to learn more about antimicrobial resistance, but several 
comments disagree with our proposal to collect species-specific 
estimates as proposed in Sec.  514.87(c). Several comments question the 
utility of the information that would result from species-specific 
data. Several comments suggest that it was unclear how species-specific 
estimates will scientifically support NARMS, or complement NAHMS. Other

[[Page 29135]]

comments state that species-specific sales estimates are inappropriate 
to report because the resulting data would not constitute sound 
scientific data. These comments assert that such data would be 
inaccurate due to complications and inconsistencies of data collection, 
would not reflect actual usage, would be subject to misinterpretation 
due to lack of complete information, and would not constitute 
sufficient data to evaluate the impact of policies and trends in 
antimicrobial resistance. Other comments support our collection of 
species-specific sales and distribution data as proposed in Sec.  
514.87(c). These comments assert that the resulting data would be 
beneficial to understanding how antimicrobials are used in food-
producing animals, the relationship between sales/use and antimicrobial 
resistance, and the impact of our policies and practices to mitigate 
antimicrobial resistance.
    (Response 5) We have carefully considered the comments in favor of 
and opposing the reporting of species-specific sales and distribution 
data as specified in proposed Sec.  514.87(c). We recognize the 
comments' concerns with regard to utility of the information but we 
respectfully disagree with the request to remove species-specific 
reporting from the rule. As we discussed in our response to Comment 1, 
having species-specific estimates of product sales and distribution for 
use in the four major food-producing categories of animal species 
(cattle, swine, chickens, turkeys) will be essential in supporting 
efforts to assess antimicrobial drug use and resistance in animal 
agriculture. This additional sales and distribution data will help 
inform microbial food safety risk assessments by providing a better 
indication of the extent to which a drug or drug class is used in a 
specific food animal species by a specific route of administration. 
Aggregate sales data do not provide this information and are more 
subject to misinterpretation.
    As noted in our response to comment 1, we also intend to consider 
estimates of species-specific sales and distribution data in 
conjunction with on-farm species-specific data on antimicrobial use, 
such as that collected under NAHMS. We expect such data to help us 
better understand the extent of antimicrobial use in the various major 
food animal species and provide additional context as we examine 
resistance data, such as those collected under NARMS. Data from 
multiple sources are needed to provide a comprehensive and science-
based picture of antimicrobial drug use and resistance in animal 
agriculture. Such information is critical to our ongoing activities 
related to slowing the development of antimicrobial resistance and 
ensuring the continued availability of safe and effective 
antimicrobials for use in treating animals and humans. For the reasons 
discussed here and in response to comments 1 and 2, we are retaining 
the requirement for sponsors to provide species-specific sales and 
distribution estimates as set forth in Sec.  514.87(c).
    (Comment 6) Several comments we received suggest that, instead of 
collecting species-specific sales estimates as proposed in Sec.  
514.87(c), antimicrobial use in food-producing animals should be 
monitored at the farm level. Some comments raise concerns about using 
sales data alone in analyses of antimicrobial drug use and resistance. 
There were multiple comments requesting that we collaborate with the 
USDA and the CDC to enhance existing collection efforts of on-farm 
antimicrobial use data that are accurate, detailed, and quantitative to 
