42326 Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices 

Æ Change in dietary or nutrient intake 

(i.e., energy intake, saturated fat 

consumption) 

Æ Adherence to treatment, including 

self-monitoring and medication 

• Clinical outcomes 

Æ Glycemic control (Hemoglobin Alt) 

Æ Change in body composition (i.e., 

weight, Body Mass Index, waist 

circumference, % body fat) 

Æ Episodes of severe hypoglycemia 

Æ Treatment for hyperglycemia 

(ketoacidosis) 

Æ Control of blood pressure and 

lipids 

Æ Development or control of 

depression or anxiety 

• Health outcomes 

Æ Quality of life (e.g., validated tools 

for health-related quality of life, life 

satisfaction, psychosocial 

adaptation to illness, patient 

satisfaction) 

Æ Development of micro- and 

macrovascular complications (i.e., 

retinopathy, nephropathy, 

neuropathy, cardiovascular 

outcomes) 

Æ Mortality (all-cause) 

• Diabetes-related health care 

utilization 

Æ Hospital admissions 

Æ Length of stay in hospital 

Æ Emergency department admissions 

Æ Visits to specialist clinics 

• Program acceptability as measured by 

participant attrition rates 

• Harms from program as reported for 

studies 

• Activity-related injury 

Timing 

Any length of followup 

Study Design 

Prospective comparative studies using a 

best evidence approach based on 

hierarchy of evidence: randomized 

controlled trials, nonrandomized 

controlled trials, prospective cohort 

studies, controlled before-after 

studies 

Settings 

• Community health setting (i.e., 

ambulatory care clinics, outpatient 

clinics, primary care clinics, family 

physician clinics, Community 

Health Centers, Rural Health 

Centers) 

• United States or other high-income 

countries with a very high Human 

Development Index 

Key Questions 5–6 

Population 

Adults (≥18 years) with T2DM who have 

undergone primary diabetes 

education 

Interventions 

• Multicomponent behavioral programs 

that include at least one of: 

Æ Diabetes self-management 

education; OR 

Æ Structured dietary intervention 

(related to any of weight loss, 

glycemic control, or reducing risk 

for complications) together with 

one or more additional components; 

OR 

Æ Structured exercise/physical 

activity intervention together with 

one or more additional components. 

Æ Additional components may 

include interventions related to: 

diet or physical activity, behavioral 

change (including but not limited 

to: Goal setting, problem solving, 

motivational interviewing, coping 

skills training, cognitive behavioral 

therapy strategies), relaxation or 

stress reduction, blood glucose 

awareness, medication adherence, 

or self-monitoring for diabetic 

complications (foot, eye, and renal 

tests). 

• Repeated provision by one or more 

trained individuals 

• Duration of intervention: Minimum 4 

weeks 

Comparators 

• Usual or standard care or an active 

comparator (e.g., behavioral 

program or intervention) as 

reported for studies 

• Delivery methods (personnel, 

intensity, communication methods 

etc.) as reported for studies 

Outcomes 

• Behavioral outcomes 

Æ Change in physical activity (e.g., 

volume of activity per week) or 

fitness (e.g., cardiorespiratory 

fitness, strength) 

Æ Change in dietary or nutrient intake 

(i.e., energy intake, saturated fat 

consumption) 

Æ Adherence to medication 

• Clinical outcomes 

Æ Glycemic control (Hemoglobin Mc) 

Æ Change in body composition (i.e., 

weight, Body Mass Index, waist 

circumference, % body fat) 

Æ Control of blood pressure and 

lipids 

Æ Sleep apnea or sleep quality 

Æ Development or control of 

depression or anxiety 

• Health outcomes 

Æ Quality of life (e.g., validated tools 

for health-related quality of life, life 

satisfaction, psychosocial 

adaptation to illness, patient 

satisfaction) 

Æ Development of micro- and 

macrovascular complications (i.e., 

retinopathy, nephropathy, 

neuropathy, cardiovascular 

outcomes) 

Æ Mortality (all-cause) 

• Diabetes-related health care 

utilization 

Æ Hospital admissions 

Æ Length of stay in hospital 

Æ Emergency department admissions 

Æ Visits to specialist clinics 

• Program acceptability as measured by 

participant attrition rates 

Timing 

Any length of followup 

Study design 

Randomized controlled trials 

Settings 

• Community health setting (i.e., 

ambulatory care clinics, outpatient 

clinics, primary care clinics, family 

physician clinics, Community 

Health Centers, Rural Health 

Centers) 

• United States or other high-income 

country with a very high Human 

Development Index 

Language 

English 

Dated: July 3, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–16669 Filed 7–18–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Statement of Organization, Functions, 

and Delegations of Authority 

Part E, Chapter E (Agency for 

Healthcare Research and Quality), of the 

Statement of Organization, Functions, 

and Delegations of Authority for the 

Department of Health and Human 

Services (61 FR 15955–58, April 10, 

1996, most recently amended at 78 FR 

38981, on June 28, 2013) is amended to 

reflect recent organizational changes. 

