PR 20-101 Federal Register Notice

PR 20-101 FRN.pdf

Handling of Animals; Contingency Plans

PR 20-101 Federal Register Notice

OMB: 0579-0479

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33567

Proposed Rules

Federal Register
Vol. 86, No. 120
Friday, June 25, 2021

This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Part 2
[Docket No. APHIS–2020–0101]
RIN 0579–AC69

Handling of Animals; Contingency
Plans
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:

The Animal and Plant Health
Inspection Service issued a final rule on
December 31, 2012, to establish
regulations under which research
facilities and dealers, exhibitors,
intermediate handlers, and carriers must
meet certain requirements for
contingency planning and training of
personnel. Implementation of the final
rule was stayed on July 31, 2013, so that
the agency could conduct additional
review to further consider the impact of
contingency plan requirements on
regulated entities. Since that time, we
have conducted such a review, and the
2021 Congressional Appropriations Act
has required us to propose to lift the
stay. We are therefore proposing to lift
the stay and make minor revisions to the
requirements in order to update
compliance dates and clarify intent. The
lifting of the stay and proposed
revisions would better ensure that
entities responsible for animals
regulated under the Animal Welfare Act
are prepared to safeguard the health and
welfare of such animals in the event of
possible emergencies or disasters.
DATES: We will consider all comments
that we receive on or before August 24,
2021.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
www.regulations.gov. Enter APHIS–
2020–0101 in the Search field.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.

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SUMMARY:

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APHIS–2020–0101, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at www.regulations.gov
or in our reading room, which is located
in room 1620 of the USDA South
Building, 14th Street and Independence
Avenue SW, Washington, DC. Normal
reading room hours are 8 a.m. to 4:30
p.m., Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
FOR FURTHER INFORMATION CONTACT: Dr.
Elizabeth Theodorson, DVM, MPH,
Assistant Deputy Administrator, Animal
Care, APHIS, 4700 River Road Unit 86,
Riverdale, MD 20737; (970) 494–7473.
SUPPLEMENTARY INFORMATION:
Background
Under the Animal Welfare Act (AWA)
(7 U.S.C. 2131 et seq.), the Secretary of
Agriculture is authorized to promulgate
standards and other requirements
governing the humane handling, care,
treatment, and transportation of certain
animals by dealers, research facilities,
exhibitors, carriers, and intermediate
handlers. The Secretary has delegated
authority for administering the AWA to
the Administrator of the U.S.
Department of Agriculture’s (USDA’s)
Animal and Plant Health Inspection
Service (APHIS). Within APHIS, the
responsibility for administering the
AWA has been delegated to the Deputy
Administrator for APHIS’ Animal Care
program (AC). Regulations and
standards established under the AWA
are contained in 9 CFR parts 1, 2, and
3 (referred to below as the regulations).
Following the events experienced
during the 2005 hurricane season, AC
concluded that entities responsible for
animals covered by the AWA could
better safeguard the health and welfare
of their animals by developing
contingency plans for possible
emergencies or disasters (situations
which could reasonably be anticipated
and expected to be detrimental to the
good health and well-being of the
animals in the regulated entity’s
possession). Consequently, on December
31, 2012, APHIS published in the
Federal Register (77 FR 76815–76824,
Docket No. APHIS–2006–0159) a final

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rule 1 establishing regulations under
which research facilities and dealers,
exhibitors, intermediate handlers, and
carriers of animals regulated under the
AWA must meet certain requirements
for developing contingency plans and
training personnel in their role and
responsibilities related to the
contingency plan.
After learning that a number of small
entities considered the requirements of
these regulations excessive for their
specific cases, and determining there to
be validity to such a claim, on July 31,
2013, we published in the Federal
Register (78 FR 46255, Docket No.
APHIS–2006–0159) a stay 2 of the
regulations to reexamine any unique
circumstances and costs that may vary
by the type and size of businesses
affected by the final rule.
Since that time, APHIS has issued de
minimis exemptions to animal
licensure. On June 4, 2018, we
published in the Federal Register (83
FR 25549–25555, Docket No. APHIS–
2014–0059) a final rule 3 that exempted
from licensing dealers with four or
fewer breeding female pet animals,
small exotic or small wild mammals
(such as hedgehogs, degus, spiny mice,
prairie dogs, flying squirrels, jerboas,
domesticated ferrets, chinchillas, and
gerbils), and/or domesticated farm-type
animals (such as cows, goats, pigs,
sheep, llamas, and alpacas), and added
an exemption from licensing for
exhibitors who maintained eight or
fewer pet animals, small exotic or small
wild mammals, and/or domesticated
farm-type animals for exhibition.
Following issuance of the 2018 final
rule, APHIS notified 525 licensees
operating small businesses that they
may be newly eligible for exemption
from requirements under the amended
regulations. As of December 2020, 259
licensees have canceled their licenses,
and we anticipate that this number will
increase on a rolling basis as licenses
meet their expiration dates. APHIS
believes that these broadened
exemptions address the concerns that
led to the stay, and that contingency
1 To view the final rule, go to https://
www.regulations.gov/document/APHIS-2006-01590209.
2 To view the stay of the regulations, go to https://
www.regulations.gov/document/APHIS-2006-01590214.
3 To view the final rule, go to https://
www.regulations.gov/document/APHIS-2014-00590032.

