58346 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 

H. Sierra, Director (QI), Stella 

Rincon, Director, Application Type: 

QI Change. 

WD Global Logistics Corp (NVO), 

1515 Kona Drive, Compton, CA 

90220, Officer: Woon Dong Huh, 

President (QI), Application Type: 

New NVO License. 

XYZ Global Express Corp. (NVO), 

1200F Woodruff Avenue, Suite #D, 

Downey, CA 90241, Officers: 

Benedict Simborio, Assistant 

Secretary (QI), Ian Hazel Co, CEO, 

Application Type: New NVO 

License. 

Pursuant to the Commission’s direct 

final rule (79 FR 56522), beginning 

October 20, 2014, these notices will no 

longer be posted in the Federal Register. 

After October 20, 2014, this information 

will be available on the Commission’s 

Web site at http://www.fmc.gov. 

By the Commission. 

Dated: September 24, 2014. 

Karen V. Gregory, 

Secretary. 

[FR Doc. 2014–23093 Filed 9–26–14; 8:45 am] 

BILLING CODE 6730–01–P 

FEDERAL RESERVE SYSTEM 

Change in Bank Control Notices; 

Acquisitions of Shares of a Bank or 

Bank Holding Company 

The notificants listed below have 

applied under the Change in Bank 

Control Act (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire shares of a bank 

or bank holding company. The factors 

that are considered in acting on the 

notices are set forth in paragraph 7 of 

the Act (12 U.S.C. 1817(j)(7)). 

The notices are available for 

immediate inspection at the Federal 

Reserve Bank indicated. The notices 

also will be available for inspection at 

the offices of the Board of Governors. 

Interested persons may express their 

views in writing to the Reserve Bank 

indicated for that notice or to the offices 

of the Board of Governors. Comments 

must be received not later than October 

14, 2014. 

A. Federal Reserve Bank of Richmond 

(Adam M. Drimer, Assistant Vice 

President) 701 East Byrd Street, 

Richmond, Virginia 23261–4528: 

1. Harold T. Keen, Four Oaks, North 

Carolina, individually and together with 

Barbara A. Keen, Four Oaks, North 

Carolina, Matthew Keen, Annapolis, 

Maryland, and Catherine Keen Hock, 

Greensboro, North Carolina, as a group 

acting in concert; to acquire voting 

shares of KS Bancorp, Inc., and thereby 

indirectly acquire voting shares of KS 

Bank, Inc., both in Smithfield, North 

Carolina. 

Board of Governors of the Federal Reserve 

System, September 24, 2014. 

Michael J. Lewandowski, 

Associate Secretary of the Board. 

[FR Doc. 2014–23088 Filed 9–26–14; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: ‘‘Patient 

Safety Organization Certification for 

Initial Listing and Related Forms, 

Patient Safety Confidentiality Complaint 

Form, and Common Formats.’’ In 

accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521, 

AHRQ invites the public to comment on 

this proposed information collection. 

This proposed information collection 

was previously published in the Federal 

Register on July 18th, 2014 and allowed 

60 days for public comment. AHRQ did 

not receive any substantive comments. 

The purpose of this notice is to allow an 

additional 30 days for public comment. 

DATES: Comments on this notice must be 

received by October 29, 2014. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at OIRA_submission@

omb.eop.gov (attention: AHRQ’s desk 

officer). 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Patient Safety Organization 

Certification for Initial Listing and 

Related Forms, Patient Safety 

Confidentiality Complaint Form, and 

Common Formats 

The Patient Safety and Quality 

Improvement Act of 2005 (hereafter the 

Patient Safety Act), 42 U.S.C. 299b-21 to 

299b–26, was enacted in response to 

growing concern about patient safety in 

the United States and the Institute of 

Medicine’s 1999 report, To Err is 

Human: Building a Safer Health System. 

The goal of the statute is to improve 

patient safety by providing an incentive 

for health care providers to work 

voluntarily with experts in patient 

safety to reduce risks and hazards to the 

safety and quality of patient care. The 

Patient Safety Act signifies the Federal 

Government’s commitment to fostering 

a culture of patient safety among health 

care providers; it offers a mechanism for 

creating an environment in which the 

causes of risks and hazards to patient 

safety can be thoroughly and honestly 

examined and discussed without fear of 

penalties and liabilities. It provides for 

the voluntary formation of Patient 

Safety Organizations (PSOs) that can 

collect, aggregate, and analyze 

confidential information reported 

voluntarily by health care providers. By 

analyzing substantial amounts of patient 

safety event information across multiple 

institutions, PSOs will be able to 

identify patterns of failures and propose 

measures to eliminate or reduce patient 

safety risks and hazards. 

