[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Notices]
[Pages 19097-19100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-22-0573; Docket No. CDC-2022-0041]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: 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 an information 
collection project titled National HIV Surveillance System (NHSS). The 
NHSS is designed to collect information on cases of human 
immunodeficiency virus (HIV) and indicators of HIV disease and HIV 
disease progression including AIDS. Data is used to monitor the extent 
and characteristics of the HIV burden in the United States.

DATES: CDC must receive written comments on or before May 31, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0041 by either 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 H21-8, 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 Prevention, 1600 Clifton 
Road NE, MS

[[Page 19098]]

H21-8, Atlanta, Georgia 30329; phone: 404-639-7118; 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;
    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; and
    5. Assess information collection costs.

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

    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 persons diagnosed with HIV 
infection and used widely at the federal, state, and local levels for 
planning and evaluating prevention programs and health-care services, 
allocating funding for prevention and care, and monitoring progress 
toward achieving national prevention goals of the Ending the HIV 
Epidemic in the U.S. initiative.
    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 and PS20-2010 Integrated HIV 
Programs for Health Departments to Support Ending the HIV Epidemic in 
the United States. The activities funded under these announcements 
promote and support improving health outcomes for persons living with 
HIV through achieving and sustaining viral suppression, and reducing 
health-related disparities by using quality, timely, and complete 
surveillance, and program data to guide HIV prevention efforts toward 
reducing new HIV infections and ending the HIV epidemic in the United 
States.
    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. The systematic data 
collection 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. NHSS data continue to be collected, maintained, and reported 
using standard case definitions, report forms and software. The system 
is periodically updated as needed 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 revisions requested in this package 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)and the Perinatal HIV Exposure Reporting (PHER) form. 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 
made to both the ACRF and PCRF include addition of two variables to 
collect sexual orientation information, updated gender identity 
response options, addition of two new HIV test types to accommodate 
changes in testing technology, addition of two new response options 
related to self-testing, addition of three new HIV testing history 
variables to summarize self-testing activities (ACRF only) and 
formatting changes to improve usability of both forms. The main changes 
to the PCRF include those related to critical perinatal exposure 
information that was consolidated across the PHER and PCRF to reduce 
redundancy across forms and include some new and revised data elements 
needed to assess progress with perinatal elimination efforts and 
support HIV prevention activities. Combining the PCRF and PHER forms 
reduced the total number of pages of information collected from two 
forms with eight total pages to one form with six pages which will 
reduce burden of data collection and increase usability of the forms. 
In all, 10 variables in the PHER form will no longer be collected; 
seven 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; five new variables were added to the PCRF including four 
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 was revised on the PCRF to align with current 
medical practices. Health departments will now use the one revised PCRF 
form to report perinatal exposures and pediatric case reports and the 
revised burden for both perinatal exposure reporting and pediatric case 
reporting is now combined and included under the PCRF form line. The 
number of respondents reporting pediatric case reports is 59 and a 
subset of those jurisdictions that have perinatal exposure reporting 
will also report some perinatal exposure

[[Page 19099]]

information using the revised PCRF form and the PCRF burden estimate 
has been revised to account for this reporting. The time per response 
for the PCRF has been revised from 20 minutes to 35 minutes on average 
per response to reflect these changes and increased reporting of 
perinatal exposure data elements. HIV Incidence data collection as 
anticipated in the previous revision was not implemented and is being 
discontinued as a separate activity. HIV incidence continues to be 
estimated by CDC via statistical methods. No other revisions to the 
other data collection forms for this ICR are proposed. Burden estimates 
have been updated to reflect the discontinuation of incidence data 
collection, discontinued use of the PHER form for perinatal exposure 
reporting, and revised PCRF which will be used for both perinatal 
exposure reporting and pediatric case reporting. In addition, the 
revised burden estimate includes small increases in burden for case and 
laboratory updates, deduplication activities and case investigations 
due to the increasing number of persons living with HIV for which 
additional laboratory and case information is reported and linkage to 
care activities are conducted. The burden estimates for case reports 
decreased slightly since the last OMB approval due to decreases in 
adult and pediatric HIV diagnoses reported.
    CDC provides funding for 59 jurisdictions to provide adult and 
pediatric HIV case reports. Additional information on perinatal 
exposures is also reported in a subset of jurisdictions when reportable 
using the same pediatric case report form and used to monitor progress 
toward perinatal HIV elimination goals. 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 approximately 789 adult HIV case 
reports and 57 perinatal exposure and 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 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. 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 3,032 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.
    Additional information will 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 929 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 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 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 cluster initial cluster 
reports, five Cluster Follow-up Form reports, and 2.5 Cluster Close-out 
Form reports annually.
    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.
    CDC requests OMB approval for an estimated 60,731 annual burden 
hours in this Revision. There are no costs to respondents other than 
their time to participate.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response  (in      (in hr)
                                                                    respondent          hr)
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Health Departments............  Adult HIV Case                59             789           20/60          15,517
                                 Report (ACRF).
Health Departments............  Perinatal                     59              57           35/60           1,962
                                 Exposure and
                                 Pediatric HIV
                                 Case Report
                                 (PCRF).
Health Departments............  Case Report                   59              85           20/60           1,672
                                 Evaluations.
Health Departments............  Case Report                   59           2,519            2/60           4,954
                                 Updates.
Health Departments............  Laboratory                    59          10,130          0.5/60           4,981
                                 Updates.
Health Departments............  Deduplication                 59           3,032           10/60          29,815
                                 Activities.
Health Departments............  Investigation                 59             929            1/60             914
                                 Reporting and
                                 Evaluation.
Health Departments............  Initial Cluster               59             2.5               1             148
                                 Report Form.
Health Departments............  Cluster Follow-               59               5             0.5             148
                                 up Form.

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Health Departments............  Cluster Close-                59             2.5               1             148
                                 out Form.
Health Departments............  Annual                        59               1               8             472
                                 Reporting:
                                 Standards
                                 Evaluation
                                 Report (SER).
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          60,731
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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. 2022-06917 Filed 3-31-22; 8:45 am]
BILLING CODE 4163-18-P