[Federal Register Volume 77, Number 133 (Wednesday, July 11, 2012)]
[Pages 40885-40887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16849]



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 23rd, 2012 and allowed 60 days for 
public comment. Several 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 August 10, 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 [email protected] (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.

Clearance Officer, (301) 427-1477, or by email at 
[email protected].


Proposed Project

American Recovery and Reinvestment Act ``Developing a Registry of 

    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

[[Page 40886]]

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 
    (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 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 
    This study is being conducted by AHRQ through its contractor, the 
Outcome DEcIDE Center, pursuant to the American Recovery and 
Reinvestment Act, Pub. L. 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
                                                                Number of
                Form name                     Number of       responses per       Hours per       Total burden
                                             respondents       respondent         response            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
                                              Number of       Total burden     Average hourly      Total cost
                Form name                    respondents          hours          wage rate*          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.

[[Page 40887]]

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       cost
Project Development.........................    $2,318,509      $772,836
Project Management..........................       409,149       136,383
Overhead....................................       456,675       152,225
  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: July 5, 2012.
Carolyn M. Clancy,
[FR Doc. 2012-16849 Filed 7-10-12; 8:45 am]