[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]


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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

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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