The specific amendments are as follows: 

I. Under Section E–10, Organization, 

delete all components and replace with 

the following: 

A. Office of the Director. 

B. Center for Delivery, Organization, 

and Markets. 

C. Center for Financing, Access, and 

Cost Trends. 

D. Center for Evidence and Practice 

Improvement. 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices 42327 

E. Center for Quality Improvement 

and Patient Safety. 

F. Office of Communications and 

Knowledge Transfer. 

G. Office of Extramural Research, 

Education, and Priority Populations. 

H. Office of Management Services. 

II. Under Section E–20, Functions, 

delete Center for Outcomes and 

Evidence (EJ) and Center for Primary 

Care, Prevention, and Clinical 

Partnerships (EK) in its entirety and 

replace with the following: 

Center for Evidence and Practice 

Improvement (EK). Generates new 

knowledge, synthesizes evidence, 

translates science for multiple 

stakeholders, and catalyzes practice 

improvement. Specifically: (1) Conducts 

and supports evidence synthesis and 

research on health care delivery and 

improvement that is informed by the 

needs of patients, clinicians, and policy 

makers, including providing scientific, 

administrative and dissemination 

support for the U.S. Preventive Services 

Task Force; (2) advances decision and 

communication sciences and 

implementation research to facilitate 

informed treatment and health care 

decision making by patients and their 

health care providers and serving as a 

trusted source for evidence-based tools, 

decision aids, and other products about 

what works in health care and practice 

improvement; (3) explores how health 

information technology can improve 

clinical decision making and health care 

quality and helping Federal partners 

and health care stakeholders use this 

evidence; (4) catalyzes and sustains 

ongoing improvements in clinical 

practice across health care settings 

through research, demonstration 

projects, and partnership development; 

(5) operates the National Center for 

Excellence in Primary Care Research. 

Division of the Evidence-Based 

Practice Center Program (EKB). 

Produces evidence syntheses by 

conducting systematic evidence reviews 

using robust and rigorous 

methodologies to advance the methods 

of evidence synthesis to ensure 

scientific rigor and unbiased reviews of 

evidence. 

Division of U.S. Preventive Services 

Task Force Support (EKC). Provides 

scientific, administrative, and 

dissemination support for the 

independent U.S. Preventive Services 

Task Force, enabling the Task Force to 

make evidence-based recommendations 

on clinical preventive services. 

Division of Decision Science and 

Patient Engagement (EKD). Provides 

evidence-based tools, decision aids, and 

other products that address what works 

in health care and practice 

improvement. Specifically: (1) 

Translates complex scientific evidence 

into tools and products targeted to 

diverse stakeholders that facilitate 

informed health care decision making 

and (2) engages with stakeholders to 

advance the field of evidence-based 

decision making to improve methods for 

engagement of all communities in 

health care decision making. 

Division of Health Information 

Technology (EKE). Develops and 

disseminates evidence and evidencebased tools to inform policy and 

practice on how health information 

technology can improve the quality of 

health care. 

Division of Practice Improvement 

Science and Implementation (EKF). 

Engages stakeholders and communities 

of learning for practice improvement, 

serves as a trusted resource of evidence 

and tools for methods, measures, and 

evaluation of practice improvement. 

Specifically: (1) Explores how to 

facilitate practice transformation and 

improvement in diverse settings and (2) 

pilots innovative models of practice 

improvement. 

All delegations and redelegations of 

authority to officers and employees of 

the Agency for Healthcare Research and 

Quality that were in effect immediately 

prior to the effective date of this 

reorganization shall continue in effect 

pending further redelegation provided 

they are consistent with this 

reorganization. 

These changes are effective upon date 

of signature. 

Dated: July 9, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–17126 Filed 7–18–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–14–14YK] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Information Collection on CauseSpecific Absenteeism in Schools— 

New—National Center for Emerging and 

Zoonotic Infectious Diseases (NCEZID), 

Division of Global Migration and 

Quarantine (DGMQ), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The Centers for Disease Control and 

Prevention (CDC), National Center for 

Emerging and Zoonotic Infectious 

Diseases (NCEZID), Division of Global 

Migration and Quarantine (DGMQ), 

requests approval of a new information 

collection to better understand the 

triggers, timing and duration of the use 

of school related measures for 

preventing and controlling the spread of 

influenza during the next pandemic. 

The information collection for which 

approval is sought is in accordance with 

DGMQ/CDC’s mission to reduce 

morbidity and mortality in mobile 

populations, and to prevent the 

introduction, transmission, or spread of 

communicable diseases within the 

United States. Insights gained from this 

information collection will assist in the 


emcdonald on DSK67QTVN1PROD with NOTICES