[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47848-47850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19675]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-12-0573]


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 404-639-7570 
and send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, 
Atlanta, GA 30333 or send an email to [email protected].
    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

    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).

Background and Brief Description

    CDC is authorized under Sections 304 and 306 of the Public Health 
Service Act (42 U.S.C. 242b and 242k) to collect information on cases 
of human immunodeficiency virus (HIV) and indicators of HIV disease and 
HIV disease progression including AIDS. These national HIV surveillance 
data collected by CDC are the primary source of information used to 
monitor the extent and characteristics of the HIV burden in the U.S.

[[Page 47849]]

    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.
    As science, technology, and our understanding of HIV have evolved, 
the NHSS has been updated periodically to meet the nation's needs for 
information. 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 2008, the surveillance case definitions for 
adults and children for HIV and AIDS were revised. Since that time, the 
enhanced HIV/AIDS reporting system (eHARS) was fully deployed (2010) 
and forms have been updated to reflect those changes (2011). 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 a reporting a confirmed case, and case 
classification (disease staging system). Recommendations for revisions 
in the case definition were adopted in a position statement by the 
Council of State and Territorial Epidemiologists in June 2012 and the 
final case definition revision is planned for 2012.
    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. CDC estimates that approximately 1,260 adult HIV case reports 
and 6 pediatric case reports are processed by each health department 
annually.
    These data are recorded on standard case report forms, processed by 
either paper or electronic format and entered into eHARS. Updates to 
case reports are also entered into eHARS by health departments, as 
additional information may be received from laboratories, vital 
statistics offices, or additional providers. CDC estimates 
approximately 1,469 updates to case reports will be processed by each 
of the 59 health departments annually. Additionally, 5,876 updates of 
laboratory test data will be processed, primarily through electronic 
laboratory reporting, by each of the 59 health departments annually. 
Health departments will de-identify compiled case report information 
and forward to CDC on a monthly basis for inclusion in the national HIV 
surveillance database. 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). CDC 
estimates approximately 127 evaluations of case reports will be 
processed by each of the jurisdictions annually.
    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 2,729 reports containing HIV Incidence Surveillance (HIS) data 
elements will be processed on average by each of the 25 health 
departments funded to collect incidence data annually. Additionally, an 
estimated 718 reports containing additional data elements on HIV 
nucleotide sequences from genotype test results will be processed on 
average by each of the 53 health departments reporting MHS data 
annually. An estimated 114 reports containing perinatal exposure data 
elements will be processed on average, annually, by each of the 35 
health departments reporting data collected as part of PHER.
    There are no costs to respondents except their time.

                                       Estimate of Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                     Number of      Avg. burden    Total annual
      Type of respondent            Form name        Number of     responses per   per response     burden  (in
                                                    respondents     respondent      (in hours)        hours)
----------------------------------------------------------------------------------------------------------------
Health Departments............  Adult HIV Case                59           1,260           20/60          24,780
                                 Report.
Health Departments............  Pediatric HIV                 59               6           20/60             118
                                 Case Report.
Health Departments............  Case Report                   59             127           20/60           2,498
                                 Evaluations.
Health Departments............  Case Report                   59           1,469            2/60           2,889
                                 Updates.
Health Departments............  Laboratory                    59           5,876            1/60           5,778
                                 Updates.
Health Departments............  HIV Incidence                 25           2,729           10/60          11,371
                                 Surveillance
                                 (HIS).
Health Departments............  Molecular HIV                 53             967            5/60           4,271
                                 Surveillance
                                 (MHS).

[[Page 47850]]

 
Health Departments............  Perinatal HIV                 35             114           30/60           1,995
                                 Exposure
                                 Reporting
                                 (PHER).
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          53,700
----------------------------------------------------------------------------------------------------------------


Kimberly Lane,
Deputy Director, Office of Scientific Integrity, Centers for Disease 
Control and Prevention.
[FR Doc. 2012-19675 Filed 8-9-12; 8:45 am]
BILLING CODE 4163-18-P