Rules of Practice for Issuance of Temporary Cease-and-Desist Orders, 34622-34623 [2014-14228]
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34622
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations
SUPPLEMENTARY INFORMATION:
12 CFR Part 611
Agriculture, Banks, banking, Rural
areas.
ehiers on DSK2VPTVN1PROD with RULES
List of Subjects
I. Background
On June 29, 2012, the Bureau
published in the Federal Register the
final Rules of Practice for Adjudication
12 CFR Part 620
Proceedings pursuant to sections
Accounting, Agriculture, Banks,
1022(b)(1) and 1053(e) of the Doddbanking, Reporting and recordkeeping
Frank Act, 12 U.S.C. 5512(b)(1) &
requirements, Rural areas.
5563(e).1 That final rule, however, does
not apply to the issuance of a TCDO
12 CFR Part 630
pursuant to section 1053(c) of the DoddAccounting, Agriculture, Banks,
Frank Act.2 The Bureau previously
banking, Organization and functions
invited comments as to whether special
(Government agencies), Reporting and
rules governing such proceedings are
recordkeeping requirements, Rural
necessary and, if so, what the rules
areas.
should provide.3 One commenter
Accordingly, the interim rule
recommended that the Bureau
amending 12 CFR parts 611, 620, and
promulgate rules governing temporary
630, which was published on March 31, cease-and-desist proceedings initiated
2014 (79 FR 17854), is adopted as a final pursuant to section 1053(c) of the Doddrule without changes.
Frank Act and pointed to the Federal
Dated: June 12, 2014.
Deposit Insurance Corporation’s (FDIC)
Dale L. Aultman,
rules governing temporary cease-andSecretary, Farm Credit Administration Board. desist proceedings, 12 CFR 308.131, as
an example of such rules.4
[FR Doc. 2014–14227 Filed 6–17–14; 8:45 am]
On September 26, 2013, 78 FR 59163,
BILLING CODE 6705–01–P
the Bureau published its interim final
rule establishing procedures for the
issuance of a temporary cease-and-desist
BUREAU OF CONSUMER FINANCIAL
order (TCDO) pursuant to section
PROTECTION
1053(c) of the Dodd-Frank Act. In
developing the interim final rule, the
12 CFR Part 1081
Bureau considered the procedures
[Docket No.: CFPB–2013–0030]
related to temporary cease-and-desist
RIN 3170–AA29
orders that are followed by other
regulatory agencies, including the FDIC,
Rules of Practice for Issuance of
the Securities and Exchange
Temporary Cease-and-Desist Orders
Commission, and the Office of the
Comptroller of the Currency. The
AGENCY: Bureau of Consumer Financial
interim final rule most closely follows
Protection.
the FDIC’s approach as codified in 12
ACTION: Final rule.
CFR 308.131. The Bureau issued the
SUMMARY: On September 26, 2013, 78 FR interim final rule to clarify (1) the basis
for the issuance of a TCDO; (2) the
59163, the Consumer Financial
Protection Bureau (Bureau) published in content, scope, and form of a TCDO; (3)
the procedures governing the issuance
the Federal Register an interim final
of a TCDO and the remedies available to
rule establishing procedures for the
issuance of a temporary cease-and-desist the Bureau in issuing a TCDO; and (4)
the rights of persons subject to a TCDO.
order (TCDO) pursuant to section
The interim final rule described each
1053(c) of the Dodd-Frank Wall Street
section of the rule and explained the
Reform and Consumer Protection Act
basis of the rule with reference to rules
(Dodd-Frank Act), which requires the
of other agencies as appropriate. After
Bureau to prescribe rules establishing
reviewing and considering the single
procedures for the conduct of
public comment offered, the Bureau
adjudication proceedings. After
adopts the interim final rule without
reviewing and considering the single
change.
public comment offered on its interim
final rule, the Bureau adopts the interim II. Legal Authority
final rule without change.
The Bureau promulgates this final
DATES: This final rule takes effect on
rule pursuant to its authority to
July 18, 2014.
implement section 1053 of the DoddFOR FURTHER INFORMATION CONTACT: John
R. Coleman, Senior Counsel, Legal
1 See 77 FR 39058 (June 29, 2012) (codified at 12
Division, Consumer Financial
CFR Part 1081).
Protection Bureau, 1700 G Street NW.,
2 Id. at 39058.
3 See 76 FR 45338, 45338 (July 28, 2011).
Washington, DC 20552; at (202) 435–
4 See 77 FR 39058, 39060 (June 29, 2012).
7254.
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Frank Act, 12 U.S.C. 5563(e), as well as
its general rulemaking authority to
promulgate rules necessary or
appropriate to carry out the Federal
consumer financial laws, 12 U.S.C.
5512(b)(1).