supplement species-specific estimates of product sales. The commenters 
further request that we use the data to evaluate the impact of 
policies, understand the relationship between usage and resistance 
trends, and construct targeted interventions.
    (Response 6) We disagree with the request to remove species-
specific reporting from the rule for the reasons discussed in our 
responses to comments 1, 2, and 5. We recognize that gathering 
information on the way medically important antimicrobials are used in 
food-producing animals is essential to: (1) Assess the rate at which 
sponsors are voluntarily revising their FDA-approved labeled use 
conditions to promote the judicious use of medically important 
antimicrobial drugs in food-producing animals, (2) help gauge the 
success of antibiotic stewardship efforts and guide their continued 
evolution and optimization, and (3) assess associations between 
antibiotic use practices and resistance.
    We agree with the suggestion to collaborate with the USDA and the 
CDC to enhance existing collection efforts of on-farm antimicrobial use 
data. We are collaborating with the USDA and the CDC to develop a plan 
for collecting additional on-farm data on antimicrobial use and 
resistance. Such data are intended to supplement existing information, 
including data on the quantity of antimicrobials sold or distributed 
for use in food-producing animals (reported under Sec.  514.87 as 
established under this final rule) and data on antimicrobial use and 
resistance, for example, data collected under the NAHMS and NARMS 
programs. Data from multiple sources are needed to provide a 
comprehensive and science-based picture of antimicrobial drug use and 
resistance in animal agriculture and ensure the continued availability 
of safe and effective antimicrobials for use in treating animals and 
humans. Each source provides unique species-specific data; collecting 
species-specific sales and distribution data will support evaluation of 
other species-specific data, such as data collected under the NAHMS and 
NARMS programs.
    As discussed in section I.A. Purpose of the Final Rule, in December 
2013, we published GFI #213, a guidance that calls on sponsors of 
approved medically important antimicrobial new animal drugs 
administered through medicated feed or water to voluntarily make 
changes to remove production uses (growth promotion and feed 
efficiency) from their product labels and bring the remaining 
therapeutic uses of these products (to treat, control, or prevent 
disease) under the oversight of a veterinarian by the end of December 
2016. The sales data collected under this final rule will assist us in 
assessing the rate at which sponsors are voluntarily revising their 
FDA-approved labeled use conditions to align with GFI #213.
    As also discussed in section I.A., the National Action Plan, issued 
by the White House in March 2015, is intended to guide the activities 
of the U.S. Government as well as the actions of public health, health 
care, and veterinary partners in a common effort to address the urgent 
and serious public health threat of drug-resistant bacterial 
infections. Objective 2.4 of the National Action Plan is to enhance 
monitoring of antibiotic resistance patterns, as well as antibiotic 
sales, usage, and management practices, at multiple points in the 
production chain for food animals and retail meat. Sub-Objective 2.4.3 
of the National Action Plan calls for the USDA and FDA to seek public 
input on a plan for collecting drug use and resistance data on farms. 
We are continuing to work with both the USDA and the CDC to develop 
this plan. A joint public meeting was held on September 30, 2015, to 
provide an opportunity for public comment on possible approaches for 
collecting additional antimicrobial drug use data.
    (Comment 7) Some comments suggest that, instead of or in addition 
to collecting the species-specific estimates that would be required as 
proposed in Sec.  514.87(c), we should collect and report the 
information already provided in

