7116 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 

agency or other federal entity that 

furnished the record or information for 

the purpose of permitting that agency or 

entity to make a decision regarding 

access to or correction of the record or 

information, or to a federal agency or 

entity for purposes of providing 

guidance or advice regarding the 

handling of a particular request. 

3. A record from this system of 

records may be disclosed to the 

Department of Justice (DOJ) to obtain 

advice regarding statutory and other 

requirements under the FOIA. 

4. A record from this system of 

records may be disclosed to the National 

Archives and Records Administration, 

Office of Government Information 

Services (OGIS), to the extent necessary 

to fulfill its responsibilities in 5 U.S.C. 

552(h) to review administrative agency 

policies, procedures, and compliance 

with the FOIA, and to facilitate OGIS’s 

offering of mediation services to resolve 

disputes between persons making FOIA 

requests and administrative agencies. 

DISCLOSURE TO CONSUMER REPORTING

AGENCIES: 

None. 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Records are maintained in paper and 

electronic form, including on computer 

databases, all of which are stored in a 

secure location. 

RETRIEVABILITY: 

Records are retrieved by any one or 

more of the following: The name of the 

requestor; the number assigned to the 

request or appeal; and in some 

instances, the name of the attorney 

representing the requestor or appellant, 

and/or the name of an individual who 

is the subject of such a request or 

appeal. 

SAFEGUARDS: 

FRTIB has adopted appropriate 

administrative, technical, and physical 

controls in accordance with FRTIB’s 

security program to protect the security, 

confidentiality, availability, and 

integrity of the information, and to 

ensure that records are not disclosed to 

or accessed by unauthorized 

individuals. 

Paper records are stored in locked file 

cabinets in areas of restricted access that 

are locked after office hours. Electronic 

records are stored on computer 

networks and protected by assigning 

usernames to individuals needing 

access to the records and by passwords 

set by unauthorized users that must be 

changed periodically. 

RETENTION AND DISPOSAL: 

Records are retained and disposed of 

in accordance with the General Records 

Schedule 4.2, item 020, issued by the 

National Archives and Records 

Administration (NARA). 

SYSTEM MANAGER(S) AND ADDRESS: 

Chief FOIA Officer, 77 K Street NE., 

Washington, DC 20002. 

NOTIFICATION PROCEDURE: 

Individuals seeking to determine 

whether this system of records contains 

information about themselves must 

submit a written request to the FOIA 

Officer, FRTIB, 77 K Street NE., 

Washington, DC 20002, and provide the 

following information: 

a. Full name; 

b. Any available information 

regarding the type of record involved; 

c. The address to which the record 

information should be sent; and 

d. You must sign your request. 

Attorneys or other persons acting on 

behalf of an individual must provide 

written authorization from that 

individual, such as a Power of Attorney, 

in order for the representative to act on 

their behalf. Individuals requesting 

access must also comply with FRTIB’s 

Privacy Act regulations regarding 

verification of identity and access to 

such records, available at 5 CFR part 

1630. 

RECORD ACCESS PROCEDURE: 

Same as Notification Procedures. 

CONTESTING RECORDS PROCEDURE: 

Same as Notification Procedures. 

RECORD SOURCE CATEGORIES: 

Records are obtained from those 

individuals who submit requests and 

administrative appeals pursuant to the 

FOIA or who file litigation regarding 

such requests and appeals; the agency 

record keeping systems searched in the 

process of responding to such requests 

and appeals; FRTIB employees assigned 

to handle such requests, appeals, and/or 

litigation; other agencies or entities that 

have referred to FRTIB requests 

concerning FRTIB records, or that have 

consulted with FRTIB regarding 

handling of particular requests; and 

submitters or subjects of records or 

information that have provided 

assistance to FRTIB in making access or 

amendment determinations. 

EXEMPTIONS CLAIMED FOR SYSTEM: 

None. 

[FR Doc. 2016–02673 Filed 2–9–16; 8:45 am] 

BILLING CODE 6760–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Request for Measures Assessing 

Health Care Organization Quality 

Improvement Activities To Improve 

Patient Understanding, Navigation, 

Engagement, and Self-Management 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), DHHS. 

