05-16370. 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 [e-mail].

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 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

Form	Number of respondents	Number of responses	Burden per response (in hours)	Total burden (in hours)
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

Dated: August 11, 2005.

Joan F. Karr,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.