[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Proposed Rules]
[Pages 28863-28872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

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


Antimicrobial Animal Drug Sales and Distribution Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Animal Drug User Fee Amendments of 2008 (ADUFA) amended 
the Federal Food, Drug, and Cosmetic Act (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 the Food and Drug Administration (FDA or Agency) on 
the amount of each such ingredient in the drug that is sold or 
distributed for use in food-producing animals, and further requires FDA 
to publish annual summary reports of the data it receives from 
sponsors. At this time, FDA is issuing proposed regulations for the 
administrative practices and procedures for animal drug sponsors who 
must report under this law. This proposal also includes an additional 
reporting provision intended to enhance FDA's understanding of 
antimicrobial animal drug sales intended for use in specific food-
producing animal species.

DATES: Submit either electronic or written comments on the proposed 
rule by August 18, 2015. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 (the PRA) by June 19, 
2015 (see the ``Paperwork Reduction Act of 1995'' section of this 
document).

ADDRESSES: You may submit comments by any of the following methods, 
except that comments on information collection issues under the PRA 
must be submitted to the Office of Information and Regulatory Affairs, 
Office of Management and Budget (OMB) (see the ``Paperwork Reduction 
Act of 1995'' section).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-0447 for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section.
    Docket: 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 document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary 
Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9062, [email protected].

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of Proposed Rule

    Section 105 of ADUFA (ADUFA 105) amended section 512 of the FD&C 
Act (21 U.S.C. 360b) to require that sponsors of approved or 
conditionally approved applications for new animal drugs containing an 
antimicrobial active ingredient submit an annual report to FDA on the 
amount of each such ingredient in the drug that is sold or distributed 
for use in food-producing animals. ADUFA 105 also requires FDA to 
publish annual summary reports of the data it receives. In accordance 
with the new law, sponsors of the affected antimicrobial new animal 
drug products began submitting their sales and distribution data to FDA 
on an annual basis, and FDA published summaries of such data for each 
calendar year beginning with 2009. The purpose of this rulemaking is to 
amend the Agency's 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. This proposal also includes an 
additional reporting provision intended to further enhance FDA's 
understanding of antimicrobial animal drug sales

[[Page 28864]]

intended for use in specific food-producing animal species.

Summary of Major Provisions

    The proposed rule, if finalized, will amend the records and reports 
regulation in part 514 to include the following:
     Procedures relating to the submission to FDA of annual 
sales and distribution data reports by sponsors of approved new animal 
drug products sold or distributed for use in food-producing animals. 
The proposal includes specific reporting criteria, including the 
requirement that sponsors submit species-specific estimates of product 
sales as a percentage of total sales.
     Procedures applicable to FDA's preparation and publication 
of summary reports on an annual basis based on the sales and 
distribution data it receives from sponsors of approved antimicrobial 
new animal drug products. The proposal 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.
     Provisions that will give sponsors of approved new animal 
drug products containing antimicrobial active ingredients that are sold 
or distributed for use in food-producing animals the opportunity to 
avoid duplicative reporting of product sales and distribution data to 
FDA under part 514.

Costs and Benefits

    FDA estimates one-time costs to industry from this proposed rule, 
if finalized, at about $138,800. FDA estimates annual costs at about 
$55,700. These costs equate to an estimated total annualized cost of 
about $75,400 at a 7 percent discount rate over 10 years and about 
$71,900 at a 3 percent discount rate over 10 years. The total 
annualized costs include the administrative cost to review the rule 
($9,700), plus the cost to those sponsors who wish to avoid duplicative 
reporting requirements under part 514 ($4,800), plus the cost of 
providing the species-specific estimate of the percent of the drug 
product distributed domestically ($61,000).
    The proposed rule would provide some flexibility for the manner in 
which new animal drug sponsors report the sales and distribution data 
under both Sec.  514.80 and proposed Sec.  514.87, by allowing for only 
one set of report submissions under certain circumstances. FDA 
estimates that this will reduce labor costs for new animal drug 
sponsors by $100,200 annually.
    Another benefit of this proposed rule would be the cost savings 
associated with reporting monthly sales and distribution data to FDA in 
terms of product units rather than calculating the amount of 
antimicrobial active ingredients associated with these monthly product 
sales and distribution data. FDA estimates the calculation reductions 
would amount to an annual benefit of about $18,600. FDA estimates total 
annual benefits at about $118,800.

