### 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—E STIMATED 

### R ESPONDENT 

### B URDEN

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—E STIMATED 

### COST 

### B URDEN

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 Ass istants (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 currentlybeing 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


### 62157 Federal Register / Vol. 79, No. 200 / Thursday, October 16, 2014 / Notices

1 Bariatric 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).

2 Children, 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 orcombinations of treatments for loss-ofcontrol eating among bariatric surgery patients?

KQ 7: What is the evidence for harmsassociated 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 orcombinations 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 reuptakeinhibitors (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)


### 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 Single Source 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: