81_FR_29220 81 FR 29129 - Antimicrobial Animal Drug Sales and Distribution Reporting

81 FR 29129 - Antimicrobial Animal Drug Sales and Distribution Reporting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 91 (May 11, 2016)

Page Range29129-29141
FR Document2016-11082

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.

Federal Register, Volume 81 Issue 91 (Wednesday, May 11, 2016)
[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Rules and Regulations]
[Pages 29129-29141]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                         29129

                                                  Issued in Fort Worth, TX, on April 27,                Administration, 7519 Standish Pl.,                    Since that time, we have published two
                                                2016.                                                   Rockville, MD 20855, 240–402–5745,                    documents inviting public input on
                                                Vonnie Royal,                                           Neal.Bataller@fda.hhs.gov.                            potential changes to our regulations
                                                Acting Manager, Operations Support Group,                 With regard to the information                      relating to records and reports for
                                                ATO Central Service Center.                             collection: FDA PRA Staff, Office of                  approved new animal drugs, including
                                                [FR Doc. 2016–10736 Filed 5–10–16; 8:45 am]             Operations, Food and Drug                             an advance notice of proposed
                                                BILLING CODE 4910–13–P                                  Administration, 8455 Colesville Rd.,                  rulemaking (77 FR 44177, July 27, 2012)
                                                                                                        COLE–14526, Silver Spring, MD 20993–                  and a proposed rule (80 FR 28863, May
                                                                                                        0002, PRAStaff@fda.hhs.gov.                           20, 2015). This final rule amends our
                                                DEPARTMENT OF HEALTH AND                                SUPPLEMENTARY INFORMATION:                            existing records and reports regulation
                                                HUMAN SERVICES                                                                                                in part 514 (21 CFR part 514) to
                                                                                                        Table of Contents
                                                                                                                                                              incorporate the sales and distribution
                                                Food and Drug Administration                            I. Executive Summary                                  data reporting requirements specific to
                                                                                                           A. Purpose of the Final Rule                       antimicrobial new animal drugs that
                                                                                                           B. Summary of the Major Provisions of the          were added to the FD&C Act by ADUFA
                                                21 CFR Part 514                                               Final Rule
                                                                                                           C. Legal Authority
                                                                                                                                                              105. ADUFA 105 was enacted to assist
                                                [Docket No. FDA–2012–N–0447]                                                                                  us in our continuing analysis of the
                                                                                                           D. Costs and Benefits
                                                RIN 0910–AG45                                           II. Background                                        interactions (including drug resistance),
                                                                                                           A. Need for the Regulation/History of the          efficacy, and safety of antimicrobials
                                                Antimicrobial Animal Drug Sales and                           Rulemaking                                      approved for use in both humans and
                                                Distribution Reporting                                     B. Summary of Comments to the Proposed             food-producing animals for the purpose
                                                                                                              Rule                                            of mitigating the public health risk
                                                AGENCY:    Food and Drug Administration,                   C. General Overview of the Final Rule              associated with antimicrobial resistance.
                                                HHS.                                                    III. Legal Authority
                                                                                                        IV. Comments on the Proposed Rule and FDA
                                                                                                                                                              This rule includes an additional
                                                ACTION:   Final rule.                                         Response                                        reporting provision intended to improve
                                                                                                           A. Introduction                                    our understanding of antimicrobial
                                                SUMMARY:    The Food and Drug                                                                                 animal drug sales intended for use in
                                                                                                           B. Description of General Comments and
                                                Administration (FDA or we) is issuing a                       FDA Response                                    specific food-producing animal species.
                                                final rule to require that the sponsor of                  C. Comments on our Legal Authority and             This additional provision assists us in
                                                each approved or conditionally                                FDA Response                                    assessing antimicrobial sales trends in
                                                approved new animal drug product that                      D. Specific Comments and FDA Response              the major food-producing animal
                                                contains an antimicrobial active                        V. Effective and Compliance Dates
                                                                                                        VI. Economic Analysis of Impacts
                                                                                                                                                              species and examining how such trends
                                                ingredient submit an annual report to us                                                                      may relate to antimicrobial resistance.
                                                on the amount of each such ingredient                   VII. Analysis of Environmental Impact
                                                in the drug product that is sold or                     VIII. Paperwork Reduction Act of 1995                    Finalizing this rule will assist us in
                                                                                                        IX. Federalism                                        assessing the rate at which sponsors are
                                                distributed for use in food-producing                   X. References
                                                animals, including information on any                                                                         voluntarily revising their FDA-approved
                                                distributor-labeled product. This final                 I. Executive Summary                                  labeled use conditions to promote the
                                                rule codifies the reporting requirements                                                                      judicious use of medically important
                                                                                                        A. Purpose of the Final Rule                          antimicrobial drugs in food-producing
                                                established in section 105 of the Animal
                                                Drug User Fee Amendments of 2008                          The purpose of this rulemaking is to                animals. In December 2013, we
                                                (ADUFA). The final rule also includes                   change the way we collect and report                  published guidance for industry (GFI)
                                                an additional reporting provision                       information related to the distribution               #213 (http://www.fda.gov/downloads/
                                                intended to enhance our understanding                   and sale of approved or conditionally                 AnimalVeterinary/
                                                of antimicrobial new animal drug sales                  approved antimicrobial new animal                     GuidanceComplianceEnforcement/
                                                intended for use in specific food-                      drug products for use in food-producing               GuidanceforIndustry/UCM299624.pdf),
                                                producing animal species and the                        animals.                                              a guidance that calls on sponsors of
                                                relationship between such sales and                       Sponsors of approved or conditionally               approved medically important
                                                antimicrobial resistance.                               approved applications for new animal                  antimicrobial new animal drugs
                                                                                                        drugs containing an antimicrobial active              administered through medicated feed or
                                                DATES: This rule is effective July 11,
                                                                                                        ingredient are required by section 512 of             water to voluntarily make changes to
                                                2016. For the applicable compliance                     the Federal Food, Drug, and Cosmetic                  remove production uses (growth
                                                dates, please see section V, ‘‘Effective                Act (the FD&C Act) (21 U.S.C. 360b), as               promotion and feed efficiency) from
                                                and Compliance Dates’’ in                               amended by section 105 of ADUFA                       their product labels and bring the
                                                SUPPLEMENTARY INFORMATION.
                                                                                                        (ADUFA 105) (Title I of Pub. L. 110–                  remaining therapeutic uses of these
                                                ADDRESSES: For access to the docket to                  316), to submit to us an annual report                products (to treat, control, or prevent
                                                read background documents or                            on the amount of each such ingredient                 disease) under the oversight of a
                                                comments received, go to http://                        in the drug that is sold or distributed for           veterinarian by the end of December
                                                www.regulations.gov and insert the                      use in food-producing animals. We are                 2016. All affected drug sponsors
                                                docket number found in brackets in the                  also required by ADUFA 105 to publish                 committed to implementing the changes
                                                heading of this final rule into the                     annual summary reports of the data we                 described in guidance for industry (GFI)
                                                ‘‘Search’’ box and follow the prompts,                  receive from animal drug sponsors. In                 #213 by the December 2016 target date.
jstallworth on DSK7TPTVN1PROD with RULES




                                                and/or go to the Division of Dockets                    accordance with the law, sponsors of                  Once the changes are fully
                                                Management, 5630 Fishers Lane, Rm.                      the affected antimicrobial new animal                 implemented, it will be illegal to use
                                                1061, Rockville, MD 20852.                              drug products began submitting their                  these medically important antibiotics
                                                FOR FURTHER INFORMATION CONTACT:                        sales and distribution data to us on an               for production purposes, and animal
                                                With regard to the final rule: Neal                     annual basis, and we have published                   producers will first need to obtain
                                                Bataller, Center for Veterinary Medicine                summaries of such data for each                       authorization from a licensed
                                                (HFV–210), Food and Drug                                calendar year beginning with 2009.                    veterinarian to use them for therapeutic


