42324 Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices 

they were produced, including any code 

if applicable. The processes can be 

submitted in text document. 

In order for an entry to be eligible to 

win this Challenge, it must meet the 

following requirements: 

1. Acceptable platforms—The tool 

must be designed for use with existing 

Web, mobile Web, electronic health 

record, or other platform. 

2. Section 508 Compliance— 

Contestants must acknowledge that they 

understand that, as a prerequisite to any 

subsequent acquisition by FAR contract 

or other method, they are required to 

make their proposed solution compliant 

with Section 508 accessibility and 

usability requirements at their own 

expense. Any electronic information 

technology that is ultimately obtained 

by HHS for its use, development, or 

maintenance must meet Section 508 

accessibility and usability standards. 

Past experience has demonstrated that it 

can be costly for solution-providers to 

‘‘retrofit’’ solutions if remediation is 

later needed. The HHS Section 508 

Evaluation Product Assessment 

Template, available at http://www.

hhs.gov/od/vendors/index.html, 

provides a useful roadmap for 

developers to review. It is a simple, 

web-based checklist utilized by HHS 

officials to allow vendors to document 

how their products do or do not meet 

the various Section 508 requirements. 

3. No HHS or OBMT logo—The app 

must not use HHS’ or OBMT’s logos or 

official seals in the Submission, and 

must not claim endorsement. 

4. Functionality/Accuracy—A 

submission may be disqualified if it fails 

to function as expressed in the 

description provided by the user, or if 

it provides inaccurate or incomplete 

information. 

5. Security—Submissions must be free 

of malware. Contestant agrees that 

OBMT may conduct testing on the app 

to determine whether malware or other 

security threats may be present. OBMT 

may disqualify the Submission if, in 

OBMT’s judgment, the app may damage 

government or others’ equipment or 

operating environment. 

Additional Information 

General Conditions: OBMT reserves 

the right to cancel, suspend, and/or 

modify the Contest, or any part of it, for 

any reason, at OBMT’s sole discretion. 

Intellectual Property 

• Each entrant retains full ownership 

and title in and to their submission. 

Entrants expressly reserve all 

intellectual property rights not 

expressly granted under the challenge 

agreement. 

• By participating in the challenge, 

each entrant hereby irrevocably grants 

to OBMT a limited, non-exclusive, 

royalty-free, worldwide license and 

right to reproduce, publically perform, 

publically display, and use the 

submission for internal HHS business 

and to the extent necessary to 

administer the challenge, and to 

publically perform and publically 

display the Submission, including, 

without limitation, for advertising and 

promotional purposes relating to the 

challenge. 

Dated: July 11, 2014. 

E.J. Holland, Jr., 

Assistant Secretary for Administration, U.S. 

Department of Health and Human Services. 

[FR Doc. 2014–17065 Filed 7–18–14; 8:45 am] 

BILLING CODE 4151–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Behavioral Programs for Diabetes 

Mellitus 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for Scientific 

Information Submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review of 

Behavioral Programs for Diabetes 

Mellitus, which is currently being 

conducted by the Evidence-based 

Practice Centers for the AHRQ Effective 

Health Care Program. Access to 

published and unpublished pertinent 

scientific information will improve the 

quality of this review. AHRQ is 

conducting this systematic review 

pursuant to Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, and Section 

902(a) of the Public Health Service Act, 

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

DATES: Submission Deadline on or 

before August 20, 2014. 

ADDRESSES: 

Online submissions: http://

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientificinformation-packets/. Please select the 

study for which you are submitting 

information from the list to upload your 

documents. 

Email submissions: SIPS@epc-src.org. 

Print submissions: Mailing Address: 

Portland VA Research Foundation 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, PO Box 69539, Portland, 

OR 97239, Shipping Address (FedEx, 

UPS, etc.): Portland VA Research 

Foundation, Scientific Resource 

Center, ATTN: Scientific Information 

Packet Coordinator, 3710 SW U.S. 

Veterans Hospital Road, Mail Code: 

R&D 71, Portland, OR 97239 

FOR FURTHER INFORMATION CONTACT: 

Ryan McKenna, Telephone: 503–220– 

8262 ext. 58653 or Email: SIPS@epcsrc.org. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the Effective 

Health Care (EHC) Program Evidencebased Practice Centers to complete a 

review of the evidence for Behavioral 

Programs for Diabetes Mellitus. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Behavioral Programs for 

Diabetes Mellitus, including those that 

describe adverse events. The entire 

research protocol, including the key 

questions, is also available online at: 

http://effectivehealthcare.AHRQ.gov/

search-for-guides-reviews-and-reports/

?pageaction=displayproduct&productID

=1917. 

