Federal Register Notice

Att 2_ 60 Day FRN_0920-0573.pdf

National HIV Surveillance System (NHSS)

Federal Register Notice

OMB: 0920-0573

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National HIV Surveillance System (NHSS)

Attachment 2.
60 Day Federal Register Notice

16868

Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices

to www.grantssolutions.gov on an
annual basis to satisfy routine
cooperative agreement reporting
requirements.
CDC will use the information
collected to monitor each awardee’s
progress and to identify facilitators and
challenges to program implementation
and achievement of outcomes.
Monitoring allows CDC to determine
whether an awardee is meeting
performance and budget goals and to

the burden of chronic diseases. Finally,
the information collection will allow
CDC to monitor the increased emphasis
on partnerships and programmatic
collaboration, and is expected to reduce
duplication of effort, enhance program
impact and maximize the use of federal
funds. OMB approval is requested for
three years. Participation in the
information collection is required as a
condition of funding. There are no costs
to respondents other than their time.

make adjustments in the type and level
of technical assistance provided to
them, as needed, to support attainment
of their performance measures.
Monitoring and evaluation activities
also allow CDC to provide oversight of
the use of federal funds, and to identify
and disseminate information about
successful prevention and control
strategies implemented by awardees.
These functions are central to
NCCDPHP’s broad mission of reducing

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

State Tobacco Control Managers .....

Annual Work Plan Progress Report
Annual Budget Progress Report ......
Annual
Performance
Measures
Progress Report.
Annual CMI Progress Report ...........
Annual APR Report ..........................

53
53
53

1
1
1

6
5
5

318
265
265

53
53

1
1

3
18

159
954

...........................................................

........................

........................

........................

1,961

Total ...........................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–08153 Filed 4–22–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–19–0573; Docket No. CDC–2019–
0034]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled National HIV Surveillance System
(NHSS). This data collection is for
continuation of the National HIV
Surveillance System which provides the

SUMMARY:

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Number of
respondents

Type of respondents

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17:49 Apr 22, 2019

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primary population-based data used to
describe the epidemiology of HIV in the
United States including adult/
adolescent and pediatric HIV case
reporting, case report evaluations and
updates, laboratory updates,
deduplication activities, investigation
reporting and evaluation, cluster
reporting, perinatal HIV exposure
reporting, and annual reporting of the
standards evaluation report.
DATES: CDC must receive written
comments on or before June 24, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0034 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and

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Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and

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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices
4. 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 submissions
of responses.
5. Assess information collection costs.

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Proposed Project
National HIV Surveillance System
(NHSS) (OMB Control 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
CDC is authorized under Sections 304
and 306 of the Public Health Service Act
(42 U.S.C. 242b and 242k) to collect
information on cases of human
immunodeficiency virus (HIV) and
indicators of HIV disease and HIV
disease progression including AIDS.
Data collected as part of the National
HIV Surveillance System (NHSS) 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 health-care
services, and 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 AIDS, the endstage 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 and identify and
respond to clusters of recent and rapid
transmission, as well as provide
information on perinatal exposures 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.

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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. In particular, the activities
funded under the announcement
promote and support improving health
outcomes for persons living with HIV
through achieving and sustaining viral
suppression, and reducing healthrelated disparities by using quality,
timely, and complete surveillance and
program data to guide HIV prevention
efforts. 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
(e.g., adjusting the average burden per
response for electronic laboratory
updates and including a separate line
item for deduplication activities
previously included with case report
evaluations and including new
cumulative deduplication activities).
CDC provides funding for 59
jurisdictions to provide adult and
pediatric HIV case reports. Health
department staff compile information
from laboratories, physicians, hospitals,

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16869

clinics and other health care providers
to complete the HIV adult and pediatric
case reports. CDC estimates that
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 intervene to interrupt ongoing
transmission and prevent future 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

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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices

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 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 cluster initial cluster reports, five
Cluster Follow-up Form reports, and 2.5
Cluster Close-out Form 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.

TABLE 1—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

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

......
......
......
......
......
......
......
......
......
......
......
......

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).

59
59
59
59
59
59
59
59
59
59
16
59

854
3
86
2,353
9,410
2,741
901
2.5
5
2.5
197
1

20/60
20/60
20/60
2/60
0.5/60
10/60
1/60
1
30/60
1
30/60
8

16,795
59
1,691
4,627
4,627
26,953
886
148
148
148
1,576
472

Total .......................

..............................................................................

........................

........................

........................

58,129

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–08152 Filed 4–22–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; National
and Tribal Evaluation of the 2nd
Generation of the Health Profession
Opportunity Grants (OMB #0970–0462)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
jbell on DSK3GLQ082PROD with NOTICES

Number of
respondents

Form name

The Administration for
Children and Families (ACF), U.S.
Department of Health and Human

SUMMARY:

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17:49 Apr 22, 2019

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Services (HHS) is proposing data
collection activities as part of the Health
Profession Opportunity Grants (HPOG)
to Serve TANF Recipients and Other
Low Income Individuals. ACF has
developed a multi-pronged research and
evaluation approach for the HPOG
Program to better understand and assess
the activities conducted and their
results. Two rounds of HPOG grants
have been awarded—the first in 2010
(HPOG 1.0) and the second in 2015
(HPOG 2.0). There are federal
evaluations associated with each round
of grants. HPOG grants provide funding
to government agencies, communitybased organizations, post-secondary
educational institutions, and tribalaffiliated organizations to provide
education and training services to
Temporary Assistance for Needy
Families (TANF) recipients and other
low-income individuals, including
tribal members. Under HPOG 2.0, ACF
provided grants to five tribal-affiliated

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organizations and 27 non-tribal entities.
OMB previously approved data
collection under OMB Control Number
0970–0462 for the HPOG 2.0 National
and Tribal Evaluation. The first
submission, approved in August 2015,
included baseline data collection
instruments and the grant performance
management system. A second
submission, approved in June 2017,
included additional data collection for
the National Evaluation impact study,
the National Evaluation descriptive
study, and the Tribal Evaluation. A
third submission for National
Evaluation impact study data collection
was approved in June 2018. The
proposed data collection activities
described in this Federal Register
Notice will provide data for the impact,
descriptive, and cost benefit studies of
the 27 non-tribal grantees participating
in the National Evaluation of HPOG 2.0.
Comments due within 30 days of
publication. OMB is required to make a

DATES:

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