49520 Federal Register / Vol. 78, No. 157 / Wednesday, August 14, 2013 / Notices 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name 

Number of 

respondents/ 

POCs 

Total burden 

hours 

Average 

hourly wage 

rate *

Total cost 

burden 

Registration Form ............................................................................................ 80 7 a 47.34 $331 

Health Plan Information Form ......................................................................... 80 160 a 47.34 7,574 

Data Use Agreement ....................................................................................... 60 3 b 85.02 255 

Data Files Submission ..................................................................................... 80 320 c 37.63 12,042 

Total .......................................................................................................... 300 490 NA 20,202 

* National Compensation Survey: Occupational wages in the United States May 2012, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ a Based on the mean hourly wage for Medical and Health Services Managers (11–9111). b Based on the mean hourly wage for Chief Executives (11–1011). c Based on the mean hourly wages for Computer Programmer (15–1131). 

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: August 8, 2013. 

Carolyn M. Clancy, 

AHRQ Director. 

[FR Doc. 2013–19712 Filed 8–13–13; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Imaging Techniques for the 

Surveillance, Diagnosis, and Staging 

of Hepatocellular Carcinoma 

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 on imaging techniques for the 

surveillance, diagnosis, and staging of 

hepatocellular carcinoma. Scientific 

information is being solicited to inform 

our review of Imaging Techniques for 

the Surveillance, Diagnosis, and Staging 

of Hepatocellular Carcinoma, 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 on 

imaging techniques for the surveillance, 

diagnosis, and staging of hepatocellular 

carcinoma will improve the quality of 

this review. AHRQ is conducting this 

comparative effectiveness 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 September 13, 2013. 

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: 

Robin Paynter, Research Librarian, 

Telephone: 503–220–8262 ext. 58652 or 

Email: SIPS@epc-src.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 Imaging 

Techniques for the Surveillance, 

Diagnosis, and Staging of 

Hepatocellular Carcinoma. 

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 imaging techniques for 

the surveillance, diagnosis, and staging 

of hepatocellular carcinoma, including 

those that describe adverse events. The 

entire research protocol, including the 

key questions, is also available online 

at: http://www.effectivehealthcare.

AHRQ.gov/search-for-guides-reviewsand-reports/?pageaction

=displayproduct&productID=1600#7839 

This notice is to notify the public that 

the EHC program would find the 

following information on imaging 

techniques for the surveillance, 

diagnosis, and staging of hepatocellular 

carcinoma helpful: 

D A list of completed studies your 

company has sponsored for this 

indication. In the list, indicate whether 

results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

D For completed studies that do not 

have results on ClinicalTrials.gov, 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 


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Federal Register / Vol. 78, No. 157 / Wednesday, August 14, 2013 / Notices 49521 

to follow-up/withdrawn/analyzed, 

effectiveness/efficacy, and safety results. 

D A list of ongoing studies your 

company 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. 

D Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

company for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution is very beneficial to 

the 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 Effective Health 

Care 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://www.effective

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

=displayproduct&productID=1600#7839 

Key Question 1 

What is the comparative effectiveness 

of available imaging-based surveillance 

strategies (listed below under 

interventions for KQ 1), used singly or 

in sequence for detecting hepatocellular 

carcinoma (HCC) among individuals 

undergoing surveillance for HCC 

(individuals at high risk for HCC and 

individuals who have undergone liver 

transplants for HCC)? 

a. What is the comparative test 

performance of imaging-based 

surveillance strategies for detecting 

HCC? 

i. How is a particular technique’s test 

performance modified by use of various 

reference standards (e.g., explanted liver 

samples, histological diagnosis, or 

clinical and imaging followup)? 

ii. How is the comparative 

effectiveness modified by patient-level 

characteristics (e.g., body mass index, 

number of lesions, tumor diameter, or 

cause of liver disease) or other factors 

(e.g., technical aspects of imaging 

techniques, biomarker levels, test 

operator or interpreter skill, setting)? 

b. What is the comparative 

effectiveness of imaging-based 

surveillance strategies on intermediate 

outcomes like diagnostic thinking? 

c. What is the comparative 

effectiveness of imaging-based 

surveillance strategies on clinical and 

patient-centered outcomes? 

d. What are the adverse effects or 

harms associated with imaging-based 

surveillance strategies? 

