34622 Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations 

1See 77 FR 39058 (June 29, 2012) (codified at 12 

CFR Part 1081). 

2 Id. at 39058. 

3See 76 FR 45338, 45338 (July 28, 2011). 

4See 77 FR 39058, 39060 (June 29, 2012). 

5Section 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. 

List of Subjects 

12 CFR Part 611 

Agriculture, Banks, banking, Rural 

areas. 

12 CFR Part 620 

Accounting, Agriculture, Banks, 

banking, Reporting and recordkeeping 

requirements, Rural areas. 

12 CFR Part 630 

Accounting, Agriculture, Banks, 

banking, Organization and functions 

(Government agencies), Reporting and 

recordkeeping requirements, Rural 

areas. 

Accordingly, the interim rule 

amending 12 CFR parts 611, 620, and 

630, which was published on March 31, 

2014 (79 FR 17854), is adopted as a final 

rule without changes. 

Dated: June 12, 2014. 

Dale L. Aultman, 

Secretary, Farm Credit Administration Board. 

[FR Doc. 2014–14227 Filed 6–17–14; 8:45 am] 

BILLING CODE 6705–01–P 

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 DoddFrank 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 DoddFrank 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 DoddFrank Act and pointed to the Federal 

Deposit Insurance Corporation’s (FDIC) 

rules governing temporary cease-anddesist proceedings, 12 CFR 308.131, as 

an example of such rules.4

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 DoddFrank 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 


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Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Rules and Regulations 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 

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. 

SUMMARY: 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. 

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 

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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