83 FR 4053 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 83, Issue 19 (January 29, 2018)
Agency for Healthcare Research and Quality
Federal Register Volume 83, Issue 19 (January 29, 2018)
| Page Range | 4053-4055 | |
| FR Document | 2018-01515 |
[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)] [Notices] [Pages 4053-4055] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01515] ======================================================================= ----------------------------------------------------------------------- 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 ``Outcome Measure Repository (OMR).'' DATES: Comments on this notice must be received by March 30, 2018. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at [email protected]. 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 emails 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 centralized 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 [[Page 4054]] (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. Second, measure stewards listing a measure record in the OMR system will be able to associate the measure with an existing patient registry in RoPR. 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, information on 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--registry stewards--must be able to enter information into the system easily and efficiently. The second group of users--parties interested in seeking information on outcome measures--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. Exhibit 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Form name Number of responses per Minutes per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- OMR Measure Profile/Sub-Element Profile......... 70 1 16/60 18.7 --------------------------------------------------------------- Total....................................... 70 1 16/60 18.7 ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Average hourly Form name Number of Total burden wage rate Total cost respondents hours [dagger] burden ---------------------------------------------------------------------------------------------------------------- OMR Measure Profile/Sub-Element Profile......... 70 18.7 $38.06 $711.72 --------------------------------------------------------------- Total....................................... 70 18.7 38.06 711.72 ---------------------------------------------------------------------------------------------------------------- * 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 [[Page 4055]] 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. Sharon B. Arnold, Deputy Director. [FR Doc. 2018-01515 Filed 1-26-18; 8:45 am] BILLING CODE 4160-90-P
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effects arising from the Transaction. below the HSR Act premerger ACTION: Notice.
Significant entry barriers include the notification thresholds.
availability of attractive real estate, the The proposed Consent Agreement SUMMARY: This notice announces the
time and cost associated with contains additional provisions designed intention of the Agency for Healthcare
constructing a new retail fuel outlet, and to ensure the effectiveness of the Research and Quality (AHRQ) to request
the time associated with obtaining proposed relief. For example, that the Office of Management and
necessary permits and approvals. Respondents have agreed to an Order to Budget (OMB) approve the proposed
Maintain Assets that will issue at the information collection project
V. The Proposed Consent Agreement ‘‘Outcome Measure Repository (OMR).’’
time the proposed Consent Agreement is
The proposed Consent Agreement accepted for public comment. The Order DATES: Comments on this notice must be
remedies the Transaction’s to Maintain Assets requires received by March 30, 2018.
anticompetitive effects by requiring 7- Respondents to operate and maintain ADDRESSES: Written comments should
Eleven to sell retail fuel outlets in some each divestiture outlet in the normal be submitted to: Doris Lefkowitz,
local markets to Sunoco and reject course of business through the date the Reports Clearance Officer, AHRQ, by
Sunoco retail fuel outlets in other local Respondents’ complete divestiture of email at doris.lefkowitz@AHRQ.hhs.gov.
markets pursuant to the Respondents’ the outlet, thereby maintaining the Copies of the proposed collection
asset purchase agreement (thereby economic viability, marketability, and plans, data collection instruments, and
allowing Sunoco to retain these assets). competitiveness of each divestiture specific details on the estimated burden
Sunoco intends to convert the acquired asset. During this period, and until such can be obtained from the AHRQ Reports
or retained stations from company- time as the buyer (or buyers) no longer Clearance Officer.
operated sites to commission agent sites. requires transitional assistance, the FOR FURTHER INFORMATION CONTACT:
This remedy would preserve Order to Maintain Assets authorizes the Doris Lefkowitz, AHRQ Reports
competition as it is today, ensure that Commission to appoint an independent Clearance Officer, (301) 427–1477, or by
the divestiture assets go to a viable, third party as a monitor to oversee the emails at doris.lefkowitz@
large-scale competitor, and reduce the Respondents’ compliance with the AHRQ.hhs.gov.
risks and costs associated with asset requirements of the proposed Consent
integration. SUPPLEMENTARY INFORMATION:
Agreement.
