Agency Forms Undergoing Paperwork Reduction Act Review, 30118-30120 [2019-13521]
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30118
Federal Register / Vol. 84, No. 123 / Wednesday, June 26, 2019 / Notices
employer groups and individual
consumers across the country. United
and DMG both offer managed care
provider organization (‘‘MCPO’’)
services to health insurers. The merger
is therefore both horizontal in nature—
because it combines two competing
MCPO service providers—and vertical,
as it combines MCPO and insurance
assets.
Staff spent more than a year and a half
investigating the competitive effects of
this acquisition, which involves assets
in several states, including Colorado,
Florida, New Mexico, Nevada, and
Washington. Based on the findings from
that investigation, the Commission has
accepted a proposed consent agreement
requiring United to divest DMG’s
healthcare provider organization (its
MCPO) in the Las Vegas, Nevada, area
to Intermountain Healthcare, a nonprofit healthcare provider system
without a presence in the market. We
join Commissioners Slaughter and
Chopra in supporting this remedy and
in thanking staff for their exceptional
effort and diligence through this long
investigation.
Our colleagues write separately,
stating they would have asked a federal
judge to block United’s acquisition of
DMG based on their belief that the
vertical integration of United’s health
insurance business and DMG’s MCPOs
and physicians in Colorado would harm
consumers. In our view, the evidence in
support of likely harm in Colorado was
not compelling, and therefore a federal
judge was unlikely to grant that relief.
As Commissioners Slaughter and
Chopra point out, the acquisition in
Colorado is purely vertical. In other
words, in that state the transaction
combines firms that operate at different
levels of the supply chain and do not
compete with one another. Specifically,
DMG’s MCPO services and physicians
serve as ‘‘inputs’’ to the MA insurance
plans that United and other health
insurers sell to employers and
individuals. The putative theory of
harm in Colorado involved raising
rivals’ costs (‘‘RRC’’). It posited that,
after acquiring DMG, United would find
it profitable to raise DMG’s prices to
rival MA insurance plans, because
doing so would reduce these plans’
benefits and induce some customers to
switch to United’s MA products. The
more business United recaptures in the
market for MA plans, the greater its
incentive to raise DMG’s prices to rivals.
We do not rule out the possibility that
vertical mergers can harm competition
under a RRC theory. We both voted to
issue the complaint, which alleges a
similar vertical theory of harm in
Nevada. And given both substantially
VerDate Sep<11>2014
18:47 Jun 25, 2019
Jkt 247001
stronger facts and the significant
horizontal overlap in that state, that was
the right call.
But vertical mergers often generate
procompetitive benefits that must also
factor into the antitrust analysis.1 A
major source of these benefits is the
elimination of double-marginalization,
which places downward pressure on
prices in the output market. We
conclude that the evidence in Colorado,
quantitative and qualitative, reflected
both dynamics, with mixed results. In
our view, taken together, the evidence
would not have convinced a judge that
the proposed acquisition was likely, on
balance, to harm consumers in
Colorado.
As our colleagues note, a lawsuit
based upon this evidence posed
significant litigation risk. Among other
things, the law on vertical mergers is
relatively underdeveloped, and an
adverse decision can impact
enforcement in later cases that present
clearer harm. Of course, all litigation
presents risks, and sometimes the risks
are worth taking. But, faced with a body
of evidence of harm that was ambiguous
in the first place, we cannot agree with
our colleagues that this was a case on
which to roll the dice.
Statement of Commissioners Rebecca
Kelly Slaughter and Rohit Chopra
UnitedHealth Group, Inc. (‘‘United’’)
proposes to acquire DaVita Medical
Group (‘‘DMG’’), which provides
healthcare services in Nevada and
Colorado, among other states. Today,
the Commission voted to accept a
proposed consent agreement that
requires a divestiture of the DMG
business serving Clark and Nye counties
in Nevada to maintain competition. We
agree with the proposed remedy for
Nevada, but we disagree with the
Commission’s decision to not pursue an
enforcement action in Colorado.
We believe the evidence uncovered by
Commission staff demonstrates that the
vertical merger of United’s health
insurance and DMG’s healthcare
services businesses would likely result
in actionable harm to competition in
Colorado. We were prepared to
challenge the transaction in court, given
the likelihood of harm. We acknowledge
that Commission action involving
Colorado would have borne significant
litigation risks, but we believe such
risks were worth taking.