In order to implement the Patient 

Safety Act, the Department of Health 

and Human Services (HHS) issued the 

Patient Safety and Quality Improvement 

Final Rule (hereafter the Patient Safety 

Rule), 42 CFR Part 3, which became 

effective on January 19, 2009. The 

Patient Safety Rule establishes a 

framework by which hospitals, doctors, 

and other health care providers may 

voluntarily report information to PSOs, 

on a privileged and confidential basis, 

for the aggregation and analysis of 

patient safety events. In addition, the 

Patient Safety Rule outlines the 

requirements that entities must meet to 

become PSOs and the process by which 

the Secretary of HHS (hereafter the 

Secretary) will review and accept 

certifications and list PSOs. 

In addition to the Patient Safety Act 

and the Patient Safety Rule, HHS issued 

Guidance Regarding Patient Safety 

Organizations’ Reporting Obligations 

and the Patient Safety and Quality 

Improvement Act of 2005 (hereafter 

Guidance) on December 30, 2010. The 

Guidance addresses questions that have 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 58347 

arisen regarding the legal obligations of 

PSOs when they or the organization of 

which they are a part report certain 

information to the Food and Drug 

Administration (FDA) under the Federal 

Food, Drug, and Cosmetic Act (FDCA) 

and its implementing regulations. This 

includes providing the FDA with access 

to its records, including access during 

an inspection of its facilities. This 

Guidance applies to all entities that seek 

to be a PSO, or are one currently, either 

alone or as a component if another 

organization that have mandatory FDAreporting obligations under the FDCA 

and its implementing regulations 

(‘‘FDA-regulated reporting entities’’). It 

also covers PSOs that are 

organizationally related to such FDAregulated reporting entities (e.g., parent 

organizations, subsidiaries, sibling 

organizations). 

When PSOs meet the requirements of 

the Patient Safety Act, the information 

collected and the analyses and 

deliberations regarding the information 

receive Federal confidentiality and 

privilege protections under this 

legislation. The Secretary delegated 

authority to the Director of the Office for 

Civil Rights (OCR) to enforce the 

confidentiality protections of the Patient 

Safety Act. 71 FR 28701–28702 (May 17, 

2006). OCR is responsible for enforcing 

protections regarding patient safety 

work product (PSWP), which generally 

includes information that could 

improve patient safety, health care 

quality, or health care outcomes and (1) 

is assembled or developed by a provider 

for reporting to a PSO and is reported 

to a PSO or (2) is developed by a PSO 

for the conduct of patient safety 

activities. Civil money penalties may be 

imposed for knowing or reckless 

impermissible disclosures of PSWP. 

AHRQ implements and administers the 

rest of the Patient Safety Act’s 

provisions. 

Pursuant to 42 CFR 3.102, an entity 

that seeks to be listed as a PSO by the 

Secretary must certify that it meets 

certain requirements and, upon listing, 

will meet other criteria. To remain listed 

for renewable three-year periods, a PSO 

must recertify that it meets these 

obligations and will continue to meet 

them while listed. The Patient Safety 

Act and Patient Safety Rule also impose 

other obligations, discussed below, that 

a PSO must meet to remain listed. In 

order for the Secretary to administer the 

Patient Safety Act and Rule, the entities 

seeking to be listed and to remain listed 

must complete the proposed forms. 

Method of Collection 

With this submission, AHRQ is 

requesting approval of the following 

proposed administrative forms: 

1. PSO Certification for Initial Listing 

Form. This form, which is to be 

completed by an entity seeking to be 

listed by the Secretary as a PSO for an 

initial three-year period, contains 

certifications that the entity meets the 

requirements for listing as a PSO, in 

accordance with 42 U.S.C. 2996–24(a)(1) 

and 42 CFR 3.102. 

