3598 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 

referred for surgical intervention, what 

is the comparative effectiveness 

(benefits/harms) of various types of 

surgical interventions (including laser 

and resection)? 

PICOTS (Population, Intervention, 

Comparator, Outcomes, Timing, 

Setting) 

KQ 1 

Population 

Newborns, infants, and children up to 

18 years of age with known or suspected 

infantile hemangiomas. 

Intervention(s) 

Diagnostic imaging: 

• Magnetic resonance imaging 

• Computed tomography 

• Magnetic resonance angiography 

• Echocardiography 

• Ultrasonography 

• Endoscopy 

Comparator 

• Other workup evaluation approaches 

for treatment planning 

• Other imaging modalities 

Outcomes 

• Ability to identify presence, number, 

and extent of hemangiomas and 

associated structural anomalies 

(sensitivity and specificity) 

• Harms including, but not limited to, 

effects of sedation or imaging dye 

Timing 

• Immediate and short-term (≤3 

months) 

• Long-term (>3 months) 

Setting 

Inpatient and outpatient settings (e.g., 

pediatric radiology clinic, 

otolaryngology clinics, dermatology 

clinics, pediatric surgical unit) 

KQs 2, 3, and 4 

Population 

Newborns, infants, and children up to 

18 years of age with infantile 

hemangiomas. 

Intervention(s) 

KQ2 Pharmacologic interventions 

• Systemic (e.g., propranolol) or topical 

(e.g., timolol) beta-blockers 

• Corticosteroids (topical, intralesional, 

or systemic) 

KQ3 Pharmacologic interventions 

• Immunosuppressants (e.g., sirolimus) 

• Immunomodulators (e.g., imiquimod, 

interferon) 

• Antineoplastics (e.g., intralesional 

bleomycin, intravenous vincristine) 

• Angiotensin-converting enzyme 

inhibitors 

• Antiangiogenic agents 

KQ4 Surgical interventions 

Laser treatment 

• Pulsed dye 

• Fractionated laser 

• Argon 

• Carbon dioxide 

• Neodymium (Nd): Yttrium 

Aluminium Garnet YAG 

• Erbium 

Surgical treatment 

• Cryotherapy 

• Resection 

• Embolization 

• Radiofrequency ablation therapy 

Comparator 

KQ2, 3 

• No treatment 

• Other pharmacologic interventions 

• Observation 

• Complementary and alternative 

medicine (CAM) (e.g., massage, 

compression therapy, essential oils) 

KQ4 

• No treatment 

• Other laser or surgical interventions 

• Observation 

• CAM (e.g., massage, compression 

therapy, essential oils) 

Outcomes 

Intermediate outcomes (KQ2, 3, 4) 

• Size/volume of hemangioma 

• Impact on vision 

• Aesthetic appearance as assessed by 

clinician or parent 

• Degree of ulceration 

• Harms 

• Quality of life 

Final outcomes (KQ2, 3, 4) 

• Marked improvement of 

hemangiomas 

• Prevention of disfigurement 

• Resolution of airway obstruction 

• Preservation of vision 

• Preservation of organ function (e.g., 

thyroid function, cardiac function) 

• Resolution of ulceration 

• Psychological impact on the patient 

• Harms including: pain, bleeding, 

sequelae of scarring, skin atrophy, 

venous prominence, disfigurement, 

distortion of anatomic landmarks, 

ulceration, infection, 

hypopigmentation 

Timing 

KQ2, 3 

• Immediate and short-term (≤2 years 

of age) 

• Long-term (>2 years of age) 

KQ4 

• Immediate and short-term (≤3 

months) 

• Long-term (>3 months) 

Setting 

Inpatient and outpatient settings (e.g., 

pediatric radiology clinic, 

otolaryngology clinics, dermatology 

clinics, pediatric surgical unit) 

Dated: December 30, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2015–00766 Filed 1–22–15; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–15LB] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC), as part of its 

continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. To request more 

information on the below proposed 

project or to obtain a copy of the 

information collection plan and 

instruments, call 404–639–7570 or send 

comments to Leroy A. Richardson, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

Comments submitted in response to 

this notice will be summarized and/or 

included in the request for Office of 

Management and Budget (OMB) 

approval. Comments are invited on: 

(a) Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 3599 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Enhancing Dialogue and Execution of 

Dust Reduction Behaviors through 

Workgroup Communication—New— 

National Institute for Occupational 

Safety and Health (NIOSH), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

NIOSH, under Public Law 91–596, 

Sections 20 and 22 (Section 20–22, 

Occupational Safety and Health Act of 

1977) has the responsibility to conduct 

research relating to innovative methods, 

techniques, and approaches dealing 

with occupational safety and health 

problems. 