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00019   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                29130             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                purposes (i.e., prevention, control, or                    • Procedures applicable to our                     product units rather than calculating the
                                                treatment of a specifically identified                  preparation and publication of summary                amount of antimicrobial active
                                                disease).                                               reports on an annual basis based on the               ingredients associated with these
                                                   Finalizing this rule also implements                 sales and distribution data we receive                monthly product sales and distribution
                                                Sub-Objective 2.4.2 (‘‘Enhance                          from sponsors of approved or                          data, as is currently the case. We
                                                collection and reporting of data                        conditionally approved antimicrobial                  estimate the calculation reductions will
                                                regarding antibiotic drugs sold and                     new animal drug products. The final                   amount to an annual benefit to animal
                                                distributed for use in food-producing                   rule includes specific parameters for the             drug sponsors of about $19,100. We
                                                animals’’) of the ‘‘National Action Plan                content of the annual summary reports                 estimate total annual benefits to
                                                for Combating Antibiotic-Resistant                      as well as provisions intended to protect             industry at about $122,300.
                                                Bacteria’’ (National Action Plan)                       confidential business information and
                                                (https://www.whitehouse.gov/sites/                      national security, consistent with                    II. Background
                                                default/files/docs/national_action_                     ADUFA 105 and this Agency’s                           A. Need for the Regulation/History of
                                                plan_for_combating_antibotic-resistant_                 regulations at § 20.61 (21 CFR 20.61).                the Rulemaking
                                                bacteria.pdf). The National Action Plan,                   • Provisions that will give sponsors of
                                                                                                                                                                 Section 512(l)(1) of the FD&C Act,
                                                released by the White House on March                    approved or conditionally approved
                                                                                                        antimicrobial new animal drug products                which was added by the Animal Drug
                                                27, 2015, was developed in response to
                                                Executive Order 13676: Combating                        that are sold or distributed for use in               Amendments of 1968 (Pub. L. 90–399),
                                                Antibiotic-Resistant Bacteria, which was                food-producing animals the opportunity                requires sponsors of approved or
                                                issued by President Barack Obama on                     to avoid duplicative reporting of                     conditionally approved new animal
                                                September 18, 2014, in conjunction                      product sales and distribution data to us             drugs to establish and maintain records
                                                with the National Strategy for                          under part 514.                                       and make such reports of data relating
                                                Combating Antibiotic-Resistant Bacteria.                                                                      to experience and other data or
                                                                                                        C. Legal Authority                                    information received or obtained by the
                                                The National Action Plan is intended to
                                                guide the activities of the U.S.                           Our legal authority for issuing this               sponsor with respect to such drug as
                                                Government as well as the actions of                    final rule is provided by section 512(l)              required by regulation or order. Part 514
                                                public health, health care, and                         of the FD&C Act relating to records and               of FDA’s regulations implements section
                                                veterinary partners in a common effort                  reports concerning approved and                       512(l) of the FD&C Act and requires new
                                                to address the urgent and serious public                conditionally approved new animal                     animal drug sponsors to report various
                                                health threat of drug-resistant bacterial               drugs. In addition, section 701(a) of the             types of information to FDA relating to
                                                infections. Objective 2.4 of the National               FD&C Act (21 U.S.C. 371(a)) gives us                  their approved drug products, including
                                                Action Plan is to ‘‘enhance monitoring                  general rulemaking authority to issue                 periodic drug experience reports under
                                                of antibiotic-resistance patterns, as well              regulations for the efficient enforcement             § 514.80(b)(4). Such reports must
                                                as antibiotic sales, usage, and                         of the FD&C Act.                                      contain detailed information as
                                                management practices, at multiple                                                                             specified in the regulations, including
                                                                                                        D. Costs and Benefits                                 information concerning the quantities of
                                                points in the production chain from
                                                food-animals on-farm, through                              We estimate one-time costs to                      the animal drug product distributed
                                                processing, and retail meat.’’                          industry from this final rule at about                under the sponsor’s approved
                                                   The provisions included in this final                $134,600. We estimate annual costs at                 application. The requirement for
                                                rule take into account stakeholder input                about $57,300. These costs equate to an               periodic reports under § 514.80(b)(4)
                                                received in response to multiple                        estimated total annualized cost of about              applies to all sponsors of approved new
                                                opportunities for public comment,                       $76,500 at a 7 percent discount rate over             animal drug products and is separate
                                                including the advance notice of                         10 years and about $73,100 at a 3                     from the reporting requirements
                                                proposed rulemaking and the proposed                    percent discount rate over 10 years. The              subsequently established under ADUFA
                                                rule.                                                   total annualized costs include the                    105 relating to antimicrobial new
                                                                                                        administrative cost to review the rule                animal drugs.
                                                B. Summary of the Major Provisions of                   ($8,800), plus the cost to those sponsors                This continuous monitoring of
                                                the Final Rule                                          who wish to avoid duplicative reporting               approved new animal drug applications
                                                  The rule amends the records and                       requirements under part 514 ($4,900),                 (NADAs) by collecting post-approval
                                                reports regulation in part 514 to include               plus the cost of providing the species-               information from sponsors is important
                                                the following:                                          specific estimates of the percent of the              because data previously submitted to
                                                  • Procedures relating to the                          drug product distributed domestically                 FDA as part of the approval process may
                                                submission to us of annual sales and                    ($62,700).                                            no longer be adequate, as animal drug
                                                distribution data reports by sponsors of                   The final rule provides some                       effects can change over time and less
                                                approved or conditionally approved                      flexibility in terms of the manner in                 apparent effects including, for example,
                                                antimicrobial new animal drug products                  which new animal drug sponsors report                 on antimicrobial resistance, can
                                                sold or distributed for use in food-                    sales and distribution data under both                sometimes take years to become evident.
                                                producing animals. Sponsors are                         § 514.80(b)(4) and § 514.87, by allowing              For this reason, post-approval reports
                                                already submitting such reports as                      the sponsor the option to satisfy its                 are one of the primary means by which
                                                required by ADUFA 105.                                  obligations under both provisions by                  FDA can obtain information regarding
                                                  • Procedures relating to the                          making only one set of report                         safety or effectiveness problems with
                                                requirement for sponsors of approved or                 submissions under certain                             marketed new animal drugs.
jstallworth on DSK7TPTVN1PROD with RULES




                                                conditionally approved antimicrobial                    circumstances. We estimate this will                     In an effort to address mounting
                                                new animal drugs to begin submitting                    reduce labor costs for new animal drug                public health concerns about
                                                species-specific estimates of product                   sponsors by $103,200 annually.                        antimicrobial drug resistance, Congress,
                                                sales as a percentage of their total sales.                Another benefit of the final rule is the           in 2008, enacted ADUFA 105 to
                                                This new reporting requirement was                      cost savings associated with sponsors                 enhance the reports collected by FDA
                                                included based on our authority under                   reporting their monthly sales and                     concerning marketed new animal drug
                                                section 512(l)(1) of the FD&C Act.                      distribution data to us in terms of                   products that contain an antimicrobial


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00020   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                          29131

                                                active ingredient. ADUFA 105 amended                    antimicrobials for animals and humans                 used. Some comments offer suggestions
                                                section 512(l) of the FD&C Act by                       (80 FR 28863 at 28864).                               for specific changes for us to consider
                                                adding section 512(l)(3). Under new                       We believe that on-farm use data also               making to the subject regulations.
                                                section 512(l)(3) of the FD&C Act,                      are needed to obtain additional
                                                                                                        information necessary to help gauge the               C. General Overview of the Final Rule
                                                sponsors of antimicrobial new animal
                                                drugs approved or conditionally                         success of antibiotic stewardship efforts               This final rule amends our animal
                                                approved for use in food-producing                      and guide their continued evolution and               drug records and reports regulation at
                                                animals must submit to us on an annual                  optimization, and assess associations                 part 514 to include administrative
                                                basis a report specifying the amount of                 between antibiotic use practices and                  practices and procedures for sponsors of
                                                each antimicrobial active ingredient in                 resistance. Shortly after we issued the               antimicrobial new animal drugs sold or
                                                the drug that is sold or distributed for                proposed rule, in the Federal Register of             distributed for use in food-producing
                                                use in food-producing animals.                          August 20, 2015 (80 FR 50638), we                     animals who must report annually
                                                Specifically, sponsors are required to                  published a notice announcing plans to                under section 512(l)(3) of the FD&C Act.
                                                report the amount of each antimicrobial                 hold a public meeting on September 30,                In addition, the rule includes a
                                                active ingredient as follows: (1) By                    2015, which we jointly sponsored with                 provision based on our broader
                                                container size, strength, and dosage                    the U.S. Department of Agriculture                    authority under section 512(l)(1) that
                                                form; (2) by quantities distributed                     (USDA) and the Centers for Disease                    requires sponsors to report
                                                domestically and quantities exported;                   Control and Prevention (CDC) to obtain                antimicrobial new animal drug sales
                                                and (3) for each dosage form, a listing                 public input on possible approaches for               intended for use in specific food-
                                                of the target animals, indications, and                 collecting additional on-farm                         producing animal species. In this
                                                production classes that are specified on                antimicrobial drug use and resistance                 rulemaking, we finalize the provisions
                                                the approved label of the product. The                  data. Such additional data are intended               in the proposed rule.
                                                information must be reported for the                    to supplement existing information,                   III. Legal Authority
                                                preceding calendar year, include                        including data on the quantity of
                                                                                                        antimicrobials sold or distributed for                   Our legal authority for issuing this
                                                separate information for each month of                                                                        final rule is provided by section 512(l)
                                                the calendar year, and be submitted to                  use in food-producing animals and data
                                                                                                        on antimicrobial use and resistance, for              of the FD&C Act relating to records and
                                                us each year no later than March 31.                                                                          reports concerning approved new
                                                The statute also requires FDA to publish                example, data collected under the
                                                                                                        National Animal Health Monitoring                     animal drugs and section 701(a) of the
                                                summary reports of the antimicrobial                                                                          FD&C Act. Section 512(l) gives FDA
                                                drug sales and distribution data                        System (NAHMS) and the National
                                                                                                        Antimicrobial Resistance Monitoring                   broad authority to collect information
                                                collected from the drug sponsors on an                                                                        from sponsors concerning their
                                                annual basis, and further requires that                 System (NARMS). In the notice of
                                                                                                        public meeting, we explained that data                approved or conditionally approved
                                                such data be reported by antimicrobial                                                                        new animal drug products. Specifically,
                                                class (section 512(l)(3) of the FD&C Act).              from multiple sources are needed to
                                                                                                        provide a comprehensive and science-                  under section 512(l)(1) of the FD&C Act,
                                                In accordance with the law, sponsors of                                                                       animal drug sponsors with approved or
                                                the affected antimicrobial new animal                   based picture of antimicrobial drug use
                                                                                                        and resistance in animal agriculture (80              conditionally approved NADAs must
                                                drug products began submitting their                                                                          ‘‘make such reports to the Secretary, of
                                                sales and distribution data to us on an                 FR 50638 at 50639). Taking into account
                                                                                                        the comments received from this public                data relating to experience, including
                                                annual basis, and we have published                                                                           experience with uses authorized under
                                                                                                        meeting, we are continuing to work with
                                                summaries of such data for each                                                                               subsection (a)(4)(A) [relating to
                                                                                                        the USDA and the CDC in developing
                                                calendar year beginning with 2009.                                                                            extralabel use], and other data or
                                                                                                        this plan to help ensure the continued
                                                  In the Federal Register of May 20,                    availability of safe and effective                    information, received or otherwise
                                                2015 (80 FR 28863), we proposed to                      antimicrobials for use in humans and                  obtained by such applicant with respect
                                                amend our existing animal drug records                  animals. The information that we will                 to such drug, or with respect to animal
                                                and reports regulation in part 514 to                   receive under this final rule is part of              feeds bearing or containing such drug,
                                                incorporate the antimicrobial drug sales                this coordinated, interagency effort to               as the Secretary may by general
                                                and distribution data reporting                         assess and minimize antimicrobial                     regulation, or by order with respect to
                                                requirements established by ADUFA                       resistance to help ensure the continued               such application, prescribe on the basis
                                                105. We proposed (80 FR 28863 at                        availability of safe and effective                    of a finding that such records and
                                                28864) to amend part 514 to include                     antimicrobial drugs for use in treating               reports are necessary in order to enable
                                                administrative practices and procedures                 infectious disease in animals and                     the Secretary to determine, or facilitate
                                                for sponsors of antimicrobial new                       humans.                                               a determination, whether there is or
                                                animal drugs sold or distributed for use                                                                      may be ground for invoking subsection
                                                in food-producing animals who must                      B. Summary of Comments to the                         (e) or subsection (m)(4) of this section
                                                report annually under section 512(l)(3)                 Proposed Rule                                         [authorizing FDA to withdraw approval
                                                of the FD&C Act. We also proposed (80                     We received approximately 440                       of a new animal drug or revoke a license
                                                FR 28863 at 28864) to collect species-                  individual comments on the proposed                   to manufacture medicated feed].’’ The
                                                specific data to assist us in assessing                 rule from veterinary, feed                            statute provides for withdrawal of
                                                antimicrobial sales trends in the major                 manufacturing, and livestock                          approval if FDA finds that new
                                                food-producing animal species and                       production associations, as well as                   information shows that the drug is no
                                                examining how such trends may relate                    consumer advocacy groups and                          longer shown to be safe for use under
jstallworth on DSK7TPTVN1PROD with RULES