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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Proposed Rules

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planning requirements remain an
important safeguard for the health and
welfare of animals regulated under the
AWA.
Additionally, on December 27, 2020,
the 2021 Congressional Appropriations
Act (Pub. L. 116–260) required APHIS to
propose to lift the stay on the final rule
establishing requirements for
contingency plans within 180 days of
issuance of that Act. Consistent with our
own evaluation, as well as the terms of
the Act, we are issuing this proposed
rule to lift the stay.
We are also proposing to make minor
changes to the contingency plan
regulations. These changes include
updating the compliance dates by which
regulated entities must create their
contingency plans to 180 days after the
effective date of a final rule following
this proposed rule; modifying the dates
regarding when regulated entities must
provide training to personnel to 60 days
after the contingency plan being put in
place; removing an extraneous reference
to additional requirements for marine
mammals to minimize confusion; and
removing the requirement that facilities
as well as dealers, exhibitors,
intermediate handlers, and carriers
document their personnel’s
participation in requisite trainings.
Finally, to increase the ease of and
decrease the time burden associated
with contingency planning, AC has
created an optional form that entities
may use to develop and document a
contingency plan. The form would be
available on the APHIS AC website, in
the USDA Forms library on the USDA
website, or upon request by email to
[email protected] or by mail to
USDA/APHIS/AC, 2150 Centre Ave.,
Building B, Mailstop 3W11, Fort
Collins, CO 80526–8117. We are
proposing to add a reference to this form
in the regulations.
Executive Order 12866 and Regulatory
Flexibility Act
This proposed rule has been
determined to be significant for the
purposes of Executive Order 12866 and,
therefore, has been reviewed by the
Office of Management and Budget.
Details on the estimated costs of this
proposed rule can be found in the rule’s
economic analysis.
We have prepared an economic
analysis for this rule. The economic
analysis provides a cost-benefit analysis,
as required by Executive Orders 12866
and 13563, which direct agencies to
assess all costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,

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environmental, public health and safety
effects, and equity). Executive Order
13563 emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. The
economic analysis also provides an
initial regulatory flexibility analysis that
examines the potential economic effects
of this rule on small entities, as required
by the Regulatory Flexibility Act. The
economic analysis is summarized
below. Copies of the full analysis are
available by contacting the person listed
under FOR FURTHER INFORMATION
CONTACT or on the Regulations.gov
website (see ADDRESSES above for
instructions for accessing
Regulations.gov).
Based on the information we have,
there is no reason to conclude that
adoption of this proposed rule would
result in any significant economic
impact on a substantial number of small
entities. However, we do not currently
have all of the data necessary for a
comprehensive analysis of the effects of
this proposed rule on small entities.
Therefore, we are inviting comments on
potential effects. In particular, we are
interested in determining the number
and kinds of small entities that may
incur benefits or costs from the
implementation of this proposed rule.
While it is difficult to quantify the
benefits of contingency planning, they
are numerous. First, contingency
planning can prevent loss of animal life
and any resulting undisposed carcasses
that pose a threat to public health.
Second, loss of valuable research
resources and income can be mitigated
with contingency planning. Third,
having a contingency plan can reduce
the time of recovery from disasters and
thus provide cost savings to the affected
businesses and organizations and allow
for business continuity. Finally,
required contingency planning will
reassure the general public that facilities
have measures in place to ensure the
welfare of the animals in times of
catastrophic and common emergencies.
APHIS’ AC program will be providing
a fillable form that can be used to
develop and document the contingency
plan; however, entities that have
contingency plans in place may use
those. For example, we believe that
Public Health Service-funded research
facilities and Association of Zoos and
Aquariums zoos and aquariums have
already developed contingency plans;
they would not need to adopt the
template. The template is intended to
aid entities currently without a written
contingency plan, and we estimate it
will take 1–2 hours per entity to
complete the plan, which includes the

