[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Proposed Rules]
[Pages 59308-59312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23488]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2012-N-0447]


Antimicrobial Animal Drug Sales and Distribution Annual Summary 
Report Data Tables

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is seeking comment on a 
proposal regarding the content and format of data tables for the 
Agency's annual summary report of sales and distribution data collected 
from sponsors of antimicrobial new animal drugs in accordance with the 
new animal drug records and reporting provisions of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) as amended by the Animal Drug 
User Fee Amendments of 2008 (ADUFA).

DATES: Submit electronic or written comments by November 25, 2013.

ADDRESSES: Submit electronic comments on this proposal to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 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.,

[[Page 59309]]

Rockville, MD 20855, 240-276-9062, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 512(l) of the FD&C Act (21 U.S.C. 360b(l)) 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. Section 105 of ADUFA 
(Pub. L. 110-316) directed the Agency to collect data and information 
about antimicrobial new animal drugs approved for use in food-producing 
animals by amending section 512(l) of the FD&C Act to include new 
reporting requirements for sponsors of these drugs. Under new section 
512(l)(3) of the FD&C Act, antimicrobial new animal drug sponsors are 
required to submit to FDA on an annual basis a report specifying the 
amount of each antimicrobial active ingredient sold or distributed for 
each of the sponsor's drug products that are approved 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 by 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 sponsors of antimicrobial new animal drugs approved 
for use in food-producing animals, and further provides that such data 
must be reported by antimicrobial class. Section 512(l)(3)(E) of the 
FD&C Act directs FDA not to independently report those antimicrobial 
classes with fewer than three distinct sponsors and further directs FDA 
to report the data in a manner consistent with protecting both national 
security and confidential business information.
    In the Federal Register of July 27, 2012 (77 FR 44177), FDA 
published an advanced notice of proposed rulemaking (ANPRM) to seek 
public comment on, among other things, additional ways in which the FDA 
could compile and present this summary information that are useful to 
the public while maintaining confidential business information. The 
proposed additional data tables for the Summary Report on 
Antimicrobials Sold or Distributed for Use in Food-Producing Animals 
presented in this notice were developed in response to the comments FDA 
received.

II. Proposed Additional Data Tables for the Summary Report on 
Antimicrobials Sold or Distributed for Use in Food-Producing Animals

    Consistent with section 512(l)(3) of the FD&C Act, FDA's current 
format for its annual summary report only includes gross antimicrobial 
drug sales and distribution data by antimicrobial drug class without 
further subdivision. This format is illustrated in Table 1 with 
supporting Table 2. FDA proposes to retain these tables in future 
summary reports. However, many of the comments we received in response 
to the July 27, 2012, ANPRM suggested that alternative summaries of the 
antimicrobial drug sales and distribution data are needed by the 
scientific community and public interest groups to enhance their 
understanding of antimicrobial resistance. Such suggestions commonly 
included further reporting by importance to human medicine, route of 
drug administration, dispensing status, or indications. In response to 
these suggestions, FDA proposes to add four additional data tables to 
its annual summary report as illustrated by Tables 3 through 6. FDA is 
seeking comment on this proposal.
    FDA believes that summarizing domestic sales and distribution data 
for antimicrobial new animal drugs approved for use in food-producing 
animals using the four additional formats (outlined in Tables 3 through 
6) is currently possible without revealing the confidential business 
information of any one new animal drug sponsor. These additional tables 
summarize the domestic sales and distribution information received by 
FDA by first aggregating the data based on human medical importance \1\ 
and then further breaking down the data by antimicrobial drug class, 
route of administration, dispensing status, and indications. Export 
sales and distribution data are not included in the proposed additional 
tables due to the limited number of categories that could be 
independently reported.
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    \1\ Draft Guidance for Industry 213 proposes that all 
antimicrobial drugs and their associated classes listed in Appendix 
A to FDA's Guidance for Industry 152 (Appendix A) be 
considered ``medically important.''
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    This approach makes it possible to present domestic sales and 
distribution data in a manner that does not violate the confidentiality 
provisions of section 512(l) of the FD&C Act. While the ``no class with 
fewer than 3 distinct sponsors'' requirement of section 512(l)(3)(E)(i) 
of the FD&C Act specifically applies to summary reporting by 
antimicrobial drug class, FDA notes that it is also obligated to comply 
with the more broadly written requirement of section 512(l)(3)(E)(ii) 
of the FD&C Act that such ``data shall be reported in a manner 
consistent with protecting . . . confidential business information.'' 
\2\ In order to ensure that we are in compliance with these 
requirements, FDA has interpreted these provisions to mean that our 
annual data summary must: (1) Only report data for a given drug class 
(or any other data category) for which there are at least three 
distinct sponsors and (2) otherwise be consistent with protecting 
confidential business information.
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    \2\ 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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    Based on our analysis of currently available information, FDA 
believes that all data categories in the proposed additional tables 
(e.g., sales reported by medical importance and indication) would 
consist of combined sales and distribution data from at least three 
sponsors. For example, in Table 5, there are only two sponsors of 
medically important antimicrobial animal drug products approved solely 
for production indications (i.e., have no therapeutic indications); 
therefore, reporting this data point would reveal each sponsor's sales 
and distribution data to the other. In order to protect confidential 
business information, this category has been combined with 
antimicrobial animal drugs approved for both production and therapeutic 
indications.
    In evaluating possible approaches to categorizing data in the 
proposed additional tables, FDA also took into account whether 
particular data points could be utilized to indirectly derive other 
data points that would reveal confidential business information. FDA 
believes the broad requirement to protect confidential business 
information means the Agency cannot independently report data if it can 
be used together with data presented elsewhere or data already in the 
public domain to derive confidential business