                                                to antimicrobial resistance. We set forth               individuals, and a member of Congress.                the approved conditions of use or the
                                                the rationale that having the improved                  Some comments support our                             drug is ineffective for uses prescribed or
                                                data would support our ongoing efforts                  rulemaking and our ongoing efforts to                 recommended in the drug’s labeling (21
                                                to encourage the judicious use of                       address the problem of antimicrobial                  U.S.C. 360b(e)(1)).
                                                antimicrobials in food-producing                        resistance, while others express concern                 Pursuant to its authority under
                                                animals to help ensure the continued                    about the manner in which data are                    section 512(l)(1) of the FD&C Act, FDA
                                                availability of safe and effective                      going to be collected, interpreted, and               issued recordkeeping and reporting


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00021   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                29132             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                regulations relating to experience with                 Code of Federal Regulations.’’ (see                   B. Description of General Comments
                                                approved new animal drugs. These                        subsection (c) of ADUFA 105).                         and FDA Response
                                                regulations, which are found at part 514,                 Section 701(a) of the FD&C Act gives                   Many comments make general
                                                include the requirement at                              us general rulemaking authority to issue              remarks supporting or opposing the
                                                § 514.80(b)(4) for animal drug sponsors                 regulations for the efficient enforcement             proposed rule without focusing on a
                                                to submit periodic drug experience                      of the FD&C Act.                                      particular proposed provision. In the
                                                reports to FDA every 6 months for the                                                                         following paragraphs of this section, we
                                                first 2 years following approval of their               IV. Comments on the Proposed Rule                     discuss and respond to such general
                                                application and subsequently on an                      and FDA Response                                      comments.
                                                annual basis. The periodic reports that                                                                          (Comment 1) Many comments from a
                                                sponsors are required to submit under                   A. Introduction
                                                                                                                                                              variety of stakeholders, including
                                                § 514.80(b)(4) must include detailed                       This section summarizes comments                   veterinary, feed manufacturing, and
                                                information as specified in the                         we received in response to the proposed               animal production associations, drug
                                                regulations, including information                      rule and our response to those                        manufacturing firms, as well as
                                                concerning the quantities of the animal                 comments. We received approximately                   consumer advocacy groups and
                                                drug product distributed under the                      440 individual comments on the                        individuals, generally support our
                                                sponsor’s approved application. The                     proposed rule by the close of the                     efforts aimed at gathering reliable
                                                requirement for sponsors to submit                      comment period, each addressing one or                information on the use of antimicrobials
                                                distribution data to us under                           more topics. Approximately 400 of                     in food-producing animals, improving
                                                § 514.80(b)(4) predates the enactment of                those comments resulted from write-in                 the manner in which that information is
                                                ADUFA 105.                                              campaigns. Several of the comments                    reported, enhancing our understanding
                                                   In addition to the broad authority                   were signed by more than one person or                of antimicrobial animal drug sales
                                                already granted to FDA under section                    group. We received comments from                      intended for use in specific food-
                                                512(l)(1) of the FD&C Act, in 2008,                     veterinary, feed manufacturing, and                   producing animal species, and working
                                                Congress established additional                         livestock production associations, as                 alongside our Federal partners to share
                                                reporting requirements under ADUFA                      well as consumer advocacy groups and                  data for the purpose of minimizing
                                                105 for sponsors of antimicrobial new                   individuals, and a member of Congress.                antimicrobial resistance.
                                                animal drug products. These new                         Some comments support our                                (Response 1) We appreciate the
                                                reporting requirements, which are set                   rulemaking and our ongoing efforts to                 general support that the comments
                                                out in section 512(l)(3) of the FD&C Act,               address the problem of antimicrobial                  express. As noted in section II.A., this
                                                did not require the Agency to issue                     resistance, while others express concern              rulemaking is part of a larger effort to
                                                implementing regulations first in order                 about the manner in which data are                    address the problem of antimicrobial
                                                for them to take effect. With respect to                going to be collected, interpreted, and               resistance. The rule is expected to
                                                approved or conditionally approved                                                                            provide us with information on the sales
                                                                                                        used. Some comments offer suggestions
                                                new animal drugs containing an                                                                                of antimicrobials intended for use in
                                                                                                        for specific changes for us to consider
                                                antimicrobial active ingredient, section                                                                      food-producing animals, including
                                                                                                        making to the subject regulations. We
                                                512(l)(3)(A) through (C) of the FD&C Act                                                                      information regarding the sales of these
                                                                                                        considered the comments we received
                                                requires sponsors of such products to                                                                         products among the various animal
                                                                                                        in response to the proposed rule in
                                                submit an annual report to FDA on the                                                                         species for which they are intended.
                                                                                                        preparing this final rule. After
                                                ‘‘amount of each antimicrobial active                                                                         Having species-specific estimates of
                                                                                                        considering these comments, we are not
                                                ingredient in the drug that is sold or                                                                        product sales and distribution in the
                                                                                                        making any changes to the codified
                                                distributed for use in food-producing                                                                         four major food-producing categories of
                                                                                                        language that was included in the
                                                animals, including information on any                                                                         animal species (cattle, swine, chickens,
                                                                                                        proposed rule.
                                                distributor labeled product’’ by March                                                                        turkeys) will be important in supporting
                                                31 of each year with separate data                         In sections IV.B. through IV.D., we                efforts such as NARMS, the national
                                                included for each month of the                          describe the comments received on the                 surveillance program that tracks trends
                                                preceding calendar year. In addition,                   proposed rule and provide our                         related to antimicrobial resistance in
                                                section 512(l)(3)(E) of the FD&C Act                    responses. To make it easier to identify              food-producing animals and humans,
                                                requires FDA to prepare summaries of                    the comments and our responses, the                   and complement data on antimicrobial
                                                the information reported by drug                        word ‘‘Comment,’’ in parentheses,                     use collected under NAHMS. The data
                                                sponsors concerning their antimicrobial                 appears before the comment’s                          will also complement the data
                                                new animal drugs and to make those                      description, and the word ‘‘Response,’’               collection plan with the USDA and the
                                                summaries available to the public. In                   in parentheses, appears before our                    CDC to obtain additional on-farm use
                                                accordance with ADUFA 105, sponsors                     response. We have numbered each                       and resistance data. The collection of
                                                of the affected antimicrobial new animal                comment to help distinguish between                   data from multiple sources, including
                                                drug products have submitted their                      different comments. We have grouped                   enhanced sales data, is needed to
                                                sales and distribution data to us, and we               similar comments together under the                   provide a comprehensive and science-
                                                have published summaries of such data,                  same number and, in some cases, we                    based picture of antimicrobial drug use
                                                for each calendar year since 2009.                      have separated different subjects                     and resistance in animal agriculture.
                                                   In enacting ADUFA 105, Congress                      discussed in the same comment and                     Such information will further enhance
                                                clarified that ‘‘[t]he reports required [to             designated them as distinct comments                  our ongoing activities related to slowing
jstallworth on DSK7TPTVN1PROD with RULES




                                                be submitted by animal drug sponsors]                   for purposes of our responses. The                    the development of antimicrobial
                                                under section 512(l)(3) of the Federal                  number assigned to each comment or                    resistance to help ensure that safe and
                                                Food, Drug, and Cosmetic Act, as added                  comment topic is purely for                           effective antimicrobial new animal
                                                by subsection (a) [of ADUFA 105], shall                 organizational purposes and does not                  drugs will remain available for use in
                                                be separate from periodic drug                          signify the comment’s value or                        human and animal medicine. We intend
                                                experience reports that are required                    importance or the order in which                      to continue working in collaboration
                                                under section 514.80(b)(4) of title 21,                 comments were received.                               with the USDA, the CDC, the


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00022   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                         29133

                                                pharmaceutical industry, veterinary                     prescribe on the basis of a finding that              meant to enhance, not limit, our general
                                                organizations, animal producers, and                    such records and reports are necessary                authority under section 512(l)(1) of the
                                                other stakeholders to address this                      in order to enable the Secretary to                   FD&C Act to require information about
                                                important public health issue.                          determine, or facilitate a determination,             marketed new animal drug products in
                                                                                                        whether there is or may be ground for’’               order to ensure their continued safety
                                                C. Comments on Our Legal Authority
                                                                                                        withdrawal of approval of the new                     and effectiveness. For example, in his
                                                and FDA Response
                                                                                                        animal drug at issue. FDA therefore has               remarks to other members of Congress,
                                                   (Comment 2) Some comments suggest                    the authority to establish reporting                  Chairman of the House Energy and
                                                that we lack the legal authority to                     requirements applicable to approved or                Commerce Subcommittee on Health,
                                                require drug sponsors to report species-                conditionally approved new animal                     Representative Frank Pallone, Jr., stated
                                                specific distribution estimates.                        drugs by regulation or order if it finds              that the ADUFA legislation he had
                                                   Specifically, one comment suggests                   those requirements are necessary to                   introduced earlier that year would
                                                that we lack authority under section                    enable it to determine, or facilitate a               ‘‘improve the uniform collection and
                                                512(l)(3) of the FD&C Act, as added by                  determination, as to whether the drugs                reporting of data to FDA on the sales
                                                ADUFA 105, to require species-specific                  are no longer shown to be safe, are                   about animal drugs that contain an
                                                distribution estimates. The comment                     ineffective, or are otherwise subject to              antibiotic ingredient’’ and that it
                                                suggests that the lack of express                       withdrawal under section 512(e) of the
                                                authority in section 512(l)(3) of the                                                                         ‘‘includes language that would enhance
                                                                                                        FD&C Act.                                             FDA’s current data collection by
                                                FD&C Act to require species-specific                      Based on its authority under section
                                                distribution estimates thus limits our                                                                        creating a new antimicrobial animal
                                                                                                        512(l)(1) of the FD&C Act, in March                   drug use data report for all food-
                                                broader authority relating to the                       2003, FDA issued regulations requiring
                                                collection of records and reports                                                                             producing animals. The report puts
                                                                                                        recordkeeping and reports concerning
                                                concerning experiences and other                                                                              critical information in one place for
                                                                                                        experience with approved new animal
                                                information with respect to approved                                                                          FDA; otherwise, the agency would have
                                                                                                        drugs at § 514.80. Under § 514.80(b)(4),
                                                new animal drugs under 512(l)(1) of the                                                                       to search through warehouses of
                                                                                                        sponsors that have approved
                                                FD&C Act, and precludes us from                                                                               multiple paper reports.’’ 154
                                                                                                        applications for new animal drugs,
                                                requiring the submission of species-                                                                          Congressional Record 17,287
                                                                                                        including sponsors of antimicrobial new
                                                specific distribution estimates under                                                                         (2008)(statement of Rep. Pallone). In
                                                                                                        animal drug products, must submit
                                                that provision as well.                                                                                       remarks Representative Waxman made
                                                                                                        periodic drug experience reports to FDA
                                                   Three comments suggest that in                       every 6 months for the first 2 years                  concerning the legislation, he stated,
                                                addition to lacking authority to require                following approval and annually                       ‘‘The ADUFA bill we are considering
                                                species-specific distribution estimates                 thereafter. These periodic drug                       includes a provision to increase the
                                                under section 512(l)(3) of the FD&C Act,                experience reports must contain, among                availability and accessibility of data on
                                                we also lack authority under section                    other things, various types of                        the amount of animal antibiotics being
                                                512(l)(1) of the FD&C Act because we                    information about the distribution of the             distributed’’ and that the
                                                have not made a ‘‘finding’’ that species-               sponsor’s drug, including data                        ‘‘reauthorization [of ADUFA] has also
                                                specific distribution estimates are                     concerning the quantity of the drug                   given us an opportunity to look at
                                                necessary in order to facilitate a                      distributed domestically and the                      providing FDA with new tools to
                                                determination of whether there may be                   quantity exported. The requirement in                 address a related public health crisis,
                                                grounds for invoking the withdrawal                     § 514.80(b)(4) for sponsors to submit                 the problem of antibiotic resistance.’’
                                                provisions of the FD&C Act.                             detailed distribution data concerning                 154 Congressional Record 17,288 (2008)
                                                   (Response 2) FDA acknowledges that                   their approved new animal drugs                       (statement of Rep. Waxman). These
                                                section 512(l)(3) of the FD&C Act, as                   predates the enactment of ADUFA 105.                  statements made by members of
                                                added by ADUFA 105, does not                            In enacting ADUFA 105, Congress left                  Congress strongly suggest that FDA was
                                                explicitly address species-specific                     intact the periodic reporting                         viewed as already having the requisite
                                                distribution estimates. In requiring such               requirements under § 514.80(b)(4)—                    legal authority under section 512(l) and
                                                estimates, we rely not on section                       including the requirement for                         that the reason Congress established the
                                                512(l)(3) but rather on our broader                     distribution data—stating at ADUFA                    requirement in section 512(l)(3) of the
                                                authority under section 512(l)(1) of the                section 105(c) that the reporting                     FD&C Act for an additional report
                                                FD&C to collect information concerning                  requirements established under section                relating to antimicrobial new animal
                                                approved and conditionally approved                     512(l)(3) of the FD&C Act for                         drugs sold for use in food-producing
                                                new animal drugs under a regulation or                  antimicrobial new animal drugs did not                animals was merely to improve the
                                                order issued by FDA. (See Section III.                  relieve the sponsors of their separate                efficiency of the reporting process for
                                                Legal Authority.) Section 512(l)(1) of the              obligation to provide periodic drug                   such drugs so that we could more
                                                FD&C Act reads in relevant part, ‘‘In the               experience reports to FDA under                       effectively address the problem of
                                                case of any new animal drug for which                   § 514.80(b)(4). In so doing, Congress                 resistance associated with the use of
                                                approval of an application filed                        clearly signaled that the reporting                   antimicrobial drugs in food animal
                                                pursuant to subsection (b) or section 571               requirements relating to antimicrobial                production. In addition to improving
                                                is in effect, the applicant shall establish             drugs in 512(l)(3) were intended to                   efficiency by establishing a more
                                                and maintain such records, and make                     supplement rather than supplant FDA’s                 uniform process for the collection of
                                                such reports to the Secretary, of data                  existing authority under section                      important information about approved
                                                relating to experience . . . and other                  512(l)(1) to impose distribution data                 antimicrobial new animal drugs sold or
jstallworth on DSK7TPTVN1PROD with RULES