[[Page 29136]]

veterinary feed directive (VFD) orders and information related to these 
orders.
    (Response 7) The VFD regulation outlines the process for 
authorizing use of VFD drugs (animal drugs intended for use in or on 
animal feed that require the supervision of a licensed veterinarian) 
and provides veterinarians in all States with a framework for 
authorizing the use of these VFD drugs, including medically important 
antimicrobials, when needed for specific animal health purposes. The 
VFD regulation provides that all distributors, regardless of whether or 
not they manufacture animal feeds bearing or containing VFD drugs, must 
keep records of receipt and distribution for 2 years from the date of 
issuance in accordance with 21 CFR 558.6(c)(3).
    We appreciate the commenters' suggestions that we gather the 
information provided in VFD orders and information related to these 
orders. While there are some limitations to the gathering of such 
information, we agree that this information has value. For that reason, 
we continue to consider options to capture such information.
    We believe that VFD records are an important source of information 
for assessing veterinary oversight of VFD drugs and compliance with the 
VFD regulation. These records are required to be made available to FDA 
during inspections. Therefore, as part of these inspectional 
activities, we intend to use these records to review compliance with 
the VFD regulations, to ensure that the VFD drug and VFD feed are used 
according to the conditions and indications of use as specified in the 
approval, conditional approval, or index listing, and within the 
supervision and oversight of a licensed veterinarian.
    (Comment 8) One comment generally supports the collection of sales 
data, but suggests that we provide a specific methodology for making 
species-specific sales estimates to reduce the likelihood of inaccurate 
reporting of these estimates.
    (Response 8) We appreciate the commenter's interest in obtaining 
the most accurate data and their suggestion that we identify a specific 
methodology for developing species-specific sales estimates. We 
appreciate and agree with the need to gather the best data. We also 
recognize that the sponsors who are required to report have different 
ways of managing their businesses, including different ways of 
capturing sales and distribution data. In other words, different 
sponsors gather sales data on similar drug products in different ways 
and, sometimes, the same sponsor may gather sales data on different 
drug products within their own drug product portfolio in different 
ways. Because of these differences, it seems likely that sponsors' 
methods of gathering these sales data will vary considerably.
    We believe that animal drug sponsors currently have access to 
information obtained in the ordinary course of their business (for 
example, through proprietary marketing analyses) that can be used to 
formulate the methodology to estimate the percentage of annual product 
sales that are sold or distributed domestically for use in any of the 
four major food-producing species that appear on the approved product 
label. In addition, sponsors have different business models that 
determine the manner in which they gather sales data; thus, specific 
methodologies to accurately estimate species-specific sales will likely 
differ among sponsors. As we finalize this rule and establish the 
requirement that sponsors estimate species-specific sales for the major 
food-producing species, we recognize that specifying a uniform 
methodology for estimating species-specific sales might cause a firm to 
provide estimates in a manner not best suited to their individual 
business processes, leading the firm to expend more time to provide 
species-specific sales estimates that may be less accurate than those 
derived from utilizing their own methodology. The provision at Sec.  
514.87(c) requires that firms provide species-specific sales estimates. 
We expect these estimates to be based on the methodology that provides 
the sponsor's most accurate estimate of these sales.
    Also, as we noted in the proposed rule, this provision is not 
intended to require animal drug sponsors to conduct studies of on-farm 
drug use practices (80 FR 28863 at 28866). For these reasons, we 
decline at this time to provide a standard methodology for developing 
species-specific sales estimates.
    (Comment 9) One comment suggests that we should not collect the 
species-specific sales and distribution estimates that we proposed to 
require under Sec.  514.87(c) until legal challenges over disclosure of 
confidential commercial information are resolved.
    (Response 9) We have carefully considered the issues regarding the 
protection of confidential commercial information. As we stated in the 
proposed rule, ``[s]ince it is likely that many sponsors would consider 
their species-specific sales and distribution estimates as proprietary 
information, and that such estimates may often be derived from 
proprietary marketing analyses, FDA would, as described in proposed 
paragraph (e) [of Sec.  514.87], consider the species-specific 
information reported by individual sponsors under paragraph (c) [of 
Sec.  514.87] to be confidential business information consistent with 
section 512 (l)(3) of the FD&C Act and this Agency's regulations at 21 
CFR 20.61.'' (80 FR 28863 at 28867). In recognition of this concern, we 
further stated in the proposed rule that, consistent with the statute, 
FDA would not ``independently report those antimicrobial classes with 
fewer than three distinct sponsors, and would further require that, in 
reporting the antimicrobial drug sales and distribution data it 
receives from drug sponsors, FDA must do so in a manner consistent with 
protecting both national security and confidential business information 
(see section 512(l)(3)(E)(i) and (ii) of the FD&C Act).'' (80 FR 28863 
at 28867.) After considering the comments received in response to the 
proposed rule, we conclude there are sufficient safeguards in place to 
ensure the protection of confidential commercial information, including 
the species-specific information required to be submitted by individual 
firms in accordance with Sec.  514.87(c). Therefore, we are not 
removing the requirement for species-specific sales and distribution 
estimates under Sec.  514.87(c) for confidentiality reasons as the 
comment requests and are finalizing the provision at Sec.  514.87(e) 
relating to the confidentiality of sales and distribution data as 
proposed.
    (Comment 10) One comment suggests that we modify proposed Sec.  
514.87(c) to include fish on the list of animal species categories for 
which sponsors are required to report species-specific estimates.
    (Response 10) We carefully considered the suggestion to include 
fish on the list of animal species categories for which species-
specific estimates must be submitted and decided to retain the 
categories that were identified in proposed Sec.  514.87(c) without 
modification. We consider the most significant risk to the public 
health associated with antimicrobial resistance related to the use of 
antimicrobial drugs in animal agriculture to be human exposure to food 
containing antimicrobial-resistant bacteria resulting from the exposure 
of food-producing animals to antimicrobials. However, when considering 
the foodborne pathway, the potential for human exposure to 
antimicrobial-resistant pathogens currently is significantly less for 
food derived from minor species than it is for food derived from the 
food-producing major species. The exposure potential is less in part 
because the amount of food derived from cattle, swine, and poultry is 
much greater than the amount of food derived from sheep,

[[Page 29137]]

