[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Rules and Regulations]
[Pages 57796-57800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20148]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2016-N-1896]
New Animal Drugs for Use in Animal Feed; Category Definitions
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, we) is
amending the animal drug regulations by revising the definitions of the
two categories of new animal drugs used in medicated feeds to base
category assignment only on approved uses in major animal species. This
revision will preserve the availability of medicated feeds intended for
therapeutic use in minor animal species and prevent a significant
disincentive for future development of additional minor species
therapies.
DATES: This rule is effective December 1, 2016. Submit either
electronic or written comments by November 7, 2016. See Section IV for
further discussion of the effective date.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-1896 for ``Category Definitions For Minor Species.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper 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: David Edwards, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-6205, [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Direct Final Rule
B. Summary of the Major Provisions of the Direct Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
III. Provisions of the Regulation
IV. Direct Final Rulemaking
V. Legal Authority
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. References
I. Executive Summary
A. Purpose of the Direct Final Rule
FDA is issuing this direct final rule to revise the definitions of
the two categories of new animal drugs used in
[[Page 57797]]
medicated feeds to base category assignment only on approved uses in
major animal species. This action is being taken to address a potential
consequence of animal drug sponsor cooperation in implementing a
strategy initiated by the FDA Center for Veterinary Medicine (CVM) to
address antimicrobial resistance by taking measures to ensure the
judicious use of antimicrobial drugs in animal agriculture. Under this
program, sponsors of antimicrobial new animal drugs that also have
importance in human medicine were requested to voluntarily withdraw
approval of production (e.g., growth production, feed efficiency)
indications for their drug products that are intended for use in the
feed or water of food-producing animals. Based on the existing drug
category definitions, the voluntary withdrawal of production
indications by these drug sponsors would, in some cases, result in a
change to a medicated feed drug's category, potentially leading to
additional consequences not foreseen at the time the program was
initiated.
The category in which a new animal drug used in medicated feeds is
placed is based on their likelihood of producing unsafe residues in the
edible products of treated animals. Category I consists of those drugs
that require no withdrawal period at the lowest use level in each
species for which they are approved. Category II consists of those
drugs that require a withdrawal period at the lowest use level for at
least one species for which they are approved, or that are regulated on
a ``no-residue'' basis or with a zero tolerance because of a
carcinogenic concern, regardless of whether a withdrawal period is
required.
New animal drugs approved for use in medicated feeds are approved
as Type A medicated articles, the most concentrated form of the drug
product for use by feed mills. Category I Type A medicated articles can
be handled by both licensed and unlicensed feed mills, whereas Category
II Type A medicated articles can be handled only by licensed feed
mills.
Certain Category I Type A medicated articles would be recategorized
to Category II when a production indication is voluntarily withdrawn by
a sponsor as part of the judicious use initiative that is currently
underway, based on the next lowest use level that remains once the
production use is withdrawn having a withdrawal period such that the
drug would then meet the definition for Category II. For Category I
Type A medicated articles that include indications for minor species,
FDA is concerned that if such a Type A medicated article is
recategorized to Category II based on a withdrawal period for an
approved therapeutic use in a minor species, sponsors may opt to
request withdrawal of approval of these minor species indications in
order to ensure the Type A medicated article can remain in Category I.
Sponsors may also decline to pursue development of additional therapies
for minor species if these uses would require a withdrawal period that
would trigger a recategorization to Category II.
This direct final rule revises the category definitions such that
they will be based only on whether a withdrawal period is required for
a major species.\1\ Under this new definition, a Category I Type A
medicated article will not be recategorized to Category II based on the
existence of a withdrawal period for an approved indication in a minor
species, even if that minor species indication is the next lowest
approved use level that remains after the production indication has
been withdrawn. However, if the next lowest use level (apart from the
minor species indication) is an indication approved for use in a major
species that has a withdrawal period, under the new definition the drug
will move to Category II.
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\1\ As a practical matter, categorization under the revised
definitions in this direct final rule will be driven by approved
indications for major food-producing species (cattle, poultry,
swine, and turkeys). While the definition for major species includes
horses, dogs, and cats, they are not regulated as food-producing
major species and thus drugs approved for use in these species do
not require an assessment of human food safety that may result in
assignment of a withdrawal period. Minor species are defined as
animals, other than humans, that are not major species. Minor
species include animals such as sheep, goats, ducks, geese, and
aquaculture species such as catfish, salmon, and trout.