I. Background

    Section 105 of ADUFA (Pub. L. 110-316) amends section 512(l) of the 
FD&C Act by adding new section 512(l)(3). Section 512(l) of the FD&C 
Act requires sponsors of approved or conditionally approved new animal 
drug applications to establish and maintain records and make such 
reports to FDA of data and other information relating to experience 
with their new animal drugs as required by regulation or order. Under 
new section 512(l)(3) of the FD&C Act, sponsors of antimicrobial new 
animal drugs approved for use in food-producing animals must submit to 
FDA 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 FDA each year no later than March 31. Section 
512(l)(3) of the FD&C Act also requires FDA to publish an annual 
summary report of the antimicrobial drug sales and distribution data 
collected from the drug sponsors, and further provides that such data 
must be reported by antimicrobial class.
    The first reporting year under new section 512(l)(3) of the FD&C 
Act was calendar year 2009. In accordance with the new law, sponsors of 
affected new animal drug products submitted their 2009 sales and 
distribution data to FDA by March 31, 2010, and FDA published a summary 
report of these data later that same year. To date, FDA has collected 
sales and distribution data, and published summary reports of such 
data, for each calendar year from 2009 through and including 2012. As 
noted earlier, the purpose of this rulemaking is to amend FDA's 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, 
including a proposed provision intended to enhance understanding of 
antimicrobial new animal drug sales intended for use in specific food-
producing animal species. Collecting species-specific data is expected 
to assist FDA in assessing antimicrobial sales trends in the major 
food-producing animal species and examining how such trends may relate 
to antimicrobial resistance. Having improved data would also support 
this Agency's 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.
    FDA previously issued an advance notice of proposed rulemaking 
(ANPRM) to obtain public input on potential amendments to its animal 
drug records and reports regulation at part 514, including the proposed 
provision to require data about specific food-producing animal species 
discussed in this document. The comments FDA received in response to 
the ANPRM were considered in preparing this proposed rule.

II. Proposed Regulations

A. Records and Reports--Conforming Changes (Proposed Sec.  
514.80(b)(4)(i))

    Under current Sec.  514.80(b)(4) of the Agency's regulations, 
sponsors of approved new animal drugs are required to submit a periodic 
drug experience report to FDA. Such reports include information 
regarding known adverse drug experiences, study reports from any 
recently conducted laboratory or clinical studies, current product 
labeling, and, under paragraph (b)(4)(i), product distribution data. In 
order to avoid duplicative reporting, FDA proposes that applicants 
submitting annual sales and distribution reports for antimicrobial new 
animal drug products under proposed Sec.  514.87 would have the option 
to choose not to report distribution data under current Sec.  
514.80(b)(4)(i) for their approved applications that include these same 
products. However, this exemption from reporting under Sec.  
514.80(b)(4)(i) would only apply provided the following proposed 
conditions are met:
     Applicants would have to submit complete periodic drug 
experience

[[Page 28865]]

reports under Sec.  514.80(b)(4), including paragraph (b)(4)(i), for 
such applications for at least 2 full years after the date of the 
initial approval of their drug product application, in addition to the 
reporting that would be required under proposed Sec.  514.87. Under 
current Sec.  514.80(b)(4), applicants of newly approved applications 
must submit periodic drug experience reports every 6 months for the 
first 2 years and such reporting is only required annually after that. 
This requirement provides FDA with enhanced drug experience feedback on 
newly approved animal drug products for which the Agency and animal 
drug industry have less practical experience compared to mature animal 
drug products that have been marketed for 2 or more years. In contrast, 
proposed Sec.  514.87, which implements recently added section 
512(l)(3) of the FD&C Act, would only require sales and distribution 
reports for antimicrobial new animal drug products once per year. By 
