62156 Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 

Survey will be administered to each 

individual 6 months after completing 

the module. On average, respondents 

will spend 5 minutes completing the 

survey. As many as 4,400 health care 

professionals are expected to complete 

the surveys, based on an average of 

2,000 health care providers taking each 

module with a 10% response rate, or 

200; 200 × 22 modules = 4,400. On 

average, respondents will spend 5 

minutes completing the survey. The 

total burden is estimated to be 367 

hours. 

EXHIBIT 1—ESTIMATED RESPONDENT BURDEN

Estimated number of 

respondents 

Average 

burden per 

respondent 

(minutes) 

Total burden 

(minutes) 

Number of 

responses per 

respondent 

Total 

respondent 

burden 

(minutes) 

Total 

burden per 

respondent 

(minutes) 

Total 

respondent 

burden 

(hours) 

A B C 

(A*B) 

D E 

(C*D) 

F 

(B*D) 

G 

(E/60) 

4400 ................................. 5 22,000 1 22,000 5 367 

EXHIBIT 2—ESTIMATED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate * 

Total cost 

burden 

AHRQ Online CME/CE 6-Month Evaluation .................................... 4,400 367 $49.83 $18,288 

Total .......................................................................................... 4,400 367 N/A 18,288 

* Based upon the mean of the average hourly wages for Physicians (29–1069; $92.25), Pharmacists (29–1051; $56.01), Physician Assistants 

(29–1071; $45.36), Nurse Practitioners (29–1171; $45.71), Registered Nurses (29–1111; $33.13), and Healthcare Practitioners (29–9099; 

$26.54), May 2013 National Occupational Employment and Wage Estimates, United States, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#29-0000 viewed May 5, 2014. 

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: October 9, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–24509 Filed 10–15–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Management and Outcomes of Binge 

Eating Disorder (BED) 

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 

Management and Outcomes of Binge 

Eating Disorder, which is currently 

being conducted by AHRQ’s Evidencebased Practice Center (EPC) 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 902(a) of the 

Public Health Service Act, 42 U.S.C. 

299a(a). 

DATES: Submission deadline on or 

before November 17, 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 P.O. 

Box 69539, Portland, OR 97239. 

Shipping Address (FedEx, UPS, etc.): 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, 37105W 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 

Evidence-based Practice Center (EPC) 

Program to complete a review of the 

evidence for Management and 

Outcomes of Binge Eating Disorder. 

The EPC 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 Management and 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 62157 

1Bariatric surgery patients may have had either 

BED or LOC eating diagnoses before surgery, but 

after surgery they are typically diagnosed only with 

LOC eating (i.e., loss-of-control eating behaviors 

without having consumed an unusually large 

amount of food). 

2Children, especially those who are 

preadolescent, tend to be diagnosed only with LOC 

eating, not BED, in part because parents or others 

may limit the quantity of food they are permitted 

to consume. 

Outcomes of Binge Eating Disorder, 

including those that describe adverse 

events. The entire research protocol, 

including the key questions is also 

available online at: http:// 

effectivehealthcare.ahrq.gov/search-forguides-reviews-and-reports/

?pageaction=displayproduct&

productID=1942. 

This notice is to notify the public that 

the EPC Program would find the 

following information on Management 

and Outcome of Binge Eating Disorder 

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 

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 EPC 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 EPC 

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 EPC 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 available online at: 

http://effectivehealthcare.ahrq.govi

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

?pageaction=displayproduct

&productID=1942. 

The Key Questions 

KQ 1: What is the evidence for the 

effectiveness of treatments or 

combinations of treatments for binge 

eating disorder? 

KQ 2: What is the evidence for harms 

associated with treatments for binge 

eating disorder? 

KQ 3: Does the effectiveness of 

treatments for binge eating disorder 

differ by age, sex, race, ethnicity, initial 

body mass index, duration of illness, or 

coexisting conditions? 

KQ 4: What is the course of illness of 

binge eating disorder? 

KQ 5: Does the course of illness of 

binge eating disorder differ by age, sex, 

race, ethnicity, sexual orientation, body 

mass index, duration of illness, or 

coexisting conditions? 

KQ 6: What is the evidence for the 

effectiveness of treatments or 

combinations of treatments for loss-ofcontrol eating among bariatric surgery 

patients? 

KQ 7: What is the evidence for harms 

associated with treatments for loss-ofcontrol eating among bariatric surgery 

patients? 

KQ 8: Does the effectiveness of 

treatments for loss-of-control eating 

among bariatric surgery patients differ 

by age, sex, race, ethnicity, initial body 

mass index, duration of illness, or 

coexisting conditions? 