This notice is to notify the public that 

the EHC Program would find the 

following information on Behavioral 

Programs for Diabetes Mellitus helpful: 

• A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 

please provide a summary, including 

the following elements: study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/

enrolled/lost to follow-up/withdrawn/

analyzed, effectiveness/efficacy, and 

safety results. 

• A list of ongoing studies that your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 


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Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices 42325 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

• Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution will be very 

beneficial to the EHC Program. 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; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EHC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EHC Program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

The systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol is also available 

online at: http://effective

healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?pageaction=

displayproduct&productID=1917. 

The Key Questions 

Question 1 

For patients with Type 1 Diabetes 

Mellitus (T1DM), are behavioral 

programs implemented in a community 

health setting effective compared with 

usual or standard care, or active 

comparators in, a) improving 

behavioral, clinical, and health 

outcomes, b) improving diabetes-related 

health care utilization, and c) achieving 

program acceptability as measured by 

participant attrition rates? 

Question 2 

For patients with T1DM, do 

behavioral programs implemented in 

the community health setting differ in 

effectiveness for behavioral, clinical, 

and health outcomes, their effect on 

diabetes-related health care utilization, 

or program acceptability, for subgroups 

of patients based on: Age (i.e., children 

and adolescents [≤18 years] and their 

families, young adults [19–30 years], 

adults [31–64 years], older adults [≥65 

years]); race or ethnicity; socioeconomic 

status (e.g., family income, education 

level, literacy); time since diagnosis 

(i.e., ≤1 year vs. >1 year); and, level of 

glycemic control (e.g., HbA1c <7 vs. ≥7 

percent)? 

Question 3 

For patients with T1DM, does the 

effectiveness of behavioral programs 

differ based on the: (a) Components; (b) 

intensity (i.e., program duration, 

frequency/periodicity of interactions); 

(b) delivery personnel (e.g., dietitian, 

exercise specialist, physician, nurse 

practitioner, certified diabetes educator, 

lay health worker); (c) method of 

communication (e.g., individual vs. 

group, face-to-face, interactive behavior 

change technology, social media); (d) 

degree of tailoring based on needs 

assessment (e.g., educational/behavioral 

deficits, age or other demographics, 

readiness to change); or (e) level and 

nature of community engagement? 

Question 4 

For patients with T1DM, what are the 

associated harms (i.e., activity-related 

injury) of behavioral programs 

implemented in a community health 

setting compared with usual care, 

standard care, or active comparators? 

Question 5 

Among behavioral programs targeted 

at adults with Type 2 Diabetes Mellitus 

(T2DM) implemented in a community 

health setting, what factors contribute 

to: (a) Their effectiveness for behavioral, 

clinical, and health outcomes; (b) their 

effect on diabetes-related health care 

utilization; and (c) program 

acceptability as measured by participant 

attrition rates? Factors include program 

components, program intensity, delivery 

personnel, methods of delivery and 

communication, degree of tailoring, and 

community engagement. 

Question 6 

Do the factors that contribute to 

program effectiveness for patients with 

T2DM vary across the following 

subpopulations: Age (i.e., young adults 

[19–30 years], adults [31–64 years], 

older adults [≥65 years]); race or 

ethnicity; socioeconomic status (e.g., 

family income, education level, 

literacy); time since diagnosis (i.e., ≤1 

year vs. >1 year); and, level of glycemic 

control (i.e., HbA1c <7 vs. ≥7 percent)? 

PICOTS (Patients, Interventions, 

Comparators, Outcomes, Timing, and 

Setting) Criteria 

PICOTS frameworks are presented 

below for the Key Questions that relate 

to Type 1 Diabetes Mellitus (T1DM) and 

Type 2 Diabetes Mellitus (T2DM). These 

frameworks will guide all the stages of 

the systematic review, including 

literature searching, study selection, and 

data abstraction. 

Key Questions 1–4 

Population 

Patients with T1DM (any age) who 

have undergone basic diabetes 

education. 

Interventions 

• Multicomponent behavioral program 

that includes 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 Self-regulation of insulin based on 

diet, physical activity, and glucose 

monitoring results 

Æ Change in physical activity (e.g., 

volume of activity per week) or 

fitness (e.g., cardiorespiratory 

fitness, strength) 


emcdonald on DSK67QTVN1PROD with NOTICES
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