retaining the requirement that applicants of such drug products submit 
complete periodic drug experience reports at 6-month intervals under 
Sec.  514.80(b)(4) for 2 full years after the date of the initial 
approval of their drug product application, this proposal would assure 
that enhanced drug experience surveillance for newly approved products 
is maintained.
     Applicants who wish to have the option of not providing 
distribution data as part of the periodic drug experience reports they 
submit under current Sec.  514.80(b)(4)(i) for those approved 
applications that include the same antimicrobial new animal drug 
products that are covered by the reporting requirements under proposed 
Sec.  514.87 would have to assure that the beginning of the reporting 
period for the annual periodic drug experience reports for such 
applications is January 1. Under Sec.  514.80(b)(4), the reporting 
period and submission deadline of yearly periodic drug experience 
reports is tied to the anniversary date of the drug's approval unless 
the applicant petitions for, and is granted, approval to change the 
reporting timeframes. For approved applications that have a reporting 
period that begins on a date other than January 1, applicants would 
submit a one-time request to change the submission date for their 
yearly (annual) periodic drug experience report such that the reporting 
period begins on January 1 and ends on December 31, as currently 
provided for in Sec.  514.80(b)(4). Such requests may be made at any 
time, but, consistent with the timeframe discussed in the previous 
paragraph, FDA will only grant such requests after at least 2 full 
years have elapsed since the date of the initial approval of the 
subject application. In accordance with section 512(l)(3) of the FD&C 
Act, reporting of antimicrobial drug sales and distribution data under 
proposed Sec.  514.87 would be by calendar year. The purpose of having 
affected applicants assure that the reporting period for their annual 
periodic drug experience reports begins on January 1 is so that the 
reporting periods for all annual reports submitted under part 514 for a 
particular application will be consistent and cover the same time 
period beginning January 1 of each year, regardless of whether 
submitted under Sec.  514.80(b)(4) or proposed Sec.  514.87.
     Once an applicant has changed the submission date to align 
with the reporting period for proposed Sec.  514.87 (beginning January 
1 of each year), the Agency would also expect the applicant to submit, 
on a one-time basis, a special drug experience report as described in 
current Sec.  514.80(b)(5)(i), that would address any gaps in 
distribution data caused by the change in reporting periods.
     Sponsors who hold approved applications for antimicrobial 
new animal drugs intended for use in food-producing animals who choose 
not to separately report distribution data for their products under 
Sec.  514.80(b)(4)(i) would have to assure that full sales and 
distribution data for each product approved under such applications are 
alternatively reported under proposed Sec.  514.87, including products 
approved under such applications that are labeled only for use in 
nonfood-producing animals. This would assure that all distribution data 
for every drug product under approved applications for antimicrobial 
new animal drugs intended for use in food-producing animals are 
reported to FDA and that all such data are reported under one 
regulation, proposed Sec.  514.87.
    FDA also proposes to revise Sec.  514.80(b)(4) by extending the 
deadline for submission of annual periodic drug experience reports from 
within 60 days to within 90 days of the anniversary date of the 
approval. For those applicants whose reporting period under Sec.  
514.80(b)(4) begins on January 1--either because the anniversary of the 
drug application's approval falls on that date or because the applicant 
petitions for, and is granted, a new submission date that aligns the 
reporting period under Sec.  514.80(b)(4) with the reporting period 
under proposed Sec.  514.87 (i.e., beginning January 1 of each year)--
this revision would harmonize the timeframe for submitting annual 
periodic drug experience reports following the close of the reporting 
period with the 90-day timeframe sponsors have to submit annual 
antimicrobial animal drug sales and distribution reports for the 
preceding calendar year (by no later than March 31) as required by 
section 512(l)(3) of the FD&C Act.

