[Federal Register: July 21, 2010 (Volume 75, Number 139)]
[Notices]
[Page 42431]
[DOCID:fr21jy10-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2985-008-MA]

Onyx Specialty Papers, Inc; Notice Soliciting Applications

July 14, 2010.
    On April 29, 2009, Onyx Specialty Papers, Inc. (Onyx), licensee for
the Willow Mill Project No. 2985, filed an application for a subsequent
license for the project pursuant to section 15(b)(1) of the Federal
Power Act (FPA). The license application was timely filed and an
Environmental Assessment was issued on February 2, 2010. On June 1,
2010, Onyx filed a withdrawal of its subsequent license application,
and concurrently filed an application to surrender its license.
    The project is located on the Housatonic River in the Town of
Stockbridge, Berkshire County, Massachusetts. The project consists of:
(1) A 14-foot-high, 150-foot-wide stone masonry gravity dam; (2) an 11-
acre impoundment; (3) a 10-foot-deep, 18-foot-wide, 50-foot-long rubble
and masonry canal connected to a 10-foot-deep, 18-foot-wide, 260-foot-
long rubble and masonry underground headrace; (4) two 5.5-foot-long, 8-
foot diameter steel penstocks; (5) a 100-kW turbine generating unit;
and (6) a 210-foot-long pipe discharging water back into the Housatonic
River. The turbine generating unit is located in the basement of
MeadWestvaco's paper mill. There are no transmission lines associated
with the project because all of the power is used internally at Willow
Mill. The applicant estimates that the total average annual generation,
with the proposed minimum flow, would be approximately 256 megawatt-
hours.
    As a result of the withdrawal of Onyx's application, the Commission
is soliciting license applications from potential applicants. This is
because the deadline for filing applications for subsequent license was
April 30, 2009, and no application other than the licensee's was filed.
Thus, the Commission is giving other interested entities the
opportunity to file.
    The licensee is required to make available to the public certain
information described in section 16.7 of the regulations. For more
information from the licensee, please contact Mr. John Clements,
Counsel for Onyx Specialty Papers, Inc., Van Ness Feldman, PC, 1050
Jefferson Street, NW., Suite 700, Washington, DC 20007-3877, (202) 298-
1800.
    Pursuant to section 16.25(b), a potential applicant that files a
notice of intent within 90 days from the date of this notice: (1) May
apply for a license under Part I of the FPA and Part 4 (except section
4.38) of the Commission's Regulations within 18 months of the date on
which it files its notice; and (2) must comply with sections 16.8 and
16.10 of the Commission's Regulations.
    Questions concerning this notice should be directed to Robert Bell,
(202) 502-6062 or<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-17731 Filed 7-20-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Rules and Regulations]
[Pages 29129-29141]
[FR Doc No: 2016-11082]

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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.

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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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    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_ADDRESS>
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

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

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

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

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

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

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

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,

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.

    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

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.

    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,''

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