Fortunately, the Attorney General of
Colorado has taken action in an effort to
address some of the harmful effects of
the merger in a separate action. We hope
1 See, e.g., United States v. AT&T, 310 F.Supp.3d
161, 192–94 (D.D.C. 2018).
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all state attorneys general actively
enforce the antitrust laws to protect
their residents from harmful mergers
and anticompetitive practices.
We thank Commission staff for their
tireless work on a complex and very
resource-intensive matter. While we
would have preferred a different
outcome, staff put the Commission in a
very strong position to make a wellinformed decision and serve the public
interest.
[FR Doc. 2019–13499 Filed 6–25–19; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–0573]
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 National HIV
Surveillance System (NHSS), 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 April 23rd, 2019 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
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
E:\FR\FM\26JNN1.SGM
26JNN1
Federal Register / Vol. 84, No. 123 / Wednesday, June 26, 2019 / Notices
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.
jbell on DSK3GLQ082PROD with NOTICES
Proposed Project
National HIV Surveillance System
(NHSS) (OMB No. 0920–0573,
Expiration 06/30/2019)—Revision—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Collected with authorization under
Sections 304 and 306 of the Public
Health Service Act (42 U.S.C. 242b and
242k) the National HIV Surveillance
System (NHSS) data are the primary
data used to monitor the extent and
characteristics of the HIV burden in the
United States. HIV surveillance data are
used to describe trends in HIV
incidence, prevalence and
characteristics of infected persons and
used widely at the federal, state, and
local levels for planning and evaluating
prevention programs and healthcare
services, and to allocate funding for
prevention and care.
As science, technology, and our
understanding of HIV have evolved, the
NHSS has been updated periodically.
CDC in collaboration with health
departments in the 50 states, the District
of Columbia, and U.S. dependent areas,
conducts national surveillance for cases
of HIV infection that includes critical
data across the spectrum of HIV disease
from HIV diagnosis, to stage 3 (AIDS),
the end stage disease caused by
infection with HIV, and death. In
addition, this national system provides
essential data to estimate HIV incidence,
monitor patterns in HIV drug resistance
and genetic diversity, identify and
respond to clusters of recent and rapid
transmission, as well as provide
information on perinatal exposure to
HIV in the United States. The CDC
surveillance case definition has been
modified periodically to accurately
monitor disease in adults, adolescents
VerDate Sep<11>2014
18:47 Jun 25, 2019
Jkt 247001
and children and reflect use of new
testing technologies and changes in HIV
treatment. Information is then updated
in the case report forms and reporting
software as needed.
In 2018, CDC implemented activities
under a new cooperative agreement
PS18–1802: Integrated HIV Surveillance
and Prevention Programs for Health
Departments. The purpose of PS18–
1802 is to implement a comprehensive
HIV surveillance and prevention
program to prevent new HIV infections
and achieve viral suppression among
persons living with HIV. These goals are
in accordance with the CDC’s and
national prevention goals, including the
President’s new initiative to End the
HIV Epidemic in America. This
information collection request revision
includes activities to continue national
surveillance program activities and
align with program priorities under the
new cooperative agreement (PS18–
1802).
The revisions requested in this
extension include minor modifications
to currently collected data elements and
forms (including the Adult Case Report
Form (ACRF) and the Pediatric Case
Report Form (PCRF)), modifications to
data system variables used to
summarize geocoded address data
collected as part of the geocoding and
data linkage activities, addition of new
cluster report forms for health
departments to report on progress for
HIV cluster response activities and
addition of investigation reporting and
evaluation activities to account for
additional data reported as part of these
activities. No changes are being
requested to data elements collected on
the Perinatal HIV Exposure Reporting
(PHER) form, but the number of
jurisdictions (respondents) completing
the form has been reduced. Minor
changes to the information collected in
the standards evaluation report form
(SER) are also requested to align with
changes in program activities under
PS18–1802. Finally, we have updated
our burden estimates to more accurately
reflect current data collection practices
that are summarized in the table below.
CDC provides funding for 59
jurisdictions to provide adult and
pediatric HIV case reports. Health
department staff compile information
from laboratories, physicians, hospitals,
clinics and other health care providers
to complete the HIV adult and pediatric
case reports. CDC estimates that on
average, approximately 854 adult HIV
case reports and three pediatric case
reports are processed by each health
department annually.