The Commission is satisfied that Proposed Project
The proposed Consent Agreement
allowing Sunoco to acquire or retain
also requires Sunoco to take steps to Outcome Measure Repository
retail fuel stations and transition them
ensure that its employees in charge of
to commission agent sites is an In accordance with the Paperwork
setting retail fuel prices at the acquired
appropriate remedy. Most importantly, Reduction Act, 44 U.S.C. 3501–3521,
the proposed remedy preserves or retained retail fuel outlets do not
AHRQ invites public comment on this
competition in each local market. have access to confidential information
proposed information collection. In
Indeed, as Sunoco controls retail fuel about Sunoco’s post-Transaction
accordance with the agency’s mission,
pricing at both its company-operated wholesale supply of 7-Eleven’s retail
AHRQ developed the Outcome Measure
stations and its commission agent fuel stations. To ensure appropriate
Repository (OMR), a web-based database
stations, Sunoco and 7-Eleven would firewalls remain in place for the
with the purpose of providing a readily
continue as independent retail fuel duration of the Respondents’ fuel
available public resource that includes
competitors in each local market. supply agreement, the proposed
definitions of outcome measures
Moreover, Sunoco is a large, viable Consent Agreement has a term of fifteen
associated with patient registries. The
competitor capable of maintaining the years.
information being collected in each
competitive landscape in each local The purpose of this analysis is to
OMR record will be visible to the public
market. Finally, the proposed Consent facilitate public comment on the
and readily available for public use.
Agreement reduces the uncertainty and proposed Consent agreement, and the This effort is in alignment the AHRQ
costs relating to integration since Commission does not intend this Registry of Patient Registries (RoPR),
Sunoco already is familiar with the analysis to constitute an official which provides a centralized point of
majority of the stations at issue. interpretation of the proposed Consent collection for information about all
The proposed Consent Agreement Agreement or to modify its terms in any patient registries in the United States.
also requires that for up to six months way. The RoPR furthers AHRQ’s goals to
following the divestiture, with up to an By direction of the Commission. enhance the description of the quality,
additional twelve months at the buyer’s Donald S. Clark, appropriateness, and effectiveness of
option, 7-Eleven make available Secretary. health services, and patient registries in
transitional services, as needed, to assist [FR Doc. 2018–01547 Filed 1–26–18; 8:45 am] particular, in a more readily available,
the buyer of each divestiture asset. The BILLING CODE 6750–01–P central location by enhancing patient
buyer may extend the period for an registry information, extracted from
additional twelve months, but only with ClinicalTrials.gov or modeled based on
Commission approval. the ClinicalTrials.gov data elements.
In addition to requiring outlet DEPARTMENT OF HEALTH AND The development of the OMR
divestitures, the proposed Consent HUMAN SERVICES continues these efforts, and aims to
Agreement also requires 7-Eleven to achieve the following objectives:
provide the Commission (and Florida, Agency for Healthcare Research and
sradovich on DSK3GMQ082PROD with NOTICES
(1) Provide a searchable database of
Texas, or Virginia, where applicable) Quality
outcome measures used in patient
notice before acquiring designated Agency Information Collection registries in the United States to
outlets in the 76 local areas for ten Activities: Proposed Collection; promote collaboration, reduce
years. The prior notice provision is Comment Request redundancy, and improve transparency;
necessary because acquisitions of the (2) Facilitate the use of standardized
designated outlets likely would raise AGENCY:Agency for Healthcare Research data elements and outcome measures;
competitive concerns and may fall and Quality, HHS. and
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dissemination functions, including proposed collection of information, recruitment due to challenges with
whether the information will have including the validity of the tracking and tracing individuals for
practical utility; (b) the accuracy of methodology and assumptions used; correct addresses. The three sites,
AHRQ’s estimate of burden (including (c) Enhance the quality, utility, and Metro-Atlanta Congenital Defect
hours and costs) of the proposed clarity of the information to be Program (MACDP), University of
collection(s) of information; (c) ways to collected; Arizona, and University of Arkansas,
enhance the quality, utility and clarity (d) Minimize the burden of the decided to conduct more intensive and
of the information to be collected; and collection of information on those who time-consuming tracking and tracing to
(d) ways to minimize the burden of the are to respond, including, through the identify more accurate contact
collection of information upon the use of appropriate automated, information for all eligible individuals
respondents, including the use of electronic, mechanical, or other and for those individuals whose
automated collection techniques or technological collection techniques or materials were returned as
other forms of information technology. other forms of information technology, undeliverable. At MACDP, this required
Comments submitted in response to e.g., permitting electronic submission of modifying a contract to include the task
this notice will be summarized and responses; and of tracking and tracing 2,313
included in the Agency’s subsequent (e) Assess information collection individuals. While the large majority of
request for OMB approval of the costs. tracking and tracing at all three sites
proposed information collection. All To request additional information on took place in the first year of the project,
comments will become a matter of the proposed project or to obtain a copy including that for the 2,313 individuals
public record. of the information collection plan and above, an additional 1,115 mothers of
instruments, call (404) 639–7570 or eligible individuals need to be sent a
Sharon B. Arnold, send an email to omb@cdc.gov. Direct contact information form to assist to
Deputy Director. written comments and/or suggestions locating their child. Due to these delays
[FR Doc. 2018–01515 Filed 1–26–18; 8:45 am] regarding the items contained in this and changes in the recruitment process,
BILLING CODE 4160–90–P notice to the Attention: CDC Desk CH STRONG data collection is expected
Officer, Office of Management and to last an additional 24 months and
Budget, 725 17th Street NW, conclude two years after receiving OMB
DEPARTMENT OF HEALTH AND Washington, DC 20503 or by fax to (202) approval.
