Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 19667 

their operations, conducting analysis, 

and presenting that analysis to HHS 

executives to inform program and policy 

decisions. 

3. Division of Health and Social Service 

Programs (AMW2) 

The Division of Health and Social 

Service Programs is responsible for 

establishing systems and procedures for 

analyzing data on the status of HHS 

health and social services programs and 

their operations, conducting analysis, 

and presenting that analysis to HHS 

executives to inform program and policy 

decisions. 

Dated: March 22, 2012. 

E.J. Holland, Jr., 

Assistant Secretary for Administration. 

[FR Doc. 2012–7807 Filed 3–30–12; 8:45 am] 

BILLING CODE 4150– 24–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: 

‘‘Development of a Health Information 

Rating System (HIRS).’’ 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 June 1, 2012. 

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@AHRO.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Development of a Health Information 

Rating System (HIRS) 

Over the past several years, limited 

health literacy has been identified as an 

important health care quality issue. 

Healthy People 2010 defined health 

literacy 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’. In 

2003, the Institute of Medicine 

identified health literacy as a crosscutting area for health care quality 

improvement. According to the 2003 

National Assessment of Adult Literacy, 

only 12 percent of adults have proficient 

health literacy. 

Persons with limited health literacy 

face numerous health care challenges. 

They often have a poor understanding of 

basic medical vocabulary and health 

care concepts. A study of patients in a 

large public hospital showed that 26 

percent did not understand when their 

next appointment was scheduled and 42 

percent did not understand instructions 

to ‘‘take medication on an empty 

stomach.’’ In addition, limited health 

literacy leads to more medication errors, 

more and longer hospital stays, and a 

generally higher level of illness. 

Health care providers can improve 

their patients’ health outcomes by 

delivering the right information at the 

right time in the right way to help 

patients prevent or manage chronic 

conditions such as diabetes, 

cardiovascular disease, hypertension, 

and asthma. Electronic health records 

(EHRs) can help providers offer patients 

the right information at the right time 

during office visits, by directly 

connecting patients to helpful resources 

on treatment and self-management. 

EHRs can also facilitate clinicians’ use 

of patient health education materials in 

the clinical encounter. However, health 

education materials delivered by EHRs, 

when available, are rarely written in a 

way that is understandable and 

actionable for patients with basic or 

below basic health literacy—an 

estimated 77 million people in the 

United States. 

In order to fulfill the promise of EHRs 

for all patients, especially for persons 

with limited health literacy, clinicians 

should have a method to determine how 

easy a health education material is for 

patients to understand and act on, have 

access to a library of easy-to-understand 

and actionable materials, understand 

the relevant capabilities and features of 

EHRs to provide effective patient 

education, and be made aware of these 

resources and information. Therefore, 

AHRQ developed a task order that 

resulted in contract 

#HHSA290200900012I to complete the 

following four major tasks: (1) Develop 

a valid and reliable Health Information 

Rating System (HIRS), (2) create a 

library of patient health education 

materials, (3) review EHR’s patient 

education capabilities and features, and 

(4) educate EHR vendors and users. This 

information collection project relates to 

the first task only. 

The goal of this information collection 

project is to develop a valid and reliable 

Health Information Rating System 

(HIRS). The HIRS will offer a systematic 

method to evaluate and compare the 

understandability and actionability of 

health education materials. Health 

education materials are understandable 

when consumers of diverse backgrounds 

and varying degrees of health literacy 

can process and explain key messages. 

Health education materials are 

actionable when consumers of diverse 

backgrounds and varying levels of 

health literacy can identify what they 

can do based on the information 

presented. 

A Draft HIRS has been developed 

through a rigorous multi-stage approach 

and draws upon existing rating systems, 

the evidence base in the literature, and 

the real-world expertise and experience 

of a Technical Expert Panel (TEP). The 

final stage of developing a reliable and 

valid rating system to assess the 

understandability and actionability of 

patient health education materials is 

testing with consumers. AHRQ is 

following a 5-step process to develop a 

valid and reliable HIRS: 

(1) Gather and synthesize evidence on 

existing rating systems and literature on 

consumers’ understanding of health 

information. Seek TEP review of the 

summary of existing health information 

rating systems. Develop item pool for 

each domain (i.e., understandability and 

actionability). 

(2) Assess the face and content 

validity of the domains (i.e., 

understandability and actionability) 

with the TEP. 