[[Page 59310]]

information. The concept that a piece of information that, in and of 
itself would not cause substantial competitive harm if released, would 
likely cause substantial competitive harm if released in light of other 
publicly available information, often referred to as the ``mosaic'' 
effect, has been recognized by the Courts as a legitimate issue of 
concern in the context of protecting confidential business 
information.\3\
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    \3\ See e.g., Timken Company v. United States Customs Service, 
491 F. Supp. 557, 559 (D.D.C. 1980) (court held that disclosure of 
data furnished by importer of Japanese roller bearings would cause 
substantial competitive harm to both the importer and the exporter 
by allowing competitors and customers to indirectly calculate the 
company's profit margin and production costs, thereby giving 
competitors insight into the company's ``competitive strengths and 
weaknesses''); Customs & International Trade Newsletter v. U.S. 
Customs and Border Protection, 588 F. Supp. 2d 51, 57 (D.D.C. 2008) 
(names and addresses of certain importers were properly withheld by 
the government because that information, ``when cross-referenced 
with publicly available . . . information . . . would reveal 
information that could cause substantial competitive harm.'').
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    After considering various approaches, FDA is proposing as a first 
level of categorization in the new tables to distinguish between those 
antimicrobial drug products that are important for human medicine and 
those that are not important for human medicine. Stakeholder comments 
to the July 2012 ANPRM docket support this presentation. In addition, 
this approach highlights the public health relevance of these data, and 
is consistent with the FDA's strategy to promote the judicious use of 
medically important antimicrobials used in food-producing animals. FDA 
also proposes, as a second level of categorization, to further break 
down the aggregated medical importance data by antimicrobial drug 
class, route of administration, indications, and dispensing status.
    FDA considered a third level of categorization for Tables 4-6, 
beyond breaking down the aggregated medical importance data by route of 
administration, indications, and dispensing status, to present such 
sales and distribution data by individual drug class. However, after 
analysis FDA found that summarizing sales and distribution data for 
antimicrobial new animal drugs approved for use in food-producing 
animals in this manner posed concerns related to disclosure of 
confidential business information, either by revealing data 
representing fewer than three sponsors or providing sufficient 
information to allow indirect calculation of confidential business 
information. If such data points were to be disclosed, this would be 
inconsistent with the confidentiality provisions of section 
512(l)(3)(E) of the FD&C Act. Alternatively, redacting or comingling 
these data points would frequently result in summary tables comprised 
primarily of data collated into a single ``not independently reported'' 
(NIR) category.
    Therefore, the Agency believes the additional data tables proposed 
for inclusion in the ``Summary Report on Antimicrobials Sold or 
Distributed for Use in Food-Producing Animals'' would provide a more 
useful summary report without violating the confidentiality provisions 
of section 512(l) of the FD&C Act. The new proposed data tables 
(described in section II.B.) are intended to augment the data tables 
provided in previous Summary Reports (described in section II.A.). FDA 
acknowledges that, based on changes that may occur in the animal drug 
industry, in the future we may further reformat the data tables as 
necessary to protect confidential business information or, if possible, 
to present the data in a more detailed manner. However, based on an 
analysis of the products marketed at this time, FDA believes the data 
tables presented in this proposal provide the most feasible approach 
for including an enhanced level of detail in the annual summary reports 
while still maintaining adequate protection for confidential business 
information.