These data are recorded using
standard case report forms either on
PO 00000
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Fmt 4703
Sfmt 4703
30119
paper or electronically and entered into
the electronic reporting system. Updates
to case reports are also entered into the
reporting system by health departments
as additional information may be
received from laboratories, vital
statistics, or additional providers.
Evaluations are also conducted by
health departments on a subset of case
reports (e.g., re-abstraction, validation).
CDC estimates that on average
approximately 86 evaluations of case
reports, 2353 updates to case reports
and 9410 updates of electronic
laboratory test data will be processed by
each of the 59 health departments
annually. In addition, all 59 health
departments will conduct routine
deduplication activities for new
diagnoses and cumulative case reports.
CDC estimates that health departments
on average will follow-up on 2741
reports as part of deduplication
activities annually. Case report
information compiled over time by
health departments is then de-identified
and forwarded to CDC on a monthly
basis to become part of the national HIV
surveillance database.
When necessary additional
information may be reported by health
departments for monitoring and
evaluation of health department
investigations including activities
identifying persons who are not in HIV
medical care and linking them to HIV
medical care (e.g., Data-to-Care
activities) and other services and
identifying and responding to clusters.
CDC estimates health departments will
on average process 901 responses
related to investigation reporting and
monitoring annually.
Clusters of HIV are groups of persons
related by recent, rapid transmission, for
which rapid response is needed in order
to interrupt ongoing transmission and
prevent further HIV infections. Health
departments may detect clusters
through multiple means, including
through routine analyses of Surveillance
data and other data reported to the
NHSS. Data on clusters of recent and
rapid HIV transmission in the United
States will be collected to monitor
situations necessitating public health
intervention, assess health department
response, and evaluate outcomes of
intervention activities. These summary
data will be collected through quarterly
cluster report forms that will be
completed by health departments for
clusters that they have identified and for
which they are actively conducting
response activities. Health departments
will complete an initial cluster report
form when a cluster is first identified,
a cluster follow-up form for each quarter
in which the cluster response remains
E:\FR\FM\26JNN1.SGM
26JNN1
30120
Federal Register / Vol. 84, No. 123 / Wednesday, June 26, 2019 / Notices
active and a cluster close-out form when
cluster response activities are closed or
at annual intervals while a cluster
response remains active. Completion of
forms will be determined by the number
of clusters detected. Health departments
that do not identify recent and rapid
clusters of HIV transmission will not
complete any cluster report forms, while
some jurisdictions will detect multiple
recent and rapid clusters of HIV
transmission, necessitating the
completion of multiple cluster report
forms. CDC estimates on average health
departments will provide information
for 2.5 initial cluster reports, five
Cluster Follow-up reports, and 2.5
Cluster Close-out reports annually.
Perinatal HIV surveillance and
prevention activities with HIV exposure
reporting and perinatal services
coordination is an integrated approach
to advancing the progress toward
perinatal HIV elimination goals. A
subset of 16 health departments in the
most affected jurisdictions will be
reporting using the Perinatal Exposure
Reporting (PHER) form to monitor and
evaluate perinatal HIV prevention
efforts. An estimated 197 reports
containing perinatal exposure data
elements will be processed on average
annually by each of the 16 health
departments reporting data collected as
part of PHER. These supplemental data
are also reported monthly to CDC.
The Standards Evaluation Report
(SER) is used by CDC and Health
Departments to improve data quality,
interpretation, usefulness, and
surveillance system efficiency, as well
as to monitor progress toward meeting
surveillance program objectives. The
information collected for the SER
includes a brief set of questions about
evaluation outcomes and the collection
of laboratory data that will be reported
one time a year by each 59 health
departments. The total estimated annual
burden hours are 58,131.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Health
Health
Health
Health
Health
Health
Health
Health
Health
Health
Health
Health
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
........................................
........................................
........................................
........................................
........................................
........................................
........................................
........................................
........................................
........................................
........................................
........................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–13521 Filed 6–25–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–18AMQ]
jbell on DSK3GLQ082PROD 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 Assessing
impact of the NIOSH research 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 July 20, 2018 to obtain
comments from the public and affected
VerDate Sep<11>2014
18:47 Jun 25, 2019
Number of
respondents
Form name
Jkt 247001
Adult HIV Case Report ..................................
Pediatric HIV Case Report .............................
Case Report Evaluations ...............................
