Agency Information Collection Activities: Proposed Collection; Comment Request, 4053-4055 [2018-01515]
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Federal Register / Vol. 83, No. 19 / Monday, January 29, 2018 / Notices
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effects arising from the Transaction.
Significant entry barriers include the
availability of attractive real estate, the
time and cost associated with
constructing a new retail fuel outlet, and
the time associated with obtaining
necessary permits and approvals.
V. The Proposed Consent Agreement
The proposed Consent Agreement
remedies the Transaction’s
anticompetitive effects by requiring 7Eleven to sell retail fuel outlets in some
local markets to Sunoco and reject
Sunoco retail fuel outlets in other local
markets pursuant to the Respondents’
asset purchase agreement (thereby
allowing Sunoco to retain these assets).
Sunoco intends to convert the acquired
or retained stations from companyoperated sites to commission agent sites.
This remedy would preserve
competition as it is today, ensure that
the divestiture assets go to a viable,
large-scale competitor, and reduce the
risks and costs associated with asset
integration.
The Commission is satisfied that
allowing Sunoco to acquire or retain
retail fuel stations and transition them
to commission agent sites is an
appropriate remedy. Most importantly,
the proposed remedy preserves
competition in each local market.
Indeed, as Sunoco controls retail fuel
pricing at both its company-operated
stations and its commission agent
stations, Sunoco and 7-Eleven would
continue as independent retail fuel
competitors in each local market.
Moreover, Sunoco is a large, viable
competitor capable of maintaining the
competitive landscape in each local
market. Finally, the proposed Consent
Agreement reduces the uncertainty and
costs relating to integration since
Sunoco already is familiar with the
majority of the stations at issue.
The proposed Consent Agreement
also requires that for up to six months
following the divestiture, with up to an
additional twelve months at the buyer’s
option, 7-Eleven make available
transitional services, as needed, to assist
the buyer of each divestiture asset. The
buyer may extend the period for an
additional twelve months, but only with
Commission approval.
In addition to requiring outlet
divestitures, the proposed Consent
Agreement also requires 7-Eleven to
provide the Commission (and Florida,
Texas, or Virginia, where applicable)
notice before acquiring designated
outlets in the 76 local areas for ten
years. The prior notice provision is
necessary because acquisitions of the
designated outlets likely would raise
competitive concerns and may fall
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below the HSR Act premerger
notification thresholds.
The proposed Consent Agreement
contains additional provisions designed
to ensure the effectiveness of the
proposed relief. For example,
Respondents have agreed to an Order to
Maintain Assets that will issue at the
time the proposed Consent Agreement is
accepted for public comment. The Order
to Maintain Assets requires
Respondents to operate and maintain
each divestiture outlet in the normal
course of business through the date the
Respondents’ complete divestiture of
the outlet, thereby maintaining the
economic viability, marketability, and
competitiveness of each divestiture
asset. During this period, and until such
time as the buyer (or buyers) no longer
requires transitional assistance, the
Order to Maintain Assets authorizes the
Commission to appoint an independent
third party as a monitor to oversee the
Respondents’ compliance with the
requirements of the proposed Consent
Agreement.
The proposed Consent Agreement
also requires Sunoco to take steps to
ensure that its employees in charge of
setting retail fuel prices at the acquired
or retained retail fuel outlets do not
have access to confidential information
about Sunoco’s post-Transaction
wholesale supply of 7-Eleven’s retail
fuel stations. To ensure appropriate
firewalls remain in place for the
duration of the Respondents’ fuel
supply agreement, the proposed
Consent Agreement has a term of fifteen
years.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent agreement, and the
Commission does not intend this
analysis to constitute an official
interpretation of the proposed Consent
Agreement or to modify its terms in any
way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2018–01547 Filed 1–26–18; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
AGENCY:
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ACTION:
4053
Notice.