HUMAN SERVICES 395–5806. Provide written comments Since July 2016, the three CH
within 30 days of notice publication. STRONG sites identified 9,228
Centers for Disease Control and individuals with CHD through their
Prevention Proposed Project respective birth defects registries. The
[30Day–18–1122] Congenital Heart Surveillance To CH STRONG project has successfully
Recognize Outcomes, Needs, and Well- tracked and traced 6,417 individuals for
Agency Forms Undergoing Paperwork being (CHSTRONG) (OMB Control current contact information. To date, the
Reduction Act Review Number 0920–1122,Expiration 07/31/ three sites have sent recruitment
2017)—Reinstatement with Change— materials to 3,651 individuals (40% of
In accordance with the Paperwork National Center on Birth Defects and all individuals).
Reduction Act of 1995, the Centers for Developmental Disabilities, Centers for The purpose of this survey is to
Disease Control and Prevention (CDC) Disease Control and Prevention (CDC). collect information on barriers to health
has submitted the information care, quality of life, social and
collection request titled Congenital Background and Brief Description educational outcomes, and transition of
Heart Survey To Recognize Outcomes, Congenital heart defects (CHDs) are care from childhood to adulthood
Needs, and well-being (CH STRONG) to the most common type of structural among adults born with CHD. Currently,
the Office of Management and Budget birth defects, affecting approximately 1 Congress has appropriated
(OMB) for review and approval. CDC in 110 live-born children. In prior approximately $4 million per year to
previously published a ‘‘Proposed Data decades, many CHDs were considered CDC to conduct surveillance among
Collection Submitted for Public fatal during infancy or childhood, but adults with CHD.
Comment and Recommendations’’ with tremendous advances in pediatric CH STRONG will survey adults aged
notice on 09/20/2017 to obtain cardiology and cardiac surgery, at least 18 to 45 years of age and born with a
comments from the public and affected 85% of patients now survive to CHD as identified through the birth
agencies. CDC did not receive comments adulthood and there are approximately defects surveillance system in three
related to the previous notice. This 1.5 million adults with CHD living in participating sites in the United States.
notice serves to allow an additional 30 the United States. The information collected from this
days for public and affected agency With vast declines in mortality from cohort will be used to identify the
comments. pediatric heart disease over the past 30 healthcare, educational, and social
CDC will accept all comments for this years, it is vital to evaluate long-term service needs of adults with CHDs.
proposed information collection project. outcomes and quality of life issues for Findings will be reported through peer-
The Office of Management and Budget adults with CHD. However, U.S. data on reviewed publications, presentations at
is particularly interested in comments long-term outcomes, quality of life state and national conferences, and
that: issues, and comorbidities of adults born webinars and reports to partners who
(a) Evaluate whether the proposed
sradovich on DSK3GMQ082PROD with NOTICES
with CHD are lacking. U.S. data is work on CHD. The findings will be used
collection of information is necessary needed to provide insight into the by national, state and local
for the proper performance of the public health questions that remain for organizations to allocate resources and
functions of the agency, including this population and to develop services develop services and programs for
whether the information will have and allocate resources to improve long- adults with CHD.
practical utility; term health and wellbeing. With the information collected in this
(b) Evaluate the accuracy of the The initial request for this project was survey, the CDC, along with its partners,
agencies estimate of the burden of the one year, but there were delays in will have information on healthcare
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Document Created: 2018-01-27 00:57:55
Document Modified: 2018-01-27 00:57:55
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this notice must be received by March 30, 2018. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by emails at [email protected] | |
| FR Citation | 83 FR 4053 |
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