[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16858-16860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08009]


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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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[[Page 16859]]

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 ``Outcome Measure Repository (OMR).''
    This proposed information collection was previously published in 
the Federal Register on January 29, 2018, and allowed 60 days for 
public comment. AHRQ received no substantive comments from the public. 
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 17, 2018.

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).

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

Outcome Measure Repository

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites public comment on this proposed information 
collection. In accordance with the agency's mission, AHRQ developed the 
Outcome Measure Repository (OMR), a web-based database with the purpose 
of providing a readily available public resource that includes 
definitions of outcome measures associated with patient registries. The 
information being collected in each OMR record will be visible to the 
public and readily available for public use.
    This effort is in alignment the AHRQ Registry of Patient Registries 
(RoPR), which provides a central point of collection for information 
about all patient registries in the United States. The RoPR furthers 
AHRQ's goals to enhance the description of the quality, 
appropriateness, and effectiveness of health services, and patient 
registries in particular, in a more readily available, central location 
by enhancing patient registry information, extracted from 
ClinicalTrials.gov or modeled based on the ClinicalTrials.gov data 
elements.
    The development of the OMR continues these efforts, and aims to 
achieve the following objectives:
    (1) Provide a searchable database of outcome measures used in 
patient registries in the United States to promote collaboration, 
reduce redundancy, and improve transparency;
    (2) Facilitate the use of standardized data elements and outcome 
measures; and
    (3) Facilitate the identification of potential areas of 
harmonization.
    The OMR system will be linked to RoPR in two key ways. First, users 
entering registry information in the RoPR system will be able to 
associate OMR measure records with the RoPR registry records, and, 
measure stewards listing a measure record in the OMR system will be 
able to associate the measure with an existing patient registry in 
RoPR. Second, users will be able to access both databases with a single 
account (i.e., users with a RoPR account will be able to log in/access 
the OMR using that account, and vice versa).
    This study is being conducted by AHRQ through its contractor, L&M 
Policy Research and subcontractors Truven Health Analytics, an IBM 
Company, and OM1, pursuant to AHRQ's statutory authority to conduct and 
support research on health care and on systems for the delivery of such 
care, including activities with respect to the outcomes, cost, cost-
effectiveness, and use of health care services and access to such 
services, and with respect to health statistics and database 
development. 42 U.S.C. 299a(a)(3) and (8).

Method of Collection

    To achieve the three objectives of this project, outcome measures 
and related sub-elements from measure stewards who populate the OMR 
database system will be collected.
    Users of the OMR will primarily fall into two types: Those 
stewarding a registry who will provide information on the data they 
collect in their registry, and those who will search for information 
about how a particular type of outcome measure is collected within 
patient registries. For the OMR to succeed, the first group of users 
must be able to enter information into the system easily and 
efficiently. The second group of users must be able to find sufficient 
information efficiently on outcome measures to identify items for use 
in their own registry or research. Meeting the needs of both sets of 
users is an important consideration in the design of the OMR.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondent's time to contribute to the OMR.
    Based on the number of respondents submitting RoPR records in 2016 
(65 respondents), it is expected that a similar number of stakeholders 
(approximately 70 respondents) will provide measure information in the 
OMR on an annual basis.
    All users will complete required fields on the ``Measure Profile'' 
form. Some users may also choose to complete the ``Sub-Element 
Profile'' form for one or more sub-elements associated with a given 
measure although this is not required. The number of sub-elements for a 
given measure is expected to vary widely. Many users may not provide 
sub-element information, while others may include five or more. It is 
expected that on average, measure stewards will enter information for 
two sub-elements.
    In September 2017, Truven Health Analytics consulted with several 
stakeholders and used a sample of existing measure definitions to 
estimate the time required to enter all OMR fields. The sample included 
measures representing a range of depth and complexity. For example, one 
measure record contained no sub-element information, only required 
fields, and short responses to open text fields (e.g., title and 
description). Another record contained two sub-elements, all optional 
fields, and longer responses to open text fields.
    As a result of the knowledge gained during these processes, it is 
estimated that it will take users 16 minutes, on average, to enter 
manually the additional fields added through the self-registration 
process (an average of 12 minutes to complete the Measure Profile form 
and 4 minutes to complete two Sub-Element Profile sub-forms). If 70 
respondents complete the Measure Profile form and two Sub-Element 
Profile sub-forms, the estimated annualized burden would be 18.7 hours 
total.

[[Page 16860]]



                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per    Minutes per    Total burden
                                                    respondents     respondent       response          hours
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OMR Measure Profile/Sub-Element Profile.........              70               1           16/60            18.7
                                                 ---------------------------------------------------------------
    Total.......................................              70               1           16/60            18.7
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    Exhibit 2 shows the estimated cost burden associated with the 
respondent's time to participate in the OMR. The total cost burden to 
respondents is estimated at an average of $711.72 annually.

                                   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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OMR Measure Profile/Sub-Element Profile.........              70            18.7          $38.06         $711.72
                                                 ---------------------------------------------------------------
    Total.......................................              70            18.7           38.06          711.72
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* Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29-0000. National Compensation
  Survey: Occupational Wages in the United States May 2016, ``U.S. Department of Labor, Bureau of Labor
  Statistics.'' Available at: https://www.bls.gov/oes/current/oes290000.htm.

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.

Karen Migdail,
Chief of Staff.
[FR Doc. 2018-08009 Filed 4-16-18; 8:45 am]
 BILLING CODE 4160-90-P