Case Report Updates ....................................
Laboratory Updates ........................................
Deduplication Activities ..................................
Investigation Reporting and Evaluation .........
Initial Cluster Report Form .............................
Cluster Follow-up Form ..................................
Cluster Close-out Form ..................................
Perinatal HIV Exposure Reporting (PHER) ...
Annual Reporting: Standards Evaluation Report (SER).
agencies. CDC received two 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
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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
59
59
59
59
59
59
59
59
59
59
16
59
Number of
responses per
respondent
854
3
86
2,353
9,410
2,741
901
2.5
5
2.5
197
1
Average
burden per
response
(in hours)
20/60
20/60
20/60
2/60
0.5/60
10/60
1/60
1
30/60
1
30/60
8
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
Assessing impact of the NIOSH
research—New—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Institute for
Occupational Safety and Health
(NIOSH) is responsible for conducting
research and making recommendations
E:\FR\FM\26JNN1.SGM
26JNN1
]]>Agencies
[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Notices]
[Pages 30118-30120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13521]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-0573]
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 National HIV Surveillance System (NHSS), 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 April 23rd, 2019 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 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
[[Page 30119]]
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 [email protected]. 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
National HIV Surveillance System (NHSS) (OMB No. 0920-0573,
Expiration 06/30/2019)--Revision--National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Collected with authorization under Sections 304 and 306 of the
Public Health Service Act (42 U.S.C. 242b and 242k) the National HIV
Surveillance System (NHSS) data are the primary data used to monitor
the extent and characteristics of the HIV burden in the United States.
HIV surveillance data are used to describe trends in HIV incidence,
prevalence and characteristics of infected persons and used widely at
the federal, state, and local levels for planning and evaluating
prevention programs and healthcare services, and to allocate funding
for prevention and care.
As science, technology, and our understanding of HIV have evolved,
the NHSS has been updated periodically. CDC in collaboration with
health departments in the 50 states, the District of Columbia, and U.S.
dependent areas, conducts national surveillance for cases of HIV
infection that includes critical data across the spectrum of HIV
disease from HIV diagnosis, to stage 3 (AIDS), the end stage disease
caused by infection with HIV, and death. In addition, this national
system provides essential data to estimate HIV incidence, monitor
patterns in HIV drug resistance and genetic diversity, identify and
respond to clusters of recent and rapid transmission, as well as
provide information on perinatal exposure to HIV in the United States.
The CDC surveillance case definition has been modified periodically to
accurately monitor disease in adults, adolescents and children and
reflect use of new testing technologies and changes in HIV treatment.
Information is then updated in the case report forms and reporting
software as needed.
In 2018, CDC implemented activities under a new cooperative
agreement PS18-1802: Integrated HIV Surveillance and Prevention
Programs for Health Departments. The purpose of PS18-1802 is to
implement a comprehensive HIV surveillance and prevention program to
prevent new HIV infections and achieve viral suppression among persons
living with HIV. These goals are in accordance with the CDC's and
national prevention goals, including the President's new initiative to
End the HIV Epidemic in America. This information collection request
revision includes activities to continue national surveillance program
activities and align with program priorities under the new cooperative
agreement (PS18-1802).
The revisions requested in this extension include minor
modifications to currently collected data elements and forms (including
the Adult Case Report Form (ACRF) and the Pediatric Case Report Form
(PCRF)), modifications to data system variables used to summarize
geocoded address data collected as part of the geocoding and data
linkage activities, addition of new cluster report forms for health
departments to report on progress for HIV cluster response activities
and addition of investigation reporting and evaluation activities to
account for additional data reported as part of these activities. No
changes are being requested to data elements collected on the Perinatal
HIV Exposure Reporting (PHER) form, but the number of jurisdictions
(respondents) completing the form has been reduced. Minor changes to
the information collected in the standards evaluation report form (SER)
are also requested to align with changes in program activities under
PS18-1802. Finally, we have updated our burden estimates to more
accurately reflect current data collection practices that are
summarized in the table below.
CDC provides funding for 59 jurisdictions to provide adult and
pediatric HIV case reports. Health department staff compile information
from laboratories, physicians, hospitals, clinics and other health care
providers to complete the HIV adult and pediatric case reports. CDC
estimates that on average, approximately 854 adult HIV case reports and
three pediatric case reports are processed by each health department
annually.
