[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
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Number of Average Burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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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]
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