[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)]
[Proposed Rules]
[Pages 28863-28872]
[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,<PHONE_NUMBER><EMAIL_ADDRESS>
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

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

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.

    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.

     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

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

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.......
                                 -------------------------------------------------------------------------------

    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

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:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>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

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]
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1. Agency/ Subagency originating request U. S. EPA/ Office of Water/ OWOW 2. OMB control number b. G None a 2040 0138 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. : Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. : Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? : No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. : Three years from approval date b. G Other Specify: / /___

7. Title: National Estuary Program 8. Agency form number( s) ( If applicable) EPA ICR No. 1500.05 9. Keywords: water quality, water resources conservation, estuaries, environmental assessments, coastal management 10. Abstract Estuaries listed under this program have management conferences set up for each to administer technical environmental assessments and actions to protect these water bodies. These conferences submit annual work plans, implementation reviews, and Government Performance Results Act reports for program planning, management, and agency approval.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. Business or other for profit e. X Federal Government c. X Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. : Voluntary b. P Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 28 b. Total annual responses 65 1. Percentage of these responses collected electronically 43 % c. Total hours requested 6,113 d. Current OMB inventory 46,767 e. Difference  40,654 f. Explanation of difference 1. Program Change 0 2. Adjustment  40,654 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 0 c. Total annualized cost requested $ 0 d. Current OMB inventory $ 0 e. Difference $ 0 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. P Program planning or management b. X Program evaluation f. __ Research c. __ General purpose statistics g. __ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. : Annually 7. Q Biannually 8.: Other ( describe) Triennially 17. Statistical methods Does this information collection employ statistical methods? Q Yes : No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Greg Colianni Phone: ( 202) 566 1249 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Notices]
[Pages 26103-26104]
[FR Doc No: 2013-10513]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Release Certain Properties From All Terms,
Conditions, Reservations and Restrictions of a Quitclaim Deed Agreement
Between the City of Zephyrhills and the Federal Aviation Administration
for the Zephyrhills Municipal Airport, Zephyrhills, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comment.

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SUMMARY: The FAA hereby provides notice of intent to release certain
airport properties 33 acres at the Zephyrhills Municipal Airport,
Zephyrhills, FL from the conditions, reservations, and restrictions as
contained in a Quitclaim Deed agreement between the FAA and the City of
Zephyrhills, dated May 15, 1947. The release of property will allow the
City of Zephyrhills to dispose of the property for other than
aeronautical purposes. The property is located on the southeast corner
of airport property. The parcel is currently designated as non-
aeronautical use. The property will be released of its federal
obligations for municipal purposes. The fair market value of this
parcel has been determined to be $500,000.
    Documents reflecting the Sponsor's request are available, by
appointment only, for inspection at the Zephyrhills Municipal Airport
and the FAA Airports District Office.

SUPPLEMENTARY INFORMATION:  Section 125 of The Wendell H. Ford Aviation
Investment and Reform Act for the 21st Century (AIR-21) requires the
FAA to provide an opportunity for public notice and comment prior to
the ``waiver'' or ``modification'' of a sponsor's Federal obligation to
use certain airport land for non-aeronautical purposes.

DATES: Comments are due on or before June 3, 2013.

ADDRESSES: Documents are available for review at the Zephyrhills
Municipal Airport, and the FAA Airports District Office, 5950 Hazeltine
National Drive, Suite 400, Orlando, FL 32822. Written comments on the
Sponsor's request

must be delivered or mailed to: Richard Owen, Program Manager, Orlando
Airports District Office, 5950 Hazeltine National Drive, Suite 400,
Orlando, FL 32822-5024.

FOR FURTHER INFORMATION CONTACT: Richard Owen, Program Manager, Orlando
Airports District Office, 5950 Hazeltine National Drive, Suite 400,
Orlando, FL 32822-5024.

Bart Vernace,
Manager, Orlando Airports District Office, Southern Region.
[FR Doc. 2013-10513 Filed 5-2-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)]
[Notices]
[Pages 57592-57593]
[FR Doc No: 2017-26247]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14581-002]

Turlock Irrigation District, Modesto Irrigation District; Notice
of Application Accepted for Filing, Soliciting Motions To Intervene and
Protests, Ready for Environmental Analysis, and Soliciting Comments,
Recommendations, Preliminary Terms and Conditions, and Preliminary
Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Major License.
    b. Project No.: 14581-002.
    c. Date filed: October 11, 2017.
    d. Applicant: Turlock Irrigation District (TID) and Modesto
Irrigation District (MID) (Districts).
    e. Name of Project: La Grange Hydroelectric Project,
    f. Location: The La Grange Project is located on the Tuolumne River
in Stanislaus and Tuolumne Counties, California. Portions of the
project occupy public lands managed by the Bureau of Land Management.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contacts: Steve Boyd, Turlock Irrigation District, 333
East Canal Drive, Turlock, California 95381-0949,<PHONE_NUMBER>; and
Anna Brathwaite, Modesto Irrigation District, P.O. Box 4060, Modesto,
CA 95352,<PHONE_NUMBER>.
    i. FERC Contact: Jim Hastreiter at<PHONE_NUMBER> or
[email protected].
    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, recommendations, preliminary
terms and conditions, and preliminary fishway prescriptions using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at

