Notice2022-19564
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
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Published
September 12, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 175 (Monday, September 12, 2022)</title>
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[Federal Register Volume 87, Number 175 (Monday, September 12, 2022)]
[Notices]
[Pages 55812-55814]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-22-0573]
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 1, 2022, to obtain
comments from the public and affected agencies. CDC received two
comments related to the previous notice. No changes were made to the
information collection plan. 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;
[[Page 55813]]
(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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 Control No. 0920-0573,
Exp. 11/30/2022)--Revision--National Center for HIV, 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, to allocate funding for
prevention and care, and to monitor progress toward achieving national
prevention goals of the Ending the HIV Epidemic in the U.S initiative.
The Division of HIV Prevention (DHP), National Center for HIV,
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC, in
collaboration with health departments in the states, the District of
Columbia, and U.S. dependent areas, conducts national surveillance for
cases of HIV infection that includes critical data reported across the
spectrum of HIV disease stages from HIV diagnosis to death. NHSS data
collection activities are currently supported through cooperative
agreements with health departments under CDC Funding Opportunity
Announcements PS18-1802: Integrated HIV Surveillance and Prevention
Programs for Health Departments; PS20-2010: Integrated HIV Programs for
Health Departments to Support Ending the HIV Epidemic in the United
States; PS18-1801: Accelerating the Prevention and Control of HIV/AIDS,
Viral Hepatitis, STDs, and TB in the U.S.--Affiliated Pacific Islands;
and PS23-2302: Accelerating the Prevention and Control of HIV, Viral
Hepatitis, STDs, and TB in the U.S. Affiliated Pacific Islands.
The systematic data collection in NHSS provides the essential data
used to calculate population-based HIV incidence estimates, describe
the geographic distribution of disease, monitor HIV transmission and
drug resistance patterns and genetic diversity of HIV among infected
persons, detect and respond to HIV clusters of recent and rapid
transmission, and monitor perinatal exposures. NHSS data are also used
locally to identify persons with HIV who are not in medical care and
linking them to care and needed services. Describing geographic
distribution allows CDC to assess social determinants of health in the
context of HIV which allows identification health inequities, and
guides steps to address and monitor the health equity over time moving
forward. NHSS data continue to be collected, maintained, and reported
using standard case definitions, report forms and software. The system
is periodically updated to keep pace with changes in testing technology
and advances in HIV care and treatment, as well as changing prevention
program monitoring and evaluation needs.
The changes requested in this Revision include program-initiated
modifications to currently collected data elements and forms including
changes to the Adult Case Report Form (ACRF), the Pediatric Case Report
Form (PCRF), the Perinatal HIV Exposure Reporting (PHER)form, and the
Standards Evaluation Report (SER). We request approval to continue data
collection using our currently approved data collection instruments
through December 2022 and implement the proposed form changes starting
in January 2023.
Changes include minor modifications to dates and time periods in
the SER to align with information needs and assess program performance
the next report cycle in 2023. Changes made to both the ACRF and PCRF
include addition of two variables to collect sexual orientation
information and updated gender identity response options. Modification
of the gender identity response options and collection of a new
variable on sexual orientation proposed in this revision will allow CDC
to better address prevention needs of sexual minority populations
(e.g., including lesbian, gay, bisexual and transgender (LGBT)
populations). In addition, to better reflect the most recent changes in
testing technology in the data collection, two new HIV test types have
been added and two new response options related to self-testing have
been added. Finally, three new HIV testing history variables to
summarize self-testing activities have been added to the ACRF (only)
and formatting changes have been made to improve usability of both
forms.
Critical perinatal exposure information has been consolidated
across the PHER and PCRF to one revised PCRF form to reduce redundancy
and include some new and revised data elements needed to assess
progress with perinatal elimination efforts and support HIV prevention
activities. In all, 10 variables in the PHER form will no longer be
collected; 7 variables from the PHER form were combined with existing
variables on the PCRF; 13 variables were moved from the PHER form to
the new PCRF; 5 new variables were added to the PCRF including 4
related to breastfeeding/chestfeeding and premastication risk behaviors
and one variable related to documentation of laboratory results in a
person's labor and delivery record; response options for the existing
delivery method variable were revised on the PCRF to align with current
medical practices.
