Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24957 

TABLE 3—COST TO THE FEDERAL GOVERNMENT—Continued 

Cost component Total cost Annualized 

cost 

Government Oversight ............................................................................................................................................. 13,710 4,570 

Total .................................................................................................................................................................. 499,877 166,626 

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 healthcare 

research and healthcare 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: April 19, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–10007 Filed 4–25–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘American Recovery and Reinvestment 

Act ‘‘Developing a Registry of 

Registries’’.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

This proposed information collection 

was previously published in the Federal 

Register on February 23, 2012 and 

allowed 60 days for public comment. No 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. 

DATES: Comments on this notice must be 

received by May 29, 2012. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

American Recovery and Reinvestment 

Act ‘‘Developing a Registry of 

Registries’’ 

The Food and Drug Administration 

Modernization Act of 1997, Public Law 

105–115, provided for the creation of a 

Clinical Trials Data Bank, known as 

ClinicalTrials.gov. Since its launch in 

2000, the ClinicalTrials.gov system has 

registered over 90,500 trials. The large 

volume of studies currently listed in 

ClinicalTrials.gov and the high usage 

numbers suggest that the system has 

been successful at improving access to 

information about clinical studies. 

However, while ClinicalTrials.gov 

supports the listing of observational 

studies, such listing is not required. 

Patient registries are a distinct type of 

observational study. Patient registries 

may be designed for many purposes, 

such as to observe the natural history of 

disease, examine comparative 

effectiveness, or fulfill post-approval 

commitments. Patient registries have 

specific characteristics that are not 

currently captured on 

ClinicalTrials.gov. To date, some 

registry sponsors have attempted to 

leverage the observational study model 

to post patient registry-type records on 

ClinicalTrials.gov. However, 

stakeholders have noted that the system 

does not fully meet their needs. 

Patient registries have received 

significant attention and funding in 

recent years. Similar to controlled 

interventional studies, patient registries 

represent some burden to patients (e.g., 

time to complete patient reported 

outcome measures, risk of loss of 

privacy), who often participate 

voluntarily in hopes of improving 

knowledge about a disease or condition. 

Patient registries also represent a 

substantial investment of health 

research resources. Despite these 

factors, registration of patient registries 

in ClinicalTrials.gov is not currently 

required, presenting the potential for 

duplication of efforts and insufficient 

dissemination of findings that are not 

published in the peer-reviewed 

literature. To ensure that resources are 

used in the most efficient manner, 

registries need to be listed in a manner 

similar to that of trials in 

ClinicalTrials.gov. 

By creating a central point of 

collection for information about all 

patient registries in the United States, 

the Registry of Patient Registries (RoPR) 

helps to further AHRQ’s goals by 

making information regarding quality, 

appropriateness, and effectiveness of 

health services (and patient registries in 

particular) more readily available and 

centralized. 

The primary goal of this project is to 

engage stakeholders in the design and 

development of a RoPR database system 

that is compatible with 

ClinicalTrials.gov and meets the 

following objectives: 

(1) Provides a searchable database of 

patient registries in the United States (to 

promote collaboration, reduce 

redundancy, and improve 

transparency); 

(2) Facilitates the use of common data 

fields and definitions in similar health 

conditions (to improve opportunities for 

sharing, comparing, and linkage); 

(3) Provides a public repository of 

searchable summary results (including 


tkelley on DSK3SPTVN1PROD with NOTICES
24958 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

results from registries that have not yet 

been published in the peer-reviewed 

literature); 

(4) Offers a search tool to locate 

existing data that researchers can 

request for use in new studies; and 

serves as a recruitment tool for 

researchers and patients interested in 

participating in patient registries. 

This study is being conducted by 

AHRQ through its contractor, the 

Outcome DEcIDE Center, pursuant to 

the American Recovery and 

Reinvestment Act, Public Law 111–5, 

and pursuant to AHRQ’s statutory 

authority to conduct and support 

research and disseminate information 

on health care and on systems for the 

delivery of such care, including 

activities with respect to the quality, 

effectiveness, efficiency, 

appropriateness and value of health care 

services and with respect to database 

development. 42 U.S.C. 299a(a)(1) and 

(8). 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented: 

(1) Collect information from registry 

holders, defining a patient registry 

profile via a web-based interface, to 

populate the RoPR database system. 

The purpose of the RoPR is to create 

a readily available public resource in 

the model of ClinicalTrials.gov to share 

information on existing patient 

registries to promote collaboration, 

reduce redundancy, and improve 

transparency in registry research. 

Patient registry research has become 

more prevalent and, based on 

stakeholder feedback, is not adequately 

served by ClinicalTrials.gov at present. 

The information being collected in the 

RoPR record will be visible to the public 

visiting the RoPR Web site and will be 

available for public use in this capacity. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden for the respondents’ 

time to participate in the RoPR. Because 

the RoPR is a voluntary system available 

to any entity conducting a patient 

registry, it is not possible to determine 

the number of potential respondents. 

We do know that over 3,800 newly 

registered records designated as 

‘‘observational studies’’ were entered 

into ClinicalTrials.gov in 2010. Only a 

subset of this number (which we will 

estimate at a maximum of 40%) would 

qualify as patient registries and would 

likely be registered in the RoPR. 