goats, and aquaculture, the minor species from which the most food is 
derived (Refs. 1 and 2). In the United States, human foodborne 
illnesses are attributed mostly to plant and land animal commodities 
(Ref. 3). Furthermore, the majority of illnesses attributed to fish 
exposure are intoxications rather than bacterial illnesses (Ref. 4). 
Additionally, most fish and seafood consumed in the United States are 
imported products (Ref. 5).
    In addition, as discussed in the proposed rule, we believe having 
species-specific estimates of product sales and distribution for use in 
the four major food-producing categories of animal species (cattle, 
swine, chickens, turkeys) will be important in supporting efforts such 
as NARMS, a surveillance program that monitors trends in antimicrobial 
resistance among foodborne bacteria from humans, retail meats, and 
animals. NARMS retail meat and animal sampling focus on the same four 
major food-producing species included in Sec.  514.87(c). NARMS does 
not currently have a surveillance system for antimicrobial resistance 
pathogens from aquaculture products. Since there is currently limited 
resistance data related to minor food-producing animals (including 
fish) and companion animals, requiring estimates of these additional 
species at this time would cause additional burden without clear 
benefit to our understanding of antimicrobial resistance. NARMS does 
collect some resistance data on import isolates of Salmonella, which 
include some seafood isolates; however, because these data are from 
imports, data on domestic distribution and sales of antimicrobials for 
use in aquaculture would not be informative to NARMS and our overall 
efforts to assess antimicrobial use and resistance domestically.
    (Comment 11) One comment suggests that we modify proposed Sec.  
514.87(c) to remove the category ``other species/unknown'' and replace 
it with two categories, ``other species'' and ``unknown'', so that 
those estimates could be independently reported.
    (Response 11) We appreciate the suggestion to collect sales data on 
both ``other species'' and ``unknown''; however, we have determined 
that there is not a clear benefit to having this information reported 
separately at this time. As noted in our response to comment 1, one of 
the reasons we believe that having species-specific estimates of 
product sales and distribution in the four major food-producing 
categories of animal species (cattle, swine, chickens, turkeys) will be 
important is to support data we obtain from NARMS. NARMS retail meat 
and animal sampling focus on the same four major food-producing 
species. The category ``other species/unknown'' will be used to capture 
the percentage of each new animal drug product that was sold or 
distributed for use in animal species other than the four major food-
producing species or otherwise unknown to the reporting drug sponsor. 
Since there is currently limited resistance data related to minor food-
producing animals and companion animals, requiring estimates of these 
additional species would cause additional burden without clear benefit.
    (Comment 12) One comment suggests that we should not report 
species-specific information in our annual reports, arguing that by 
doing so we would disclose confidential commercial information in 
violation of proposed Sec.  514.87(e).
    (Response 12) As discussed in our response to comment 9, we have 
carefully considered the issues regarding the protection of 
confidential commercial information and the disclosure of species-
specific information in our annual summary reports. After considering 
the comments received in response to the proposed rule, we are not 
persuaded that reporting species-specific information in our annual 
summary reports will lead to the disclosure of confidential commercial 
information. We will only provide sales data in our summary reports 
that has been aggregated to avoid disclosing confidential commercial 
information. We are finalizing the rule as proposed, which includes 
safeguards for the protection of confidential business information 
related to the reporting of species-specific estimates of sales by drug 
sponsors, consistent with section 512(l)(3)(E) of the FD&C Act and our 
disclosure regulations at Sec.  20.61.
    (Comment 13) Several comments suggest we report a wider scope of 
information in our annual summary reports that would be required under 
proposed Sec.  514.87(f). One comment suggests we should provide more 
detailed information on why antimicrobials are used; for example, to 
distinguish use for growth promotion or disease prevention from use for 
disease control or treatment. Another comment suggests that we should 
collaborate with the USDA and the CDC to develop a communication plan 
to explain the implications of collected data for human and animal 
health.
    (Response 13) We appreciate the comment that we report a wider 
scope of information in our annual summary reports. As required by 
ADUFA 105, sponsors of the affected antimicrobial new animal drug 
products began submitting their sales and distribution data to us on an 
annual basis, and we have published summary reports of such data for 
each calendar year beginning with 2009. Starting in 2014, we increased 
the amount of data provided in our annual summary reports by including 
``additional data tables on the importance of each drug class in human 
medicine, the approved routes of administration for these 
antimicrobials, whether these antimicrobials are available over-the-
counter or require veterinary oversight, and whether the antimicrobial 
drug products are approved for therapeutic purposes, or both 
therapeutic and production purposes.'' (80 FR 28863 at 28867.)
    Sponsors currently are not required to report sales and 
distribution data broken out by the specific purpose for which these 
drug products are used. Many sales of antimicrobials by drug sponsors 
are to distributors who, in turn, may sell to other distributors or to 
end users (e.g., feed mills or animal producers). Thus, this type of 
information (i.e., how the drug product sold by the sponsor is 
ultimately used in a labeled species) is generally not even known by 
the drug sponsor. Also, as we note in our response to comment 8, 
reporting species-specific estimates of sales and distribution under 
Sec.  514.87 is not intended to require animal drug sponsors to conduct 
studies of on-farm drug use practices (80 FR 28863 at 28866) (e.g., use 
in particular species for particular indications). Because the sales 
and distribution data we are collecting from drug sponsors does not 
include information about how the drugs were ultimately used, such data 
also will not be included in our annual summary reports.
    As we note in our response to comments 1, 5, and 6, we recognize 
that data from multiple sources are needed to provide a comprehensive 
and science-based picture of antimicrobial drug use and resistance in 
animal agriculture. We are collaborating with the USDA and the CDC to 
develop a plan for collecting additional on-farm data on antimicrobial 
use and resistance. Such data are intended to supplement existing 
information, including data on the quantity of antimicrobials sold or 
distributed for use in food-producing animals (reported under Sec.  
514.87 as established under this final rule) and data on antimicrobial 
use and resistance, for example, data collected under the NAHMS and 
NARMS programs.