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time to collect and document the
required information. We anticipate that
the use of this form will improve
compliance and expedite the time for
annual review by regulated entities of
the plan. APHIS also estimates it will
take up to 1 hour to train employees on
the operations of the plan, which
consists of familiarizing employees with
their roles and responsibilities as
outlined in the plan. APHIS invites
comments on the time it may take to
develop and implement contingency
plans for the proposed rule and to
provide the employee training required
by the proposed rule. The Agency
invites suggestions for guidance or other
information that would help regulated
facilities achieve compliance at
minimum costs.
We estimated lower and upper range
estimates of costs for licensees and
registrants to develop contingency plans
in the first year. As noted above, we
assume an average of 1 to 2 hours is
required to prepare and implement a
contingency plan using the form and 1
hour for employee training in the first
year. We multiplied this time by the
average industry-specific wage rate of
the entities. Our estimate of the total
one-time cost to develop the
contingency plans across all affected
entity categories ranges from about
$185,000 to about $370,000 and
$185,000 for employee training, as well
as possible capital costs, which will
differ from entity to entity and which
we accordingly are not able to estimate
in aggregate. These estimates may be
high, given our inclusion of entities that
may currently have comparable
contingency plans and already provide
employee training, but for which we
lack verifying information. We request
specific public comment on our
estimates.
The 1 to 2 hours that we assume
would be required to develop a
contingency plan includes the time
needed to identify resources for the
plan’s preparation and documentation.
The 1-hour training estimate for all
current and new employees considers
the time it would take an employee to
become familiar with their roles and
responsibilities as outlined in the plan.
The costs included in this analysis
reflect training for the first year only.
Contingency planning also requires
recordkeeping, ensuring that the
contingency plans are kept current, and
employee training. The type of training
and type of contingency plan required
may differ depending on the type of
organization or business, as well as its
location and the location’s climate
history.

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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Proposed Rules
Executive Order 12372
This program/activity is listed in the
Catalog of Federal Domestic Assistance
under No. 10.025 and is subject to
Executive Order 12372, which requires
intergovernmental consultation with
State and local officials. (See 2 CFR
chapter IV.)

Based on the foregoing, the USDA’s
Office of Tribal Relations (OTR) has
assessed the impact of this rule on
Indian Tribes and determined that
consultation is not required at this time.
If consultation is requested, OTR will
work with APHIS to ensure quality
consultation is provided.

Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. It is not intended to
have retroactive effect. The Act does not
provide administrative procedures
which must be exhausted prior to a
judicial challenge to the provisions of
this rule.

Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection or recordkeeping
requirements included in this proposed
rule have been submitted for approval to
the Office of Management and Budget
(OMB). Written comments and
recommendations for the proposed
information collection should be sent
within 60 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function. Please send a copy of
your comments to: (1) Docket No.
APHIS–2020–0101, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238, and (2)
Clearance Officer, OCIO, USDA, Room
404–W, 14th Street and Independence
Avenue SW, Washington, DC 20250. A
comment to OMB is best assured of
having its full effect if OMB receives it
within 30 days of publication of this
proposed rule.
The proposed rule would amend the
current regulations and would require
all licensees and registrants, which
include research facilities, dealers,
exhibitors, intermediate handlers, and
carriers, to develop, document, and
maintain contingency plans for the
handling of animals during all
emergencies or disasters.
We are soliciting comments from the
public (as well as affected agencies)
concerning the new proposed optional
APHIS form for creating and
documenting them, as well as our
proposed information collection and
recordkeeping requirements. These
comments will help us:
(1) Evaluate whether the proposed
information collection is necessary for
the proper performance of our agency’s
functions, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the proposed
information collection, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and