Therefore, we use 1,520 (3,800*0.40) in 

Exhibits 1 and 2 below as a very rough, 

but high, estimation of the potential 

number of respondents who will enter 

registries into the RoPR annually. The 

actual number of respondents will 

depend on a variety of factors and could 

vary widely. It should be remembered 

that mandates could evolve making 

registration in the RoPR mandatory. Our 

estimates therefore attempt to factor an 

upper threshold for volume. 

Each respondent will enter a new 

RoPR record only once and is estimated 

to take 45 minutes. An estimated 50% 

(760 records) of RoPR records will be 

updated once a year and will take about 

15 minutes. This estimate is based on a 

query of ClinicalTrials.gov which 

showed that about 50% of observational 

studies registered in ClinicalTrials.gov 

had been updated in the past year. The 

total respondent burden is estimated to 

be 1,330 hours annually. 

Exhibit 2 shows the estimated cost 

burden associated with the respondent’s 

time to participate in the RoPR. The 

total cost burden is estimated to be 

$45,579 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

New RoPR Record .......................................................................................... 1,520 1 45/60 1,140 

Review/update RoPR Record .......................................................................... 760 1 15/60 190 

Total .......................................................................................................... 2,280 na na 1,330 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form Name Number of 

espondents 

Total burden 

hours 

Average 

hourly rate + 

Total cost 

burden 

New RoPR Record .......................................................................................... 1,520 1,140 $34.27 $39,068 

Review/update RoPR Record .......................................................................... 760 190 34.27 6,511 

Total .......................................................................................................... 2,280 1,330 na $45,579 

+ Based upon the mean average wage for Healthcare Practitioners and Technical Occupations, May 2010 National Occupational Employment 

and Wage Estimates, U.S. Department of Labor, Bureau of Labor Statistics. Available at: http://www.bls.gov/oes/current/oes_nat.htm#29–0000. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost to the government 

to create and maintain the RoPR for 3 

years. The total cost is estimated to be 

$3,184,333. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $2,318,509 $772,836 

Project Management ................................................................................................................................................ 409,149 136,383 

Overhead ................................................................................................................................................................. 456,675 152,225 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24959 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost Annualized 

cost 

Total .................................................................................................................................................................. 3,184,333 1,061,444 

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 healthcare 

research and healthcare 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: April 19, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–10009 Filed 4–25–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Local Therapies for Unresectable 

Primary 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 

manufacturers of local, minimally 

invasive, medical devices for 

unresectable primary hepatocellular 

carcinoma (e.g., ablation, radiotherapy, 

or embolization devices). Scientific 

information is being solicited to inform 

our Comparative Effectiveness Review 

of Local Therapies for Unresectable 

Primary 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 this device will improve 

the quality of this comparative 

effectiveness review. AHRQ is 

requesting this scientific information 

and conducting this comparative 

effectiveness review pursuant to Section 

1013 of the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173. 

DATES: Submission Deadline on or 

before May 29, 2012. 

ADDRESSES: 

Online submissions: http://effective

healthcare.AHRQ.gov/index.cfm/submit

scientific-information-packets/. Please 

select the study for which you are 

submitting information from the list of 

current studies and complete the form 

to upload your documents. 

Email submissions: ehcsrc@ohsu.edu 

(please do not send zipped files—they 

are automatically deleted for security 

reasons). 

Print submissions: Robin Paynter, 

Oregon Health and Science University, 

Oregon Evidence-based Practice Center, 

3181 SW Sam Jackson Park Road, Mail 

Code: BICC, Portland, OR 97239–3098. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Research Librarian, 

Telephone: 503–494–0147 or Email: 

ehcsrc@ohsu.edu. 

SUPPLEMENTARY INFORMATION: 

In accordance with Section 1013 of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, the Agency 

for Healthcare Research and Quality has 

commissioned the Effective Health Care 

(EHC) Program Evidence-based Practice 

Centers to complete a comparative 

effectiveness review of the evidence for 

local therapies for unresectable primary 

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 systematically requesting 

information (e.g., details of studies 

conducted) from medical device 

industry stakeholders through public 

information requests, including via the 

Federal Register and direct postal and/ 

or online solicitations. We are looking 

for studies that report on local therapies 

for unresectable primary hepatocellular 

carcinoma, including those that describe 

adverse events, as specified in the key 

questions detailed below. The entire 

research protocol, including the key 

questions, is also available online at: 

http://www.effective

healthcare.AHRQ.gov/index.cfm/

search-for-quides-reviews-and-reports/

?productid=1012&pageaction=display

product#5056. 

This notice is a request for industry 

stakeholders to submit the following: 

• A current product label, if 

applicable (preferably an electronic PDF 

file). 

• Information identifying published 

randomized controlled trials and 

observational studies relevant to the 

clinical outcomes. Please provide both a 

list of citations and reprints if possible. 

• Information identifying 

unpublished randomized controlled 

trials and observational studies relevant 

to the clinical outcomes. If possible, 

please provide a summary that includes 

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 withdrawn/follow-up/ 

analyzed, and effectiveness/efficacy and 

safety results. 

• Registered ClinicalTrials.gov 

studies. Please provide a list including 

the ClinicalTrials.gov identifier, 

condition, and intervention. 

Your contribution is very beneficial to 

this program. AHRQ is not requesting 

and will not consider marketing 

material, health economics information, 

or information on other indications. 

This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. In addition to your scientific 

information please submit an index 

document outlining the relevant 

information in each file along with a 

statement regarding whether or not the 

submission comprises all of the 

complete information available. 


tkelley on DSK3SPTVN1PROD with NOTICES