B. Annual Sponsor Reports of Antimicrobial Animal Drug Sales and 
Distribution Information (Proposed Sec.  514.87(a) Through (e))

    Proposed paragraph (a) would reflect 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 FDA 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 new animal drug 
application or abbreviated new animal drug application, as well as 
products that are conditionally approved under section 571 of the FD&C 
Act (21 U.S.C. 360ccc). Proposed paragraph (a) would also incorporate 
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).
    Proposed paragraph (b) sets out what information would need to be 
included in the drug sponsor's annual report in order to satisfy 
paragraph (a). Specifically, proposed paragraph (b) would require each 
annual report to identify the approved or conditionally approved 
application for the subject antimicrobial new animal drug product and 
include the following product-specific information (see section 
512(l)(3)(B) and (C)(iii) of the FD&C Act):
     A listing of each antimicrobial active ingredient 
contained in the product;
     a description of each unique marketed product by unit 
(i.e., container size, strength, and dosage form);
     for each such product, a listing of the target animal 
species, indications, and production classes that are specified on the 
approved label;
     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
     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.

[[Page 28866]]

    Currently, animal drug sponsors are complying with the requirements 
of section 512(l)(3) of the FD&C Act through a two-step process. First, 
they collect monthly sales and distribution data for their affected new 
animal drug products in terms of unit sales. Then they calculate the 
amount of antimicrobial active ingredients associated with those 
product sales and report those figures to FDA. After several years of 
collecting and collating sales and distribution data under section 
512(l)(3) of the FD&C Act, FDA believes the most effective and 
efficient method for achieving the goals of this statutory provision is 
for animal drug sponsors to limit their annual reporting to product 
sales and distribution data in terms of unit sales, and then FDA can 
use that information to calculate the exact amounts of antimicrobial 
active ingredients associated with those product sales. Animal drug 
sponsors are very experienced at collecting and reporting accurate 
sales and distribution data in terms of units of product sold or 
distributed because of their current obligation to annually report such 
information to FDA in their periodic drug experience reports under 
Sec.  514.80(b)(4). However, our experience has shown great variability 
in reporting accuracy when sponsors are asked to convert product sales 
data into active ingredient sales data. Such variability causes 
confusion for the Agency and requires more time to verify submitted 
data with sponsors. Therefore, FDA believes this approach will not only 
reduce the burden on both the sponsors and the Agency, but will greatly 
increase the accuracy of the final results.
    The Agency also believes a ``reporting by product'' approach is 
consistent with the requirements of ADUFA 105. Section 512(l)(3)(B) of 
the FD&C Act acknowledges that antimicrobial active ingredients are 
sold and distributed as products through its requirement that sponsors 
report their antimicrobial data by, among other things, ``container 
size, strength, and dosage form,'' and, ``for each such dosage form, a 
listing of the target animals, indications, and production classes that 
are specified on the approved label of the product.'' The container 
size, strength, and dosage form define a unique marketed product within 
an approved or conditionally approved application; therefore, under 
this proposal, if finalized, drug sponsors subject to the ADUFA 105 
reporting requirements would need to continue to provide separate 
antimicrobial sales and distribution data for each of these unique 
marketed products in their reports. With knowledge of all the unique 
marketed products within an approved or conditionally approved 
application, along with the unit sales and distribution data for each 
of these products, the amount of antimicrobial active ingredient 
associated with those sales can then be calculated. The only question 
is who will perform the calculations and, as noted earlier, FDA 
believes that the Agency is best suited to perform this function in 
order to maximize accuracy and efficiency.
    Further, proposed paragraph (b) would require the sponsor of an 
approved or conditionally approved antimicrobial new animal drug 
product to list in its annual report the target animals, indications, 
and production classes that are specified on the approved label of each 
unique product. FDA believes this requirement is consistent with the 
reporting requirements added to the FD&C Act by ADUFA 105. Section 
512(l)(3)(B) of the FD&C Act provides for sponsors to report their 
antimicrobial data by, among other things, container size, strength, 
and dosage form and, ``for each such dosage form, a listing of the 
target animals, indications, and production classes that are specified 
on the approved label of the product.'' As previously stated, the 
container size, strength, and dosage form define a unique marketed 
product within an approved or conditionally approved application. The 
dosage form is part of what defines a unique marketed product; thus, 
listing the target animals, indications, and production classes that 
are specified on the approved label of each unique product provides the 
information required by ADUFA 105.
    Proposed paragraph (c) would require that each annual report to FDA 
provide a species-specific estimate of the percentage of each new 
animal drug product containing an antimicrobial active ingredient that 
was sold or distributed domestically for use in cattle, swine, 
chickens, or turkeys, but only if such animal species appears on the 
approved label. This provision is not intended to require animal drug 
sponsors to conduct studies of on-farm drug use practices. FDA believes 
that animal drug sponsors have access to information obtained in the 
ordinary course of their business (for example, through marketing 
activities) to estimate the percentage of annual product sales that are 
sold or distributed domestically for use in any of these four major 
food-producing species that appear on the approved product label. While 
certain products may be legally used in an extralabel manner, promotion 
of such extralabel use is prohibited, and FDA believes that drug 
sponsors are unlikely to possess meaningful data on the percentage of 
their products that may be sold for extralabel use, especially for 
species not on the product label. If, however, a sponsor is aware of 
extralabel product sales for use in any of the four major food-
producing species listed on the product's label, these sales would be 
included in deriving the estimate reported under proposed paragraph (c) 
for that species.
    The Agency believes 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) would 
be important in supporting efforts such as the National Antimicrobial 
Resistance Monitoring System (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 proposed 
here. 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.
    In order to assure that the total of the species-specific 
percentages reported for each product adds up to 100 percent of its 
sales and distribution, a fifth category for ``other species/unknown'' 
would also be included in this provision. This category would 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.
    The following hypothetical scenarios are presented here as 
illustration:
     An antimicrobial product is approved for use only in 
cattle and swine, and the sponsor estimates that 100 percent of the 
annual sales were for use in cattle. In this situation, the sponsor 
would report: Cattle 100 percent, swine 0 percent, chickens 0 percent, 
turkeys 0 percent, other species/unknown 0 percent.
     An antimicrobial product is approved for use only in 
cattle and swine, and the sponsor estimates that 50 percent of the 
annual sales were for use in cattle, 30 percent were for use in swine, 
and 20 percent were unknown to the sponsor. In this situation, the 
sponsor would report: Cattle 50 percent, swine 30 percent, chickens 0 
percent, turkeys 0 percent, other species/unknown 20 percent.

[[Page 28867]]