                                                data or information, received or                        reporting requirements on the same                    distributed for use in food-producing
                                                otherwise obtained by such applicant                    parties covered by section 512(l)(3) of               animals, ADUFA 105 also streamlined
                                                with respect to such drug, or with                      the FD&C Act.                                         the process for putting these reporting
                                                respect to animal feeds bearing or                        Further, the scant legislative history              requirements in place by eliminating the
                                                containing such drug, as the Secretary                  relating to ADUFA 105 that exists                     need for the Agency to first engage in
                                                may by general regulation, or by order                  supports the conclusion that in                       time-consuming rulemaking activities
                                                with respect to such application,                       establishing section 512(l)(3) Congress               that otherwise would have been


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00023   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                29134             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                required under section 512(l)(1) of the                 D. Specific Comments and FDA                          animal drug sponsors to capture in their
                                                FD&C Act prior to collecting such data.                 Response                                              sales and distribution data reports
                                                   In light of what we consider to be                     Many comments make specific                         information regarding any distributor
                                                clear evidence that Congress intended                                                                         labeled products (see section
                                                                                                        remarks supporting or opposing a
                                                section 512(l)(3) of the FD&C Act to                                                                          512(l)(3)(A) of the FD&C Act). We
                                                                                                        particular proposed provision. In this
                                                bolster rather than limit our existing                                                                        decline to implement the suggestion to
                                                                                                        section, we discuss and respond to such
                                                authority to require information to be                                                                        limit the reporting to ‘‘medically
                                                                                                        comments. The order of the discussion
                                                reported concerning approved new                                                                              important antimicrobials’’ due to the
                                                                                                        reflects the order in the regulatory text.
                                                animal drugs, we conclude that the                                                                            statutory reporting requirements under
                                                                                                          (Comment 3) Several comments
                                                comment’s assertion, that by                                                                                  section 512(l)(3) of the FD&C Act, which
                                                                                                        support our effort to eliminate
                                                establishing section 512(l)(3) Congress                                                                       apply to a new animal drug product that
                                                                                                        duplicative reporting of sales and
                                                has somehow curtailed our ability to                                                                          is approved or conditionally approved
                                                                                                        distribution data by sponsors of
                                                exercise authority we would otherwise                                                                         and contains an antimicrobial active
                                                                                                        antimicrobial new animal drugs.
                                                have under section 512(l)(1), is without                                                                      ingredient without limitation.
                                                                                                          (Response 3) We agree with the
                                                merit.                                                                                                           With regard to the comment about
                                                   We now respond to the comments                       comments and therefore, in this final
                                                                                                                                                              live cultures and complex products, we
                                                asserting that we may not rely on                       rule, we are keeping language as
                                                                                                                                                              understand the comment to be referring
                                                section 512(l)(1) of the FD&C Act absent                proposed at § 514.80(b)(4)(i)(B). As
                                                                                                                                                              to products that contain one or more
                                                a finding that species-specific                         described in the proposed rule (80 FR
                                                                                                                                                              microorganisms. We carefully
                                                distribution estimates are necessary in                 28863 at 28871), we are providing an
                                                                                                                                                              considered the issues the comment
                                                order to facilitate a determination of                  opportunity for sponsors of                           raises and are finalizing the proposed
                                                whether there may be grounds for                        antimicrobial new animal drugs to                     rule without change. Currently, there
                                                invoking the withdrawal provisions of                   modify the reporting period for these                 are no approved new animal drug
                                                the FD&C Act. Although we stated in                     drug products in order to eliminate                   products that contain microorganisms
                                                the proposed rule that collection of                    duplicative reporting of quantity                     and such products do not appear in
                                                species-specific sales and distribution                 marketed under current § 514.80(b)(4)                 Appendix A, GFI #152 as being
                                                estimates would help to ensure ‘‘the                    and new § 514.87.                                     important in human clinical medicine
                                                continued availability of safe and                        (Comment 4) Several comments                        (http://www.fda.gov/downloads/
                                                effective antimicrobials for animals and                support reporting of sales and                        AnimalVeterinary/
                                                humans,’’ we agree that language more                   distribution data but suggest                         GuidanceComplianceEnforcement/
                                                clearly stating our finding is                          modification of the proposed                          GuidanceforIndustry/ucm052519.pdf).
                                                appropriate. Accordingly, we find that                  requirement in § 514.87(a) and (b)(1) to              A live culture or complex product could
                                                the collection of species-specific sales                report the antimicrobial active                       potentially be the subject of a NADA if
                                                and distribution estimates, in addition                 ingredient. One comment suggests that                 because of its intended use the
                                                to other information about antimicrobial                we reduce the scope of what we require                particular product at issue meets the
                                                use in food-producing animals and drug                  to be reported so that we only collect                statutory definition of a drug in section
                                                resistance, is necessary to enable us to                data for what it characterizes as                     201(g) of the FD&C Act (21 U.S.C.
                                                determine, or to facilitate a                           ‘‘medically important antimicrobials.’’               321(g)) (an article intended for use in
                                                determination, as to whether there may                  Another comment suggests that we                      the diagnosis, cure, mitigation,
                                                be grounds for additional measures                      expand the scope of what we require to                treatment, or prevention of disease or an
                                                short of and, where appropriate,                        be reported to include data on what the               article (other than food) intended to
                                                including withdrawal of approval or                     comment characterizes as live cultures                affect the structure or any function of
                                                specific portions of the approval in                    and complex products ‘‘intentionally                  the body) and the statutory definition of
                                                certain instances in the future to                      developed and marketed for                            a new animal drug in section 201(v) of
                                                minimize antimicrobial resistance and                   antimicrobial production.’’                           the FD&C Act. Furthermore, should a
                                                ensure the continued availability of safe                 (Response 4) We have carefully                      live culture or complex product be
                                                and effective antimicrobials for use in                 considered the comments’ suggested                    approved as a new animal drug, and
                                                treating animals and humans. In                         changes to the scope of reporting of the              should any of the active ingredients of
                                                particular, such information is needed,                 antimicrobial active ingredient. The                  that product be approved specifically
                                                among other reasons, to support ongoing                 requirement to report the antimicrobial               for an antimicrobial use or be known to
                                                efforts to promote the judicious use of                 active ingredient under § 514.87(a)                   have antimicrobial properties, then
                                                antimicrobials in food-producing                        reflects the requirement, under section               sponsors of such an approved product
                                                animals and evaluate the success of                     512(l)(3) of the FD&C Act, for each                   would be required to submit data to us
                                                those efforts; to aid in our assessment of              sponsor of a new animal drug product                  on the amount of each such ingredient
                                                antimicrobial sales trends in the major                 that is approved or conditionally                     in this drug product sold or distributed
                                                food-producing animal species and our                   approved and contains an antimicrobial                for use in food-producing animals.
                                                examination of how these species-                       active ingredient, to report to us on an                 (Comment 5) Comments on the
                                                specific sales trends may relate to                     annual basis the amount of each                       proposed rule generally support our
                                                antimicrobial resistance; and to help                   antimicrobial active ingredient in the                effort to learn more about antimicrobial
                                                inform microbial food safety risk                       drug product that is sold or distributed              resistance, but several comments
                                                assessments. In addition, because many                  for use in food-producing animals. This               disagree with our proposal to collect
                                                antimicrobial drugs are approved for use                includes products that are the subject of             species-specific estimates as proposed
jstallworth on DSK7TPTVN1PROD with RULES