A. Existing Data Table Formats

    FDA has included the following tables in previous Summary Reports 
and proposes to continue including these types of data summaries in 
future reports.
1. Sales and Distribution Data Reported by Drug Class
    Table 1 presents data on annual domestic and export sales and 
distribution of antimicrobial active ingredients approved for use in 
food-producing animals, broken down by antimicrobial drug class.

Table 1--Antimicrobial Drugs Approved for Use in Food-Producing Animals:
 Sales and Distribution Data Reported by Antimicrobial Class Marketed in
                                  20XX
------------------------------------------------------------------------
                                                          Annual Totals
                                   Antimicrobial Class       (kg \1\)
------------------------------------------------------------------------
Domestic.......................  Antimicrobial Class 1.  ...............
                                 Antimicrobial Class 2   ...............
                                  \2\.
                                 Antimicrobial Class 3,  ...............
                                  Etc.*.
                                 NIR \3\...............  ...............
Export \4\.....................  Antimicrobial Class 1.  ...............
                                 Antimicrobial Class 2   ...............
                                  \2\.
                                 Antimicrobial Class 3,  ...............
                                  Etc.*.
                                 NIRE \5\..............  ...............
------------------------------------------------------------------------
\1\ kg = kilogram of active ingredient. Antimicrobials which were
  reported in International Units (IU) (e.g., Penicillins) were
  converted to kg. Antimicrobial class includes drugs of different
  molecular weights, with some drugs reported in different salt forms.
\2\ Includes antimicrobial drug products which are approved and labeled
  for use in multiple species, including both food- and nonfood-
  producing animals, such as dogs and cats.
\3\ NIR = Not Independently Reported. Antimicrobial classes for which
  fewer than three distinct sponsors actively marketed products
  domestically were not independently reported. These classes include:
  [list of drug classes].
\4\ Only includes exports of FDA-approved, U.S.-labeled antimicrobial
  drugs approved for use in food-producing animals.
\5\ NIRE = Not Independently Reported Export. Antimicrobial classes for
  which fewer than three distinct sponsors exported products were not
  independently reported. These classes include: [list of drug classes].
* Drug classes independently reported are based on number of distinct
  sponsors marketing drug products in each class during the calendar
  year.


[[Page 59311]]

2. Marketed Antimicrobial Drugs and Drug Classes Approved for Use in 
Food-Producing Animals

    Table 2 lists all antimicrobial active ingredients approved for use 
in food-producing animals broken down by antimicrobial drug classes 
that were actively marketed during the specific calendar year for which 
sales and distribution data were reported.

 Table 2--Antimicrobial Drug Classes and Active Ingredients Approved for
            Use in Food-Producing Animals * Marketed in 20XX
------------------------------------------------------------------------
         Antimicrobial Class 1            Antimicrobial Class 2, Etc.***
------------------------------------------------------------------------
Active Ingredient A....................  Active Ingredient A.
Active Ingredient B....................  Active Ingredient B.
Active Ingredient C, Etc.**............  Active Ingredient C, Etc.**
------------------------------------------------------------------------
* Includes some antimicrobial drug products which are approved and
  labeled for use in multiple species, including both food- and nonfood-
  producing animals, such as dogs and cats.
** Active ingredients reported are based on drug products actively
  marketed during the calendar year.
*** Antimicrobial classes reported are based on drug products actively
  marketed in each class during the calendar year.

B. Proposed Additional Tables

    Comments received in response to the July 27, 2012, ANPRM (77 FR 
44177) commonly included suggestions for further reporting of 
antimicrobial classes by route of drug administration, dispensing 
status, or indications, and differentiation between drug classes of 
human medical importance and those not important to human medicine. 
Based on the comments received in response to the 2012 ANPRM, FDA has 
developed four additional proposed tables for inclusion in its annual 
Summary Report. In developing these new tables, FDA initially attempted 
to further break down the data for individual drug classes by route of 
administration, dispensing status, and indications, but found that very 
few classes could be independently reported in a manner consistent with 
protecting confidential business information. Therefore, FDA determined 
that reporting the data instead by medical importance with further 
divisions by drug class (Table 3); route of administration (Table 4); 
indications (Table 5); and dispensing status (Table 6) would present 
more meaningful information while continuing to protect confidential 
business information. Export data were not included in the proposed 
additional tables due to the limited number of categories that could be 
independently reported. FDA proposes to include these additional tables 
in future reports and to update previously published annual summaries 
to include similar data tables.

1. Domestic Sales and Distribution Data Reported by Medical Importance 
and Drug Class

    Table 3 presents data on annual domestic sales and distribution of 
antimicrobial active ingredients approved for use in food-producing 
animals broken down by human medical importance and antimicrobial drug 
class.