[[Page 29138]]

    We appreciate the comment suggesting that we collaborate with the 
USDA and the CDC to develop a communication plan to explain the 
implications of collected data for human and animal health. We will 
also continue to work with the USDA, the CDC, and other government 
agencies to analyze and report on the implications of the collected 
data.
    (Comment 14) We received several comments suggesting modifications 
to how we report the data that we proposed to collect. One comment 
suggests we should make as much of this data as possible available to 
the public, while protecting confidential business information. Other 
comments suggest we should publish monthly sales data and State- or 
regional-level data.
    (Response 14) We plan to report aggregate data on domestic sales 
and distribution for the entire reporting year, but not to include 
separate information for each month of the reporting year. ADUFA 105 
requires drug sponsors to report sales and distribution data to us 
broken out by month; however, antimicrobial drug products may be used 
at any time up to several years after distribution. As noted in the 
proposed rule, we consider monthly fluctuations in drug product sales 
to be of limited value in reflecting when products may actually be 
administered to animals and interpreting antimicrobial resistance 
trends, since much of monthly patterns are more reflective of 
distribution and business practices rather than of any fluctuations in 
use by or sales to the end user (80 FR 28863 at 28867).
    Regarding the suggestion that we report State- or regional-level 
data, sponsors are not required to report sales and distribution data 
broken out by States or regions. As we note in our response to comment 
13, many sales of antimicrobials by drug sponsors are to distributors 
who, in turn, may sell to other distributors or to end users (e.g., 
feed mills or animal producers). Thus, geographic distribution of sales 
as detailed as State- or regional-level sales data are generally not 
even known by the drug sponsors. For these reasons, we decline to make 
the modifications to our summary reports suggested by the commenters 
and are finalizing the language in Sec.  514.87(f) as proposed.
    (Comment 15) Several comments ask that we adhere to the proposed 
deadline of December 31st of the following year for the annual 
reporting of sales data.
    (Response 15) We plan to publish our annual summary report for each 
calendar year by December 31st of the following year. We note that this 
deadline is widely supported by advocacy groups and some animal 
industry groups. Adhering to this deadline would provide up-to-date 
data to the stakeholders and would be necessary to inform current 
regulatory decisions.
    In addition to the comments specific to this rulemaking that we 
addressed previously in this preamble, we received general comments 
expressing views about the use of antimicrobials, antimicrobial 
resistance, animal health and husbandry practices, the expansion of 
NARMS sampling, the enhancement of on-farm collection of information, 
and human antimicrobial drug use. These comments express broad policy 
views and do not address specific points related to this rulemaking. 
Therefore, these general comments do not require a response.

V. Effective and Compliance Dates

    This rule is effective July 11, 2016. Sponsors must comply with the 
reporting requirements in the final rule when submitting their reports 
covering the period of calendar year 2016.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. We believe that this final rule 
is not a significant regulatory action as defined by Executive Order 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the final rule will impose average annualized costs 
that amount to less than 0.01 percent of average annual revenues on 
those small entities that we expect to sponsor NADAs, we have 
determined that the final rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $144 
million, using the most current (2014) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    The Economic Analysis of Impacts of the final rule performed in 
accordance with Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is 
available at http://www.regulations.gov under the docket number(s) for 
this final rule and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
provisions are shown in the following paragraphs with an estimate of 
the one-time and annual reporting and recordkeeping burdens. Included 
in the estimate is the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.
    Title: Antimicrobial Animal Drug Distribution Reports and 
Recordkeeping (21 CFR part 514)--OMB Control No. 0910-0659--Revision
    Description: The ADUFA 105 legislation was enacted in 2008 to 
address the problem of antimicrobial resistance and to help ensure that 
we have the necessary information to examine safety concerns related to 
the use of antibiotics in food-producing animals. ADUFA 105 amended 
section 512 of the FD&C Act to require that sponsors of approved or 
conditionally approved applications for new animal drugs containing an 
antimicrobial active