                                                in multiple species, in those instances                 an approved NADA or abbreviated                       in § 514.87(c). Several comments
                                                where we believe appropriate grounds                    NADA, as well as products that are                    question the utility of the information
                                                may exist to withdraw approval, having                  conditionally approved under section                  that would result from species-specific
                                                species-specific information also will be               571 of the FD&C Act (21 U.S.C. 360ccc).               data. Several comments suggest that it
                                                necessary to help us determine which                    The requirement in § 514.87(a) also                   was unclear how species-specific
                                                specific portions of the approval may                   incorporates the requirement from                     estimates will scientifically support
                                                need to be withdrawn.                                   section 512(l)(3) of the FD&C Act for                 NARMS, or complement NAHMS. Other


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00024   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                           29135

                                                comments state that species-specific                    information is critical to our ongoing                under the NAHMS and NARMS
                                                sales estimates are inappropriate to                    activities related to slowing the                     programs. Data from multiple sources
                                                report because the resulting data would                 development of antimicrobial resistance               are needed to provide a comprehensive
                                                not constitute sound scientific data.                   and ensuring the continued availability               and science-based picture of
                                                These comments assert that such data                    of safe and effective antimicrobials for              antimicrobial drug use and resistance in
                                                would be inaccurate due to                              use in treating animals and humans. For               animal agriculture and ensure the
                                                complications and inconsistencies of                    the reasons discussed here and in                     continued availability of safe and
                                                data collection, would not reflect actual               response to comments 1 and 2, we are                  effective antimicrobials for use in
                                                usage, would be subject to                              retaining the requirement for sponsors                treating animals and humans. Each
                                                misinterpretation due to lack of                        to provide species-specific sales and                 source provides unique species-specific
                                                complete information, and would not                     distribution estimates as set forth in                data; collecting species-specific sales
                                                constitute sufficient data to evaluate the              § 514.87(c).                                          and distribution data will support
                                                impact of policies and trends in                           (Comment 6) Several comments we                    evaluation of other species-specific data,
                                                antimicrobial resistance. Other                         received suggest that, instead of                     such as data collected under the
                                                comments support our collection of                      collecting species-specific sales                     NAHMS and NARMS programs.
                                                species-specific sales and distribution                 estimates as proposed in § 514.87(c),                    As discussed in section I.A. Purpose
                                                data as proposed in § 514.87(c). These                  antimicrobial use in food-producing                   of the Final Rule, in December 2013, we
                                                comments assert that the resulting data                 animals should be monitored at the farm               published GFI #213, a guidance that
                                                would be beneficial to understanding                    level. Some comments raise concerns                   calls on sponsors of approved medically
                                                how antimicrobials are used in food-                    about using sales data alone in analyses              important antimicrobial new animal
                                                producing animals, the relationship                     of antimicrobial drug use and resistance.             drugs administered through medicated
                                                between sales/use and antimicrobial                     There were multiple comments                          feed or water to voluntarily make
                                                resistance, and the impact of our                       requesting that we collaborate with the               changes to remove production uses
                                                policies and practices to mitigate                      USDA and the CDC to enhance existing                  (growth promotion and feed efficiency)
                                                antimicrobial resistance.                               collection efforts of on-farm                         from their product labels and bring the
                                                   (Response 5) We have carefully                       antimicrobial use data that are accurate,             remaining therapeutic uses of these
                                                considered the comments in favor of                     detailed, and quantitative to supplement              products (to treat, control, or prevent
                                                and opposing the reporting of species-                  species-specific estimates of product                 disease) under the oversight of a
                                                specific sales and distribution data as                 sales. The commenters further request                 veterinarian by the end of December
                                                specified in proposed § 514.87(c). We                   that we use the data to evaluate the                  2016. The sales data collected under
                                                recognize the comments’ concerns with                   impact of policies, understand the                    this final rule will assist us in assessing
                                                regard to utility of the information but                relationship between usage and                        the rate at which sponsors are
                                                we respectfully disagree with the                       resistance trends, and construct targeted
                                                                                                                                                              voluntarily revising their FDA-approved
                                                request to remove species-specific                      interventions.
                                                                                                                                                              labeled use conditions to align with GFI
                                                reporting from the rule. As we discussed                   (Response 6) We disagree with the
                                                                                                        request to remove species-specific                    #213.
                                                in our response to Comment 1, having
                                                species-specific estimates of product                   reporting from the rule for the reasons                  As also discussed in section I.A., the
                                                sales and distribution for use in the four              discussed in our responses to comments                National Action Plan, issued by the
                                                major food-producing categories of                      1, 2, and 5. We recognize that gathering              White House in March 2015, is intended
                                                animal species (cattle, swine, chickens,                information on the way medically                      to guide the activities of the U.S.
                                                turkeys) will be essential in supporting                important antimicrobials are used in                  Government as well as the actions of
                                                efforts to assess antimicrobial drug use                food-producing animals is essential to:               public health, health care, and
                                                and resistance in animal agriculture.                   (1) Assess the rate at which sponsors are             veterinary partners in a common effort
                                                This additional sales and distribution                  voluntarily revising their FDA-approved               to address the urgent and serious public
                                                data will help inform microbial food                    labeled use conditions to promote the                 health threat of drug-resistant bacterial
                                                safety risk assessments by providing a                  judicious use of medically important                  infections. Objective 2.4 of the National
                                                better indication of the extent to which                antimicrobial drugs in food-producing                 Action Plan is to enhance monitoring of
                                                a drug or drug class is used in a specific              animals, (2) help gauge the success of                antibiotic resistance patterns, as well as
                                                food animal species by a specific route                 antibiotic stewardship efforts and guide              antibiotic sales, usage, and management
                                                of administration. Aggregate sales data                 their continued evolution and                         practices, at multiple points in the
                                                do not provide this information and are                 optimization, and (3) assess associations             production chain for food animals and
                                                more subject to misinterpretation.                      between antibiotic use practices and                  retail meat. Sub-Objective 2.4.3 of the
                                                   As noted in our response to comment                  resistance.                                           National Action Plan calls for the USDA
                                                1, we also intend to consider estimates                    We agree with the suggestion to                    and FDA to seek public input on a plan
                                                of species-specific sales and distribution              collaborate with the USDA and the CDC                 for collecting drug use and resistance
                                                data in conjunction with on-farm                        to enhance existing collection efforts of             data on farms. We are continuing to
                                                species-specific data on antimicrobial                  on-farm antimicrobial use data. We are                work with both the USDA and the CDC
                                                use, such as that collected under                       collaborating with the USDA and the                   to develop this plan. A joint public
                                                NAHMS. We expect such data to help                      CDC to develop a plan for collecting                  meeting was held on September 30,
                                                us better understand the extent of                      additional on-farm data on                            2015, to provide an opportunity for
                                                antimicrobial use in the various major                  antimicrobial use and resistance. Such                public comment on possible approaches
                                                food animal species and provide                         data are intended to supplement                       for collecting additional antimicrobial
jstallworth on DSK7TPTVN1PROD with RULES




                                                additional context as we examine                        existing information, including data on               drug use data.
                                                resistance data, such as those collected                the quantity of antimicrobials sold or                   (Comment 7) Some comments suggest
                                                under NARMS. Data from multiple                         distributed for use in food-producing                 that, instead of or in addition to
                                                sources are needed to provide a                         animals (reported under § 514.87 as                   collecting the species-specific estimates
                                                comprehensive and science-based                         established under this final rule) and                that would be required as proposed in
                                                picture of antimicrobial drug use and                   data on antimicrobial use and                         § 514.87(c), we should collect and report
                                                resistance in animal agriculture. Such                  resistance, for example, data collected               the information already provided in


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00025   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                29136             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                veterinary feed directive (VFD) orders                  portfolio in different ways. Because of               sponsors under paragraph (c) [of
                                                and information related to these orders.                these differences, it seems likely that               § 514.87] to be confidential business
                                                   (Response 7) The VFD regulation                      sponsors’ methods of gathering these                  information consistent with section 512
                                                outlines the process for authorizing use                sales data will vary considerably.                    (l)(3) of the FD&C Act and this Agency’s
                                                of VFD drugs (animal drugs intended for                    We believe that animal drug sponsors               regulations at 21 CFR 20.61.’’ (80 FR
                                                use in or on animal feed that require the               currently have access to information                  28863 at 28867). In recognition of this
                                                supervision of a licensed veterinarian)                 obtained in the ordinary course of their              concern, we further stated in the
                                                and provides veterinarians in all States                business (for example, through                        proposed rule that, consistent with the
                                                with a framework for authorizing the                    proprietary marketing analyses) that can              statute, FDA would not ‘‘independently
                                                use of these VFD drugs, including                       be used to formulate the methodology to               report those antimicrobial classes with
                                                medically important antimicrobials,                     estimate the percentage of annual                     fewer than three distinct sponsors, and
                                                when needed for specific animal health                  product sales that are sold or distributed            would further require that, in reporting
                                                purposes. The VFD regulation provides                   domestically for use in any of the four               the antimicrobial drug sales and
                                                that all distributors, regardless of                    major food-producing species that                     distribution data it receives from drug
                                                whether or not they manufacture animal                  appear on the approved product label.                 sponsors, FDA must do so in a manner
                                                feeds bearing or containing VFD drugs,                  In addition, sponsors have different                  consistent with protecting both national
                                                must keep records of receipt and                        business models that determine the                    security and confidential business
                                                distribution for 2 years from the date of               manner in which they gather sales data;               information (see section 512(l)(3)(E)(i)
                                                issuance in accordance with 21 CFR                      thus, specific methodologies to                       and (ii) of the FD&C Act).’’ (80 FR 28863
                                                558.6(c)(3).                                            accurately estimate species-specific                  at 28867.) After considering the
                                                   We appreciate the commenters’                        sales will likely differ among sponsors.              comments received in response to the
                                                suggestions that we gather the                          As we finalize this rule and establish                proposed rule, we conclude there are
                                                information provided in VFD orders and                  the requirement that sponsors estimate                sufficient safeguards in place to ensure
                                                information related to these orders.                    species-specific sales for the major food-            the protection of confidential
                                                While there are some limitations to the                 producing species, we recognize that                  commercial information, including the
                                                gathering of such information, we agree                 specifying a uniform methodology for                  species-specific information required to
                                                that this information has value. For that               estimating species-specific sales might               be submitted by individual firms in
                                                reason, we continue to consider options                 cause a firm to provide estimates in a                accordance with § 514.87(c). Therefore,
                                                to capture such information.                            manner not best suited to their                       we are not removing the requirement for
                                                   We believe that VFD records are an                   individual business processes, leading                species-specific sales and distribution
                                                important source of information for                     the firm to expend more time to provide               estimates under § 514.87(c) for
                                                assessing veterinary oversight of VFD                   species-specific sales estimates that may             confidentiality reasons as the comment
                                                drugs and compliance with the VFD                       be less accurate than those derived from              requests and are finalizing the provision
                                                regulation. These records are required to               utilizing their own methodology. The                  at § 514.87(e) relating to the
                                                be made available to FDA during                         provision at § 514.87(c) requires that                confidentiality of sales and distribution
                                                inspections. Therefore, as part of these                firms provide species-specific sales                  data as proposed.
                                                inspectional activities, we intend to use               estimates. We expect these estimates to                  (Comment 10) One comment suggests
                                                these records to review compliance with                 be based on the methodology that                      that we modify proposed § 514.87(c) to
                                                the VFD regulations, to ensure that the                 provides the sponsor’s most accurate                  include fish on the list of animal species
                                                VFD drug and VFD feed are used                          estimate of these sales.                              categories for which sponsors are
                                                according to the conditions and                            Also, as we noted in the proposed                  required to report species-specific
                                                indications of use as specified in the                  rule, this provision is not intended to               estimates.
                                                approval, conditional approval, or index                require animal drug sponsors to conduct                  (Response 10) We carefully
                                                listing, and within the supervision and                 studies of on-farm drug use practices (80             considered the suggestion to include
                                                oversight of a licensed veterinarian.                   FR 28863 at 28866). For these reasons,                fish on the list of animal species
                                                   (Comment 8) One comment generally                    we decline at this time to provide a                  categories for which species-specific
                                                supports the collection of sales data, but              standard methodology for developing                   estimates must be submitted and
                                                suggests that we provide a specific                     species-specific sales estimates.                     decided to retain the categories that
                                                methodology for making species-                            (Comment 9) One comment suggests                   were identified in proposed § 514.87(c)
                                                specific sales estimates to reduce the                  that we should not collect the species-               without modification. We consider the
                                                likelihood of inaccurate reporting of                   specific sales and distribution estimates             most significant risk to the public health
                                                these estimates.                                        that we proposed to require under                     associated with antimicrobial resistance
                                                   (Response 8) We appreciate the                       § 514.87(c) until legal challenges over               related to the use of antimicrobial drugs
                                                commenter’s interest in obtaining the                   disclosure of confidential commercial                 in animal agriculture to be human
                                                most accurate data and their suggestion                 information are resolved.                             exposure to food containing
                                                that we identify a specific methodology                    (Response 9) We have carefully                     antimicrobial-resistant bacteria resulting
                                                for developing species-specific sales                   considered the issues regarding the                   from the exposure of food-producing
                                                estimates. We appreciate and agree with                 protection of confidential commercial                 animals to antimicrobials. However,
                                                the need to gather the best data. We also               information. As we stated in the                      when considering the foodborne
                                                recognize that the sponsors who are                     proposed rule, ‘‘[s]ince it is likely that            pathway, the potential for human
                                                required to report have different ways of               many sponsors would consider their                    exposure to antimicrobial-resistant
                                                managing their businesses, including                    species-specific sales and distribution               pathogens currently is significantly less
jstallworth on DSK7TPTVN1PROD with RULES