III. Public Comment on the Interim
Final Rule
In response to the interim final rule,
the Bureau received one comment letter
that did not contain any specific
comments or suggestions pertaining to
the interim final rule. Accordingly, the
Bureau is adopting the interim final rule
without change.
IV. Section 1022(b) Provisions
In developing the interim final and
final rules, the Bureau has considered
the potential benefits, costs, and
impacts and has consulted or offered to
consult with the prudential regulators,
the Department of Housing and Urban
Development, and the Federal Trade
Commission, including with regard to
consistency with any prudential,
market, or systemic objectives
administered by such agencies.5
The Dodd-Frank Act requires the
Bureau to prescribe rules establishing
such procedures as may be necessary to
carry out section 1053 of the Act, which
provides for temporary cease-and-orders
in subsection (c). The final rule itself
does not impose significant costs upon
covered persons, but, consistent with
section 1053, provides a straightforward
and efficient process for the issuance of
a temporary cease-and-desist order, and
a direct route to judicial review.
The final rule has no unique impact
on insured depository institutions or
insured credit unions with $10 billion
or less in assets described in section
1026(a) of the Dodd-Frank Act, nor does
it have a unique impact on rural
consumers.
V. Regulatory Requirements
As the Bureau noted in publishing the
interim final rule, this rule relates solely
5 Section 1022(b)(2)(A) of the Dodd-Frank Act
calls for the Bureau to consider the potential
benefits and costs of a regulation to consumers and
covered persons, including the potential reduction
of access by consumers to consumer financial
products or services; the impact on depository
institutions and credit unions with $10 billion or
less in total assets as described in section 1026 of
the Dodd-Frank Act; and the impact on consumers
in rural areas. Section 1022(b)(2)(B) directs the
Bureau to consult with the appropriate prudential
regulators or other Federal agencies regarding
consistency with objectives those agencies
administer. The manner and extent to which these
provisions apply to a rulemaking of this kind,
which establishes Bureau procedures and imposes
no standards of conduct, is unclear. Nevertheless,
to inform this rulemaking more fully, the Bureau
performed the analyses and consultations described
in those provisions of the Dodd-Frank Act.
E:\FR\FM\18JNR1.SGM
18JNR1
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations
to agency procedure and practice and,
thus, is not subject to the notice and
comment requirements of the
Administrative Procedure Act, 5 U.S.C.
553(b). Because no notice of proposed
rulemaking is required, these
regulations are not a ‘‘rule’’ as defined
by the Regulatory Flexibility Act, 5
U.S.C. 601(2), and no initial or final
regulatory flexibility analysis is
required.
VI. Paperwork Reduction Act
The Bureau has determined that the
regulations in this subpart do not
impose any new recordkeeping,
reporting, or disclosure requirements on
covered entities or members of the
public that would constitute collections
of information requiring approval under
the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
List of Subjects in 12 CFR Part 1081
Administrative practice and
procedure, Banking, Banks, Consumer
protection, Credit, Credit unions, Law
enforcement, National banks, Savings
associations, Trade practices.
Authority and Issuance
For the reasons set forth above, the
interim final rule amending 12 CFR part
1081 published at 78 FR 59163,
September 26, 2013, is adopted as a
final rule without change.
Dated: June_10, 2014.
Richard Cordray,
Director, Bureau of Consumer Financial
Protection.
[FR Doc. 2014–14228 Filed 6–17–14; 8:45 am]
BILLING CODE 4810–AM–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. FDA–2012–N–0677]
Dental Devices; Reclassification of
Blade-Form Endosseous Dental
Implant
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is issuing a final
order to reclassify the blade-form
endosseous dental implant, a
preamendments class III device, into
class II (special controls). On its own
initiative, based on new information,
FDA is revising the classification of
blade-form endosseous dental implants.
ehiers on DSK2VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
15:22 Jun 17, 2014
Jkt 232001
DATES:
This order is effective July 18,
2014.
FOR FURTHER INFORMATION CONTACT:
Michael J. Ryan, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1615,
Silver Spring, MD 20993, 301–796–
6283, michael.ryan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105–115), the
Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250), the Medical Devices Technical
Corrections Act (Pub. L. 108–214), the
Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85), and the Food and Drug
Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112–144), among
other amendments, established a
comprehensive system for the regulation
of medical devices intended for human
use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories
(classes) of devices, reflecting the
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513(d) of the FD&C Act,
devices that were in commercial
distribution before the enactment of the
1976 amendments, May 28, 1976
(generally referred to as preamendments
devices), are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
FDA has classified most
preamendments devices under these
procedures.
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
postamendments devices), are
automatically classified by section
513(f) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless, and
until, the device is reclassified into class
I or II or FDA issues an order finding the
device to be substantially equivalent, in
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34623
accordance with section 513(i) of the
FD&C Act, to a predicate device that
does not require premarket approval.
