[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Notices]
[Pages 16868-16870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08152]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-19-0573; Docket No. CDC-2019-0034]


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.

-----------------------------------------------------------------------

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 a proposed 
information collection project titled National HIV Surveillance System 
(NHSS). This data collection is for continuation of the National HIV 
Surveillance System which provides the primary population-based data 
used to describe the epidemiology of HIV in the United States including 
adult/adolescent and pediatric HIV case reporting, case report 
evaluations and updates, laboratory updates, deduplication activities, 
investigation reporting and evaluation, cluster reporting, perinatal 
HIV exposure reporting, and annual reporting of the standards 
evaluation report.

DATES: CDC must receive written comments on or before June 24, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0034 by any 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-D74, 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-D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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; and

[[Page 16869]]

    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.
    5. Assess information collection costs.

Proposed Project

    National HIV Surveillance System (NHSS) (OMB Control 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

    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 infected persons and used 
widely at the federal, state, and local levels for planning and 
evaluating prevention programs and health-care services, and 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 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 and identify and respond to 
clusters of recent and rapid transmission, as well as provide 
information on perinatal exposures 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. In particular, the activities funded under the 
announcement 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. 
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 (e.g., adjusting 
the average burden per response for electronic laboratory updates and 
including a separate line item for deduplication activities previously 
included with case report evaluations and including new cumulative 
deduplication activities).
    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 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 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

[[Page 16870]]

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 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 cluster 
initial cluster reports, five Cluster Follow-up Form reports, and 2.5 
Cluster Close-out Form 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.

                                   Table 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per  response   Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Health Departments............  Adult HIV Case                59             854           20/60          16,795
                                 Report.
Health Departments............  Pediatric HIV                 59               3           20/60              59
                                 Case Report.
Health Departments............  Case Report                   59              86           20/60           1,691
                                 Evaluations.
Health Departments............  Case Report                   59           2,353            2/60           4,627
                                 Updates.
Health Departments............  Laboratory                    59           9,410          0.5/60           4,627
                                 Updates.
Health Departments............  Deduplication                 59           2,741           10/60          26,953
                                 Activities.
Health Departments............  Investigation                 59             901            1/60             886
                                 Reporting and
                                 Evaluation.
Health Departments............  Initial Cluster               59             2.5               1             148
                                 Report Form.
Health Departments............  Cluster Follow-               59               5           30/60             148
                                 up Form.
Health Departments............  Cluster Close-                59             2.5               1             148
                                 out Form.
Health Departments............  Perinatal HIV                 16             197           30/60           1,576
                                 Exposure
                                 Reporting
                                 (PHER).
Health Departments............  Annual                        59               1               8             472
                                 Reporting:
                                 Standards
                                 Evaluation
                                 Report (SER).
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          58,129
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-08152 Filed 4-22-19; 8:45 am]
BILLING CODE 4163-18-P