[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76045-76046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-0573]


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 
(404) 639-7570 or send an email to [email protected]. 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

[[Page 76046]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average Burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Health Departments....................  Adult...................              59           1,260           20/60
                                        HIV Case Report.........
Health Departments....................  Pediatric...............              59               6           20/60
                                        HIV Case Report.........
Health................................  Case Report.............              59             127           20/60
Departments...........................  Evaluations.............
Health Departments....................  Case Report Updates.....              59           1,469            2/60
Health Departments....................  Laboratory..............              59           5,876            1/60
                                        Updates.................
Health Departments....................  HIV.....................              25           2,729           10/60
                                        Incidence Surveillance
                                         (HIS).
Health Departments....................  Molecular HIV                         53             967            5/60
                                         Surveillance (MHS).
Health Departments....................  Perinatal HIV Exposure                35             114           30/60
                                         Reporting (PHER).
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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]
BILLING CODE 4163-18-P