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The purpose of this revision is to preserve the present
availability of medicated feeds intended for therapeutic uses in minor
species and to prevent a significant disincentive for future
development of additional therapies for minor species. We believe this
revision will not compromise public health due to the comparatively
lower exposure by humans to potential drug residues in edible tissues
of food-producing minor species inherent in their less frequent
consumption.
B. Summary of the Major Provisions of the Direct Final Rule
FDA is amending 21 CFR 558.3 Definitions and general considerations
applicable to this part (Sec. 558.3) to base the definition for each
of the two categories (Category I and Category II) of new animal drugs
used in medicated feeds only on approved uses in major species.
Definitions for ``major species'' and ``minor species'' are also being
added to this section.
C. Legal Authority
FDA is issuing these regulations based on its authority under the
new animal drug provisions in sections 512 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) and under section
701(a) of the FD&C Act (21 U.S.C. 371(a)), which gives the Agency
general rulemaking authority to issue regulations for the efficient
enforcement of the FD&C Act.
D. Costs and Benefits
The revisions made by this direct final rule are intended to
preserve the availability of medicated feeds intended for therapeutic
use in minor animal species. In addition, these revisions will prevent
a significant disincentive for future development of additional
therapies for minor species. No additional costs or benefits will
accrue from this rulemaking.
II. Background
FDA is issuing this direct final rule to revise the definitions of
the two categories of new animal drugs used in medicated feeds to base
category assignment only on approved uses in major animal species. To
strengthen the Agency's medicated feed program, FDA issued a final rule
in the Federal Register of March 3, 1986 (51 FR 7382), which, among
other things, established two categories of new animal drugs used in
medicated feeds. As discussed in the final rule, the Agency placed
these drugs into categories based on their likelihood of producing
unsafe residues in the edible products of treated animals (51 FR 7382).
Category I consists of those drugs that require no withdrawal period at
the lowest use level in each species for which they are approved.
Category II consists of those drugs that require a withdrawal period at
the lowest use level for at least one species for which they are
approved, or that are regulated on a ``no-residue'' basis or with a
zero tolerance because of a carcinogenic concern, regardless of whether
a withdrawal period is required.
New animal drugs approved for use in medicated feeds are approved
as Type A medicated articles, the most concentrated form of the drug
product for use by feed mills. Category I Type A medicated articles can
be handled by both licensed and unlicensed feed mills, whereas Category
II Type A medicated articles can be handled only by licensed feed
mills.
This action is being taken to address a potential consequence of
animal drug
[[Page 57798]]
sponsor cooperation in implementing a strategy initiated by CVM to
address antimicrobial resistance by taking measures to ensure the
judicious use of antimicrobials of importance to human medicine (i.e.,
medically important antimicrobials) in animal agriculture.
Specifically, CVM's initiative to ensure the judicious use of medically
important antimicrobial drugs in animal agriculture advocates two
specific changes to the approved conditions of use of medically
important antimicrobials that are administered through the medicated
feed or water of food-producing animals.
These changes, which are described in Guidance for Industry (GFI)
#213, ``New Animal Drugs and New Animal Drug Combination Products
Administered in or on Medicated Feed or Drinking Water of Food-
Producing Animals: Recommendations for Drug Sponsors for Voluntarily
Aligning Product Use Conditions with GFI #209,'' published December
2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), are
intended to reduce the development of antimicrobial resistance and
thereby preserve the effectiveness of these important drugs for use in
treating infections in humans. Following publication of GFI #213, all
sponsors of these medically important antimicrobial new animal drug
products approved for use in the feed or water of food-producing
animals notified FDA in writing of their intent to voluntarily make
changes to their affected products as outlined in the guidance.
Under GFI #213, sponsors of medically important antimicrobial new
animal drugs approved for over-the-counter use in the feed or water of
food-producing animals were asked to change the marketing status of
their products to veterinary prescription (Rx) marketing status in the
case of new animal drugs administered in water, or to veterinary feed
directive (VFD) marketing status for drugs administered in or on animal
feed. New animal drugs with Rx or VFD marketing status can legally only
be used with a veterinarian's oversight. Prescription animal drugs
require a veterinarian's prescription, while use of VFD drugs requires
a VFD; both types of orders must be issued by a licensed veterinarian
in the course of the veterinarian's professional practice.
In addition, under GFI #213 sponsors of medically important new
animal drugs used in animal feed or water that have production
indications were requested to voluntarily withdraw these indications;
approved therapeutic indications for use of these drugs would remain.