ACTION: Notice of request for measures. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) requests 

information from the public (including 

health care delivery organizations, 

health information developers, payers, 

quality measure developers, clinicians, 

and health care consumers) about 

quality improvement measures designed 

to help health care organizations 

monitor initiatives aimed at: 

• Improving patient understanding of 

health information, 

• simplifying navigation of health 

care systems and facilities, and 

• enhancing patients’ ability to 

manage their health. 

Specifically, AHRQ seeks quality 

improvement measures in four domains: 

1. Communication, 

2. Ease of Navigation, 

3. Patient Engagement and SelfManagement, and 

4. Organizational Structure, Policy, 

and Leadership. 

AHRQ is interested in measures that 

do not require patient survey data and 

that health care organizations are 

currently using, or have used in the 

past, to guide quality improvement 

activities designed to address these 

domains. AHRQ is also interested in 

information about relevant measures 

that are under development or are 

suggested for future development. 

DATES: Please submit one or more 

quality improvement measures and 

supporting information on or before 

March 4, 2016. AHRQ will not respond 

individually to submitters, but will 

consider all submitted measures and 

publicly report the results of the review 

of the submissions in aggregate. 

ADDRESSES: Submissions should follow 

the Submission Instructions below. 

Electronic responses are preferred and 

should be addressed to HealthLiteracy@

AHRQ.HHS.gov. Non-electronic 

responses will also be accepted. Please 

send these by mail to: Cindy Brach, 

Center for Delivery, Organization, and 

Markets, Agency for Healthcare 

Research and Quality, 5600 Fisher Lane, 

Rockville, MD 20857, Mailstop: 

07W25B. 


asabaliauskas on DSK9F6TC42PROD with NOTICES2
Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 7117 

FOR FURTHER INFORMATION CONTACT: 

HealthLiteracy@AHRQ.HHS.gov or 

Cindy Brach at the address above. 

SUPPLEMENTARY INFORMATION: 

Background Information 

The health care system is complex 

and demanding. Health care 

organizations can help patients to 

succeed in the health care environment 

by ensuring that patients and caregivers 

are able to understand health 

information, navigate the health care 

system, engage in the health care 

process, and take an active and effective 

role in the management of their health. 

This Request for Measures is part of 

a project that aims to: 

• Identify existing measures that 

organizations use or could use to 

monitor progress related to the four 

domains described above; and, 

• Refine and cull identified measures 

to establish a set of measures that 

reflects patient priorities, has expert 

support, and will be recommended for 

more formal measure development and 

testing. 

The project focuses on identifying 

measures that are not generated from 

patient survey data. 

The project is guided by a conceptual 

framework that builds on the concept of 

organizational health literacy. As 

described in the Institute of Medicine’s 

Roundtable on Health Literacy, 

organizational health literacy is the 

‘‘implementation and monitoring of 

organizational policies, practices, and 

structures that support patients in 

understanding health information, 

navigating the health care system, and 

managing their health’’ (Brach et al. 

2012). The conceptual framework 

identifies four domains as key 

components of organizational health 

literacy. 

1. Communication (e.g., the quality of 

verbal and written communication with 

patients, families, caregivers) 

2. Ease of Navigation (e.g., the degree 

to which an organization’s physical 

environment and systems of care are 

designed in a manner that simplifies 

navigation and use of services) 

3. Patient Engagement and SelfManagement (e.g., the degree to which 

an organization encourages patient 

engagement and provides support to 

enhance the ability of patients to 

manage their health) 

4. Organizational Structure, Policy, 

and Leadership (e.g., leadership support 

for organizational health literacy; 

implementation of policies, procedures, 

and structures that serve to improve 

communication with patients, simplify 

patient navigation, and enhance patient 

engagement and self-management) 

Quality improvement measures 

selected for further measure 

development and testing will assess key 

features of one or more of these 

domains. 