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National Environmental Policy Act
To provide the public with
documentation of APHIS’ review and
analysis of any potential environmental
impacts associated with contingency
planning, we have prepared an
environmental assessment. The
environmental assessment was prepared
in accordance with: (1) The National
Environmental Policy Act of 1969
(NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on
Environmental Quality for
implementing the procedural provisions
of NEPA (40 CFR parts 1500–1508), (3)
USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS’ NEPA
Implementing Procedures (7 CFR part
372).
The environmental assessment may
be viewed on the Regulations.gov
website or in our reading room. (A link
to Regulations.gov and information on
the location and hours of the reading
room are provided under the heading
ADDRESSES at the beginning of this
proposed rule.) In addition, copies may
be obtained by calling or writing to the
individual listed under FOR FURTHER
INFORMATION CONTACT.
Executive Order 13175
This rule has been reviewed in
accordance with the requirements of
Executive Order 13175, ‘‘Consultation
and Coordination with Indian Tribal
Governments.’’ Executive Order 13175
requires Federal agencies to consult and
coordinate with Tribes on a
government-to-government basis on
policies that have Tribal implications,
including regulations, legislative
comments or proposed legislation, and
other policy statements or actions that
have substantial direct effects on one or
more Indian Tribes, on the relationship
between the Federal Government and
Indian Tribes or on the distribution of
power and responsibilities between the
Federal Government and Indian Tribes.

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(4) Minimize the burden of the
information collection on those who are
to respond (such as through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology; e.g., permitting
electronic submission of responses).
Estimate of burden: Public burden for
this collection of information is
estimated to average 1.75 hours per
response.
Respondents: Dealers, exhibitors,
research facilities, carriers, and
intermediate handlers.
Estimated annual number of
respondents: 8,795.
Estimated annual number of
responses per respondent: 2.
Estimated annual number of
responses: 17,590.
Estimated total annual burden on
respondents: 30,783 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
A copy of the information collection
may be viewed on the Regulations.gov
website or in our reading room. (A link
to Regulations.gov and information on
the location and hours of the reading
room are provided under the heading
ADDRESSES at the beginning of this
proposed rule.) A copy may also be
obtained from Mr. Joseph Moxey,
APHIS’ Paperwork Reduction Act
Coordinator, at (301) 851–2483. APHIS
will respond to any ICR-related
comments in the final rule. All
comments will also become a matter of
public record.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E-Government Act
to promote the use of the internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this proposed rule, please contact Mr.
Joseph Moxey, APHIS’ Paperwork
Reduction Act Coordinator, at (301)
851–2483.
List of Subjects in 9 CFR Part 2
Animal welfare, Pets, Reporting and
recordkeeping requirements, Research.
Accordingly, we propose to amend 9
CFR part 2 as follows:
PART 2—REGULATIONS
1. The authority citation for part 2
continues to read as follows:

■

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33570

Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Proposed Rules

Authority: 7 U.S.C. 2131–2159; 7 CFR
2.22, 2.80, and 371.7.

2. Amend § 2.38:
a. By lifting the stay on paragraph (l);
b. In paragraph (l)(2):
i. In the first sentence by removing the
date ‘‘July 29, 2013’’ and adding
‘‘[DATE 180 DAYS AFTER EFFECTIVE
DATE OF FINAL RULE]’’ in its place;
■ ii. In the next to last sentence by
removing the words ‘‘and training
records’’; and
■ ii. By revising the last sentence; and
■ c. By revising paragraph (l)(3).
The revisions read as follows:
■
■
■
■

§ 2.38

Miscellaneous.

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*

*
*
*
*
(l) * * *
(2) * * * The APHIS Contingency
Plan form may be used to keep and
maintain the information required by
paragraph (l)(1) of this section and this
paragraph (l)(2).
(3) The facility must provide training
for its personnel regarding their roles
and responsibilities as outlined in the
plan. For current registrants, training of
facility personnel must be completed
within 60 days of the research facility
putting their plan in place; for research
facilities registered after [DATE 180
DAYS AFTER EFFECTIVE DATE OF
FINAL RULE] training of facility
personnel must be completed within 60
days of the facility putting its
contingency plan in place. To fulfill this
training requirement, employees hired
30 days or more before the contingency
plan is put in place must be trained by
the date the facility puts its contingency
plan in place. For employees hired less
than 30 days before that date or after
that date, training must be conducted
within 30 days of their start date. Any
changes to the plan as a result of the
annual review must be communicated
to employees through training which
must be conducted within 30 days of
making the changes.
■ 3. Amend § 2.134:
■ a. By lifting the stay on the section;
■ b. In paragraph (b):
■ i. In the first sentence by removing the
date ‘‘July 29, 2013’’ and adding
‘‘[DATE 180 DAYS AFTER EFFECTIVE
DATE OF FINAL RULE]’’ in its place;
■ ii. In the fifth sentence by removing
the words ‘‘and training records’’; and
■ iii. By revising the last sentence; and
■ c. By revising paragraph (c).
The revisions read as follows:
§ 2.134

Contingency planning.