These data are recorded using standard case report forms either on
paper or electronically and entered into the electronic reporting
system. Updates to case reports are also entered into the reporting
system by health departments as additional information may be received
from laboratories, vital statistics, or additional providers.
Evaluations are also conducted by health departments on a subset of
case reports (e.g., re-abstraction, validation). CDC estimates that on
average approximately 86 evaluations of case reports, 2353 updates to
case reports and 9410 updates of electronic laboratory test data will
be processed by each of the 59 health departments annually. In
addition, all 59 health departments will conduct routine deduplication
activities for new diagnoses and cumulative case reports. CDC estimates
that health departments on average will follow-up on 2741 reports as
part of deduplication activities annually. Case report information
compiled over time by health departments is then de-identified and
forwarded to CDC on a monthly basis to become part of the national HIV
surveillance database.
When necessary additional information may be reported by health
departments for monitoring and evaluation of health department
investigations including activities identifying persons who are not in
HIV medical care and linking them to HIV medical care (e.g., Data-to-
Care activities) and other services and identifying and responding to
clusters. CDC estimates health departments will on average process 901
responses related to investigation reporting and monitoring annually.
Clusters of HIV are groups of persons related by recent, rapid
transmission, for which rapid response is needed in order to interrupt
ongoing transmission and prevent further HIV infections. Health
departments may detect clusters through multiple means, including
through routine analyses of Surveillance data and other data reported
to the NHSS. Data on clusters of recent and rapid HIV transmission in
the United States will be collected to monitor situations necessitating
public health intervention, assess health department response, and
evaluate outcomes of intervention activities. These summary data will
be collected through quarterly cluster report forms that will be
completed by health departments for clusters that they have identified
and for which they are actively conducting response activities. Health
departments will complete an initial cluster report form when a cluster
is first identified, a cluster follow-up form for each quarter in which
the cluster response remains
[[Page 30120]]
active and a cluster close-out form when cluster response activities
are closed or at annual intervals while a cluster response remains
active. Completion of forms will be determined by the number of
clusters detected. Health departments that do not identify recent and
rapid clusters of HIV transmission will not complete any cluster report
forms, while some jurisdictions will detect multiple recent and rapid
clusters of HIV transmission, necessitating the completion of multiple
cluster report forms. CDC estimates on average health departments will
provide information for 2.5 initial cluster reports, five Cluster
Follow-up reports, and 2.5 Cluster Close-out reports annually.
Perinatal HIV surveillance and prevention activities with HIV
exposure reporting and perinatal services coordination is an integrated
approach to advancing the progress toward perinatal HIV elimination
goals. A subset of 16 health departments in the most affected
jurisdictions will be reporting using the Perinatal Exposure Reporting
(PHER) form to monitor and evaluate perinatal HIV prevention efforts.
An estimated 197 reports containing perinatal exposure data elements
will be processed on average annually by each of the 16 health
departments reporting data collected as part of PHER. These
supplemental data are also reported monthly to CDC.
The Standards Evaluation Report (SER) is used by CDC and Health
Departments to improve data quality, interpretation, usefulness, and
surveillance system efficiency, as well as to monitor progress toward
meeting surveillance program objectives. The information collected for
the SER includes a brief set of questions about evaluation outcomes and
the collection of laboratory data that will be reported one time a year
by each 59 health departments. The total estimated annual burden hours
are 58,131.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Health Departments.................... Adult HIV Case Report... 59 854 20/60
Health Departments.................... Pediatric HIV Case 59 3 20/60
Report.
Health Departments.................... Case Report Evaluations. 59 86 20/60
Health Departments.................... Case Report Updates..... 59 2,353 2/60
Health Departments.................... Laboratory Updates...... 59 9,410 0.5/60
Health Departments.................... Deduplication Activities 59 2,741 10/60
Health Departments.................... Investigation Reporting 59 901 1/60
and Evaluation.
Health Departments.................... Initial Cluster Report 59 2.5 1
Form.
Health Departments.................... Cluster Follow-up Form.. 59 5 30/60
Health Departments.................... Cluster Close-out Form.. 59 2.5 1
Health Departments.................... Perinatal HIV Exposure 16 197 30/60
Reporting (PHER).
Health Departments.................... Annual Reporting: 59 1 8
Standards Evaluation
Report (SER).
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-13521 Filed 6-25-19; 8:45 am]
BILLING CODE 4163-18-P
