[Federal Register Volume 71, Number 220 (Wednesday, November 15, 2006)]
[Notices]
[Pages 66530-66531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19258]



[[Page 66530]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-07-0573]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 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), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC is seeking a three-year OMB approval to continue data 
collection of the HIV/AIDS case reports with revision of currently 
approved data collection. Revisions include additional data elements on 
testing and treatment, specimen quality and sequence information for 
drug resistance and HIV-1 subtypes, and clinical and behavioral 
information on HIV-infected mothers and their infants.
    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 59 reporting areas (states, 
territories, possessions, and the District of Columbia), conducts 
national surveillance for cases of human immunodeficiency virus (HIV) 
infection and the acquired immunodeficiency syndrome (AIDS), the end-
stage of disease caused by infection with HIV. HIV/AIDS surveillance 
data collection by CDC is authorized and protected under Section 306 of 
the Public Health Service Act (42 U.S.C. 242k).
    Currently, all 59 areas mandate and collect AIDS surveillance data. 
In addition, 50 of the areas currently mandate and collect confidential 
name-based surveillance data on HIV cases which have not progressed to 
AIDS. The Adult HIV/AIDS Confidential Case Report form is used for 
patients >= 13 years of age. The Pediatric HIV/AIDS Confidential Case 
Report form is used for patients <= twelve years of age at the time of 
diagnosis. We anticipate that over the next three years all 59 areas 
will mandate collection of confidential name-based HIV surveillance 
data. Therefore, the estimated burden for the next three years is based 
on HIV case reporting in 59 areas.
    The purpose of HIV/AIDS surveillance data is to monitor trends in 
HIV/AIDS and describe the characteristics of infected persons (e.g., 
demographics, risk behaviors, 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 the only nationally available data on persons 
reported with HIV and AIDS and 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 case reports are sent to state/local health departments by 
laboratories, physicians, hospitals, clinics, and other health care 
providers. 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. An improved HIV reporting system 
(eHARS) is currently in development and is scheduled to replace HARS 
during the period of this clearance.
    We anticipate making a modification to the layout of both the Adult 
and the Pediatric HIV/AIDS confidential case report forms during this 
period which would include the addition of a blank space in the top 
portion and bottom portion of the forms. Areas could then have the 
option of using this space to assign a local form number. This form 
number would be for local use only and not be reported to CDC.
    The burden estimate for this revision includes estimated burden for 
evaluations of HIV/AIDS surveillance and case report updates. In 
addition, the burden estimate also includes additional data on HIV 
testing and treatment 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 STARHS results, 
information on testing reason, frequency, location, dates tested, prior 
positive and negative tests, and use of HIV-related medicines.
    The table also includes burden estimates of additional information 
requested 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.
    The burden estimate also includes enhanced data collection on HIV-
infected mothers and their infants in 15 areas. Proposed data 
collection for enhanced perinatal surveillance (EPS) will supplement 
information collected on both the adult and pediatric case report form 
and include data on prenatal care, clinical history, testing, and 
antiretroviral therapy. These clinical and behavioral data will be used 
to better monitor the effects of HIV testing, prevention, and treatment 
guidelines and to maximally reduce perinatal HIV transmission.
    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. The total 
estimated annual burden hours are 57,774.

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                                        Estimated Annualized Burden Hours
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                                                                                      Average         Average
                                                                     Number of       number of      burden per
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
State Health Departments..............  Adult Case Report: AIDS.              59             890         \20/60\
                                        Adult Case Report: HIV..              59             932         \20/60\
State Health Departments..............  Peds Case Report: AIDS..              59               3         \20/60\
                                        Peds Case Report: HIV...              59              11         \20/60\
State Health Departments..............  Case Report Updates.....              59              85          \5/60\
State Health Departments..............  Incidence...............              30           2,833         \10/60\
State Health Departments..............  VARHS...................              24           2,917          \5/60\
State Health Departments..............  EPS.....................              15             200         \25/60\
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    Dated: November 8, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E6-19258 Filed 11-14-06; 8:45 am]
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