Table 3--Antimicrobial Drugs Approved for Use in Food-Producing Animals:
  * Domestic Sales and Distribution Data Reported by Medical Importance
                     and Drug Class Marketed in 20XX
------------------------------------------------------------------------
                                                Annual totals (kg) \1\
------------------------------------------------------------------------
Medically Important: \2\
  Antimicrobial Class 1....................  ...........................
  Antimicrobial Class 2....................  ...........................
  Antimicrobial Class 3, Etc.**............  ...........................
  NIR \3\..................................  ...........................
Not Medically Important: \4\                 ...........................
  Antimicrobial Class 1....................  ...........................
  Antimicrobial Class 2....................  ...........................
  Antimicrobial Class 3, Etc.**............  ...........................
  NIR \5\..................................  ...........................
------------------------------------------------------------------------
\1\ kg = kilogram of active ingredient. Antimicrobials which were
  reported in International Units (IU) (e.g., Penicillins) were
  converted to kg. Antimicrobial class includes drugs of different
  molecular weights, with some drugs reported in different salt forms.
\2\ Draft Guidance for Industry 213 proposes that all
  antimicrobial drugs and their associated classes listed in Appendix A
  to FDA's Guidance for Industry 152 (Appendix A) be considered
  ``medically important.''
\3\ NIR = Not Independently Reported. Medically Important antimicrobial
  classes for which there were less than three distinct sponsors
  actively marketing products domestically were not independently
  reported. These classes include: [list of drug classes].
\4\ ``Not Medically Important'' refers to any antimicrobial class not
  currently listed in Appendix A.
\5\ NIR = Not Independently Reported. Not Medically Important
  antimicrobial classes for which there were less than three distinct
  sponsors actively marketing products domestically were not
  independently reported. These classes include: [list of drug classes].
* Includes some antimicrobial drug products which are approved and
  labeled for use in multiple species, including both food- and nonfood-
  producing animals, such as dogs and cats.
** The total number of antimicrobial classes independently reported
  depends upon the number of distinct sponsors marketing drug products
  in each class during the calendar year. Only those antimicrobial
  classes with 3 or more distinct sponsors will be reported
  independently.

2. Domestic Sales and Distribution Data Reported by Medical Importance 
and Route of Administration

    Table 4 presents data on annual domestic sales and distribution of 
antimicrobial active ingredients approved for use in food-producing 
animals broken down by medical importance and route of administration.

Table 4--Antimicrobial Drugs Approved for Use in Food-Producing Animals:
  * Domestic Sales and Distribution Data Reported by Medical Importance
              and Route of Administration Marketed in 20XX
------------------------------------------------------------------------
                                                Annual totals (kg) \1\
------------------------------------------------------------------------
Medically Important:                         ...........................
  Feed.....................................  ...........................
  Water....................................  ...........................
  Injection................................  ...........................
  Other Routes \2\.........................  ...........................
Not Medically Important:                     ...........................
  Feed.....................................  ...........................
  Water....................................  ...........................
  Injection................................  ...........................
  Other Routes \2\.........................  ...........................
------------------------------------------------------------------------
\1\ kg = kilogram of active ingredient. Antimicrobials which were
  reported in International Units (IU) (e.g., Penicillins) were
  converted to kg. Antimicrobial class includes drugs of different
  molecular weights, with some drugs reported in different salt forms.
\2\ The Other Routes category includes the following: Water/Topical
  Immersion for Fish, Water/Drench, Intramammary, Oral, and Topical.

[[Page 59312]]

 
* Includes some antimicrobial drug products which are approved and
  labeled for use in multiple species, including both food- and nonfood-
  producing animals, such as dogs and cats.

3. Domestic Sales and Distribution Data Reported by Medical Importance 
and Indications

    Table 5 presents data on annual domestic sales and distribution of 
antimicrobial active ingredients approved for use in food-producing 
animals broken down by medical importance and indications. 
Antimicrobials are approved for two basic categories of indications in 
food-producing animals: Therapeutic (treatment, control, or prevention 
of a specific bacterial disease), and production (increased rate of 
weight gain or improved feed efficiency). While 512(l)(3) of the FD&C 
Act requires that sponsors report a listing of indications that are 
specified on the approved label of the product, sponsors currently are 
not required to report sales and distribution data broken down by 
individual indications. Most products are approved for more than one 
indication; therefore, FDA is unable to report sales and distribution 
data for specific active ingredients broken down by individual 
indications. Very few products are approved solely for production 
indications; therefore this category could not be independently 
reported. Many, however, are approved solely for therapeutic 
indications, or for a combination of therapeutic and production 
indications. As a result, it is possible to present sales and 
distribution data for products approved solely for therapeutic 
indications, and products approved for both production and therapeutic 
indications, but not for the few products approved solely for 
production indications (see Table 5, footnote 4). It is important to 
note that this latter category does not represent the quantity actually 
used for production purposes, since the vast majority of antimicrobials 
in this category also have therapeutic claims.