2. PSO Certification for Continued 

Listing Form. In accordance with 42 

U.S.C. 299b–24(a)(2) and the Patient 

Safety Rule, this form is to be completed 

by a listed PSO seeking continued 

listing as a PSO by the Secretary for an 

additional three year period. 

3. PSO Two Bona Fide Contracts 

Requirement Certification Form. To 

remain listed, a PSO must have 

contracts with more than one provider, 

within successive 24 month periods, 

beginning with the date of its initial 

listing. 42 U.S.C. 2996–24(b)(1)(C). This 

form is to be used by a PSO to certify 

whether it has met this requirement. 

4. PSO Disclosure Statement Form. A 

PSO must submit this form when it (i) 

has a Patient Safety Act contract with a 

health care provider and (ii) it has 

financial, reporting, and contractual 

relationships with that contracting 

provider or is not independent of that 

contracting provider. 42 U.S.C. 299b– 

24(b)(1)(E); 42 CFR 3.102(d)(2). 

5. PSO Profile Form. This form, 

previously called the PSO Information 

Form, gathers information on PSOs and 

the type of health care providers and 

settings that they are working with to 

conduct patient safety activities in order 

to improve patient safety. It is designed 

to collect a minimum level of data 

necessary to develop aggregate statistics 

relating to the Patient Safety Act, 

including types of institutions 

participating and their general location 

in the U.S. This information will be 

included in AHRQ’s annual quality 

report, required by 42 U.S.C. 299b– 

23(c). 

6. PSO Change of Listing Information 

Form. The Secretary is required under 

42 U.S.C. 299b–24(d) and the Patient 

Safety Rule to maintain a publicly 

available list of PSOs that includes, 

among other information, contact 

information for each entity. The Patient 

Safety Rule, section 3.102(a)(vi), also 

requires that a PSO must promptly 

notify the Secretary during its period of 

listing if there have been any changes in 

the accuracy of the information 

submitted for listing, along with the 

pertinent changes. This form is to be 

used by a PSO to revise its listing 

information, to include updating its 

contact information that will be used in 

the Secretary’s list of PSOs. 

The forms described above, other than 

the PSO Change of Listing Information 

Form, are revised collection instruments 

that were previously approved by OMB 

in 2008 and 2011. These forms, along 

with the new PSO Change of Listing 

Information Form, will be used by 

AIIRQ to obtain information necessary 

to implement the Patient Safety Act and 

Patient Safety Rule, e.g., obtaining 

initial and subsequent certifications 

from entities seeking to be listed as 

PSOs and for making the statutorilyrequired determinations prior to and 

during an entity’s period of listing as a 

PSO. This information is used by the 

PSO Program Office housed in AHRQ’s 

Center for Quality Improvement and 

Patient Safety. 

OCR is requesting approval of the 

following administrative form: 

Patient Safety Confidentiality 

Complaint Form. The purpose of this 

collection is to allow OCR to collect the 

minimum information needed from 

individuals filing patient safety 

confidentiality complaints with the OCR 

so that there is a basis for initial 

processing of those complaints. 

In addition, AHRQ is requesting 

approval for a set of common definitions 

and reporting formats (hereafter 

Common Formats). Pursuant to 42 

U.S.C. 29913–23(b), AHRQ coordinates 

the development of the Common 

Formats that allow PSOs and health care 

providers to voluntarily collect and 

submit standardized information 

regarding patient safety events. 

Estimated Annual Respondent Burden 

While there are a number of 

information collection forms described 

below, the forms will be implemented at 

different times and frequency due to the 

voluntary nature of seeking listing and 

remaining listed as a PSO, filing a 

Patient Safety Confidentiality Complaint 

Form, and using the Common Formats. 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondent to provide the requested 

information, and Exhibit 2 shows the 

estimated annualized cost burden 

associated with the respondents’ time to 

provide the requested information. The 

total burden hours are estimated to be 

100,704 hours annually and the total 

cost burden is estimated to be 

$3,618,294.72 annually. 

PSO Certification for Initial Listing Form 

The average annual burden for the 

collection of information requested by 

the certification forms for initial listing 


tkelley on DSK3SPTVN1PROD with NOTICES
58348 Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 

is based upon a total average estimate of 

17 respondents per year and an 

estimated time of 18 hours per response. 