This project focuses on mineworkers’ 

overexposure to respirable coal dust and 

how using the Continuous Personal 

Dust Monitor (CPDM), as an educational 

tool, can help provide information to 

mineworkers and their respective 

workgroups, about ways to reduce 

respirable coal dust exposure in their 

work environment. NIOSH proposes a 3 

year approval for a project that seeks to 

understand what group communication 

practices are important for mine worker 

H&S and how those practices can be 

developed, implemented, and 

maintained over time. The following 

questions guide this study: 

What impact does a communication/ 

technology intervention model that was 

designed and implemented have on: 

(1) Workers’ health/safety behaviors, 

including those that lower exposure to 

dust; and (2) workers’ perceptions of 

their organizations’ health and safety 

values? 

To answer the above questions, 

NIOSH researchers developed an 

intervention that focuses on workers’ 

communication about and subsequent 

actions taken to reduce respirable dust 

exposure over time, using information 

provided by their Continuous Personal 

Dust Monitor (CPDM). The intervention 

will inform how workgroups 

communicate with each other about 

health and how this communication 

impacts individual behavior such as 

corrective dust actions taken by 

workers. 

Coal Workers’ Pneumoconiosis (CWP) 

or ‘‘Black Lung Disease’’ is caused by 

miners’ exposure to respirable coal mine 

dust and is the leading cause of death 

due to occupational illness among US 

coal miners—making this an issue 

worth placing emphasis in mine health 

research. X-rays provided from the US 

National Coal Workers’ X-ray 

Surveillance Program show that new 

cases of CWP are occurring among 

miners who have worked exclusively 

under previous respirable coal mine 

dust exposure limits. Previously, federal 

law stated that respirable coal dust 

levels must not exceed 2 mg/m3 for any 

work shift [Code of Federal 

Regulations]. However, under the new 

respirable dust rule that passed May 1, 

2014 (CFR part 70), the dust level may 

not exceed 1.5 mg/m3. The new rule 

also requires mine operators to use 

CPDMs by February 1, 2016, for 

designated occupations (DO). Although 

CPDMs provide miners with near realtime feedback about their level of 

respirable coal dust exposure, they do 

not ensure that miners will use the 

information to reduce their level of 

exposure. Previous research indicates 

that the use of information technology 

can enhance lateral and horizontal 

communication within organizations, 

showing support for using the CPDM in 

the current study (Hinds & Kiesler, 

1995). 

The intervention is designed to 

involve workers in the interpretation of 

CPDM feedback and discuss, with their 

coworkers/workgroups, potential 

changes to work practices that can 

decrease exposure to respirable coal 

mine dust. Data is collected during three 

time points throughout a six-week 

intervention to assess the ongoing 

communication using CPDM feedback 

and effects of the workgroup 

communication on behavior. Data 

collection and analysis will occur via a 

pre/post survey with workers and focus 

groups with workers and mine site 

leaders. Safety circles are used to 

communicate and encourage specific 

behavior changes. A typical circle 

includes a facilitator or leader (who 

directs the meetings), 7–10 members, 

and one-hour weekly meetings that take 

place during the workday. During the 

meetings, members review data relevant 

to the problem and brainstorm possible 

solutions. Industries have successfully 

used ‘‘safety circles’’ to generate lists of 

safety concerns that circle members 

would like to analyze and solve. 

Edwards [1983] documented that one 

surface coal mine was able to decrease 

the number of accidents on circle 

members’ shifts by 27%. If underground 

coal miners are able to actively 

participate in the discussion of 

respirable coal mine dust exposure 

levels and what can be done to limit 

future exposure, they may be more 

inclined to behave in ways that limit 

their exposure. 

With the stricter regulations that just 

passed the opportunity to proactively 

improve communication around the 

CPDM and identify appropriate 

corrective actions, as required by the 

Mine Health and Safety Administration, 

is favorable. NIOSH proposes this 

intervention design at three coal mine 

sites. Coal mine sites will be recruited 

who have inquired interest in learning 

how to improve utility of the CPDM on 

their site and/or interest in improving 

their employees’ communication efforts. 

Only a small sample of workers will 

participate at each mine site because of 

the time required for completion and to 

ensure the longitudinal data can be 

adequately collected over the six weeks. 

In other words, we would rather collect 

data multiple times with the same 

worker and have fewer participants than 

collect data from more workers but not 

have the ability to appropriately followup during the subsequent two visits. 