                                                different ways of capturing sales and                   estimates as proprietary information,                 for food derived from minor species
                                                distribution data. In other words,                      and that such estimates may often be                  than it is for food derived from the food-
                                                different sponsors gather sales data on                 derived from proprietary marketing                    producing major species. The exposure
                                                similar drug products in different ways                 analyses, FDA would, as described in                  potential is less in part because the
                                                and, sometimes, the same sponsor may                    proposed paragraph (e) [of § 514.87],                 amount of food derived from cattle,
                                                gather sales data on different drug                     consider the species-specific                         swine, and poultry is much greater than
                                                products within their own drug product                  information reported by individual                    the amount of food derived from sheep,


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00026   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                            29137

                                                goats, and aquaculture, the minor                       important is to support data we obtain                sponsors of the affected antimicrobial
                                                species from which the most food is                     from NARMS. NARMS retail meat and                     new animal drug products began
                                                derived (Refs. 1 and 2). In the United                  animal sampling focus on the same four                submitting their sales and distribution
                                                States, human foodborne illnesses are                   major food-producing species. The                     data to us on an annual basis, and we
                                                attributed mostly to plant and land                     category ‘‘other species/unknown’’ will               have published summary reports of
                                                animal commodities (Ref. 3).                            be used to capture the percentage of                  such data for each calendar year
                                                Furthermore, the majority of illnesses                  each new animal drug product that was                 beginning with 2009. Starting in 2014,
                                                attributed to fish exposure are                         sold or distributed for use in animal                 we increased the amount of data
                                                intoxications rather than bacterial                     species other than the four major food-               provided in our annual summary
                                                illnesses (Ref. 4). Additionally, most                  producing species or otherwise                        reports by including ‘‘additional data
                                                fish and seafood consumed in the                        unknown to the reporting drug sponsor.                tables on the importance of each drug
                                                United States are imported products                     Since there is currently limited                      class in human medicine, the approved
                                                (Ref. 5).                                               resistance data related to minor food-                routes of administration for these
                                                   In addition, as discussed in the                     producing animals and companion                       antimicrobials, whether these
                                                proposed rule, we believe having                        animals, requiring estimates of these                 antimicrobials are available over-the-
                                                species-specific estimates of product                   additional species would cause                        counter or require veterinary oversight,
                                                sales and distribution for use in the four              additional burden without clear benefit.              and whether the antimicrobial drug
                                                major food-producing categories of                        (Comment 12) One comment suggests                   products are approved for therapeutic
                                                animal species (cattle, swine, chickens,                that we should not report species-                    purposes, or both therapeutic and
                                                turkeys) will be important in supporting                specific information in our annual                    production purposes.’’ (80 FR 28863 at
                                                efforts such as NARMS, a surveillance                   reports, arguing that by doing so we                  28867.)
                                                program that monitors trends in                         would disclose confidential commercial                   Sponsors currently are not required to
                                                antimicrobial resistance among                          information in violation of proposed                  report sales and distribution data broken
                                                foodborne bacteria from humans, retail                  § 514.87(e).                                          out by the specific purpose for which
                                                meats, and animals. NARMS retail meat                     (Response 12) As discussed in our
                                                                                                                                                              these drug products are used. Many
                                                and animal sampling focus on the same                   response to comment 9, we have
                                                                                                                                                              sales of antimicrobials by drug sponsors
                                                four major food-producing species                       carefully considered the issues
                                                                                                                                                              are to distributors who, in turn, may sell
                                                included in § 514.87(c). NARMS does                     regarding the protection of confidential
                                                                                                                                                              to other distributors or to end users (e.g.,
                                                not currently have a surveillance system                commercial information and the
                                                                                                                                                              feed mills or animal producers). Thus,
                                                for antimicrobial resistance pathogens                  disclosure of species-specific
                                                                                                                                                              this type of information (i.e., how the
                                                from aquaculture products. Since there                  information in our annual summary
                                                                                                                                                              drug product sold by the sponsor is
                                                is currently limited resistance data                    reports. After considering the comments
                                                                                                        received in response to the proposed                  ultimately used in a labeled species) is
                                                related to minor food-producing animals
                                                                                                        rule, we are not persuaded that                       generally not even known by the drug
                                                (including fish) and companion
                                                                                                        reporting species-specific information in             sponsor. Also, as we note in our
                                                animals, requiring estimates of these
                                                                                                        our annual summary reports will lead to               response to comment 8, reporting
                                                additional species at this time would
                                                                                                        the disclosure of confidential                        species-specific estimates of sales and
                                                cause additional burden without clear
                                                                                                        commercial information. We will only                  distribution under § 514.87 is not
                                                benefit to our understanding of
                                                                                                        provide sales data in our summary                     intended to require animal drug
                                                antimicrobial resistance. NARMS does
                                                collect some resistance data on import                  reports that has been aggregated to avoid             sponsors to conduct studies of on-farm
                                                isolates of Salmonella, which include                   disclosing confidential commercial                    drug use practices (80 FR 28863 at
                                                some seafood isolates; however, because                 information. We are finalizing the rule               28866) (e.g., use in particular species for
                                                these data are from imports, data on                    as proposed, which includes safeguards                particular indications). Because the
                                                domestic distribution and sales of                      for the protection of confidential                    sales and distribution data we are
                                                antimicrobials for use in aquaculture                   business information related to the                   collecting from drug sponsors does not
                                                would not be informative to NARMS                       reporting of species-specific estimates of            include information about how the
                                                and our overall efforts to assess                       sales by drug sponsors, consistent with               drugs were ultimately used, such data
                                                antimicrobial use and resistance                        section 512(l)(3)(E) of the FD&C Act and              also will not be included in our annual
                                                domestically.                                           our disclosure regulations at § 20.61.                summary reports.
                                                   (Comment 11) One comment suggests                      (Comment 13) Several comments                          As we note in our response to
                                                that we modify proposed § 514.87(c) to                  suggest we report a wider scope of                    comments 1, 5, and 6, we recognize that
                                                remove the category ‘‘other species/                    information in our annual summary                     data from multiple sources are needed
                                                unknown’’ and replace it with two                       reports that would be required under                  to provide a comprehensive and
                                                categories, ‘‘other species’’ and                       proposed § 514.87(f). One comment                     science-based picture of antimicrobial
                                                ‘‘unknown’’, so that those estimates                    suggests we should provide more                       drug use and resistance in animal
                                                could be independently reported.                        detailed information on why                           agriculture. We are collaborating with
                                                   (Response 11) We appreciate the                      antimicrobials are used; for example, to              the USDA and the CDC to develop a
                                                suggestion to collect sales data on both                distinguish use for growth promotion or               plan for collecting additional on-farm
                                                ‘‘other species’’ and ‘‘unknown’’;                      disease prevention from use for disease               data on antimicrobial use and
                                                however, we have determined that there                  control or treatment. Another comment                 resistance. Such data are intended to
                                                is not a clear benefit to having this                   suggests that we should collaborate with              supplement existing information,
                                                information reported separately at this                 the USDA and the CDC to develop a                     including data on the quantity of
jstallworth on DSK7TPTVN1PROD with RULES




                                                time. As noted in our response to                       communication plan to explain the                     antimicrobials sold or distributed for
                                                comment 1, one of the reasons we                        implications of collected data for human              use in food-producing animals (reported
                                                believe that having species-specific                    and animal health.                                    under § 514.87 as established under this
                                                estimates of product sales and                            (Response 13) We appreciate the                     final rule) and data on antimicrobial use
                                                distribution in the four major food-                    comment that we report a wider scope                  and resistance, for example, data
                                                producing categories of animal species                  of information in our annual summary                  collected under the NAHMS and
                                                (cattle, swine, chickens, turkeys) will be              reports. As required by ADUFA 105,                    NARMS programs.


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00027   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                29138             Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

                                                   We appreciate the comment                            deadline is widely supported by                       rule that includes any Federal mandate
                                                suggesting that we collaborate with the                 advocacy groups and some animal                       that may result in the expenditure by
                                                USDA and the CDC to develop a                           industry groups. Adhering to this                     State, local, and tribal governments, in
                                                communication plan to explain the                       deadline would provide up-to-date data                the aggregate, or by the private sector, of
                                                implications of collected data for human                to the stakeholders and would be                      $100,000,000 or more (adjusted
                                                and animal health. We will also                         necessary to inform current regulatory                annually for inflation) in any one year.’’
                                                continue to work with the USDA, the                     decisions.                                            The current threshold after adjustment
                                                CDC, and other government agencies to                      In addition to the comments specific               for inflation is $144 million, using the
                                                analyze and report on the implications                  to this rulemaking that we addressed                  most current (2014) Implicit Price
                                                of the collected data.                                  previously in this preamble, we                       Deflator for the Gross Domestic Product.
                                                   (Comment 14) We received several                     received general comments expressing                  This final rule would not result in an
                                                comments suggesting modifications to                    views about the use of antimicrobials,                expenditure in any year that meets or
                                                how we report the data that we                          antimicrobial resistance, animal health               exceeds this amount.
                                                proposed to collect. One comment                        and husbandry practices, the expansion                  The Economic Analysis of Impacts of
                                                suggests we should make as much of                      of NARMS sampling, the enhancement                    the final rule performed in accordance
                                                this data as possible available to the                  of on-farm collection of information,                 with Executive Order 12866, Executive
                                                public, while protecting confidential                   and human antimicrobial drug use.                     Order 13563, the Regulatory Flexibility
                                                business information. Other comments                    These comments express broad policy                   Act, and the Unfunded Mandates
                                                suggest we should publish monthly                       views and do not address specific points              Reform Act is available at http://
                                                sales data and State- or regional-level                 related to this rulemaking. Therefore,                www.regulations.gov under the docket
                                                data.                                                   these general comments do not require                 number(s) for this final rule and at
                                                   (Response 14) We plan to report                      a response.                                           http://www.fda.gov/AboutFDA/
                                                aggregate data on domestic sales and                                                                          ReportsManualsForms/Reports/
                                                distribution for the entire reporting year,             V. Effective and Compliance Dates
                                                                                                                                                              EconomicAnalyses/default.htm.
                                                but not to include separate information                   This rule is effective July 11, 2016.
                                                for each month of the reporting year.                   Sponsors must comply with the                         VII. Analysis of Environmental Impact
                                                ADUFA 105 requires drug sponsors to                     reporting requirements in the final rule                We have determined under 21 CFR
                                                report sales and distribution data to us                when submitting their reports covering                25.30(h) that this action is of a type that
                                                broken out by month; however,                           the period of calendar year 2016.                     does not individually or cumulatively
                                                antimicrobial drug products may be                                                                            have a significant effect on the human
                                                                                                        VI. Economic Analysis of Impacts
                                                used at any time up to several years                                                                          environment. Therefore, neither an
                                                after distribution. As noted in the                        We have examined the impacts of the                environmental assessment nor an
                                                proposed rule, we consider monthly                      final rule under Executive Order 12866,               environmental impact statement is
                                                fluctuations in drug product sales to be                Executive Order 13563, the Regulatory                 required.
                                                of limited value in reflecting when                     Flexibility Act (5 U.S.C. 601–612), and
                                                                                                        the Unfunded Mandates Reform Act of                   VIII. Paperwork Reduction Act of 1995
                                                products may actually be administered
                                                to animals and interpreting                             1995 (Pub. L. 104–4). Executive Orders                  This final rule contains information
                                                antimicrobial resistance trends, since                  12866 and 13563 direct us to assess all               collection provisions that are subject to
                                                much of monthly patterns are more                       costs and benefits of available regulatory            review by the Office of Management and
                                                reflective of distribution and business                 alternatives and, when regulation is                  Budget (OMB) under the Paperwork
                                                practices rather than of any fluctuations               necessary, to select regulatory                       Reduction Act of 1995 (44 U.S.C. 3501–
                                                in use by or sales to the end user (80 FR               approaches that maximize net benefits                 3520). The title, description, and
                                                28863 at 28867).                                        (including potential economic,                        respondent description of the
                                                   Regarding the suggestion that we                     environmental, public health and safety,              information collection provisions are
                                                report State- or regional-level data,                   and other advantages; distributive                    shown in the following paragraphs with
                                                sponsors are not required to report sales               impacts; and equity). We have                         an estimate of the one-time and annual
                                                and distribution data broken out by                     developed a comprehensive Economic                    reporting and recordkeeping burdens.
                                                States or regions. As we note in our                    Analysis of Impacts that assesses the                 Included in the estimate is the time for
                                                response to comment 13, many sales of                   impacts of the final rule. We believe that            reviewing instructions, searching
                                                antimicrobials by drug sponsors are to                  this final rule is not a significant                  existing data sources, gathering and
                                                distributors who, in turn, may sell to                  regulatory action as defined by                       maintaining the data needed, and
                                                other distributors or to end users (e.g.,               Executive Order 12866.                                completing and reviewing each
                                                feed mills or animal producers). Thus,                     The Regulatory Flexibility Act                     collection of information.
                                                geographic distribution of sales as                     requires us to analyze regulatory options               Title: Antimicrobial Animal Drug
                                                detailed as State- or regional-level sales              that would minimize any significant                   Distribution Reports and Recordkeeping
                                                data are generally not even known by                    impact of a rule on small entities.                   (21 CFR part 514)—OMB Control No.
                                                the drug sponsors. For these reasons, we                Because the final rule will impose                    0910–0659—Revision
                                                decline to make the modifications to our                average annualized costs that amount to                 Description: The ADUFA 105
                                                summary reports suggested by the                        less than 0.01 percent of average annual              legislation was enacted in 2008 to
                                                commenters and are finalizing the                       revenues on those small entities that we              address the problem of antimicrobial
                                                language in § 514.87(f) as proposed.                    expect to sponsor NADAs, we have                      resistance and to help ensure that we
                                                   (Comment 15) Several comments ask                    determined that the final rule will not               have the necessary information to
jstallworth on DSK7TPTVN1PROD with RULES




                                                that we adhere to the proposed deadline                 have a significant economic impact on                 examine safety concerns related to the
                                                of December 31st of the following year                  a substantial number of small entities.               use of antibiotics in food-producing
                                                for the annual reporting of sales data.                    The Unfunded Mandates Reform Act                   animals. ADUFA 105 amended section
                                                   (Response 15) We plan to publish our                 of 1995 (section 202(a)) requires us to               512 of the FD&C Act to require that
                                                annual summary report for each                          prepare a written statement, which                    sponsors of approved or conditionally
                                                calendar year by December 31st of the                   includes an assessment of anticipated                 approved applications for new animal
                                                following year. We note that this                       costs and benefits, before issuing ‘‘any              drugs containing an antimicrobial active


                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00028   Fmt 4700   Sfmt 4700   E:\FR\FM\11MYR1.SGM   11MYR1


                                                                        Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                                                                                29139

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

                                                                                                   TABLE 1—ESTIMATED ONE-TIME NUMBER REPORTING BURDEN 1
                                                                                                                                                                         Number of                                                Average
                                                                                                                                              Number of                                            Total annual
                                                                               21 CFR Section                                                                          responses per                                            burden per              Total hours
                                                                                                                                             respondents                                            responses
                                                                                                                                                                         respondent                                              response

                                                514.87(a) through (e)—Administrative Review of the Rule:
                                                  Sponsors With Active Applications ..................................                                          20                           1                        20                         24              480
                                                514.87(a) through (e)—Administrative Review of the Rule:
                                                  Sponsors With Inactive Applications ................................                                           7                           1                          7                         1                   7
                                                514.87(c)—Report Species-Specific Estimate of Percent of
                                                  Products Distributed Domestically ...................................                                         20                      7.50                        150                           2              300

                                                     Total ..............................................................................   ........................   ........................   ........................   ........................            787
jstallworth on DSK7TPTVN1PROD with RULES




                                                   1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


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



                                           VerDate Sep<11>2014       15:15 May 10, 2016          Jkt 238001       PO 00000       Frm 00029       Fmt 4700        Sfmt 4700      E:\FR\FM\11MYR1.SGM                11MYR1


                                                29140                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations

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

                                                                                                            TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                        Number of                                                Average
                                                                                                                                             Number of                                            Total annual
                                                                 21 CFR Section                                     FDA form                                          responses per                                            burden per              Total hours
                                                                                                                                            respondents                                            responses
                                                                                                                                                                        respondent                                              response

                                                514.87(a) through (e)—Annual Reports
                                                  for Sponsors With Active Applica-
                                                  tions—Paper Submission .....................                                  3744                           10                        7.5                        75                         62             4,650
                                                514.87(a) through (e)—Annual Reports
                                                  for Sponsors With Active Applica-
                                                  tions—Electronic Submission ...............                                   3744                           10                        7.5                        75                         52             3,900
                                                514.87(a) through (e)—Annual Reports
                                                  for Sponsors With Inactive Applica-
                                                  tions—Paper Submission .....................                                 3744                              4                     26.5                       106                             2             212
                                                514.87(a) through (e)—Annual Reports
                                                  for Sponsors With Inactive Applica-
                                                  tions—Electronic Submission ...............                                   3744                            3                         35                       105                            2             210

                                                     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                                 These collections of information are                                         levels of government. Accordingly, we
                                                annual reporting burden associated with                                 subject to review by OMB under the                                           conclude that the rule does not contain
                                                the final rule. While we expect new                                     Paperwork Reduction Act of 1995. The                                         policies that have federalism
                                                § 514.87(c) will require 3 burden hours                                 collections of information in § 514.80                                       implications as defined in the Executive
                                                resulting from including species-                                       are approved under OMB control                                               Order and, consequently, a federalism
                                                specific estimates, we believe 1 hour                                   number 0910–0284. The collections of                                         summary impact statement is not
                                                will be saved by eliminating the                                        information in 21 CFR 211.196 are                                            required.
                                                requirement for sponsors to calculate                                   approved under OMB control number
                                                                                                                                                                                                     X. References
                                                the amount of antimicrobial active                                      0910–0139.
                                                ingredients associated with their                                          The information collection provisions                                       The following references are on
                                                monthly product sales and distribution                                  of this final rule have been submitted to                                    display in the Division of Dockets
                                                data (§ 514.80(b)(4)(i)(A)). Consequently,                              OMB for review as required by section                                        Management (see ADDRESSES) and are
                                                we estimate that the 20 sponsors with                                   3507(d) of the Paperwork Reduction Act                                       available for viewing by interested
                                                active applications will each expend                                    of 1995. Prior to the effective date of this                                 persons between 9 a.m. and 4 p.m.
                                                approximately 2 additional reporting                                    final rule, FDA will publish a notice in                                     Monday through Friday; they are also
                                                hours annually for new § 514.87.                                        the Federal Register announcing OMB’s                                        available electronically at http://
                                                Because the Agency, upon                                                decision to approve, modify, or                                              www.regulations.gov. FDA has verified
                                                implementation of the rule, will accept                                 disapprove the information collection                                        the Web site addresses, as of the date
                                                both paper and electronic submissions,                                  provisions in this final rule. An Agency                                     this document publishes in the Federal
                                                and we assume that half of the                                          may not conduct or sponsor, and a                                            Register, but Web sites are subject to
                                                respondents will report electronically,                                 person is not required to respond to, a                                      change over time.
                                                we estimate 10 respondents for each                                     collection of information unless it                                          1. USDA, ‘‘Livestock & Meat Domestic Data,’’
                                                submission method as shown in rows 1                                    displays a currently valid OMB control                                             http://www.ers.usda.gov/data-products/
                                                and 2.                                                                  number.                                                                            livestock-meat-domestic-data.
                                                                                                                                                                                                     2. ‘‘Food Fish Production and Sales by
                                                  While we estimate no increase in
                                                                                                                        IX. Federalism                                                                     Species, by Size Category, by State and
                                                burden for the seven sponsors of                                                                                                                           United States: 2005,’’ http://www.
                                                inactive applications, we similarly will                                  We have analyzed this final rule in                                              agcensus.usda.gov/Publications/2002/
                                                accept both paper and electronic                                        accordance with the principles set forth                                           Aquaculture/aquacen2005_08.pdf.
                                                submissions. Accordingly we have                                        in Executive Order 13132. We have                                            3. Painter, J. A., R. M. Hoekstra, T. Ayers, et
jstallworth on DSK7TPTVN1PROD with RULES




