[Federal Register Volume 70, Number 159 (Thursday, August 18, 2005)]
[Notices]
[Pages 48551-48553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16370]


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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 [email protected].
    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
                                                 -----------------
    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]
BILLING CODE 4163-18-P