Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Notices 42815 

unauthorized access to sensitive 

customer information, issues of 

confidentiality may arise if the Board 

were to obtain a copy of a customer 

notice during the course of an 

examination, a copy of a SAR, or other 

sensitive customer information. In such 

cases, the information would likely be 

exempt from disclosure to the public 

under the Freedom of Information Act 

(5 U.S.C. 552(b)(3), (4), (6), and (8)). 

Also, a federal employee is prohibited 

by law from disclosing a SAR or the 

existence of a SAR (31 U.S.C. 5318(g)). 

Board of Governors of the Federal Reserve 

System, September 6, 2017. 

Ann E. Misback, 

Secretary of the Board. 

[FR Doc. 2017–19217 Filed 9–11–17; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The applications listed below, as well 

as other related filings required by the 

Board, are available for immediate 

inspection at the Federal Reserve Bank 

indicated. The applications will also be 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

Unless otherwise noted, comments 

regarding each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than October 5, 

2017. 

A. Federal Reserve Bank of Kansas 

City (Dennis Denney, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. Central Bancshares, Inc. to acquire, 

through its newly formed subsidiaries, 

CBI Midco, Inc. and CBI Merger Sub, 

Inc., all of Cambridge, Nebraska, up to 

100 percent of the voting shares of 

Republic Corporation, and thereby 

indirectly acquire United Republic 

Bank, both of Omaha, Nebraska. 

In connection with this application 

CBI Midco, Inc. and CBI Merger Sub, 

Inc., have applied to become bank 

holding companies. 

B. Federal Reserve Bank of San 

Francisco (Gerald C. Tsai, Director, 

Applications and Enforcement) 101 

Market Street, San Francisco, California 

94105–1579: 

1. Pacific Premier Bancorp, Inc.; to 

acquire 100 percent of Plaza Bancorp, 

and thereby indirectly acquire Plaza 

Bank, all of Irvine, California. 

Board of Governors of the Federal Reserve 

System, September 6, 2017. 

Yao-Chin Chao, 

Assistant Secretary of the Board. 

[FR Doc. 2017–19211 Filed 9–11–17; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4765] 

Center for Devices and Radiological 

Health Premarket Approval Application 

Critical to Quality Pilot Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency or we) 

Center for Devices and Radiological 

Health (CDRH or Center), Office of 

Compliance (OC) and Office of In Vitro 

Diagnostics and Radiological Health 

(OIR) is announcing its Premarket 

Approval Application Critical to Quality 

(PMA CtQ) pilot program. Participation 

in the PMA CtQ pilot program is 

voluntary and the program aims to 

evaluate device design and 

manufacturing process quality 

information early on to assist FDA in its 

review of the PMA manufacturing 

section and post-approval inspections. 

This voluntary pilot program is part of 

the FDA’s ongoing Case for Quality 

effort to apply innovative strategies that 

promote medical device quality and is 

a joint effort between the FDA’s CDRH 

and Office of Regulatory Affairs (ORA). 

The pilot program is intended to 

provide qualifying PMA applicants with 

the option to engage FDA on 

development of CtQ controls for their 

device and forego the standard PMA 

preapproval inspection. FDA would in 

turn, focus on the PMA applicant’s 

implementation of the CtQ controls 

during a postmarket inspection. 

DATES: FDA is seeking participation in 

the voluntary PMA CtQ pilot program 

starting from September 29, 2017. See 

the ‘‘Participation’’ section for 

instructions on how to submit a request 

to participate. This pilot program will 

run from September 29, 2017, to 

December 31, 2018. The voluntary PMA 

CtQ pilot program will accept the first 

nine participants with submissions that 

meet the acceptance criteria. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 


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