KQ 9: What is the course of illness of 

loss-of-control eating among bariatric 

surgery patients? 

KQ 10: Does the course of illness of 

loss-of-control eating among bariatric 

surgery patients differ by age, sex, race, 

ethnicity, sexual orientation, initial 

body mass index, duration of illness, or 

coexisting conditions? 

KQ 11: What is the evidence for the 

effectiveness of treatments or 

combinations of treatments for loss-ofcontrol eating among children? 

KQ 12: What is the evidence for 

harms associated with treatments for 

loss-of-control eating among children? 

KQ 13: Does the effectiveness of 

treatments for loss-of-control eating 

among children differ by age, sex, race, 

ethnicity, initial body mass index, 

duration of illness, or coexisting 

conditions? 

KQ 14: What is the course of illness 

of loss-of-control eating among 

children? 

KQ 15: Does the course of illness of 

loss-of-control eating among children 

differ by age, sex, race, ethnicity, initial 

body mass index, duration of illness, or 

coexisting conditions? 

PICOTS (Population(s), Intervention(s), 

Comparator(s), Outcome(s), Timing, 

Setting) 

Population(s) 

• Individuals meeting either DSM–IV or 

DSM–5 criteria for binge eating 

disorder (BED) 

• Post-bariatric surgery patients meeting 

criteria for loss-of-control (LOC) 

eating after surgery l

• Children (6 years of age and older) 

meeting criteria for LOC eating 2

Interventions 

Applies only to KQs on effectiveness 

and harms of BED treatment in adults 

(KQs 1, 2, and 3), LOG treatment in 

bariatric patients (KQs 6, 7, and 8), and 

LOG treatment in children (KQs 11, 12, 

and 13). 

• Pharmacological interventions 

Æ Antidepressants, including: (1) 

Selective serotonin reuptake 

inhibitors (SSRIs); (2) serotoninnorepinephrine reuptake inhibitors 

(SNRIs, excluding Sibutramine 

because it is unavailable in the United 

States); (3) norepinephrine reuptake 

inhibitors (NRIs); and (4) tricyclic 

antidepressants 

Æ Anticonvulsants (antiepileptics) 

Æ Weight loss drugs (orlistat) 

Æ Appetite suppressants (excluding 

rimonabant because it is unavailable 

in the United States) 

Æ Gamma-aminobutyric acid agonists 

Æ Mixed gamma-aminobutyric acid 

agonist/glutamate antagonists 

Æ Central nervous system stimulants 

• Psychological or behavioral 

interventions 

Æ Cognitive behavioral therapy (CBT) 

Æ Interpersonal psychotherapy (IPT) 

Æ Dialectical behavior therapy (DBT) 

Æ Family-based therapy (for LOC eating 

in children and adolescents) 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
62158 Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices 

Æ Parent training (for LOC eating in 

children and adolescents) 

Æ Behavioral weight loss interventions 

Æ Virtual reality therapy 

Æ Nutritional counseling or low-calorie 

diet (or both) 

Æ Exercise 

Æ Health education 

• Complementary and alternative 

medicine (CAM) interventions 

Æ Nutraceuticals and dietary 

supplements 

Æ Acupuncture 

• Combinations of pharmacotherapies; 

combinations of psychological 

interventions; combinations of CAM 

interventions; combinations of 

pharmacotherapy, psychological, 

behavioral, and/or CAM interventions 

• Characteristics of interventions 

Æ Pharmacotherapy and CAM: Dosages, 

duration of treatment 

Æ Psychological or behavioral: Format 

(e.g., individual or group, therapistled or self-help), frequency, duration 

of treatment 

Comparators 

Applies only to KQs on effectiveness 

and harms of BED treatment in adults 

(KQs 1, 2, and 3), LOC treatment in 

bariatric patients (KQs 6, 7, and 8), and 

LOC treatment in children (KQs 11, 12, 

and 13). 