*

*
*
*
*
(b) * * * The APHIS Contingency
Plan form may be used to keep and
maintain the information required by
§ 2.38(l)(1) and (2).

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(c) Dealers, exhibitors, intermediate
handlers, and carriers must provide
training for their personnel regarding
their roles and responsibilities as
outlined in the plan. For current
licensees and registrants, training of
dealer, exhibitor, intermediate handler,
and carrier personnel must be
completed within 60 days of the
licensee and registrant putting their
contingency plan in place; for new
dealers, exhibitors, intermediate
handlers, or carriers licensed or
registered after [DATE 180 DAYS
AFTER EFFECTIVE DATE OF FINAL
RULE], training of personnel must be
completed within 60 days of the dealer,
exhibitor, intermediate handler, or
carrier putting their contingency plan in
place. To fulfill this requirement,
employees hired 30 days or more before
the contingency plan is put in place
must be trained by the date the licensee
or registrant puts their contingency plan
in place. For employees hired less than
30 days before that date or after that
date, training must be conducted within
30 days of their start date. Any changes
to the plan as a result of the annual
review must be communicated to
employees through training which must
be conducted within 30 days of making
the changes.
Done in Washington, DC, this 16th day of
June 2021.
Mae Wu,
Deputy Under Secretary for Marketing and
Regulatory Programs.
[FR Doc. 2021–13152 Filed 6–24–21; 8:45 am]
BILLING CODE 3410–34–P

FEDERAL DEPOSIT INSURANCE
CORPORATION
12 CFR Part 365
RIN 3064–AF72

Real Estate Lending Standards
Federal Deposit Insurance
Corporation (FDIC).
ACTION: Notice of proposed rulemaking
and request for comment.
AGENCY:

The FDIC is inviting comment
on a proposed rule to amend
Interagency Guidelines for Real Estate
Lending Policies (Real Estate Lending
Standards). The purpose of the
proposed rule is to align the Real Estate
Lending Standards with the community
bank leverage ratio (CBLR) rule, which
does not require electing institutions to
calculate tier 2 capital or total capital.
The proposed rule would allow a
consistent approach for calculating the
ratio of loans in excess of the

SUMMARY:

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supervisory loan-to-value limits (LTV
Limits) at all FDIC-supervised
institutions, using a methodology that
approximates the historical
methodology the FDIC has followed for
calculating this measurement without
requiring institutions to calculate tier 2
capital. The proposed rule would also
avoid any regulatory burden that could
arise if an FDIC-supervised institution
subsequently decides to switch between
different capital frameworks.
DATES: Comments must be received by
July 26, 2021.
ADDRESSES: Interested parties are
encouraged to submit written
comments. Commenters should use the
title ‘‘Real Estate Lending Standards
(RIN 3064–AF72)’’ to facilitate the
organization of comments. Interested
parties are invited to submit written
comments, identified by RIN 3064–
AF72, by any of the following methods:
• FDIC website: https://www.fdic.gov/
resources/regulations/federal-registerpublications/.
• Mail: James P. Sheesley, Assistant
Executive Secretary, Attention:
Comments/Legal ESS (RIN 3064–AF72),
Federal Deposit Insurance Corporation,
550 17th Street NW, Washington, DC
20429.
• Hand Delivery/Courier: The guard
station at the rear of the 550 17th Street
NW, building (located on F Street) on
business days between 7:00 a.m. and
5:00 p.m.
• Email: [email protected].
Comments submitted must include
‘‘RIN 3064–AF72.’’
Please include your name, affiliation,
address, email address, and telephone
number(s) in your comment. All
statements received, including
attachments and other supporting
materials, are part of the public record
and are subject to public disclosure.
You should submit only information
that you wish to make publicly
available.
Please note: All comments received
will be posted generally without change
to https://www.fdic.gov/resources/
regulations/federal-registerpublications/, including any personal
information provided.
FOR FURTHER INFORMATION CONTACT:
Alicia R. Marks, Examination
Specialist, Division of Risk Management
and Supervision, (202) 898–6660,
[email protected]; Navid K.
Choudhury, Counsel, (202) 898–6526, or
Catherine S. Wood, Counsel, (202) 898–
3788, Federal Deposit Insurance
Corporation, 550 17th Street NW,
Washington, DC 20429. For the hearing
impaired only, TDD users may contact
(202) 925–4618.

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