[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14581-002.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The La Grange Project consists of the following existing
facilities: (1) La Grange dam, a 310-foot-long, 131-foot-high, masonry
arch dam; (2) La Grange reservoir with a storage capacity of about 500
acre-feet; (3) MID headworks, canal, and sluice gates are part of MID's
retired irrigation canal facilities; (4) TID irrigation intake and
tunnel; (5) a powerhouse with two Francis turbine-generator units with
a maximum capacity of 4.9 megawatts. The project's estimated average
annual generation is about 19,638 megawatt-hours.
    The Districts propose to: (1) Provide a minimum flow of
approximately 5 to 10 cubic feet per second to the plunge pool
downstream of La Grange diversion dam at all times; (2) install a fish
exclusion barrier at the TID sluice channel entrance; (3) conduct
dissolved oxygen monitoring in the vicinity of the La Grange
powerhouse; (4) construct a recreational foot trail extending from the
former Don Pedro Visitor Center parking lot to the La Grange headpond;
and (5) develop an HPMP in consultation with Tribes, Bureau of Land
Management, and State Historical Preservation Officer to manage
potential effects on historic properties.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, and .214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title PROTEST,
MOTION TO INTERVENE, COMMENTS, REPLY COMMENTS, RECOMMENDATIONS,
PRELIMINARY TERMS AND CONDITIONS, or PRELIMINARY FISHWAY PRESCRIPTIONS;
(2) set forth in the heading the name of the applicant and the project
number of the application to which the filing responds; (3) furnish the
name, address, and telephone number of the person protesting or
intervening; and (4) otherwise comply with the requirements of 18 CFR
385.2001 through 385.2005. All comments, recommendations, terms and
conditions or prescriptions must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    o. Procedural Schedule:
    The application will be processed according to the following
revised Hydro Licensing Schedule. Revisions to the schedule may be made
as appropriate.

------------------------------------------------------------------------
                 Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations, preliminary      January 2018.
 terms and conditions, and preliminary
 fishway prescriptions.
Commission issues Draft Environmental       August 2018.
 Statement (EIS).
Comments on Draft EIS.....................  October 2018.
Modified Terms and Conditions.............  December 2018.
Commission Issues Final EIS...............  March 2019.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in 5.22: (1) A copy of the water
quality certification; (2) a copy of the request for certification,
including proof of the date on which the certifying agency received the
request; or (3) evidence of waiver of water quality certification.

    Dated: November 30, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-26247 Filed 12-5-17; 8:45 am]
 BILLING CODE 6717-01-P


From:	Aaron Worstell/R8/USEPA/US
To:	Gail Fallon/R8/USEPA/US@EPA
Cc:	Jonah Staller/R8/USEPA/US@EPA
Date:	02/27/2012 03:40 PM
Subject:	Comparison of capital costs for Coal Creek Station

The purpose of this message is to clarify differences between SNCR costs at Coal Creek Station as supplied by GRE, as calculated in EPA's proposed action, and as revised for EPA's final action.

For background, in EPA's Control Cost Manual (6th Edition, January 2002), for both SNCR and SCR, direct capital costs (DCC) include the purchased equipment cost AND the direct installation costs.  That is, the cost of the equipment and the (direct) cost of installing that equipment are not treated separately.  Here is a quote from the CCM (Section 4.2, Chapter 1, p. 1-31):

"The direct capital cost estimate includes PEC such as SNCR system equipment, instrumentation, sales tax and freight. This includes costs associated with field measurements, numerical modeling and system design. It also includes direct installation costs such as auxiliary equipment (e.g., ductwork, compressor), foundations and supports, handling and erection, electrical, piping, insulation and painting. In addition costs such as asbestos removal are included."

You would then add indirect capital costs of 20% (of DCC), plus project contingencies, and miscellaneous other (small) costs.

By contrast, GRE used the CCM to calculate the DCC ($3,600,000 per GRE's 11/21/2011 report) and then:

(1)  Added 43% for instrumentation (10%), site specific and contractor markup (28%), and freight (5%).  Instrumentation and freight are already explicitly included in the DCC (per CCM quote above).  My opinion is that the DCC already includes the contractor markup as well.  GRE did not supply any documentation to justify site specific costs.

(2)  Arbitrarily applied a 1.6 retrofit factor.  The CCM manual algorithms are already based on retrofit applications.  Here is a quote from the CCM (Section 4.2, Chapter 1, page 1-4):

"The costing algorithms in this report are based on retrofit applications of SNCR to existing coal-fired, dry bottom, wall-fired and tangential, balanced draft boilers. There is little difference between the cost of SNCR retrofit of an existing boiler and SNCR installation on a new boiler [10]. Therefore, the cost estimating procedure is suitable for retrofit or new boiler applications of SNCR on all types of coal-fired electric utilities and large industrial boilers."

Also, to the extent that any retrofit factor should be used, it seems that it is redundant to the site-specific multiplier previous applied above.

(3)  Largely followed the remainder of the CCM to arrive at the total capital investment, including applying indirect capital cost of 21%.

EPA's costs conform to the Control Cost Manual, but were inadvertently not adjusted to 2009$ in the proposed action.

The table below shows the differences between the cost supplied by GRE (11/21/11), EPA's original costs, and EPA's costs adjusted to 2009$.

See final EPA cost spreadsheet attached.

EPA SNCR Cost Analysis Coal Creek Station Unit 1 Final.xlsx

Aaron J. Worstell
Environmental Engineer
U.S. Environmental Protection Agency - Region 8
Air Program - Mail Code 8P-AR
1595 Wynkoop Street
Denver, CO 80202
Phone:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>