In some instances, once a sponsor withdraws the production
indication from a drug approved for use in animal feed (which is
generally the lowest use level of the drug), the remaining lowest
therapeutic use level will require a withdrawal period. Based on the
existing definitions of the feed drug categories, this results in a
Category I new animal drug being recategorized as a Category II drug,
the more restrictive of the two possible categories of drugs used in
medicated feed. Category II drugs require that the manufacture of Type
B and Type C medicated feeds from Type A medicated articles be done in
facilities possessing a medicated feed mill license, which number
roughly 900 in the United States. In contrast, there are tens of
thousands of unlicensed feed mills in this country. Such a
recategorization to Category II, thereby limiting the use of the Type A
medicated article to a much smaller subset of feed mills, may disrupt
the existing movement of these medicated feeds through distribution
channels.
FDA believes that sponsors may request voluntary withdrawal of
those specific therapeutic indications as a way to keep their products
in the less restrictive Category I when the recategorization of a drug
to Category II is triggered by a therapeutic indication for a minor
species. For certain drug products, the only therapeutic indications
requiring a withdrawal period that would remain following the voluntary
withdrawal of approval of production uses are those for minor species.
The loss of therapeutic indications for minor species would adversely
affect the availability of therapeutic medicated feeds necessary for
the health of minor species, which is a matter of significant concern
for the Agency.
This foreseeable adverse effect on the health of minor species
would directly undermine the intent of Congress in passing the Minor
Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282) as
well as to our intent in establishing the implementing regulations
under that statute. The Category I drugs likely to be affected have
been safely used in this category for decades, and we have no reason to
believe they would not continue to be safely used in this category
moving forward.
Under the current category definitions in Sec. 558.3 for feed use
drugs, a drug will be included in Category II if the lowest use level
of the drug in any approved species requires a withdrawal period. This
approach equates the existence of a withdrawal period for a particular
use with the potential risk that edible tissues from animals
administered a medicated feed might contain a residue of concern.
However, the toxicological analysis of animal drugs used to
calculate a withdrawal period is based on lifetime exposure by humans
to potential drug residues. This assessment of lifetime exposure does
not consider the lower risk to the public health from the use of these
same new animal drugs in food-producing minor species attributable to
the lower human consumption over time of edible tissues from food-
producing minor species (Refs. 1 and 2). For this reason, FDA does not
at this time believe this revision of the category definitions presents
a risk to the public health.
In a manner similar to its effect on drug indications that are
already approved, CVM believes the existing categorization scheme would
pose a significant disincentive for future development of additional
minor species therapies for existing Category I drugs if those new uses
would require a withdrawal period and thus trigger a change to Category
II for that drug.
Given the potential for implementation of GFI #213 to result in the
foreseeable consequence of the withdrawal of approval of needed
therapeutic indications for minor species, the definitions of the two
categories of new animal drugs used in medicated feeds in Sec. 558.3
are being revised to base category assignment only on uses in major
species. This revision is expected to preserve the availability of
drugs intended for therapeutic use in minor species and also prevent a
significant disincentive for future development of additional therapies
for minor species without compromising public health.
III. Provisions of the Regulation
We are amending paragraphs (b)(1)(i) and (ii) of this Agency's
regulations at Sec. 558.3 (Definitions and general considerations
applicable to this part.) to base the definition for each of the two
categories of new animal drugs (Category I and Category II) used in
medicated feeds only on approved uses in major species. Section
558.3(b) is further amended to add definitions for ``major species''
and ``minor species'' that are identical to the definitions of those
terms found in FDA's regulations for new animal drugs for minor use and
minor species (21 CFR 516.3). We are revising the feed drug category
definitions in Sec. 558.3 to preserve the availability of medicated
feeds intended for use in minor species and prevent a
[[Page 57799]]
likely disincentive for development of additional therapies for minor
species.
IV. Direct Final Rulemaking
FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. FDA is amending Sec. 558.3(b)(1) by revising
the definitions of Category I and Category II new animal drugs
administered in or on medicated feed. This rule is intended to make
noncontroversial changes to existing regulations. The Agency does not
anticipate receiving any significant adverse comments on this rule.
Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule. The companion proposed rule and this direct final rule
are substantively identical. The companion proposed rule provides the
procedural framework within which the rule may be finalized in the
event the direct final rule is withdrawn because of any significant
adverse comment. The comment period for this direct final rule runs
concurrently with the comment period of the companion proposed rule.
Any comments received in response to the companion proposed rule will
also be considered as comments regarding this direct final rule.