Key Question 2 

What is the comparative effectiveness 

of imaging techniques (listed under the 

interventions for KQ 2), used singly, in 

combination, or in sequence in 

diagnosing HCC among individuals in 

whom an abnormal lesion has been 

detected while undergoing surveillance 

for HCC (individuals at high risk for 

HCC and individuals who have 

undergone liver transplants for HCC) or 

through the evolution of symptoms and 

abdominal imaging done for other 

indications? 

a. What is the comparative test 

performance of imaging techniques for 

diagnosing HCC? 

i. How is a particular technique’s test 

performance modified by use of various 

reference standards (e.g., explanted liver 

samples, histological diagnosis, or 

clinical and imaging followup)? 

ii. How is the comparative 

effectiveness modified by patient-level 

characteristics (e.g., body mass index, 

number of lesions, tumor diameter, or 

cause of liver disease) or other factors 

(e.g., technical aspects of imaging 

techniques, biomarker levels, test 

operator or interpreter skill, setting)? 

b. What is the comparative 

effectiveness of the various imaging 

techniques on intermediate outcomes 

like diagnostic thinking and use of 

additional diagnostic procedures such 

as fine-needle or core biopsy? 

c. What is the comparative 

effectiveness of the various imaging 

techniques on clinical and patientcentered outcomes? 

d. What are the adverse effects or 

harms (related to testing or a testassociated diagnostic workup) 

associated with the various imaging 

techniques? 

Key Question 3 

What is the comparative effectiveness 

of imaging techniques (listed under the 

interventions for KQ 3), used singly, in 

combination, or in sequence in staging 

HCC among patients diagnosed with 

HCC? 

a. What is the comparative test 

performance of imaging techniques to 

predict HCC tumor stage? 

i. How is a particular technique’s test 

performance modified by use of various 

reference standards (e.g., explanted liver 

samples, histological diagnosis, or 

clinical and imaging followup)? 

ii. How is the comparative 

effectiveness modified by patient-level 

characteristics (e.g., body mass index, 

number of lesions, tumor diameter, or 

cause of liver disease) or other factors 

(e.g., technical aspects of imaging 

techniques, biomarker levels, test 

operator or interpreter skill, setting)? 

b. What is the comparative test 

performance of imaging techniques on 

diagnostic thinking? 

c. What is the comparative 

effectiveness of imaging techniques on 

clinical and patient-centered outcomes? 

d. What are the adverse effects or 

harms associated with using imaging 

techniques related to testing or testassociated diagnostic workup? 

PICOTS (Population(s), Interventions, 

Comparators, Outcomes, Timing, 

Settings) by Key Question 

Population(s) 

• Key Question 1. 

• Patients at high risk for HCC 

undergoing surveillance. The 

population of high-risk patients is 

defined, as per the AASLD clinical 

guidelines, as composed of the 

following: Asian male HBV carriers 

over age 40, Asian female HBV 

carriers over age 50, HBV carriers 

with a family history of HCC, 

African/North American black HBV 

carriers, all individuals with 

cirrhosis (including alcoholic 

cirrhosis), HBV or HCV carriers 

with cirrhosis, and patients with 

stage 4 primary biliary cirrhosis.6 

Other definitions of high-risk 

patients as defined by the primary 

studies will be accepted. 

• Patients who have undergone liver 

transplants for HCC, either with or 

without HCC detected in the 

explanted liver. 

• Both population groups will be 

considered separately. 

• Key Question 2. 

• Patients at high risk for HCC in 


tkelley on DSK3SPTVN1PROD with NOTICES
49522 Federal Register / Vol. 78, No. 157 / Wednesday, August 14, 2013 / Notices 

whom a suspicious lesion(s) has 

been detected by surveillance or by 

other means. 

• Patients who have undergone liver 

transplants for HCC, either with or 

without HCC detected in the 

explanted liver. 

• Both population groups will be 

considered separately. 

• Key Question 3 

• Patients diagnosed with HCC who 

require staging before initial 

treatment. 

• All Key Questions 

• Patients with cholangiocarcinoma 

will be excluded. 

Interventions 

• Key Question 1 

• US, spiral CT, multidetector CT 

(MDCT), dual energy CT, or MRI. 

• Studies that included surveillance 

strategies of any other imaging test 

with or without additional 

biomarkers would also be included. 

The strategies could include the 

techniques being used singly or in 

a specific sequence. 

• Key Question 2 

• Imaging techniques, used singly, in 

combination, or in a specific 

sequence, including US, spiral CT, 

MDCT, dual energy CT, MRI 

(including contrast agents like GdEOB–DTPA and SPIO), or 

fluorodeoxyglucose positron 

emission tomography (FDG–PET) 

with different tracers (including 

18F, fluorothymidine [FLT], 11Ccholine, and 11C = methionine, or 

others). 

• Key Question 3 

• Imaging techniques, used singly, in 

combination, or in a specific 

sequence, including US, spiral CT, 

MDCT, dual energy CT, MRI with 

contrast (including contrast agents 

such as Gd-EOB–DTPA and SPIO), 

FDG–PET with different tracers 

(including 18F, FLT, 11C-choline, 

and 11C-methionine, or others), or 

contrast CT. 

• Test performance of imaging 

techniques will be stratified by the 

different staging systems used. 