The estimated response number not 

only includes submissions by entities 

that are successfully listed as PSOs, but 

also submissions by entities that submit 

an initial listing form that do not 

become a PSO. During the past three 

years, AHRQ has provided substantial 

technical assistance about the PSO 

Program, including to entities seeking 

initial listing. After submitting an initial 

listing form, an entity may withdraw its 

form or submit a revised form, 

particularly after receiving technical 

assistance from AHRQ. In addition, 

AHRQ, on behalf of the Secretary, may 

deny listing if an entity does not meet 

the requirements of the Patient Safety 

Act and Patient Safety Rule or if the 

entity does not provide other 

information determined to be necessary 

to make the listing determination, such 

as a lack of response to requests for 

clarifications by AHRQ on the 

attestations and responses on the form. 

This collection of information takes 

place on an ongoing basis. 

Certification for Continued Listing Form 

The average annual burden for the 

collection of information requested by 

the certification form for continued 

listing is an estimated time of eight 

hours per response and 16 responses 

annually. The Certification for 

Continued Listing Form must be 

completed by any interested PSO at 

least 75 days before the end of its 

current three-year listing period. The 

number of respondents is based upon 

the estimate that 65% of the projected 

77 listed PSOs will submit forms for 

continued listing. The estimated 

number of responses reflects the fact 

that a PSO can choose to voluntarily 

relinquish its status as a PSO for any 

reason or that a PSO can choose to not 

seek continued listing and allow its 

listing to expire. In addition, AHRQ, on 

behalf of the Secretary, can revoke the 

listing of a PSO if it is found to no 

longer meet the requirements of the 

Patient Safety Act or Patient Safety 

Rule. Therefore, AHRQ estimates that 

approximately two thirds of PSOs will 

seek continued listing and submit the 

form. 

Two Bona Fide Contracts Requirement 

Certification 

The average annual burden for the 

collection of information requested by 

the two-contract requirement is based 

upon an estimate of 30 respondents per 

year and an estimated one hour per 

response. This collection of information 

takes place when the PSO notifies the 

Secretary that it has entered into two 

contracts. 

Disclosure Statement Form 

AHRQ assumes that only a small 

percentage of entities will need to file a 

disclosure form. However, AHRQ is 

providing a high estimate of 2 

respondents and thus presumably 

overestimating respondent burden. The 

average annual burden estimate of six 

hours for the collection of information 

requested by the disclosure form is 

based upon an estimated three hours per 

response. This information collection 

takes place when a PSO first reports 

having any of the specified types of 

additional relationships with a health 

care provider with which it has a 

contract to carry out patient safety 

activities. 

Profile Form 

The overall annual burden estimate of 

231 hours for the collection of 

information requested by the PSO 

Profile Form is based upon an estimate 

of 77 respondents per year and an 

estimated three hours per response. 

Newly listed PSOs first report in the 

calendar year after their listing by the 

Secretary. 

Patient Safety Confidentiality 

Complaint Form 

The overall annual burden estimate of 

one hour for the collection of 

information requested by the form is 

based on an estimate of three 

respondents per year and an estimated 

20 minutes per response. OCR’s 

information collection using this form 

will not begin until after there is an 

allegation of a violation of the statutory 

protection of PSWP. 

PSO Change of Listing Information 

Form 

The average annual burden for the 

collection of information requested by 

the change of listing information forms 

is based upon a total average estimate of 

24 respondents per year and an 

estimated time of five minutes per 

response. This collection of information 

takes place when the PSO notifies the 

Secretary that its listing information has 

changed. 

Common Formats 

AHRQ estimates that 5% FTE of a 

Patient Safety Manager at a hospital will 

be spent to administer the Common 

Formats, which is approximately 100 

hours a year. In the previous 

submission, AHRQ estimated that 1,000 

hospitals would be using the Common 

Formats in year 3. AHRQ estimates the 

number of hospitals using Common 

Formats will remain level for the next 

three years at 1,000 hospitals. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form Number of 

respondents 

Number of 

responses 

per 

respondent 

Hours per 

response 

Total burden 

hours 

Certification for Initial Listing Form * ................................................................ 17 1 18 306 

Certification for Continued Listing Form * ........................................................ 16 1 8 128 

Two Bona Fide Contracts Requirement Form ** ............................................. 30 1 1 30 

Disclosure Statement Form *** ........................................................................ 2 1 3 6 