[[Page 29139]]

ingredient submit an annual report to us on the amount of each such 
ingredient in the drug that is sold or distributed for use in food-
producing animals. Each report must specify: (1) The amount of each 
antimicrobial active ingredient by container size, strength, and dosage 
form; (2) quantities distributed domestically and quantities exported; 
and (3) a listing of the target animals, indications, and production 
classes that are specified on the approved label of the product. The 
report must cover the period of the preceding calendar year and include 
separate information for each month of the calendar year. This rule 
also includes an additional reporting provision intended to further 
enhance our understanding of antimicrobial animal drug sales intended 
for use in specific food-producing animal species. ADUFA 105 also 
requires us to publish annual summary reports of the data we receive. 
In accordance with ADUFA 105, sponsors of the affected antimicrobial 
new animal drug products have submitted their sales and distribution 
data to us, and we have published summaries of such data, for each 
calendar year since 2009. Collection of information on the amount of 
animal antimicrobials being distributed, including species-specific 
information, is necessary to support our ongoing efforts to encourage 
the judicious use of antimicrobials in food-producing animals to help 
ensure the continued availability of safe and effective antimicrobials 
for animals and humans. We intend to use these data to supplement 
existing information, including data collected under the NAHMS and 
NARMS programs. Data from multiple sources are needed to provide a 
comprehensive and science-based picture of antimicrobial drug use and 
resistance in animal agriculture.
    The final rule amends our records and reports regulation in part 
514 to include the following:
     Procedures relating to the submission to us of annual 
sales and distribution data reports by sponsors of approved or 
conditionally approved antimicrobial new animal drug products sold or 
distributed for use in food-producing animals.
     Procedures relating to the requirement that such sponsors 
submit species-specific estimates of product sales as a percentage of 
total sales.
     Procedures applicable to our preparation and publication 
of summary reports on an annual basis based on the sales and 
distribution data we receive from sponsors of approved antimicrobial 
new animal drug products. The final rule includes specific parameters 
for the content of the annual summary reports as well as provisions 
intended to protect confidential business information and national 
security, consistent with ADUFA 105 and this Agency's regulations at 
Sec.  20.61.
     Provisions that give sponsors of approved or conditionally 
approved antimicrobial new animal drug products that are sold or 
distributed for use in food-producing animals the opportunity to avoid 
duplicative reporting of product sales and distribution data to us 
under part 514.
    The final rule codifies in part 514 the reporting requirements 
established in ADUFA 105 and includes an additional reporting provision 
intended to enhance our understanding of new animal drug sales intended 
for use in specific food-producing animal species. The final rule also 
revises Form FDA 3744 by providing for species-specific information to 
be reported. Consequently FDA is revising the reporting requirements in 
the associated information collection. However, the final rule does not 
change the recordkeeping provisions already approved under OMB control 
number 0910-0659.
    Therefore, in compliance with the Paperwork Reduction Act of 1995 
(44 U.S.C. 3506(c)(2)(B)), we requested public comment on the 
information collection provisions of the proposed rule (80 FR 28863 at 
28868). We received some public comments on the information collection 
topics solicited in the proposed rule as addressed previously in 
section IV (supporting our effort to eliminate duplicative reporting, 
suggesting specific modifications and different approaches, questioning 
or supporting the utility of the information, suggesting we wait for 
resolution of the current legal disputes over disclosure of 
confidential commercial information and suggesting we provide a 
specific methodology for making species-specific sales estimates). 
However, none of the comments suggests that we modify our burden 
estimates.
    Description of Respondents: Animal Drug Manufacturers (Sponsors).
    The total annual estimated burden for this collection of 
information is 9,759 hours and 538 responses. This reflects a marginal 
increase in burden to that currently approved under OMB control number 
0910-0659 resulting from the revised reporting provisions associated 
with the final rule. At the same time, a review of our records reflects 
an overall increase in respondents to the program from 26 to 27 and we 
have therefore adjusted our respondent numbers accordingly.
    We estimate the burden of this collection of information as 
follows:

                             Table 1--Estimated One-Time Number Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
514.87(a) through (e)--                       20               1              20              24             480
 Administrative Review of the
 Rule: Sponsors With Active
 Applications...................
514.87(a) through (e)--                        7               1               7               1               7
 Administrative Review of the
 Rule: Sponsors With Inactive
 Applications...................
514.87(c)--Report Species-                    20            7.50             150               2             300
 Specific Estimate of Percent of
 Products Distributed
 Domestically...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             787
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimate of the average burden per response on our 
recent experience with the existing antimicrobial animal drug 
distribution reports program. We base our estimate of the number of 
affected respondents reported in tables 1 and 2 on a review of our 
records of sponsors with active and inactive applications, which show 
that in the past 3 years the number of sponsors have increased from 26 
to 27.

