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Notice

Agency Forms Undergoing Paperwork Reduction Act Review

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Information about this document as published in the Federal Register.

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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 (404) 639-7570 or send an email to omb@cdc.gov. Send written comments to 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

The National HIV Surveillance System (NHSS) (OMB No. 0920-0573, Expiration 01/31/2013)-Revision- National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). This title is being changed from the previously approved title Adult and Pediatric HIV/AIDS Confidential Case Reports for National HIV/AIDS Surveillance in 2009.

Background and Brief Description

The purpose of HIV surveillance is to monitor trends in HIV 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 among persons with HIV). HIV 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.

CDC, in collaboration with health departments in the 50 states, the District of Columbia, and U.S. dependent areas, conduct national surveillance for cases of HIV infection. National surveillance includes tracking critical data across the spectrum of HIV disease from HIV diagnosis, to 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 viral resistance and HIV-1 subtypes, as well as provide information on perinatal exposures in the U.S.

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 2012, CDC convened an expert consultation to consider revisions of various aspects of the case definition including criteria for reporting a potential case, criteria for reporting a confirmed case, and case classification (disease staging system). Recommendations for revisions in the case definition were adopted by the Council of State and Territorial Epidemiologists in June 2012 and the final case definition revision is planned for implementation in 2013 after publication.

The revisions requested include modifications to currently collected data elements and forms to align with anticipated changes in the case definitions for HIV surveillance to be published in 2012 and continuation of HIV surveillance activities funded under the new funding opportunity announcement CDC-RFA-PS13-1302 National HIV Surveillance System (NHSS). These include minor modifications of testing categories to accommodate new testing algorithms and modifications to staging criteria and non-substantial editorial changes aimed at improving the format and usability of the forms such as improved wording of terms and changes in the format of some response options. In addition, the number of data elements from the former enhanced perinatal surveillance (EPS) was reduced and the form modified for continuation in 2013 as Perinatal HIV Exposure Reporting (PHER). Surveillance data collection on variant and atypical strains (formerly variant, atypical and resistant HIV surveillance (VARHS)) will be continued as Molecular HIV Surveillance (MHS) with a reduced number of data elements previously approved under VARHS.

CDC provides funding for 59 jurisdictions to conduct adult and pediatric HIV case surveillance. Health department staffs compile information from laboratories, physicians, hospitals, clinics and other health care providers in order to complete the HIV and pediatric case reports. Updates to case reports are also entered into enhanced HIV/AIDS Reporting system (eHARS) 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. including 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 MHS, and 35 areas will be reporting data as part of PHER annually. The total estimated annual burden hours are 53,700.

Estimated Annualized Burden Hours

Exhibit 12.A Estimates of Annualized Burden Hours

Type of respondentForm nameNumber of respondentsNumber of responses per respondentAverage Burden per response (in hours)
Health DepartmentsAdult HIV Case Report591,26020/60
Health DepartmentsPediatric HIV Case Report59620/60
Health DepartmentsCase Report Evaluations5912720/60
Health DepartmentsCase Report Updates591,4692/60
Health DepartmentsLaboratory Updates595,8761/60
Health DepartmentsHIV Incidence Surveillance (HIS)252,72910/60
Health DepartmentsMolecular HIV Surveillance (MHS)539675/60
Health DepartmentsPerinatal HIV Exposure Reporting (PHER)3511430/60

Kimberly S. Lane,

Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.

[FR Doc. 2012-31010 Filed 12-21-12; 4:15 pm]

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