Profile Form   ............................................................................................... 77 1 3 231 

Patient Safety Confidentiality Complaint Form ** * ........................................... 3 1 20/60 1 

Change of Listing Information *** ..................................................................... 24 1 05/60 2 

Common Formats ............................................................................................ 1,000 1 100 100,000 

Total *** ..................................................................................................... 1,169 NA NA 100,704 

* AHRQ expects the number of PSOs to remain relatively stable, with 65% of listed PSOs seeking continued listing. The number of new entities seeking listing as PSOs and PSOs seeking continued listing will be offset by the number of entities that will voluntarily relinquish their status 

as a PSO, allow their listing to expire, or have their listing revoked for cause by AHRQ. 

** The Two Bona Fide Contracts Requirement Form will be completed by each PSO within the 24-month period after listing by the Secretary. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 188 / Monday, September 29, 2014 / Notices 58349 

*** The Disclosure Statement Form and the Change of Listing Information form may be submitted by individual PSOs in different years. Due to 

changes in their operations, a PSO can submit more than one Change of Listing Information in a year. OCR is anticipating considerable variation 

in the number of complaints per year. Hence, the total for each year is expressed as an average of the expected total over the three year collection period. 

**** The Profile Form collects data from listed PSOs each calendar year. The prior version of this form, the PSO Information Form, began collecting data from listed PSOs each calendar year in 2011. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form Number of 

respondents 

Total 

burden 

hours 

Average 

hourly 

wage rate 

Total cost 

Certification for Initial Listing Form .................................................................. 17 306 $35.93 $10,994.58 

Certification for Continued Listing Form .......................................................... 16 128 35.93 4,599.04 

Two Bona Fide Contracts Requirement Form ................................................. 30 30 35.93 1,077.90 

Disclosure Statement Form ............................................................................. 2 6 35.93 215.58 

Profile Form ..................................................................................................... 77 231 35.93 8,299.83 

Patient Safety Confidentiality Complaint Form ................................................ 3 1 35.93 35.93 

Change of Listing Information ......................................................................... 24 2 35.93 71.86 

Common Formats ............................................................................................ 1,000 100,000 35.93 3,593,000.00 

Total .......................................................................................................... 1,169 100,704 NA 3,618,294.72 

* Based upon the mean of the hourly wages for healthcare practitioner and technical occupations, 29–0000, National Compensation Survey, 

May 2013, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ (http://www.bls.gov/oes/current/oes_nat.htm#29-0000). 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ health care 

research and health care information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: September 18, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–22700 Filed 9–26–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘Improving Hospital Informed Consent 

with Training on Effective Tools and 

Strategies.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously titled and published as 

‘‘Improving Hospital Informed Consent 

with an Informed Consent Toolkit’’ in 

the Federal Register on July 9th, 2014 

and allowed 60 days for public 

comment. AHRQ received one 

substantive comment. The purpose of 

this notice is to allow an additional 30 

days for public comment. 

DATES: Comments on this notice must be 

received by October 29, 2014. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at OIRA_submission@

omb.eop.gov (attention: AHRQ’s desk 

officer). 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Improving Hospital Informed Consent 

With Training on Effective Tools and 

Strategies 

The ultimate aim of this project is to 

pilot test training modules to improve 

the informed consent process in U.S. 

hospitals. 

Clinical informed consent is the 

process by which a patient is told about 

the risks and benefits of proposed 

treatments or procedures, as well as 

alternatives, and makes a decision based 

on that information. Informed consent 

may be jeopardized by incorrect 

clinician assumptions about patient 

comprehension, the manner in which 

consent is sought, and poor readability 

of consent forms (Paasche-Orlow et al., 

2013). All too frequently, patients do 

not understand the risks, benefits, and 

alternatives of their treatments even 

after signing a consent form (Braddock 

et al., 1999; Sudore et al., 2006). Deidentified accreditation data analyzed as 

part of AHRQ’s preliminary research for 

this data collection effort suggest that 

some hospitals are not following the 

basic ethical principles underlying 

informed consent. These data, as well as 

the guidance from the study’s Expert 

and Stakeholder Panel, indicate that 

hospital administrators and clinicians 

could benefit from training on evidencebased practices to improve the informed 


tkelley on DSK3SPTVN1PROD with NOTICES