     An antimicrobial product is approved for use only in 
cattle, sheep, and dogs, and the sponsor estimates that 50 percent of 
the annual sales were for use in cattle, 10 percent were for use in 
sheep, and 40 percent were for use in dogs. Since dogs are companion 
animals and sheep are a minor species, sales estimates for these would 
be reported together in the ``other species/unknown'' category. Thus, 
in this situation, the sponsor would report: Cattle 50 percent, swine 0 
percent, chickens 0 percent, turkeys 0 percent, other species/unknown 
50 percent.
    As noted earlier, under this proposal, sponsors who hold approved 
applications for antimicrobial new animal drugs intended for use in 
food-producing animals who choose not to separately report distribution 
data for their products under Sec.  514.80(b)(4)(i) would have to 
assure that full sales and distribution data for each product approved 
under such applications are alternatively reported under proposed Sec.  
514.87, including products approved under such applications that are 
labeled only for use in nonfood-producing animals. In this situation, 
sponsors would report the species-specific estimate of sales for the 
products labeled only for use in nonfood-producing animals as 100 
percent ``other species/unknown.''
    All species-specific estimates would reflect domestic sales for the 
entire reporting year and would not include separate information for 
each month of the reporting year. ADUFA 105 requires drug sponsors to 
report sales and distribution data to FDA broken out by month; however, 
antimicrobial drug products may be used at any time up to several years 
after distribution. The Agency considers 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; therefore, FDA reports yearly sales and distribution 
information in its annual summary reports instead of monthly amounts. 
The Agency believes that requiring sponsors to report monthly species-
specific estimates would entail a greater burden to drug sponsors 
without providing meaningful information.
    Most antimicrobial new animal drug products that are approved for 
use in food-producing animals are labeled for use in more than one 
animal species, in some cases five or more species. Therefore, since 
the antimicrobial sales and distribution data reported to FDA by drug 
sponsors under section 512(l)(3) of the FD& Act are derived from drug 
product sales, very little can be concluded about antimicrobial sales 
intended for use in any one particular species for products that are 
approved for use in more than one species. The Agency believes 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) would be important in supporting efforts such 
as NARMS, a surveillance program that tracks trends related to 
antimicrobial resistance in food-producing animals and humans. FDA 
believes that this additional sales and distribution information would 
be useful to better understand how the use of medically important 
antimicrobial drugs in food-producing animals may contribute to the 
emergence or selection of antimicrobial resistant bacteria. 
Specifically, this information could 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. From this, it may be possible to draw 
conclusions about how antimicrobial sales and distribution data compare 
with data from NARMS. In addition, such information could further 
enhance FDA's ongoing activities related to slowing the development of 
antimicrobial resistance and is consistent with the recommendations in 
guidance recently issued by this Agency addressing the judicious use of 
medically important antimicrobial drugs in food-producing animals 
(Guidance for Industry #209, entitled ``The Judicious Use of Medically 
Important Antimicrobial Drugs in Food-Producing Animals'').
    Since 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), consider 
the species-specific information reported by individual sponsors under 
paragraph (c) 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.
    Proposed paragraph (d) would incorporate the requirement specified 
in section 512(l)(3)(C) of the FD&C Act that each annual antimicrobial 
drug sales and distribution data report be submitted to FDA not later 
than March 31 of each year and cover the period of the preceding 
calendar year (see section 512(l)(3)(C)(i) and (ii) of the FD&C Act). 
Proposed paragraph (d) would also require that each such report be 
submitted to FDA using Form FDA 3744, ``Antimicrobial Animal Drug 
Distribution Report.''

C. Annual Summary Reports Published by FDA (Proposed Sec.  514.87(f))

    Proposed paragraph (f) would incorporate the requirement 
established by ADUFA 105 for FDA to publish an annual summary report of 
the antimicrobial drug sales and distribution data collected from drug 
sponsors by antimicrobial class (see section 512(l)(3)(E) of the FD&C 
Act). Consistent with the statute, this proposed paragraph would also 
require that FDA 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).
    Proposed paragraph (f) would also require FDA to publish its annual 
summary report of the information it receives under this section for 
each calendar year by December 31 of the following year. Proposed 
paragraph (f) also provides that, in addition to summarizing sales and 
distribution data by antimicrobial drug class, the annual summary 
report may also include additional summaries of the data received under 
this section, as determined by FDA. For example, on October 2, 2014, 
FDA published annual summary reports that include 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 for production purposes, or both 
therapeutic and production purposes.
    Paragraph (f) also proposes that the publication of any summary 
data in addition to drug class would be limited by the same 
confidentiality and national security protections as is required by the 
statute, as noted previously, for the publication of summary data by 
drug class. Specifically, each individual datum appearing in the 
summary report, regardless of its classification or source, would be 
required to: (1) Reflect cumulative product sales and distribution data 
from three or more distinct sponsors of approved products that were 
actively sold or distributed that reporting year and (2) be reported

[[Page 28868]]

in a manner consistent with protecting both national security and 
confidential business information. This approach would make it possible 
to present sales and distribution data in a manner consistent with the 
confidentiality provisions of section 512(l) of the FD&C Act.\1\
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    \1\ It should also be noted that the Trade Secrets Act, 18 
U.S.C. 1905, a broadly worded criminal statute, also imposes 
obligations on the Agency to protect confidential business 
information, including that obtained from the drug sponsors. A 
violation of the Trade Secrets Act can carry criminal penalties.
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III. Legal Authority

    FDA's authority for issuing this proposed rule is provided by 
section 512(l) of the FD&C Act. In addition, section 701(a) of the FD&C 
Act (21 U.S.C. 371(a)) gives FDA general rulemaking authority to issue 
regulations for the efficient enforcement of the FD&C Act.

