[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