(3) Assess the inter-rater reliability of 

the HIRS on 16 different health 

education materials (8 English-language 

materials and 8 Spanish-language 

materials) using a total of 8 raters —4 

raters per material. Seek TEP review of 

results and provide guidance on how to 

address discrepancies. 

(4) Assess the construct validity of the 

HIRS by conducting testing with 48 

consumers — 24 English-speaking and 

24 Spanish-speaking consumers. 

Consumers will review materials and be 

asked questions to test whether they 

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19668 Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 

understand the materials and whether 

they know what actions to take. 

(5) Finalize the HIRS and instructions 

for users, and make them publicly 

available on AHRQ’s Web site. 

Steps 1, 2 and 3 do not involve data 

collections requiring OMB approval and 

have already been completed. 

This study is being conducted by 

AHRQ through its contractor, Abt 

Associates, 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 

To complete steps 4 and 5 the 

following data collections and activities 

will be implemented: 

(1) Demographic Questionnaire—The 

demographic questionnaire will collect 

basic demographic information about 

each consumer participant. This data 

will allow the analysis to detect 

differences in health literacy by 

population subgroups. 

(2) Short Test of Functional Health 

Literacy in Adults (S–TOFHLA) 

Questionnaire—The S–TOFHLA will be 

administered to all participants to 

access their level of health literacy. 

(3) Health Education Materials & 

Interview—English, Inhaler—Each 

English-speaking participant will be 

randomly assigned one of a set of three 

materials on using asthma inhalers, 

which include: (1) A video entitled 

‘‘How to Use an Inhaler,’’ by the 

American College of Physicians 

Foundation, (2) a material accessed via 

the internet entitled ‘‘Inhaled Asthma 

Medications: Tips to Remember,’’ by the 

American Academy of Allergy, Asthma 

& Immunology, and (3) a material 

accessed via the internet entitled ‘‘How 

to Use Your Metered-Dose Inhaler the 

Right Way,’’ by the McKinley Health 

Center. After seeing the video or reading 

the randomly assigned material, a brief 

interview will be conducted to assess 

the participants’ understanding of how 

to use an inhaler and what actions to 

take based on the material. 

(4) Health Education Materials & 

Interview—English, Colonoscopy—Each 

English-speaking participant will be 

randomly assigned one of a set of three 

materials about colonoscopy, which 

include: (1) A video entitled 

‘‘Colonoscopy,’’ by Medline Plus, (2) a 

pdf material accessed via the internet 

entitled ‘‘Colonoscopy,’’ by the 

American College of Surgeons and (3) a 

material accessed via the interne 

entitled, ‘‘Colonoscopy,’’ by Jackson 

Siegelbaum Gastroenterology. After 

seeing the video or reading the 

randomly assigned material, a brief 

interview will be conducted to assess 

the participants’ understanding of the 

colonoscopy procedure and what 

actions to take based on the material. 

(5) Health Education Materials & 

Interview—Spanish, High Blood 

Pressure—Each Spanish-speaking 

participant will be randomly assigned 

one of a set of three materials about high 

blood pressure, which include: (1) A 

video entitled ‘‘Hipertension esencial,’’ 

by Medline Plus, (2) a Web site material 

accessed via the internet entitled ‘‘¿Que 

es la presio ́n arterial alta?,’’ by the 

National Heart Lung and Blood Institute 

(NHLBI) and (3) a pdf material accessed 

via the internet entitled, ‘‘Presion 

Sanguinea Alta,’’ by the National Center 

for Farmworker Health. After seeing the 

video or reading the randomly assigned 

material, a brief interview will be 

conducted to assess the participants’ 

understanding of high blood pressure 

and what actions to take based on the 

material. 

(6) Health Education Materials & 

Interview—Spanish, Colonoscopy— 

Each Spanish-speaking participant will 

be randomly assigned one of a set of 

three materials about colonoscopy, 

which include: (1) A video entitled 

‘‘Colonoscopia,’’ Main Line Health, (2) a 

pdf material accessed via the internet 

entitled ‘‘Colonoscopia: Lo Que Usted 

Debe Saber,’’ by the Nebraska 

Department of Health and Human 

Services (DHHS) and (3) a material 

accessed via the internet entitled, 

‘‘Colonoscopı ́a,’’ by Centro Medicao 

ABC. After seeing the video or reading 

the randomly assigned material, a brief 

interview will be conducted to assess 

the participants’ understanding of the 

colonoscopy procedure and what 

actions to take based on the material. 