IV. Preliminary Regulatory Impact Analysis

    FDA has examined the impacts of the proposed 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 Agencies 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). The Agency believes that this proposed rule is not an 
economically significant regulatory action as defined by Executive 
Order 12866.
    FDA has developed a preliminary regulatory impact analysis (PRIA) 
that presents the benefits and costs of this proposed rule to 
stakeholders and the government. The summary analysis of benefits and 
costs included in the Executive Summary of this document is drawn from 
the detailed PRIA, which is available at http://www.regulations.gov 
(Docket No. FDA-2012-N-0447), and is also available on FDA's Web site 
at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/Default.htm.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the PRA of 1995 (44 U.S.C. 3501-
3520). A description of these provisions is given in the Description 
section that follows with an estimate of the annual reporting and 
recordkeeping burden. 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.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Section 105 of the Animal Drug User Fee Amendments of 2008 
(ADUFA 105) Regulation Information Collection.
    Description: The ADUFA 105 legislation was enacted to address the 
problem of antimicrobial resistance and to help ensure safety related 
to the use of antibiotics in food-producing animals.
    With these concerns in mind, Congress passed and the President 
signed ADUFA 105 in 2008, which 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 FDA 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.
    ADUFA 105 also requires FDA to publish annual summary reports of 
the data it receives.
    In accordance with the new law, sponsors of the affected 
antimicrobial new animal drug products have submitted their sales and 
distribution data to FDA, and FDA has published summaries of such data, 
for each calendar year since 2009.
    The proposed rule, if finalized, will amend the records and reports 
regulation in part 514 to include the following:
     Procedures relating to the submission to FDA of annual 
sales and distribution data reports by sponsors of approved new animal 
drug products sold or distributed for use in food-producing animals. 
The proposal includes specific reporting criteria, including the 
requirement that sponsors submit species-specific estimates of product 
sales as a percentage of total sales.
     Procedures applicable to FDA's preparation and publication 
of summary reports on an annual basis based on the sales and 
distribution data it receives from sponsors of approved antimicrobial 
new animal drug products. The proposal 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.
     Provisions that will give sponsors of approved new animal 
drug products containing antimicrobial active ingredients that are sold 
or distributed for use in food-producing animals the opportunity to 
avoid duplicative reporting of product sales and distribution data to 
FDA under part 514.
    Description of Respondents: Animal Drug Manufacturers (Sponsors).
    This proposed rule would, among other things, revise existing OMB 
control number 0910-0659 (expiration date November 30, 2016) for 
antimicrobial drug products under ADUFA 105 by codifying statutory 
provisions. Many of the provisions of the information collection will 
not be affected by the proposed rule, if finalized. Therefore, this PRA 
section will concentrate on the changes being proposed in this 
rulemaking and will describe how the paperwork reduction implications 
will be affected.
    FDA estimates the burden of this collection of information as 
follows:

Proposed Reporting Requirement--One-Time Reporting Burden and Costs

    Because the information collection requirements of ADUFA 105 have 
been in effect for some time (the first report sponsors submitted was 
for calendar year 2009), one-time capital costs for the design of the 
report by firms have already occurred and need not be reported here.
    In addition, the paper Form FDA 3744, the e-Form FDA 3744a, and

[[Page 28869]]

reporting via the Electronic Submission Gateway are provided by FDA at 
no cost. Thus, there is no one-time capital cost for report design or 
forms under the provisions of the proposed rule, and FDA considers the 
possession of computers and Internet accessibility to be usual and 
customary business practices.
    Table 1 provides the one-time costs for the proposed rule, if 
finalized, which is estimated at $138,800, about one-half of which is 
the unavoidable cost of reviewing the rule and developing a compliance 
plan. Current sponsors of approved or conditionally approved 
applications for antimicrobial new animal drugs sold or distributed for 
use in food-producing animals would need to review the rule; however, 
since the proposed rule would mostly codify current practices, sponsors 
would not require significant review time. FDA estimates that there are 
34 sponsors total, 23 sponsors with active (i.e., currently marketed) 
applications and 11 sponsors with only inactive applications, 
respectively, that would need to review the rule. This would require 24 
hours each for the 23 active sponsors and 1 hour each for the 11 
inactive sponsors. The sponsors with inactive applications would 
require less time to perform the review and would not need to develop 
the compliance plan. FDA estimates that one-half of the active sponsors 
would use personnel at the general and operations manager level ($134 
per hour times 24 hours times 11.5 equals approximately $36,900). The 
other half of active sponsors would use an industrial production 
manager ($109 per hour times 11.5 times 24 hours equals approximately 
$30,100). (Please note that both estimates are rounded to be in 
accordance with the PRIA.) The total cost for review by sponsors of 
active approved applications is estimated at about $67,000.
    For the one-time, 1-hour review of the rule for the 11 sponsors of 
inactive approved applications, FDA assigns one-half, or 5.5 hours, at 
the $134 per hour adjusted rate for general and operations managers, 
while one-half, or 5.5 hours, is assigned at the $109 adjusted rate for 
industrial production managers. The total cost for the review by 
sponsors of inactive approved applications is estimated at about $1,300 
(rounded to be in accordance with the PRIA).
    FDA estimates that the total administrative costs for rule review 
and compliance plan development to be about $68,300 ($67,000 + $1,300).