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 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
emails at doris.lefkowitz@
AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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
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29JAN1
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Federal Register / Vol. 83, No. 19 / Monday, January 29, 2018 / Notices
(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 selfregistration 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
respondents
Form name
Number of
responses
er
respondent
Minutes per
response
Total burden
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
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate †
Total cost
burden
70
18.7
$38.06
$711.72
Total ..........................................................................................................
sradovich on DSK3GMQ082PROD with NOTICES
OMR Measure Profile/Sub-Element Profile .....................................................
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
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information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
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information is necessary for the proper
performance of AHRQ health care
research and health care information
E:\FR\FM\29JAN1.SGM
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Federal Register / Vol. 83, No. 19 / Monday, January 29, 2018 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–1122]
sradovich on DSK3GMQ082PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Congenital
Heart Survey To Recognize Outcomes,
Needs, and well-being (CH STRONG) to
the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on 09/20/2017 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
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18:19 Jan 26, 2018
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proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Congenital Heart Surveillance To
Recognize Outcomes, Needs, and Wellbeing (CHSTRONG) (OMB Control
Number 0920–1122,Expiration 07/31/
2017)—Reinstatement with Change—
National Center on Birth Defects and
Developmental Disabilities, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Congenital heart defects (CHDs) are
the most common type of structural
birth defects, affecting approximately 1
in 110 live-born children. In prior
decades, many CHDs were considered
fatal during infancy or childhood, but
with tremendous advances in pediatric
cardiology and cardiac surgery, at least
85% of patients now survive to
adulthood and there are approximately
1.5 million adults with CHD living in
the United States.
With vast declines in mortality from
pediatric heart disease over the past 30
years, it is vital to evaluate long-term
outcomes and quality of life issues for
adults with CHD. However, U.S. data on
long-term outcomes, quality of life
issues, and comorbidities of adults born
with CHD are lacking. U.S. data is
needed to provide insight into the
public health questions that remain for
this population and to develop services
and allocate resources to improve longterm health and wellbeing.
The initial request for this project was
one year, but there were delays in
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4055
recruitment due to challenges with
tracking and tracing individuals for
correct addresses. The three sites,
Metro-Atlanta Congenital Defect
Program (MACDP), University of
Arizona, and University of Arkansas,
decided to conduct more intensive and
time-consuming tracking and tracing to
identify more accurate contact
information for all eligible individuals
and for those individuals whose
materials were returned as
undeliverable. At MACDP, this required
modifying a contract to include the task
of tracking and tracing 2,313
individuals. While the large majority of
tracking and tracing at all three sites
took place in the first year of the project,
including that for the 2,313 individuals
above, an additional 1,115 mothers of
eligible individuals need to be sent a
contact information form to assist to
locating their child. Due to these delays
and changes in the recruitment process,
CH STRONG data collection is expected
to last an additional 24 months and
conclude two years after receiving OMB
approval.
Since July 2016, the three CH
STRONG sites identified 9,228
individuals with CHD through their
respective birth defects registries. The
CH STRONG project has successfully
tracked and traced 6,417 individuals for
current contact information. To date, the
three sites have sent recruitment
materials to 3,651 individuals (40% of
all individuals).
The purpose of this survey is to
collect information on barriers to health
care, quality of life, social and
educational outcomes, and transition of
care from childhood to adulthood
among adults born with CHD. Currently,
Congress has appropriated
approximately $4 million per year to
CDC to conduct surveillance among
adults with CHD.
CH STRONG will survey adults aged
18 to 45 years of age and born with a
CHD as identified through the birth
defects surveillance system in three
participating sites in the United States.
The information collected from this
cohort will be used to identify the
healthcare, educational, and social
service needs of adults with CHDs.
Findings will be reported through peerreviewed publications, presentations at
state and national conferences, and
webinars and reports to partners who
work on CHD. The findings will be used
by national, state and local
organizations to allocate resources and
develop services and programs for
adults with CHD.
With the information collected in this
survey, the CDC, along with its partners,
will have information on healthcare
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]]>Agencies
[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4053-4055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
