[Federal Register: August 18, 2005 (Volume 70, Number 159)]
[Notices]
[Page 48551-48553]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au05-43]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-05-0573]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-371-5983
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Adult and Pediatric HIV/AIDS Confidential Case Reports (OMB Control
No. 0920-0573)--Revision-National Center for HIV, STD, and TB
Prevention (NCHSTP), Divisions of HIV/AIDS Prevention, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC is seeking a 3-year approval from the Office of Management and
Budget (OMB) to continue data collection of the HIV/AIDS case reports.
CDC is proposing to collect additional data on testing history for
improved monitoring of HIV incidence (HIV testing history pre-test and
post-test data collection forms), on specimen quality and
[[Page 48552]]
sequence information for drug resistance and HIV-1 subtype
surveillance.
The National Adult and Pediatric HIV/AIDS Confidential Case Reports
are collected as part of the HIV/AIDS Surveillance System. CDC in
collaboration with health departments in the states, territories, and
the District of Columbia, conducts national surveillance for cases of
HIV infection and AIDS, the end-stage of disease caused by infection
with HIV. HIV/AIDS surveillance data collection by CDC is authorized
under Sections 301 and 306 of the Public Health Service Act (42 U.S.C.
241 and 242k).
Currently, 59 areas (states/territories/possessions) mandate and
collect AIDS surveillance data. In addition, 43 areas currently mandate
and collect confidential name-based surveillance data on HIV cases
which have not progressed to AIDS in adults/adolescents and/or children
using the HIV case report forms. We anticipate that over the next 3
years additional areas will mandate collection of name-based HIV
surveillance data. Therefore, the estimated burden for the next 3 years
is based on HIV case reporting in 59 areas. Respondents in this data
collection are state, local, and territorial health departments. The
purpose of HIV/AIDS surveillance data is to monitor trends in HIV/AIDS
and describe the characteristics of infected persons (e.g.,
demographics, modes of exposure to HIV, clinical and laboratory markers
of HIV disease, manifestations of severe HIV disease, and deaths due to
AIDS). Because HIV infection results in untimely death and most often
infects younger adults in the prime years of life, large amounts of
federal, state, and local government funding have been allocated to
address all aspects of HIV infection, including prevention and
treatment. HIV/AIDS surveillance data are widely used at all government
levels to assess the impact of HIV infection on morbidity and
mortality, to allocate medical care resources and services, and to
guide prevention and disease control activities.
HIV/AIDS reports are sent to state/local health departments by
laboratories, physicians, hospitals, clinics, and other health care
providers using standard adult and pediatric case report forms. Areas
use a microcomputer system developed by CDC (the HIV/AIDS Reporting
System, HARS) to store and analyze data, as well as transmit encrypted
data to CDC. A Public Health Information Network (PHIN) compliant HIV
reporting system is currently in development and is scheduled to
replace HARS by 2007.
This request to OMB includes one modification to both the Adult/
Adolescent and Pediatric HIV/AIDS confidential case report forms. The
forms to be used during this period will include an additional blank
space in the top and bottom portions of the forms. Areas could then
have the option of using this space to assign a form number. This form
number would be for local use only and not be reported to CDC.
The burden estimate for this renewal includes estimated burden for
evaluations of HIV/AIDS surveillance based on these forms. In addition,
the burden estimate also includes forms that will be used to collect
additional data on testing history for the purpose of estimating HIV
incidence. The availability of a serologic testing algorithm for recent
HIV seroconversion (STARHS) allows surveillance systems to determine
how many among a group of new diagnoses are from new infections. In
order to derive a population-based estimate of HIV incidence based on
data from those individuals who choose to have an HIV antibody test and
who test positive (those reported to HIV surveillance systems),
additional data are needed to assign statistical weights to individual
STARHS results. These additional data include information on
individual's reason for testing, the frequency with which he/she tests,
place where he/she was tested, when he/she was most recently tested,
when he/she was first tested, whether he/she has ever tested negative,
and questions regarding use of HIV-related medicines.
The table also includes burden estimates of additional information
on specimen quality and genotyping test results for drug resistance and
HIV-1 subtypes as part of variant, atypical and resistant HIV
surveillance (VARHS). These data will be reported to CDC by
participating health departments for the purpose of calculating
population-based estimates of prevalence of HIV drug resistance and
HIV-1 subtypes among individuals with newly diagnosed HIV. These data
are provided routinely by the testing laboratory to health departments
requiring no additional data collection form.
No other Federal agency collects this type of national HIV/AIDS
data. In addition to providing technical assistance for use of the case
report forms, CDC also provides reporting areas with technical support
for the HARS software. There is no cost to respondents other than their
time.
Estimate of Annualized Burden Table
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Burden per
Form Number of Number of response (in Total burden
respondents responses hours) (in hours)
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Adult Case Report: AIDS......................... 59 814 10/60 8,004
Adult Case Report: HIV.......................... 59 809 10/60 7,955
Peds Case Report: AIDS.......................... 59 2 10/60 20
Peds Case Report: HIV........................... 59 9 10/60 89
HIV Testing History Form Pre-test version....... 6 1,577 2/60 315
HIV Testing History Form Post-test version...... 24 1,577 2/60 1,262
VARHS........................................... 24 1,577 0.5/60 315
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Total....................................... .............. .............. .............. 17,960
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[[Page 48553]]
Dated: August 11, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-16370 Filed 8-17-05; 8:45 am]
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