Data collection will take place with 

no more than 150 mine workers and 

nine mine site leaders over three years. 

The respondents targeted for this study 

include any active mine worker and any 

active site leader at a coal mine site. It 

is estimated that a sample of up to 150 

mine workers will participate, which 

includes participating in three focus 

groups (in the form of workgroup 

meetings) that will take approximately 

60 minutes. The focus groups will 

debrief general CPDM data so 

participants can dialogue about ways to 

lower their exposure levels. In addition, 

workers will be asked to complete a pre 

and post-test survey (∼15 minutes). It 

also is estimated that a sample of up to 

nine mine site leaders will participate in 

the form of interviews/focus groups 

about HSMS practices at the same 

mining operations which have agreed to 

participate. The interviews/focus groups 

also will occur three times during each 

of the NIOSH field visits and will take 

no more than 30 minutes each. 

All participants will be between the 

ages of 18 and 75, currently employed, 

and living in the United States. 

Participation will require no more than 

3.5 hours of workers’ time over the sixweek intervention and no more than 1.5 

hours of site leaders’ time over the sixweek intervention period. 

There is no cost to respondents other 

than their time. 


tkelley on DSK3SPTVN1PROD with NOTICES
3600 Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Mine Site Leaders/Managers.Mine Recruitment Script ...................................... 3 1 5/60 1 

Initial/Mid/Post HSMS interview or focus group .. 3 3 30/60 5 

Mine Worker .................. Individual Miner Recruitment Script .................... 50 1 5/60 4 

Pre/Post Org Perceptions Survey ....................... 50 2 15/60 25 

Pre/Mid/Post Behavior Focus Groups ................. 50 3 1 150 

Total ........................ .............................................................................. ........................ ........................ ........................ 185 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–01094 Filed 1–22–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–15ZK] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC), as part of its 

continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. To request more 

information on the below proposed 

project or to obtain a copy of the 

information collection plan and 

instruments, call 404–639–7570 or send 

comments to Leroy A. Richardson, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

Comments submitted in response to 

this notice will be summarized and/or 

included in the request for Office of 

Management and Budget (OMB) 

approval. Comments are invited on: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Research on the Efficacy and 

Feasibility of Essentials for Parenting 

Toddlers and Preschoolers—New— 

National Center for Injury Prevention 

and Control (NCIPC), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

It is estimated that 1 in 58 U.S. 

children had been maltreated in a 1-year 

period (i.e., victims of physical, sexual, 

and emotional abuse or neglect). Parent 

training is arguably the single most 

effective prevention initiative 

recognized to date. The Centers for 

Disease Control and Prevention has 

developed ‘‘Essentials for Parenting 

Toddlers and Preschoolers’’ (EFP). This 

web-based resource uses a 

psychoeducational approach 

incorporating modeling (through its 

videos) and practice (through its 

activities). Thus, EFP is likely to 

improve parenting (e.g., discipline 

practices), reduce child behavior 

problems, and may ultimately reduce 

child maltreatment. Moreover, it is free 

for parents and can be accessed through 

any device that can use the Internet, 

including computers, tablets, and smart 

phones. If it proves to be effective, it 

may ultimately be less expensive to 

develop, evaluate, and disseminate EFP. 

CDC is proposing an information 

collection to OMB for a period of one 

year. The purpose of this data collection 

request is to determine whether a webbased platform for delivery of positive 

parenting information yields changes in 

parent and child behaviors that are 

consistent with those observed in the 

clinic setting. If EFP is successful at 

increasing positive parenting and safe, 

stable, nurturing relationships and 

environments for children, then CDC 

has a resource that can be easily and 

freely disseminated to communities that 

can potentially impact rates of child 

maltreatment. 

We will conduct a two-arm study of 

200 parents of 2- to 4-year-old children. 

In one arm, parents will be guided in 

how and when they use specific 

intervention modules. In the other arm, 

parents will have access to the same 

EFP content but will use as much or as 

little of the intervention as they wish 

and on whatever time line they wish. 

Parents in both arms will complete 

assessments of child externalizing 

behavior, parenting behaviors (e.g., use 

of praise and time outs), parenting 

thoughts (e.g., perceived parenting 

competence and burden), and parent 

psychological adjustment (e.g., 

depression and anxiety), as well as 

knowledge and perceived usefulness of 

EFP intervention content. The impact of 

this data collection on participants’ 

privacy is low. 

The survey data will be housed in a 

database on encrypted, password 

protected electronic storage files. All 

information shared will be in an 

aggregate form for the scientific 


tkelley on DSK3SPTVN1PROD with NOTICES