Benefits of Proposed Sec.  514.87

    The proposed rule would allow applicants submitting annual sales 
and distribution reports for antimicrobial new animal drug products 
under Sec.  514.87 the option to not report distribution data under 
Sec.  514.80(b)(4)(i)(A) for the approved applications that include 
these same products, but only provided certain conditions are met. One 
condition is that sponsors 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 for their annual 
periodic drug experience report such that the reporting period begins 
on January 1 and ends on December 31, as described in Sec.  
514.80(b)(4). A second, and related, condition, is that applicants that 
change their reporting submission date must also, on a one-time basis, 
submit a special drug experience report, as described in current Sec.  
514.80(b)(5)(i), that addresses any gaps in distribution data caused by 
the change in reporting periods.
    FDA estimates that 90 percent of the sponsors currently marketing 
approved new animal drugs containing an antimicrobial active ingredient 
for use in food-producing animals would make the request to change the 
submission date such that the reporting period begins on January 1 and 
ends on December 31. There are 23 sponsors of 153 approved 
applications. Ninety percent of 153 applications equates to about 138 
applications held by 21 sponsors. FDA estimates that it would take 
approximately 2 hours for personnel to meet the first two conditions, 
making the change of date request for each application and preparing 
the one-time special drug experience report for each application. This 
results in approximately 276 hours. At the overhead and other benefits-
adjusted wage rate of about $134 per hour for general and operations 
managers for one-half of the hours, and at $109 per hour for industrial 
production managers for the other one-half of the hours, the one-time 
cost would be about $33,400 (rounded to be in accordance with the 
PRIA).

Costs of Proposed Sec.  514.87

    Proposed Sec.  514.87(c) would require that each report containing 
the amount of antimicrobial ingredient that is sold or distributed 
contain a species-specific estimate of the percentage of each product 
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.
    FDA estimates that an individual would spend about 5 hours 
complying with this requirement in the first year. (Subsequent years 
are estimated to require about 3 hours to comply.) The additional 2 
hours in the first year is a one-time cost incurred as individual 
company personnel discuss and settle upon a method to calculate these 
species-specific estimates. With the labor split evenly over the two 
wage rates, these 2 hours amount to a one-time cost of about $37,100 
for the 153 active applications.

                                Table 1--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
      21 U.S.C. 360b(b)(1)           Number of     responses per       Total        burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Administrative Review of the                  23               1              23              24             552
 Rule: Sponsors with Active
 Applications...................
Administrative Review of the                  11               1              11               1              11
 Rule: Sponsors with Inactive
 Applications...................
Requesting a Change of Date and               21            6.57             138               2         \2\ 275
 Submit Special Drug Experience
 Report to Avoid Duplicative
 Reporting......................
Report Species-Specific Estimate              23            6.65             153               2             306
 of Percent of Products
 Distributed Domestically.......
                                 -------------------------------------------------------------------------------

[[Page 28870]]

 
    Total.......................  ..............  ..............  ..............  ..............           1,144
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
\2\ Hourly burden estimate adjusted to be in accordance with the PRIA.

Proposed Reporting Requirements--Annual Hourly Burden and Costs 
Benefits of Proposed Sec.  514.87

    A benefit of the proposed rule is to provide some flexibility in 
which new animal drug sponsors report the sales and distribution data 
under both Sec.  514.80 and proposed Sec.  514.87 by allowing sponsors 
to meet two separate reporting obligations under part 514 with one set 
of report submissions under certain circumstances. FDA estimates that 
90 percent of the sponsors currently marketing approved new animal 
drugs containing an antimicrobial active ingredient for use in food-
producing animals would make the request to change the submission date 
such that the reporting period begins on January 1 and ends on December 
31, as provided in proposed Sec.  514.87. These 138 approved 
applications (90 percent of 152) would still have to account for the 
costs of data collection and preparation, but they would no longer be 
required to include distribution data along with the other information 
required in the Drug Experience Report (DER) under Sec.  
514.80(b)(4)(i). FDA estimates that the time saved per application from 
the removal of the requirement for the distribution data in the DER 
could be as much as 6 hours per application. Using the same adjusted 
wage rates and distribution of hours by adjusted wage rates (one-half 
of the total hours at each rate), the annual benefit of the reduction 
of 138 hours times an average of $121 per hour is about $100,200.\2\
---------------------------------------------------------------------------

    \2\ OMB control numbers 0910-0284 and 0910-0645.
---------------------------------------------------------------------------

    Another benefit of this proposed rule would be the cost savings 
associated with reporting monthly product sales and distribution data 
to FDA rather than calculating the amount of antimicrobial active 
ingredients associated with these monthly product sales and 
distribution data. Proposed Sec.  514.87, if finalized, would eliminate 
the need for sponsors to perform and report calculations of the amount 
of antimicrobial active ingredients associated with monthly product 
sales and distribution data. These data have shown a wide variability 
in accuracy, causing additional verification efforts for FDA personnel. 
Therefore, it would be more efficient for sponsors (and for FDA) if 
sponsors were to limit their annual reporting to product sales and 
distribution data. This would allow FDA to calculate the exact amounts 
of antimicrobial active ingredients associated with those product 
sales. FDA estimates that this would reduce the industry reporting 
effort by 1 hour per application. FDA estimates that 153 approved 
applications for antimicrobial new animal drugs that are currently 
marketed would be affected by this change in policy, resulting in 153 
fewer compliance hours annually. At the overhead and other benefits-
adjusted wage rate of about $134 per hour for general and operations 
manager for one-half of the hours, and at $109 per hour for industrial 
production managers for the other one-half of the hours, the annual 
cost saving would be about $18,600 (rounded to be in accordance with 
the PRIA).
    FDA estimates total annual benefits of this proposed rule, if 
finalized, at about $118,800.