                                                reported, unchanged, the 2 hours of                                     determined that the rule does not                                                  al., ‘‘Attribution of Foodborne Illnesses,
                                                burden already approved under OMB                                       contain policies that have substantial                                             Hospitalizations, and Deaths to Food
                                                control number 0910–0659 in rows 3                                                                                                                         Commodities by Using Outbreak Data,
                                                                                                                        direct effects on the States, on the                                               United States, 1998–2008,’’ Emerging
                                                and 4.                                                                  relationship between the National                                                  Infectious Diseases, 19(3):407–415, 2013.
                                                  This final rule also refers to other                                  Government and the States, or on the                                         4. Gould, L. H., K. A. Walsh, A. R. Vieira, et
                                                currently approved collections of                                       distribution of power and                                                          al., ‘‘Surveillance for Foodborne Disease
                                                information found in our regulations.                                   responsibilities among the various                                                 Outbreaks—United States, 1998–2008,’’



                                           VerDate Sep<11>2014       15:15 May 10, 2016         Jkt 238001      PO 00000        Frm 00030       Fmt 4700        Sfmt 4700      E:\FR\FM\11MYR1.SGM                11MYR1


                                                                  Federal Register / Vol. 81, No. 91 / Wednesday, May 11, 2016 / Rules and Regulations                                                29141

                                                     Morbidity and Mortality Weekly Report.             annual periodic drug experience reports               United States (i.e., quantities exported)
                                                     Surveillance Summaries, 62(2):1–34,                for such applications is January 1. For               for each month of the reporting year.
                                                     2013.                                              applications that currently have a                      (c) Each report must also provide a
                                                5. ‘‘Aquaculture in the United States,’’ http://        reporting period that begins on a date                species-specific estimate of the
                                                     www.nmfs.noaa.gov/aquaculture/
                                                                                                        other than January 1, applicants must                 percentage of each product described in
                                                     aquaculture_in_us.html.
                                                                                                        request a change in reporting                         paragraph (b)(2) of this section that was
                                                List of Subjects in 21 CFR Part 514                     submission date such that the reporting               sold or distributed domestically in the
                                                  Administrative practice and                           period begins on January 1 and ends on                reporting year for use in any of the
                                                procedure, Animal drugs, Confidential                   December 31, as described in paragraph                following animal species categories, but
                                                business information, Reporting and                     (b)(4) of this section.                               only for such species that appear on the
                                                recordkeeping requirements.                                (3) Applicants that change their                   approved label: Cattle, swine, chickens,
                                                                                                        reporting submission date must also                   turkeys. The total of the species-specific
                                                  Therefore, under the Federal Food,
                                                                                                        submit a special drug experience report,              percentages reported for each product
                                                Drug, and Cosmetic Act and under
                                                                                                        as described in paragraph (b)(5)(i) of this           must account for 100 percent of its sales
                                                authority delegated to the Commissioner
                                                                                                        section, that addresses any gaps in                   and distribution; therefore, a fifth
                                                of Food and Drugs, 21 CFR part 514 is
                                                                                                        distribution data caused by the change                category of ‘‘other species/unknown’’
                                                amended as follows:
                                                                                                        in date of submission.                                must also be reported.
                                                PART 514—NEW ANIMAL DRUG                                   (4) Applicants who choose not to                     (d) Each report must:
                                                                                                        report under paragraph (b)(4)(i)(A) of                  (1) Be submitted not later than March
                                                APPLICATIONS
                                                                                                        this section must ensure that full sales              31 each year;
                                                ■  1. The authority citation for part 514               and distribution data for each product                  (2) Cover the period of the preceding
                                                is revised to read as follows:                          approved under such applications are                  calendar year; and
                                                                                                        alternatively reported under § 514.87,                  (3) Be submitted using Form FDA
                                                  Authority: 21 U.S.C. 321, 331, 351, 352,                                                                    3744, ‘‘Antimicrobial Animal Drug
                                                354, 356a, 360b, 360ccc, 371, 379e, 381.                including products that are labeled for
                                                                                                        use only in nonfood-producing animals.                Distribution Report.’’
                                                ■ 2. In § 514.80, revise the fifth sentence                                                                     (e) Sales and distribution data and
                                                of paragraph (b)(4) introductory text and               *      *     *     *    *                             information reported under this section
                                                paragraph (b)(4)(i) to read as follows:                 ■ 3. Add § 514.87 to subpart B to read                will be considered to fall within the
                                                                                                        as follows:                                           exemption for confidential commercial
                                                § 514.80 Records and reports concerning                                                                       information established in § 20.61 of
                                                experience with approved new animal                     § 514.87 Annual reports for antimicrobial
                                                drugs.                                                  animal drug sales and distribution.                   this chapter and will not be publicly
                                                                                                                                                              disclosed, except that summary reports
                                                *     *      *     *     *                                (a) The applicant for each new animal
                                                                                                                                                              of such information aggregated in such
                                                  (b) * * *                                             drug product approved under section
                                                                                                                                                              a way that does not reveal information
                                                  (4) * * * The yearly periodic drug                    512 of the Federal Food, Drug, and
                                                                                                                                                              that is not available for public
                                                experience reports must be submitted                    Cosmetic Act, or conditionally approved
                                                                                                                                                              disclosure under this provision will be
                                                within 90 days of the anniversary date                  under section 571 of the Federal Food,
                                                                                                                                                              prepared by FDA and made available to
                                                of the approval of the NADA or                          Drug, and Cosmetic Act, and containing
                                                                                                                                                              the public as provided in paragraph (f)
                                                ANADA. * * *                                            an antimicrobial active ingredient, must
                                                                                                                                                              of this section.
                                                  (i) Distribution data. (A) Information                submit an annual report to FDA on the
                                                                                                                                                                (f) FDA will publish an annual
                                                about the distribution of each new                      amount of each such antimicrobial
                                                                                                                                                              summary report of the data and
                                                animal drug product, including                          active ingredient in the drug that is sold
                                                                                                                                                              information it receives under this
                                                information on any distributor-labeled                  or distributed in the reporting year for
                                                                                                                                                              section for each calendar year by
                                                product. This information must include                  use in food-producing animal species,
                                                                                                                                                              December 31 of the following year. Such
                                                the total number of distributed units of                including information on any
                                                                                                                                                              annual reports must include a summary
                                                each size, strength, or potency (e.g.,                  distributor-labeled product.
                                                                                                                                                              of sales and distribution data and
                                                100,000 bottles of 100 5-milligram                        (b) This report must identify the                   information by antimicrobial drug class
                                                tablets; 50,000 10-milliliter vials of 5-               approved or conditionally approved                    and may include additional summary
                                                percent solution). This information                     application and must include the                      data and information as determined by
                                                must be presented in two categories:                    following information for each new                    FDA. In order to protect confidential
                                                Quantities distributed domestically and                 animal drug product described in                      commercial information, each
                                                quantities exported.                                    paragraph (a) of this section:                        individual datum appearing in the
                                                  (B) Applicants submitting annual                        (1) A listing of each antimicrobial                 summary report must:
                                                sales and distribution reports for                      active ingredient contained in the                      (1) Reflect combined product sales
                                                antimicrobial new animal drug products                  product;                                              and distribution data and information
                                                under § 514.87 have the option not to                     (2) A description of each product sold              obtained from three or more distinct
                                                report distribution data under paragraph                or distributed by unit, including the                 sponsors of approved products that
                                                (b)(4)(i)(A) of this section for the                    container size, strength, and dosage                  were actively sold or distributed that
                                                approved applications that include                      form of such product units;                           reporting year, and
                                                these same products, but only provided                    (3) For each such product, a listing of               (2) Be reported in a manner consistent
                                                each of the following conditions are                    the target animal species, indications,               with protecting both national security
                                                met:                                                    and production classes that are                       and confidential commercial
jstallworth on DSK7TPTVN1PROD with RULES




                                                  (1) Applicants must have submitted                    specified on the approved label;                      information.
                                                complete periodic drug experience                         (4) For each such product, the number
                                                                                                        of units sold or distributed in the United              Dated: May 6, 2016.
                                                reports under this section for such
                                                applications for at least 2 full years after            States (i.e., domestic sales) for each                Leslie Kux,
                                                the date of their initial approval.                     month of the reporting year; and                      Associate Commissioner for Policy.
                                                  (2) Applicants must ensure that the                     (5) For each such product, the number               [FR Doc. 2016–11082 Filed 5–10–16; 8:45 am]
                                                beginning of the reporting period for the               of units sold or distributed outside the              BILLING CODE 4164–01–P




                                           VerDate Sep<11>2014   15:15 May 10, 2016   Jkt 238001   PO 00000   Frm 00031   Fmt 4700   Sfmt 9990   E:\FR\FM\11MYR1.SGM   11MYR1



Document Created: 2016-05-11 01:11:23
Document Modified: 2016-05-11 01:11:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis rule is effective July 11, 2016. For the applicable compliance dates, please see section V, ``Effective and Compliance Dates'' in SUPPLEMENTARY INFORMATION.
ContactWith 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]
FR Citation81 FR 29129 
RIN Number0910-AG45
CFR AssociatedAdministrative Practice and Procedure; Animal Drugs; Confidential Business Information and Reporting and Recordkeeping Requirements

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR