[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7800-7802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03046]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-0573]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of
[[Page 7801]]
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 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]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
National HIV Surveillance System (NHSS) (OMB Control No. 0920-0573,
Expires 02/29/2016)--Revision--National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Data collected as part of the National HIV Surveillance System
(NHSS) are the primary data used to monitor the impact of HIV infection
in the United States. The NHSS provides critical data that are used to
describe the incidence and prevalence of HIV disease and the
characteristics of infected persons. HIV surveillance data are used
widely at the local, state and national levels for planning, evaluation
and allocation of funding for HIV prevention and care programs.
The NHSS has been updated periodically as science, technology, and
our understanding of HIV has evolved. 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 and monitor
patterns in HIV drug resistance and genetic diversity, 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 2014, following extensive consultation and peer review, CDC and
the Council of State and Territorial Epidemiologists (CSTE) revised and
combined the surveillance case definitions for human immunodeficiency
virus (HIV) infection into a single case definition for persons of all
ages. Laboratory criteria for defining a confirmed case now accommodate
new multi-test algorithms, including criteria for differentiating
between HIV-1 and HIV-2 infection and for recognizing early HIV
infection. Clinical (non-laboratory) criteria for defining a case for
surveillance purposes have been made more practical by eliminating the
requirement for information about laboratory tests. The surveillance
case definition is intended primarily for monitoring the HIV infection
burden and planning for prevention and care on a population level, not
as a basis for clinical decisions for individual patients. CDC and CSTE
recommend that all states and territories conduct case surveillance of
HIV infection using this revised surveillance case definition.
Modifications to data elements to accommodate the 2014 HIV case
surveillance definition were approved in the last renewal of OMB
Control No. 0920-0573. The revisions requested in this extension
include modifications to currently collected data elements and forms to
accommodate new testing technologies as well as clinical practice
guidelines. Specifically, the HIV Testing and Antiretroviral Use
History section will be revised on the adult/adolescent and pediatric
case report forms to include new laboratory tests, additional
information on use of antiretrioviral (ARV) medications for pre-
exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP),
prevention of mother-to-child-transmission among HIV infected women
during pregnancy, and hepatitis B virus (HBV) treatment. Other changes
include addition of dates to the address and patient ID fields to
better track residence information and minor formatting changes to the
form used for Perinatal HIV Exposure Reporting (PHER).
The revisions to this request also include the addition of burden
hours for annual reporting by health departments for the Standards
Evaluation Report (SER) and Annual Performance Report (APR). Findings
from these reports are used to improve data quality and ensure the
accuracy, timeliness, and completeness of the national HIV
surveillance, as well as to monitor performance and progress in
achieving both state and national HIV surveillance program objectives.
Fifty-nine health departments funded for HIV surveillance will report a
Standards Evaluation Report (SER) and APR annually.
CDC provides funding for 59 health departments to conduct adult and
pediatric HIV case surveillance and report information to CDC. Health
department staff compile information from laboratories, physicians,
hospitals, clinics and other health care providers to complete adult
and adolescent and pediatric HIV confidential case reports. Updates to
case reports are also entered into an electronic database by health
departments, as additional information may be received from
laboratories, vital statistics offices, or additional providers.
Evaluations are also conducted by health departments on a subset of
case reports (e.g., re-abstraction/validation activities and routine
interstate de-duplication) in all jurisdictions.
Supplemental surveillance data are collected in a subset of areas
to provide additional information necessary to estimate HIV incidence,
to better describe the extent of HIV viral resistance and quantify HIV
subtypes among persons infected with HIV and to monitor and evaluate
perinatal HIV prevention efforts. Health departments funded for these
supplemental data collections obtain this information from
laboratories, health care providers, and medical records. CDC estimates
that 25 health departments will be reporting data elements containing
HIV Incidence Surveillance (HIS) data, 53 health departments will
report additional data elements on HIV nucleotide sequences as part of
Molecular HIV Surveillance (MHS), and 35 areas will be reporting data
as part of 35 health departments will be reporting data collected as
part of Perinatal HIV Exposure Reporting (PHER) annually. The total
estimated annual burden hours are 50,504.
[[Page 7802]]
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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Health Departments................... Adult HIV Case Report.. 59 1,061 20/60
Health Departments................... Pediatric HIV Case 59 5 20/60
Report.
Health Departments................... Case Report Evaluations 59 107 20/60
Health Departments................... Case Report Updates.... 59 1,576 2/60
Health Departments................... Laboratory Updates..... 59 6,303 1/60
Health Departments................... HIV Incidence 25 2,288 10/60
Surveillance (HIS).
Health Departments................... Molecular HIV 53 829 5/60
Surveillance (MHS).
Health Departments................... Perinatal HIV Exposure 35 114 30/60
Reporting (PHER).
Health Departments................... Annual Reporting: 59 1 8
Standards Evaluation
Report (SER).
Health Departments................... Annual Reporting: 59 1 42
Annual Performance
Report (APR).
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-03046 Filed 2-12-16; 8:45 am]
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