[[Page 29140]]

    Table 1 shows the estimated one-time burden associated with the new 
reporting provisions of this final rule. We expect that current 
sponsors of approved or conditionally approved applications for 
antimicrobial new animal drugs sold or distributed for use in food-
producing animals will need to review the provisions of the final rule 
and develop a compliance plan. Based on our records, we estimate there 
are a total of 27 sponsors, where 20 sponsors hold active (i.e., 
currently marketed) applications and 7 sponsors hold only inactive 
applications, as reflected in rows 1 and 2. We estimate that the 20 
sponsors with active applications will take 24 hours to complete the 
review and develop a compliance plan. We expect that the seven sponsors 
with inactive applications will take 1 hour to complete the review and 
will not need to develop a compliance plan.
    We also estimate that the 20 sponsors with 150 applications will 
each spend approximately 2 hours to discuss and settle upon a method to 
calculate the species-specific information required under Sec.  
514.87(c). This estimate is reflected in row 3.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of                        Average
                     21 CFR Section                          FDA form        Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.87(a) through (e)--Annual Reports for Sponsors With             3744              10             7.5              75              62           4,650
 Active Applications--Paper Submission..................
514.87(a) through (e)--Annual Reports for Sponsors With             3744              10             7.5              75              52           3,900
 Active Applications--Electronic Submission.............
514.87(a) through (e)--Annual Reports for Sponsors With             3744               4            26.5             106               2             212
 Inactive Applications--Paper Submission................
514.87(a) through (e)--Annual Reports for Sponsors With             3744               3              35             105               2             210
 Inactive Applications--Electronic Submission...........
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           8,972
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 2 shows the estimated recurring annual reporting burden 
associated with the final rule. While we expect new Sec.  514.87(c) 
will require 3 burden hours resulting from including species-specific 
estimates, we believe 1 hour will be saved by eliminating the 
requirement for sponsors to calculate the amount of antimicrobial 
active ingredients associated with their monthly product sales and 
distribution data (Sec.  514.80(b)(4)(i)(A)). Consequently, we estimate 
that the 20 sponsors with active applications will each expend 
approximately 2 additional reporting hours annually for new Sec.  
514.87. Because the Agency, upon implementation of the rule, will 
accept both paper and electronic submissions, and we assume that half 
of the respondents will report electronically, we estimate 10 
respondents for each submission method as shown in rows 1 and 2.
    While we estimate no increase in burden for the seven sponsors of 
inactive applications, we similarly will accept both paper and 
electronic submissions. Accordingly we have reported, unchanged, the 2 
hours of burden already approved under OMB control number 0910-0659 in 
rows 3 and 4.
    This final rule also refers to other currently approved collections 
of information found in our regulations. These collections of 
information are subject to review by OMB under the Paperwork Reduction 
Act of 1995. The collections of information in Sec.  514.80 are 
approved under OMB control number 0910-0284. The collections of 
information in 21 CFR 211.196 are approved under OMB control number 
0910-0139.
    The information collection provisions of this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995. Prior to the effective date of this 
final rule, FDA will publish a notice in the Federal Register 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions in this final rule. An Agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.

IX. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive Order and, consequently, a federalism summary impact 
statement is not required.

X. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m. Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. USDA, ``Livestock & Meat Domestic Data,'' http://www.ers.usda.gov/data-products/livestock-meat-domestic-data.
2. ``Food Fish Production and Sales by Species, by Size Category, by 
State and United States: 2005,'' http://www.agcensus.usda.gov/Publications/2002/Aquaculture/aquacen2005_08.pdf.
3. Painter, J. A., R. M. Hoekstra, T. Ayers, et al., ``Attribution 
of Foodborne Illnesses, Hospitalizations, and Deaths to Food 
Commodities by Using Outbreak Data, United States, 1998-2008,'' 
Emerging Infectious Diseases, 19(3):407-415, 2013.
4. Gould, L. H., K. A. Walsh, A. R. Vieira, et al., ``Surveillance 
for Foodborne Disease Outbreaks--United States, 1998-2008,''

[[Page 29141]]

Morbidity and Mortality Weekly Report. Surveillance Summaries, 
62(2):1-34, 2013.
5. ``Aquaculture in the United States,'' http://www.nmfs.noaa.gov/aquaculture/aquaculture_in_us.html.

List of Subjects in 21 CFR Part 514

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
514 is amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
1. The authority citation for part 514 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 
360ccc, 371, 379e, 381.

0
2. In Sec.  514.80, revise the fifth sentence of paragraph (b)(4) 
introductory text and paragraph (b)(4)(i) to read as follows:


Sec.  514.80  Records and reports concerning experience with approved 
new animal drugs.