Costs of Proposed Sec.  514.87

    As stated previously, proposed Sec.  514.87(c) would require that 
each report containing the amount of antimicrobial ingredient that is 
sold or distributed contain a species-specific estimate of the 
percentage of each product 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. FDA estimates that 
affected sponsors will require about 3 hours to comply with this 
provision annually. FDA estimates that 153 approved, currently marketed 
applications containing antimicrobial drugs as active ingredients would 
be affected by this change in policy, resulting in 459 additional 
compliance hours annually. At the overhead and other benefits-adjusted 
wage rate of about $134 per hour for general and operations managers 
for one-half of the hours, and at $109 per hour for industrial 
production managers for the other one-half of the hours, the additional 
459 hours results in an additional annual cost of approximately $55,700 
(rounded to be in accordance with the PRIA).
    Data for 2012 was submitted by 23 sponsors of 153 active 
applications for antimicrobial new animal drug products sold or 
distributed for use in food-producing animals. FDA estimates that 60 
hours are currently required to collect the necessary data and prepare 
the submission to FDA for each of the estimated one-half of active 
applications for which data is submitted on a paper Form FDA 3744, for 
a total of 4,590 hours. FDA estimates that 50 hours are required to 
collect the necessary data and prepare the submission to FDA for each 
of the estimated one-half of active applications for which data is 
submitted on e-Form FDA 3744a, for a total of 3,825 hours. Thus, FDA 
estimates a total of 8,415 burden hours are currently needed for the 23 
sponsors of 153 active applications to report to FDA. At the overhead 
and other benefits-adjusted wage rate of about $134 per hour for 
general and operations managers for one-half of the hours, and at $109 
per hour for industrial production managers for the other one-half of 
the hours, the annual cost of reporting to FDA is currently 
approximately $1.02 million.
    FDA estimates that under the proposed rule, if finalized, affected 
sponsors would need 62 hours to report the necessary data on a paper 
Form FDA 3744 and 52 hours to report via e-Form FDA 3744a (3 additional 
hours for the species-specific reporting requirement minus 1 hour for 
cessation of the requirement to calculate the amount of antimicrobial 
ingredients associated with monthly product sales and distribution 
data). The total annual burden hours for the 23 sponsors of the 153 
active applications to report under the proposed rule, if finalized 
would be 8,721 hours (4,743 hours for one-half of the industry using 
paper Form FDA 3744 and 3,978 hours for one-half of the industry using 
e-Form FDA 3744a), an

[[Page 28871]]

additional 306 hours over the current hourly burden. At the overhead 
and other benefits-adjusted wage rate of about $134 per hour for 
general and operations managers for one-half of the hours, and at $109 
per hour for industrial production managers for the other one-half of 
the hours, the total annual cost of reporting for the industry under 
the proposed rule, if finalized, would be approximately $1.06 million. 
The cost of the additional 306 hours needed to annually report under 
the proposed rule, if finalized, is approximately $37,100 (rounded to 
be in accordance with the PRIA).
    The 2012 data also show 11 sponsors with only inactive applications 
for antimicrobial new animal drug products for use in food-producing 
animals. FDA estimates that sponsors of these inactive applications for 
antimicrobial drug products need 2 hours per application to prepare and 
submit a report stating that there were no products distributed for the 
year, a total of 196 inactive approved applications times 2 hours 
annually equals 392 hours. This burden estimate would not be affected 
by the proposed rule, if finalized, and thus is not included in the 
following table.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                            Average
                                                                        Number of        Number of       Total annual      additional
               21 U.S.C. 360b(b)(1)                   Form FDA No.     respondents     responses per      responses        burden per      Total hours
                                                                                         respondent                       response \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reports for Sponsors With Active                       3744               23             6.65              153                2              306
 Applications.....................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs and no operating and maintenance costs associated with this information collection.
\2\ Average additional burden per response in hours is the marginal difference between the current burden of OMB control number 0910-0659 and the
  additional burden per response resulting from this proposed rule.

Current Recordkeeping Burden

    FDA will not address the recordkeeping provisions of all affected 
sponsors (34), who prepare 1 report per year and spend 2 hours annually 
maintaining those records (68 hours total), because the number of 
burden hours would not be affected by the proposed rule, if finalized.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, 
or emailed to [email protected]. All comments should be 
identified with the title ``Animal Drug User Fee Amendments (ADUFA 105) 
Regulation Information Collection.''
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These requirements 
will not be effective until FDA obtains OMB approval. FDA will publish 
a notice concerning OMB approval of these requirements in the Federal 
Register.

VI. Environmental Impact

    The Agency has 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.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
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, the Agency tentatively concludes that the proposed 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.

VIII. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

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, it is 
proposed that 21 CFR part 514 be amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
1. The authority citation for 21 CFR 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. Amend Sec.  514.80 by revising the fifth sentence of paragraph 
(b)(4) and by revising 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

[[Page 28872]]

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 assure 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 assure 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 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 which 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 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12081 Filed 5-19-15; 8:45 am]
 BILLING CODE 4164-01-P