This project is being conducted by 

AHRQ pursuant to its statutory 

authority to conduct and support 

research on healthcare and on systems 

for the delivery of such care, including 

activities with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(2). 

Submission Guidance 

Submit a measure(s) that is currently 

in use, in development, or for which a 

need has been identified, in one or more 

of the four domains (i.e., 

Communication; Ease of Navigation; 

Patient Engagement and SelfManagement; and Organizational 

Structure, Policy, and Leadership). For 

this Request for Measures, AHRQ is 

specifically interested in measures that 

do not require or use patient reported 

data obtained using a patient survey. 

Your contribution will be very 

beneficial to AHRQ. The contents of all 

submissions will be made available to 

the public upon request. Materials 

submitted must be publicly available or 

can be made public. Materials that are 

considered confidential and marketing 

materials cannot be used by AHRQ. This 

is a voluntary request for information, 

and all costs for complying with this 

request must be borne by the submitter. 

AHRQ and its contractor, will 

evaluate all submitted measures and 

supporting documentation. As a set of 

measures is identified and evaluated for 

further refinement and testing, 

submissions may be included in whole 

or in part or may be modified for 

inclusion in the measurement set. 

AHRQ will assume responsibility for the 

final measurement sets as well as any 

future modifications. 

Submission Instructions 

To facilitate handling of submissions, 

please include the name and email 

address of the measure developer or 

contact. 

The responses most helpful to the 

Agency will include all or most of the 

following: 

1. A brief cover letter, 

2. a description of the measure and 

how it is calculated (e.g., who/what is 

included in the numerator, who/what is 

included in the denominator, who/what 

is excluded in calculating the measure), 

3. the source of the measure (e.g., 

publications, organizations where 

measure has been used to guide quality 

improvement activities), 

4. the domain best aligned with the 

measure (i.e., Communication; Ease of 

Navigation; Patient Engagement and 

Self-Management; and Organizational 

Structure, Policy, and Leadership), 

5. the source of data used to calculate 

the measure (e.g., electronic health 

records, internal monitoring and 

reporting systems), 

6. a description of data collection 

strategies (e.g., who is responsible for 

data collection, how is the information 

needed to calculate the measure 

collected), 

7. a list of health care settings in 

which the measure has been or would 

be used and characteristics of the 

patient populations in these health care 

settings, 

8. a description of how the measure 

has been used to support performance 

improvement (e.g., to whom is the 

measure reported, what actions have 

been taken based on the measure), 

9. a summary of unintended negative 

consequences resulting from use of the 

measure (e.g., evidence that 

implementation of the measure has 

negatively impacted patients, staff, 

clinical process, or other features of the 

implementing organization), and 

10. evidence that the measure is: 

a. Valid and reliable, 

b. associated with important 

outcomes, 

c. meaningful to patients, families, 

clinicians, and/or administrators, 

d. feasible to compute with accuracy 

and without undue cost, burden, or 

delay, and 

e. generalizable across health care 

settings. 

11. title, author(s), publication year, 

journal name, volume, issue, and page 

numbers of cited articles. 

12. a statement of willingness to grant 

to AHRQ the right to use and 

disseminate submitted measures and 

their documentation to the public as 

part of a set of organizational health 

literacy measures. 

Submission of copies of existing 

documentation or reports describing the 

measure and its properties, existing data 

sources, etc. is highly desirable but not 

required. 

Reference Material 

Brach, C., Keller, D., Hernandez, L.M., et al. 

(2012). Ten attributes of a health literate 

health care organization. Washington 

DC: Institute of Medicine. 

Kripalani, S., Wallston, K., Cavanaugh, K.L., 

Osborn, C., Mulvaney, S., Scott, A.M., & 

Rothman, R.L. (2014). Measures to assess 

a health-literate organization. 


asabaliauskas on DSK9F6TC42PROD with NOTICES2
7118 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Notices 

Washington DC: Institute of Medicine. 

Sharon B. Arnold, 

Deputy Director. 