• Placebo or usual care 

• Any active intervention or 

combination of active interventions 

from among those listed above 

Outcomes 

• Intermediate outcomes 

Æ Change in weight or body mass index 

(BMI) (or both) 

Æ Appetite-regulating peptide hormones 

Æ Blood lipids (cholesterol, 

triglycerides) 

Æ Blood glucose, hemoglobin Alc 

Æ Blood pressure 

• Final health outcomes 

Æ Behavioral 

• Binge eating: Frequency of binge 

episodes, frequency of binge days, 

binge abstinence 

• LOC eating: Frequency of LOC eating 

episodes, LOC eating abstinence 

Æ Psychological 

• Shape and weight concerns, restraint, 

hunger, disinhibition 

• Depressive disorders and symptoms 

• Anxiety 

• Substance abuse 

Æ Physical health and functioning 

• BMI, weight status or stabilization 

• Hypertension 

• Type 2 diabetes, impaired glucose 

tolerance, insulin resistance 

• Dyslipidemia 

• Heart disease 

• Gastric reflux (gastroesophageal reflux 

disorder), gastroparesis, other 

gastrointestinal diagnoses or problems 

• Irritable bowel syndrome 

• Menstrual problems (female), 

hormonal problems (male or female) 

• Reproductive function 

Æ Social and occupational functioning 

• Work or school days lost 

• Marital or partner status 

• Quality of life: Health-related quality 

of life or patient-reported outcomes 

not otherwise listed above 

• Harms: Applies only to harms of 

treatment (KQs 2, 7, and 12) 

Æ Pharmacotherapy and CAM: 

Sedation, dry mouth, headache, 

nausea, insomnia, diarrhea, fatigue, 

increased urinary frequency, sexual 

dysfunction, abnormal dreams, 

sweating, palpitations, arrhythmia, 

cramping, diffuse pain, weight gain 

Æ Psychological or behavioral therapy: 

Negative effects of disclosing 

symptoms during initial evaluation or 

therapy 

Æ Worsening of BED or LOC eating (or 

associated symptoms) 

• Health care use and costs 

Æ Use of health care services: 

Emergency room visits, 

hospitalizations (psychiatric 

hospitals, residential institutions, 

general hospitals), ambulatory 

physician visits (medical care, 

psychiatric care), ambulatory visits to 

other health care professionals (e.g., 

clinical psychologists), nutritional 

counseling 

Æ Costs of services: Emergency room 

visits, hospitalizations (psychiatric 

hospitals, residential institutions, 

general hospitals), ambulatory 

physician visits (medical care, 

psychiatric care), ambulatory visits to 

other health care professionals, 

pharmacotherapies, and treatment 

costs for any harms 

Timing 

• Treatment studies: No minimum 

duration 

• Course of illness studies: 1-year 

minimum followup 

Settings 

• Inpatient, including hospitals and 

residential treatment centers 

• Outpatient, including schools and 

homes 

The relationship between the patient 

population, interventions, comparators, 

outcomes and timing of outcomes 

assessment (PICOTs) is depicted for 

each of the treatment KQs (Figure 1 in 

http://effectivehealthcare.ahrq.gov/

search-for-guides-reviews-and-reqorts/

?pageaction=displayproduct&productID

=1942#9028) and each of the course of 

illness KQs (Figure 2 in http://

effectivehealthcare.ahrq.gov/search-forguides-reviews-and-reports/?pageaction

=displayproduct&productID=

1942#9028). 

Dated: October 6, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–24507 Filed 10–15–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

[CFDA Number: 93.508] 

Announcing the Award of Four SingleSource Expansion Supplement Grants 

Under the Tribal Maternal, Infant, and 

Early Childhood Home Visiting 

(MIECHV) Program for the Tribal Early 

Learning Initiative 

AGENCY: Office of Child Care, ACF, 

HHS. 

ACTION: Notice of the award of four 

single-source program expansion 

supplement grants to Tribal Maternal, 

Infant, and Early Childhood Home 

Visiting (MIECHV) grantee participants 

in the Tribal Early Learning Initiative. 

SUMMARY: This announces the award of 

single-source program expansion 

supplement grants to the following 

Tribal Maternal, Infant, and Early 

Childhood Home Visiting (MIECHV) 

grantees to support their ongoing 

participation in the Tribal Early 

Learning Initiative, by the Office of 

Child Care, in the Administration for 

Children and Families (ACF): Choctaw 

Nation of Oklahoma in Durant, OK, 

Pueblo of San Felipe in San Felipe 

Pueblo, NM, Confederated Salish and 

Kootenai Tribes in Pablo, MT, and 

White Earth Band of Chippewa Indians 

in White Earth, MN. 

The program expansion supplement 

awards will support expanded efforts by 

the grantees to identify and analyze 

systems to improve their effectiveness 

and efficiency as models for use across 

early childhood programs; to share their 

action plans to improve outcomes; to 

continue the implementation of, and 

expand the development of, concrete 

community plans; and to develop peer 

learning relationships. 

DATES: The period of support is 

September 30, 2014–September 29, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Rudisill, Director, Office of 

Child Care, 901 D Street SW., 

Washington, DC 20447. Telephone: 


asabaliauskas on DSK5VPTVN1PROD with NOTICES