The data collected from this project 

will be used to assess the construct 

validity of and inform revisions to the 

HIRS. The HIRS will be the first system 

that can assess the understandability 

and actionability of patient health 

education materials that can be 

incorporated into an EHR, including 

print and multimedia materials. Note 

that the materials to be assessed need 

not currently be incorporated into EHRs; 

for now, AHRQ is focusing on materials 

that have the potential to be 

incorporated into EHRs. 

No claim is made that the results from 

this study will be generalizable in the 

statistical sense. Rather, the consumer 

testing will be informative and critical 

to ensuring we have developed a valid 

rating system by conducting consumer 

testing. 

Estimated Annual Respondent Burden 

Exhibit 1 presents estimates of the 

annualized burden hours for the 

respondents’ time to participate in this 

research. The Demographic and S– 

TOFHLA questionnaires will be 

completed by all 48 participants and 

takes 5 and 7 minutes, respectively, to 

complete. Each of the 48 participants 

will review 2 different sets of health 

education materials and then participate 

in a short interview for each material 

topic. English-speaking participants will 

review materials related to inhaler use 

and colonoscopy while Spanishspeaking participants will review 

materials related to high blood pressure 

and colonoscopy. To review each 

material and participate in the 

associated interview requires 30 

minutes (15 minutes to review the 

materials and 15 minutes for the 

interview). The total annualized burden 

is estimated to be 58 hours. 

Exhibit 2 presents the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this research. The total cost burden is 

estimated at $962. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Demographic Questionnaire ............................................................................ 48 1 5/60 4 

S-TOFHLA Questionnaire ................................................................................ 48 1 7/60 6 

Health Education Materials & Interview—English, Inhaler .............................. 24 1 30/60 12 

Health Education Materials & Interview —English & Spanish, Colonoscopy 48 1 30/60 24 

Health Education Materials & Interview—Spanish, High Blood Pressure ...... 24 1 30/60 12 

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Federal Register / Vol. 77, No. 63 / Monday, April 2, 2012 / Notices 19669 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Data collection Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Total .......................................................................................................... 192 na na 58 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Data collection Number of 

respondents 

Total burden 

hours 

Average 

hourly 

wage rate* 

Total cost 

burden 

Demographic Questionnaire ............................................................................ 48 4 $21.35 $85 

S-TOFHLA Questionnaire ................................................................................ 48 6 21.35 128 

Health Education Materials & Interview—English, Inhaler .............................. 24 12 21.35 256 

Health Education Materials & Interview —English & Spanish, Colonoscopy 48 24 21.35 512 

Health Education Materials & Interview—Spanish, High Blood Pressure ...... 24 12 21.35 256 

Total .......................................................................................................... 192 58 na 1,237 

* Based upon the mean wage for all occupations, National Compensation Survey: Occupational wages in the United States May 2010, ‘‘U.S. 

Department of Labor, Bureau of Labor Statistics.’’ 

Estimated Annual Costs to the Federal 

Government 

The total cost of this contract to the 

government is $524,945, and the project 

extends over 3 years (July 19, 2010 to 

July 18, 2013). The data collection for 

which we are seeking OMB clearance 

will take place from September 1, 2012 

to December 31, 2012. Exhibit 3 shows 

a breakdown of the total cost as well as 

the annualized cost for the data 

collection, processing and analysis 

activity for this entire contract. 

EXHIBIT 3—ESTIMATED COST

Cost Component Total Cost Annual Cost 

Project Development ....................................................................................................................................... $66,447 $22,149 

Data Collection Activities ................................................................................................................................. 129,547 43,182 

Data Processing and Analysis ......................................................................................................................... 129,548 43,183 

Publication of Results ...................................................................................................................................... 131,571 43,857 

Project Management ........................................................................................................................................ 67,832 22,611 

Total .......................................................................................................................................................... 524,945 174,982 

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: March 22, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–7768 Filed 3–30–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center For Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for 

Scientific Review Special Emphasis 

Panel; Neurodegeneration: Mechanisms 

and Therapeutic Targets. 

Date: April 17, 2012. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

6701 Rockledge Drive, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Laurent Taupenot, 

Ph.D, Scientific Review Officer, Center 

for Scientific Review, National Institutes 

of Health, 6701 Rockledge Drive, Room 

4811, MSC 7850, Bethesda, MD 20892, 

301–435–1203, taupenol@csr.nih.gov. 

Name of Committee: Center for 

Scientific Review Special Emphasis 

mstockstill on DSK4VPTVN1PROD with NOTICES