Federal Register, Volume 77 Issue 36 (Thursday, February 23, 2012)

[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Pages 10746-10748]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3911]

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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.

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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.

DATES: Comments on this notice must be received by April 23, 2012.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
doris.lefkowitz@AHRQ.hhs.gov.
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:

[[Page 10747]]

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 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
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Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
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New RoPR Record................................. 1,520 1 45/60 1,140

[[Page 10748]]

Review/update RoPR Record....................... 760 1 15/60 190
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Total....................................... 2,280 na na 1,330
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Exhibit 2--Estimated Annualized Cost Burden
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Average hourly
Form name Number of Total burden wage rate Total cost
respondents hours [dagger] burden
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New RoPR Record................................. 1,520 1,140 $34.27 $39,068
Review/update RoPR Record....................... 760 190 34.27 6,511
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Total....................................... 2,280 1,330 na 45,579
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[dagger] Based upon the mean average wage for Healthcare Practitioners and Technical Occupations, May 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
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Annualized
Cost component Total cost cost
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Project Development..................... $2,318,509 $772,836
Project Management...................... 409,149 136,383
Overhead................................ 456,675 152,225
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Total............................... 3,184,333 1,061,444
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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: February 6, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-3911 Filed 2-22-12; 8:45 am]
BILLING CODE 4160-90-M