• All Key Questions 

• Outdated imaging techniques (e.g., 

conventional, nonspiral/ 

nonmultidetector CT, or imaging 

techniques used before 1995) will 

be excluded. 

• Imaging techniques not available or 

in use in the United States (e.g., 

hepatic portography) will be 

excluded. 

Comparators 

• For studies of diagnostic accuracy 

(comparative test performance), the 

reference standard comparators will be 

histopathology (based on explanted 

liver specimens or biopsy) or clinical 

and imaging followup, and the imaging 

comparators will be alternative imaging 

tests or strategies. 

• For studies of comparative 

effectiveness, the comparators will be 

no imaging or alternative imaging 

strategies. 

Outcomes for Each Key Question 

Key Question 1 

• Diagnostic outcomes include: 

• Detection rates of HCC lesions. 

• Types of HCC lesions detected. 

• Test performance (e.g., sensitivity 

and specificity, predictive values, 

likelihood ratios, area under the 

receiver operating curve, or others) 

for diagnosing HCC, including 

stage-specific accuracy. 

• For all KQs, potential modifiers of 

measures of test performance will 

be evaluated, including the 

reference standards used (e.g., 

explanted liver samples, 

histological diagnosis, or clinical 

and imaging followup), patient and 

tumor-level characteristics (e.g., 

body mass index, number of 

lesions, tumor diameter, or cause of 

liver disease), or other factors (e.g., 

technical aspects of the imaging 

techniques, biomarker levels, test 

operator or interpreter skill, 

setting). 

• Intermediate outcomes include: 

• Effects on diagnostic thinking. 

• Effects on clinical decisionmaking. 

• Clinical and patient-centered 

outcomes include: 

• Overall mortality or survival. 

• Recurrence of HCC, including rates 

of seeding by fine-needle aspiration. 

• Quality of life as measured with 

scales such as the Short-Form 

Health Survey (SF–36) or EuroQol 

5D (EQ–5TM) or as defined by the 

primary studies. 

• Psychosocial effects of diagnostic 

testing on patients, patients’ 

caregivers, and other family 

members, as measured by selfreported questionnaire instruments. 

• Resource utilization and patient 

burden (e.g., costs associated with 

the imaging procedure, access to the 

imaging facility, the number of 

imaging procedures, and other 

procedures conducted). 

Key Question 2 

• Diagnostic outcomes include: 

• Type of HCC lesions detected. 

• Test performance (e.g., sensitivity 

and specificity, predictive values, 

likelihood ratios, area under the 

receiver operating curve, or others) 

for diagnosing HCC. As in KQ 1, 

potential modifiers of measures of 

test performance will be evaluated, 

including the reference standards 

used (e.g., explanted liver samples, 

histological diagnosis, or clinical 

and imaging followup), patient and 

tumor-level characteristics (e.g., 

body mass index, number of 

lesions, tumor diameter, or cause of 

liver disease), or other factors (e.g., 

technical aspects of the imaging 

techniques, biomarker levels, test 

operator or interpreter skill, 

setting). 

• Intermediate outcomes include: 

• Effects on diagnostic thinking. 

• Effects on clinical decisionmaking. 

• Clinical and patient centered 

outcomes include: 

• Overall mortality or survival. 

• Recurrence of HCC, including rates 

of seeding by fine-needle aspiration 

• Quality of life as measured with 

scales such as the Short-Form 

Health Survey (SF–36) or EuroQol 

5D (EQ–5TM) or as defined by the 

primary studies. 

• Psychosocial effects of diagnostic 

testing on patients, patients’ 

caregivers, and other family 

members, as measured by selfreported questionnaire instruments. 

• Resource utilization and patient 

burden (e.g., costs associated with 

the imaging procedure, access to the 

imaging facility, the number of 

imaging procedures and other 

procedures conducted). 

Key Question 3 

• Diagnostic outcomes include: 

• Measures for stage-specific accuracy 

of imaging (e.g., Obuchowski 

method for calculating the area 

under the receiver operating curve, 

stage reclassification rates). 

• Intermediate outcomes include: 

• Effects on diagnostic thinking. 

• Effects on clinical decisionmaking. 

• Clinical and patient-centered 

outcomes include: 

• Overall mortality or survival. 

• Recurrence of HCC, including rates 

of seeding by fine-needle aspiration 

• Quality of life as measured with 

scales such as the Short-Form 

Health Survey (SF–36) or EuroQol 

5D (EQ–5TM) or as defined in the 

primary studies. 

• Psychosocial effects of diagnostic 

testing on patients, patients’ 

caregivers, and other family 

members as measured by selfreported questionnaire instruments. 

• Resource utilization and patient 

burden (e.g., costs associated with 

the imaging procedure, access to the 

imaging facility, the number of 

imaging procedures and additional 

procedures conducted). 