* * * * *
    (b) * * *
    (4) * * * The yearly periodic drug experience reports must be 
submitted within 90 days of the anniversary date of the approval of the 
NADA or ANADA. * * *
    (i) Distribution data. (A) Information about the distribution of 
each new animal drug product, including information on any distributor-
labeled product. This information must include the total number of 
distributed units of each size, strength, or potency (e.g., 100,000 
bottles of 100 5-milligram tablets; 50,000 10-milliliter vials of 5-
percent solution). This information must be presented in two 
categories: Quantities distributed domestically and quantities 
exported.
    (B) Applicants submitting annual sales and distribution reports for 
antimicrobial new animal drug products under Sec.  514.87 have the 
option not to report distribution data under paragraph (b)(4)(i)(A) of 
this section for the approved applications that include these same 
products, but only provided each of the following conditions are met:
    (1) Applicants must have submitted complete periodic drug 
experience reports under this section for such applications for at 
least 2 full years after the date of their initial approval.
    (2) Applicants must ensure that the beginning of the reporting 
period for the annual periodic drug experience reports for such 
applications is January 1. For applications that currently have a 
reporting period that begins on a date other than January 1, applicants 
must request a change in reporting submission date such that the 
reporting period begins on January 1 and ends on December 31, as 
described in paragraph (b)(4) of this section.
    (3) Applicants that change their reporting submission date must 
also submit a special drug experience report, as described in paragraph 
(b)(5)(i) of this section, that addresses any gaps in distribution data 
caused by the change in date of submission.
    (4) Applicants who choose not to report under paragraph 
(b)(4)(i)(A) of this section must ensure that full sales and 
distribution data for each product approved under such applications are 
alternatively reported under Sec.  514.87, including products that are 
labeled for use only in nonfood-producing animals.
* * * * *

0
3. Add Sec.  514.87 to subpart B to read as follows:


Sec.  514.87  Annual reports for antimicrobial animal drug sales and 
distribution.

    (a) The applicant for each new animal drug product approved under 
section 512 of the Federal Food, Drug, and Cosmetic Act, or 
conditionally approved under section 571 of the Federal Food, Drug, and 
Cosmetic Act, and containing an antimicrobial active ingredient, must 
submit an annual report to FDA on the amount of each such antimicrobial 
active ingredient in the drug that is sold or distributed in the 
reporting year for use in food-producing animal species, including 
information on any distributor-labeled product.
    (b) This report must identify the approved or conditionally 
approved application and must include the following information for 
each new animal drug product described in paragraph (a) of this 
section:
    (1) A listing of each antimicrobial active ingredient contained in 
the product;
    (2) A description of each product sold or distributed by unit, 
including the container size, strength, and dosage form of such product 
units;
    (3) For each such product, a listing of the target animal species, 
indications, and production classes that are specified on the approved 
label;
    (4) For each such product, the number of units sold or distributed 
in the United States (i.e., domestic sales) for each month of the 
reporting year; and
    (5) For each such product, the number of units sold or distributed 
outside the United States (i.e., quantities exported) for each month of 
the reporting year.
    (c) Each report must also provide a species-specific estimate of 
the percentage of each product described in paragraph (b)(2) of this 
section that was sold or distributed domestically in the reporting year 
for use in any of the following animal species categories, but only for 
such species that appear on the approved label: Cattle, swine, 
chickens, turkeys. The total of the species-specific percentages 
reported for each product must account for 100 percent of its sales and 
distribution; therefore, a fifth category of ``other species/unknown'' 
must also be reported.
    (d) Each report must:
    (1) Be submitted not later than March 31 each year;
    (2) Cover the period of the preceding calendar year; and
    (3) Be submitted using Form FDA 3744, ``Antimicrobial Animal Drug 
Distribution Report.''
    (e) Sales and distribution data and information reported under this 
section will be considered to fall within the exemption for 
confidential commercial information established in Sec.  20.61 of this 
chapter and will not be publicly disclosed, except that summary reports 
of such information aggregated in such a way that does not reveal 
information that is not available for public disclosure under this 
provision will be prepared by FDA and made available to the public as 
provided in paragraph (f) of this section.
    (f) FDA will publish an annual summary report of the data and 
information it receives under this section for each calendar year by 
December 31 of the following year. Such annual reports must include a 
summary of sales and distribution data and information by antimicrobial 
drug class and may include additional summary data and information as 
determined by FDA. In order to protect confidential commercial 
information, each individual datum appearing in the summary report 
must:
    (1) Reflect combined product sales and distribution data and 
information obtained from three or more distinct sponsors of approved 
products that were actively sold or distributed that reporting year, 
and
    (2) Be reported in a manner consistent with protecting both 
national security and confidential commercial information.

    Dated: May 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11082 Filed 5-10-16; 8:45 am]
 BILLING CODE 4164-01-P