The Agency determines whether new
devices are substantially equivalent to
predicate devices by means of
premarket notification procedures in
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and 21 CFR part 807.
A preamendments device that has
been classified into class III may be
marketed by means of premarket
notification procedures (510(k) process)
without submission of a premarket
approval application (PMA) until FDA
issues a final order under section 515(b)
of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval or until
the device is subsequently reclassified
into class I or class II.
On July 9, 2012, FDASIA was enacted.
Section 608(a) of FDASIA amended
section 513(e) of the FD&C Act,
changing the mechanism for
reclassifying a device from rulemaking
to an administrative order.
Section 513(e) of the FD&C Act
governs reclassification of classified
preamendments devices. This section
provides that FDA may, by
administrative order, reclassify a device
based upon ‘‘new information.’’ FDA
can initiate a reclassification under
section 513(e) of the FD&C Act or an
interested person may petition FDA to
reclassify a preamendments device. The
term ‘‘new information,’’ as used in
section 513(e) of the FD&C Act, includes
information developed as a result of a
reevaluation of the data before the
Agency when the device was originally
classified, as well as information not
presented, not available, or not
developed at that time. (See, e.g.,
Holland-Rantos Co. v. United States
Department of Health, Education, and
Welfare, 587 F.2d 1173, 1174 n.1 (D.C.
Cir. 1978); Upjohn v. Finch, 422 F.2d
944 (6th Cir. 1970); Bell v. Goddard, 366
F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously
before the Agency is an appropriate
basis for subsequent action where the
reevaluation is made in light of newly
available authority (see Bell, 366 F.2d at
181; Ethicon, Inc. v. FDA, 762 F.Supp.
382, 388–391 (D.D.C. 1991)) or in light
of changes in ‘‘medical science’’
(Upjohn, 422 F.2d at 951). Whether data
before the Agency are old or new data,
the ‘‘new information’’ to support
reclassification under section 513(e) of
the FD&C Act must be ‘‘valid scientific
evidence,’’ as defined in section
513(a)(3) and 21 CFR 860.7(c)(2). (See,
e.g., General Medical Co. v. FDA, 770
F.2d 214 (D.C. Cir. 1985); Contact Lens
Manufacturers Association v. FDA, 766
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Agencies
[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Rules and Regulations]
[Pages 34622-34623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14228]
=======================================================================
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BUREAU OF CONSUMER FINANCIAL PROTECTION
12 CFR Part 1081
[Docket No.: CFPB-2013-0030]
RIN 3170-AA29
Rules of Practice for Issuance of Temporary Cease-and-Desist
Orders
AGENCY: Bureau of Consumer Financial Protection.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On September 26, 2013, 78 FR 59163, the Consumer Financial
Protection Bureau (Bureau) published in the Federal Register an interim
final rule establishing procedures for the issuance of a temporary
cease-and-desist order (TCDO) pursuant to section 1053(c) of the Dodd-
Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),
which requires the Bureau to prescribe rules establishing procedures
for the conduct of adjudication proceedings. After reviewing and
considering the single public comment offered on its interim final
rule, the Bureau adopts the interim final rule without change.
DATES: This final rule takes effect on July 18, 2014.
FOR FURTHER INFORMATION CONTACT: John R. Coleman, Senior Counsel, Legal
Division, Consumer Financial Protection Bureau, 1700 G Street NW.,
Washington, DC 20552; at (202) 435-7254.
SUPPLEMENTARY INFORMATION:
I. Background
On June 29, 2012, the Bureau published in the Federal Register the
final Rules of Practice for Adjudication Proceedings pursuant to
sections 1022(b)(1) and 1053(e) of the Dodd-Frank Act, 12 U.S.C.
5512(b)(1) & 5563(e).\1\ That final rule, however, does not apply to
the issuance of a TCDO pursuant to section 1053(c) of the Dodd-Frank
Act.\2\ The Bureau previously invited comments as to whether special
rules governing such proceedings are necessary and, if so, what the
rules should provide.\3\ One commenter recommended that the Bureau
promulgate rules governing temporary cease-and-desist proceedings
initiated pursuant to section 1053(c) of the Dodd-Frank Act and pointed
to the Federal Deposit Insurance Corporation's (FDIC) rules governing
temporary cease-and-desist proceedings, 12 CFR 308.131, as an example
of such rules.\4\
---------------------------------------------------------------------------
\1\ See 77 FR 39058 (June 29, 2012) (codified at 12 CFR Part
1081).
\2\ Id. at 39058.
\3\ See 76 FR 45338, 45338 (July 28, 2011).
\4\ See 77 FR 39058, 39060 (June 29, 2012).