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Federal Register / Vol. 78, No. 157 / Wednesday, August 14, 2013 / Notices 49523 

Key Questions 1d, 2d, and 3d (Adverse 

Events or Harms) 

• Adverse effects or harms associated 

with the imaging techniques (e.g., 

test-related anxiety, adverse events 

secondary to venipuncture, contrast 

allergy, exposure to radiation). 

• Adverse effects or harms associated 

with test-associated diagnostic 

workup (e.g., harms of biopsy or 

harms associated with workup of 

other incidental tumors discovered 

on imaging). 

Timing 

• No restrictions will be placed on 

timing. 

• For studies of comparative 

effectiveness, duration of followup, 

timing of interventions, and frequency 

of interventions will be recorded. 

Settings 

• All relevant care settings (e.g., 

primary and secondary care). 

Dated: August 6, 2013. 

Carolyn M. Clancy, 

AHRQ Director. 

[FR Doc. 2013–19714 Filed 8–13–13; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30-Day-13–0743] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–7570 or send an 

email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Assessment and Monitoring of 

Breastfeeding-Related Maternity Care 

Practices in Intra-partum Care Facilities 

in the United States and Territories 

(OMB No. 0920–0743, exp. 12/31/ 

2011)—Reinstatement with Changes— 

National Center for Chronic Disease 

Prevention and Health Promotion 

(NCCDPHP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Health professionals recommend at 

least 12 months of breastfeeding, and 

Healthy People 2020 establishes specific 

national breastfeeding goals. In addition 

to increasing overall rates, a significant 

public health priority in the United 

States (U.S.) is to reduce variation in 

breastfeeding rates across population 

subgroups. Because hospital practices 

strongly influence infant feeding 

outcomes, the health care system is one 

of the most important and effective 

settings for improving breastfeeding 

initiation rates. 

In 2007, CDC conducted the first 

national survey of Maternity Practices in 

Infant Nutrition and Care, known as the 

mPINC Survey. The survey inquired 

about care practices and support for 

breastfeeding throughout the maternity 

stay as well as staff training and 

maternity care practices. Following the 

collection of baseline information in 

2007, the mPINC survey was conducted 

again in 2009 and 2011. 

CDC proposes to repeat the mPINC in 

2013 and 2015, with changes. In 

previous cycles of data collection, two 

versions of the mPINC survey 

instrument were used: one for hospitals 

and one for birth centers. In 2013 and 

2015, one instrument will be used for 

both hospitals and birth centers. There 

are no changes to survey content, other 

than the minor changes needed to 

produce a single streamlined instrument 

for all facilities. There is no change to 

the estimated burden per response (30 

minutes). Similarly, in 2013 and 2015 

screening for eligible facilities will be 

conducted with a single screening 

instrument. 

Facilities will identified by using 

information obtained through the 

American Association of Birth Centers 

(AABC) and the American Hospital 

Association (AHA) Annual Survey of 

Hospitals. Facilities that will be invited 

to participate in the survey include 

those that participated in previous 

iterations and those that were invited 

but did not participate in the previous 

iterations, as well as those that have 

become eligible since the most recent 

mPINC survey. All birth centers and 

hospitals with ≥1 registered maternity 

bed will be screened for eligibility via 

a brief phone call to assess their 

eligibility, identify additional locations, 

and identify the appropriate point of 

contact. 

As with the initial surveys, a major 

goal of the 2013 and 2015 follow-up 

surveys is to be fully responsive to 

facilities’ needs for information and 

technical assistance. CDC will provide 

direct feedback to respondents in a 

customized benchmark report of their 

results and identify and document 

progress since 2007 on their quality 

improvement efforts. CDC will use 

information from the mPINC surveys to 

identify, document, and share 

information related to incremental 

changes in practices and care processes 

over time at the hospital, state, and 

national levels. Data will be also used 

by researchers to better understand the 

relationships between hospital 

characteristics, maternity-care practices, 

state level factors, and breastfeeding 

initiation and continuation rates. 

OMB approval is requested for three 

years. On an annualized basis, CDC 

estimates initial contact with 2,570 

facilities that will complete Part A of the 

Screening Telephone Call, and 2,200 

respondents that will also complete Part 

B of the Screening Telephone Call. CDC 

estimates receipt of completed surveys 

from 1,825 facilities. 

Participation in the survey is 

voluntary, and responses may be 

submitted by mail or through a Webbased system. There are no costs to 

respondents other than their time. The 

total estimated annualized burden hours 

are 1,103. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Maternity facility ................................. Screening telephone call script ......... Part A .......... 2,570 1 1/60 

Part B .......... 2,200 1 4/60 

mPINC Facility Survey 1,825 1 30/60 


tkelley on DSK3SPTVN1PROD with NOTICES