[FR Doc. 2016–02679 Filed 2–9–16; 8:45 am] 

BILLING CODE 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: ‘‘Making 

It Easier for Patients to Understand 

Health Information and Navigate Health 

Care Systems: Developing Quality 

Improvement Measures.’’ In accordance 

with the Paperwork Reduction Act, 44 

U.S.C. 3501–3521, AHRQ invites the 

public to comment on this proposed 

information collection. 

DATES: Comments on this notice must be 

received by April 11, 2016. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

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

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance 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 

Making It Easier for Patients To 

Understand Health Information and 

Navigate Health Care Systems: 

Developing Quality Improvement 

Measures 

A goal of Healthy People 2020 is to 

increase Americans’ health literacy, 

defined as ‘‘the degree to which 

individuals have the capacity to obtain, 

process, and understand basic health 

information and services needed to 

make appropriate health decisions.’’ 1

The effects of limited health literacy are 

numerous and serious, including 

medication non-adherence resulting 

from patients’ inability to read and 

comprehend medication labels; 

underuse of preventive measures, such 

as vaccines; poor self-management of 

conditions such as asthma and diabetes; 

and higher utilization of inpatient and 

emergency department care. According 

to the 2003 National Assessment of 

Adult Literacy, 88% of U.S. adults have 

significant difficulties understanding 

widely used health information. By 

adopting ‘‘health literacy universal 

precautions,’’ health care providers and 

organizations can create an environment 

in which all patients—regardless of 

health literacy level—can successfully 

(1) understand health information, (2) 

navigate the health care system, (3) 

engage in medical decision-making, and 

(4) manage their health. 

Numerous resources have been 

developed to support health care 

organizations in their attempts to 

address limitations in patient health 

literacy. However, little work has been 

done to establish valid quality 

improvement measures that 

organizations can use to monitor the 

impact of initiatives aimed at improving 

patient understanding, navigation, 

engagement, and self-management. 

Absent such measures, organizations 

may be unable to accurately assess 

whether their initiatives are effective. 

This research has the following goals: 

1. Identify existing quality 

improvement measures and gather 

proposals for additional measures (not 

generated from patient survey data) that 

organizations may use to monitor 

progress related to enhancing patient 

understanding, navigation, engagement, 

and self-management; and 

2. Identify a set of quality 

improvement measures that reflect 

patient priorities, has expert support, 

and can be recommended for more 

formal measure development and 

testing. 

This project is being conducted by 

AHRQ through its contractor, Board of 

Regents of the University of Colorado, 

pursuant to AHRQ’s statutory authority 

to conduct and support research on 

health care and on systems for the 

delivery of such care, including 

activities with respect to the quality, 

effectiveness, efficiency, 

appropriateness and value of health care 

services and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

Environmental Scan Interviews: 

Representatives from 25 health care 

organizations engaged in relevant 

quality improvement efforts will be 

interviewed to obtain information about 

the quality improvement measures they 

use in assessing their work to improve 

patient understanding, navigation, 

engagement, and self-care. 

The planned environmental scan 

interviews will provide the information 

needed to: 

• Identify and document the 

characteristics of relevant quality 

improvement measures that are already 

in use; and 

• identify additional measures that 

would be useful to stakeholders in the 

field. 

The findings from these interviews 

will be used, along with the results from 

other activities (i.e., input from a 

Technical Expert Panel, literature 

review, a Request for Information 

published in the Federal Register, and 

focus groups with patients), to identify 

and document a set of quality 

improvement measures that can be 

recommended for rigorous testing and 

validation. Measures that are assessed to 

be valid and reliable will be eligible to 

be disseminated by AHRQ to support 

health care organizations in their efforts 

to improve patient understanding of 

health information, navigation of the 

health care system, engagement in 

medical decision-making, and 

management of their health. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondents’ time to participate in 

Environmental Scan Interviews. The 

Environmental Scan Interviews will be 

completed by 50 respondents (2 

representatives from each of the 25 

organizations targeted for participation). 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Environmental Scan Interviews ....................................................................... 50 1 2 100 


asabaliauskas on DSK9F6TC42PROD with NOTICES2