Table 5--Antimicrobial Drugs Approved for Use in Food-Producing Animals:
  * Domestic Sales and Distribution Data Reported by Medical Importance
                    and Indications Marketed in 20XX
------------------------------------------------------------------------
                                                 Annual totals (kg) \1\
------------------------------------------------------------------------
Medically Important:
  Therapeutic \2\ Indications Only             .........................
  Production \3\ and Therapeutic Indications   .........................
   \4\
Not Medically Important:                       .........................
  Therapeutic Indications Only                 .........................
  Production and Therapeutic Indications \4\   .........................
------------------------------------------------------------------------
\1\ kg = kilogram of active ingredient. Antimicrobials which were
  reported in International Units (IU) (e.g., Penicillins) were
  converted to kg. Antimicrobial class includes drugs of different
  molecular weights, with some drugs reported in different salt forms.
\2\ Therapeutic Indications = treatment, control, or prevention of a
  specific bacterial disease.
\3\ Production Indications = ``increased rate of weight gain'' or
  ``improved feed efficiency.''
\4\ In both the Medically Important and the Not Medically Important
  categories, there are currently fewer than three distinct sponsors
  marketing antimicrobial animal drug products approved solely for
  production indications (no therapeutic indications). To protect
  confidential business information these data cannot be independently
  reported and have, therefore, been included with drugs approved for
  both production and therapeutic indications.
* Includes some antimicrobial drug products which are approved and
  labeled for use in multiple species, including both food- and nonfood-
  producing animals, such as dogs and cats.

4. Domestic Sales and Distribution Data Reported by Medical Importance 
and Dispensing Status

    Table 6 presents data on annual domestic sales and distribution of 
antimicrobial active ingredients approved for use in food-producing 
animals broken down by medical importance and dispensing status (i.e., 
whether the product is sold over-the-counter or requires veterinary 
oversight). Medicated feeds requiring veterinary oversight are 
designated ``veterinary feed directive'' (VFD) status; all other new 
animal drug products requiring veterinary oversight are designated 
``prescription'' status. This table combines products requiring 
veterinary oversight because the VFD category currently only includes 
three ``medically important'' products marketed by two distinct 
sponsors; therefore reporting the VFD category independently would not 
be in a manner consistent with the protection of confidential business 
information. If the prescription and VFD categories are able to be 
reported independently at a later date, the table will reflect this.

Table 6--Antimicrobial Drugs Approved for Use in Food-Producing Animals:
  * Domestic Sales and Distribution Data Reported by Medical Importance
                 and Dispensing Status Marketed in 20XX
------------------------------------------------------------------------
                                                Annual totals (kg) \1\
------------------------------------------------------------------------
Medically Important:
  OTC \2\..................................  ...........................
  Rx \3\ or VFD 4 5........................  ...........................
Not Medically Important:
  OTC......................................  ...........................
  Rx.......................................  ...........................
------------------------------------------------------------------------
\1\ kg = kilogram of active ingredient. Antimicrobials which were
  reported in International Units (IU) (e.g., Penicillins) were
  converted to kg. Antimicrobial class includes drugs of different
  molecular weights, with some drugs reported in different salt forms.
\2\ OTC = Over-The-Counter veterinary drug products. Such products are
  available without a prescription or veterinary feed directive.
\3\ Rx = prescription veterinary drug products. Such products require a
  prescription from a licensed veterinarian.
\4\ VFD = Veterinary Feed Directive drug products. Such products are
  intended for use in or on animal feed and must be used under the
  professional supervision or oversight of a veterinarian.
\5\ The ``Rx or VFD'' category includes three medically important VFD
  products marketed by two distinct sponsors and, therefore, cannot be
  independently reported. There are no VFD products in the Not Medically
  Important category.
* Includes some antimicrobial drug products which are approved and
  labeled for use in multiple species, including both food- and nonfood-
  producing animals, such as dogs and cats.

III. 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.

    Dated: September 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23488 Filed 9-25-13; 8:45 am]
BILLING CODE 4160-01-P