[Federal Register Volume 87, Number 175 (Monday, September 12, 2022)]
[Notices]
[Pages 55812-55814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------


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