Health departments will use the revised PCRF form to report both
perinatal exposures and pediatric case reports. The number of
jurisdictions that will submit pediatric case reports is 59 and a
subset will also report perinatal exposure information using the
revised PCRF form. The estimated burden per response for the PCRF has
been revised from an average of 20 minutes to 35 minutes per response
to account for these changes and increased reporting of perinatal
exposure data elements.
Burden estimates have been revised to reflect program changes when
needed. HIV Incidence data collection is being discontinued as a
separate activity and removed from the ICR. HIV incidence continues to
be estimated by CDC via statistical methods. Burden estimates have been
updated to reflect the
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discontinuation of incidence data collection, discontinued use of the
PHER form for perinatal exposure reporting, and the revised PCRF.
Additionally, the revised burden estimate includes small increases in
burden for case and laboratory updates, deduplication activities and
increased case investigations due to the increase in the number of
persons living with HIV, requiring additional laboratory and case
information reporting and linkage to care activities. Small decreases
were made to the burden estimates for case reports to account for
decreases in adult and pediatric HIV diagnoses reported.
Health department staff compile information from laboratories,
physicians, hospitals, clinics, and other health care providers to
complete the HIV adult and pediatric case and perinatal exposure
reports. These data are recorded using standard report forms either on
paper or electronically and entered in the electronic reporting system.
CDC estimates that approximately 789 adult HIV case reports and 57
perinatal exposure and pediatric case reports are processed by each
health department annually.
Updates to case reports are also entered into the reporting system
by health departments if additional information is received from
laboratories, vital statistics, or additional providers. Health
departments also conduct evaluations on a subset of case reports (e.g.,
re-abstraction, validation). CDC estimates that on average
approximately 85 evaluations of case reports, 2,519 updates to case
reports and 10,130 updates of electronic laboratory test data will be
processed by each of the 59 health departments annually. All 59 health
departments will also conduct routine deduplication activities for new
diagnoses and cumulative case reports. CDC estimates that health
departments on average will follow-up on 3,032 reports as part of
deduplication activities annually. Case report information is compiled
over time by health departments, de-identified and forwarded to CDC on
monthly basis for inclusion in the national HIV surveillance database.
Additional information will be reported by health departments for
monitoring and evaluation of health department investigations,
including activities to identify persons who are not in HIV medical
care, linking them to HIV medical care (e.g., Data-to-Care activities)
and other services and for identifying and responding to clusters. CDC
estimates health departments will on average process 929 responses
related to investigation reporting and monitoring annually.
Health departments actively review HIV surveillance and other data
to detect clusters that include groups of persons with HIV related by
recent and rapid transmission. Data on clusters will be collected to
monitor situations necessitating public health intervention, assess
health department response, and evaluate outcomes of intervention
activities. Health departments with detected clusters 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. CDC estimates on average health departments will
provide information for 2.5 initial cluster reports, five Cluster
Follow-up Form reports, and 2.5 Cluster Close-out Form reports
annually.
The annual 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.
OMB approval is requested for three years. The total estimated
annualized burden in hours is 60,731. There are no costs to the
respondents other than time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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Health Departments.................... Adult HIV Case Report 59 789 20/60
(ACRF).
Health Departments.................... Perinatal Exposure and 59 57 35/60
Pediatric HIV Case
Report (PCRF).
Health Departments.................... Case Report Evaluations. 59 85 20/60
Health Departments.................... Case Report Updates..... 59 2,519 2/60
Health Departments.................... Laboratory Updates...... 59 10,130 0.5/60
Health Departments.................... Deduplication Activities 59 3,032 10/60
Health Departments.................... Investigation Reporting 59 929 1/60
and Evaluation.
Health Departments.................... Initial Cluster Report 59 2.5 1
Form.
Health Departments.................... Cluster Follow-up Form.. 59 5 0.5
Health Departments.................... Cluster Close-out Form.. 59 2.5 1
Health Departments.................... Annual Reporting: 59 1 8
Standards Evaluation
Report (SER).
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-19564 Filed 9-9-22; 8:45 am]
BILLING CODE 4163-18-P
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