FDA is providing a comment period for the direct final rule of 75
days after the date of publication in the Federal Register. If FDA
receives a significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one that explains why the rule would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without a change. In
determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, the Agency will consider whether the
comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process in accordance with section 553
of the Administrative Procedure Act (APA) (5 U.S.C. 553).
Comments that are frivolous, insubstantial, or outside the scope of
this direct final rule will not be considered significant or adverse
under this procedure. For example, a comment recommending a regulation
change in addition to those in the rule would not be considered a
significant adverse comment unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to an amendment, paragraph, or
section of this rule and that provision can be severed from the
remainder of the rule, FDA may adopt as final those provisions of the
rule that are not the subject of a significant adverse comment.
If FDA withdraws the direct final rule, all comments received will
be considered under the companion proposed rule in developing a final
rule under the usual notice-and-comment procedures under the APA (5
U.S.C. 552 et seq.). If FDA does not receive a significant adverse
comment in response to the direct final rule, the Agency will publish,
within 30 days after the comment period ends, a document in the Federal
Register confirming the effective date of the final rule. The Agency
intends to make the direct final rule effective December 1, 2016.
A full description of FDA's policy on direct final rule procedures
may be found in a guidance document announced in the Federal Register
of November 21, 1997 (62 FR 62466). The guidance document may be
accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
V. Legal Authority
We are issuing these regulations under the legal authority provided
by section 512 of the FD&C Act relating to new animal drugs and section
701(a) of the FD&C Act. Section 512 gives FDA the authority to approve
new animal drug applications (NADAs). Such approval establishes
conditions of use under which the drug can be used in a safe and
effective manner. Categorization of new animal drugs used in medicated
feeds is one such condition of use. In addition, section 701(a) of the
FD&C Act gives FDA general rulemaking authority to issue regulations
for the efficient enforcement of the FD&C Act.
VI. Economic Analysis of Impacts
We have examined the impacts of the direct final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us
to assess all costs and benefits of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). We believe that this direct final rule is not a
significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this direct final rule would not impose any
compliance costs on the sponsors of animal drug products that are
currently marketed or in development, we certify that this direct final
rule will not have a significant economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This direct final rule would not result in an
expenditure in any year that meets or exceeds this amount.
This direct final rule allows certain new animal drugs approved for
use in animal feed that would otherwise be recategorized as Category II
drugs under the current definitions in Sec. 558.3 following withdrawal
of approval of production indications during GFI #213 implementation to
remain in Category I if the change to Category II would have been
triggered by a minor species indication.
Based on the revised definitions of the two feed drug categories,
there is one drug, sulfamerazine for control of furunculosis in trout
(21 CFR 558.582), that will be recategorized from Category II to
Category I as a result of this direct final rule. No compliance costs
will be incurred due to this recategorization because no changes to the
approved application are required for continued marketing of the drug.
VII. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
[[Page 57800]]
VIII. Paperwork Reduction Act of 1995
This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.
IX. Federalism
We have analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this direct final rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we have concluded that this direct final rule does not contain policies
that have federalism implications as defined in the Executive Order
and, consequently, a federalism summary impact statement is not
required.
X. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. U.S. Department of Agriculture, ``Livestock & Meat Domestic
Data,'' http://www.ers.usda.gov/data-products/livestock-meat-domestic-data (accessed on June 23, 2016).
2. ``Food Fish Production and Sales by Species, by Size Category, by
State and United States: 2005,'' http://www.agcensus.usda.gov/Publications/2002/Aquaculture/aquacen2005_08.pdf (accessed on June
23, 2016).
List of Subjects in 21 CFR Part 558
Animal drugs, animal feeds.
Therefore, under the Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
2. In Sec. 558.3, revise paragraphs (b)(1)(i) and (ii); and add
paragraphs (b)(13) and (14) to read as follows:
Sec. 558.3 Definitions and general considerations applicable to this
part.
* * * * *
(b) * * *
(1) * * *
(i) Category I--These drugs require no withdrawal period at the
lowest use level in each major species for which they are approved or
are approved for use only in minor species.
(ii) Category II--These drugs require a withdrawal period at the
lowest use level for at least one major species for which they are
approved, or are regulated on a ``no-residue'' basis or with a zero
tolerance because of carcinogenic concern regardless of whether a
withdrawal period is required in any species.
* * * * *
(13) ``Major species'' means cattle, horses, swine, chickens,
turkeys, dogs, and cats.
(14) ``Minor species'' means animals, other than humans, that are
not major species.
Dated: August 18, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-20148 Filed 8-23-16; 8:45 am]
BILLING CODE 4164-01-P