---------------------------------------------------------------------------
On September 26, 2013, 78 FR 59163, the Bureau published its
interim final rule establishing procedures for the issuance of a
temporary cease-and-desist order (TCDO) pursuant to section 1053(c) of
the Dodd-Frank Act. In developing the interim final rule, the Bureau
considered the procedures related to temporary cease-and-desist orders
that are followed by other regulatory agencies, including the FDIC, the
Securities and Exchange Commission, and the Office of the Comptroller
of the Currency. The interim final rule most closely follows the FDIC's
approach as codified in 12 CFR 308.131. The Bureau issued the interim
final rule to clarify (1) the basis for the issuance of a TCDO; (2) the
content, scope, and form of a TCDO; (3) the procedures governing the
issuance of a TCDO and the remedies available to the Bureau in issuing
a TCDO; and (4) the rights of persons subject to a TCDO.
The interim final rule described each section of the rule and
explained the basis of the rule with reference to rules of other
agencies as appropriate. After reviewing and considering the single
public comment offered, the Bureau adopts the interim final rule
without change.
II. Legal Authority
The Bureau promulgates this final rule pursuant to its authority to
implement section 1053 of the Dodd-Frank Act, 12 U.S.C. 5563(e), as
well as its general rulemaking authority to promulgate rules necessary
or appropriate to carry out the Federal consumer financial laws, 12
U.S.C. 5512(b)(1).
III. Public Comment on the Interim Final Rule
In response to the interim final rule, the Bureau received one
comment letter that did not contain any specific comments or
suggestions pertaining to the interim final rule. Accordingly, the
Bureau is adopting the interim final rule without change.
IV. Section 1022(b) Provisions
In developing the interim final and final rules, the Bureau has
considered the potential benefits, costs, and impacts and has consulted
or offered to consult with the prudential regulators, the Department of
Housing and Urban Development, and the Federal Trade Commission,
including with regard to consistency with any prudential, market, or
systemic objectives administered by such agencies.\5\
---------------------------------------------------------------------------
\5\ Section 1022(b)(2)(A) of the Dodd-Frank Act calls for the
Bureau to consider the potential benefits and costs of a regulation
to consumers and covered persons, including the potential reduction
of access by consumers to consumer financial products or services;
the impact on depository institutions and credit unions with $10
billion or less in total assets as described in section 1026 of the
Dodd-Frank Act; and the impact on consumers in rural areas. Section
1022(b)(2)(B) directs the Bureau to consult with the appropriate
prudential regulators or other Federal agencies regarding
consistency with objectives those agencies administer. The manner
and extent to which these provisions apply to a rulemaking of this
kind, which establishes Bureau procedures and imposes no standards
of conduct, is unclear. Nevertheless, to inform this rulemaking more
fully, the Bureau performed the analyses and consultations described
in those provisions of the Dodd-Frank Act.
---------------------------------------------------------------------------
The Dodd-Frank Act requires the Bureau to prescribe rules
establishing such procedures as may be necessary to carry out section
1053 of the Act, which provides for temporary cease-and-orders in
subsection (c). The final rule itself does not impose significant costs
upon covered persons, but, consistent with section 1053, provides a
straightforward and efficient process for the issuance of a temporary
cease-and-desist order, and a direct route to judicial review.
The final rule has no unique impact on insured depository
institutions or insured credit unions with $10 billion or less in
assets described in section 1026(a) of the Dodd-Frank Act, nor does it
have a unique impact on rural consumers.
V. Regulatory Requirements
As the Bureau noted in publishing the interim final rule, this rule
relates solely
[[Page 34623]]
to agency procedure and practice and, thus, is not subject to the
notice and comment requirements of the Administrative Procedure Act, 5
U.S.C. 553(b). Because no notice of proposed rulemaking is required,
these regulations are not a ``rule'' as defined by the Regulatory
Flexibility Act, 5 U.S.C. 601(2), and no initial or final regulatory
flexibility analysis is required.
VI. Paperwork Reduction Act
The Bureau has determined that the regulations in this subpart do
not impose any new recordkeeping, reporting, or disclosure requirements
on covered entities or members of the public that would constitute
collections of information requiring approval under the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq.
List of Subjects in 12 CFR Part 1081
Administrative practice and procedure, Banking, Banks, Consumer
protection, Credit, Credit unions, Law enforcement, National banks,
Savings associations, Trade practices.
Authority and Issuance
For the reasons set forth above, the interim final rule amending 12
CFR part 1081 published at 78 FR 59163, September 26, 2013, is adopted
as a final rule without change.
Dated: June--10, 2014.
Richard Cordray,
Director, Bureau of Consumer Financial Protection.
[FR Doc. 2014-14228 Filed 6-17-14; 8:45 am]
BILLING CODE 4810-AM-P