[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7800-7802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0573]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of

[[Page 7801]]

the functions of the agency, including whether the information will 
have practical utility; (b) Evaluate the accuracy of the agencies 
estimate of the burden of the proposed collection of information, 
including the validity of the methodology and assumptions used; (c) 
Enhance the quality, utility, and clarity of the information to be 
collected; (d) Minimize the burden of the collection of information on 
those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and (e) Assess information 
collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: 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

    National HIV Surveillance System (NHSS) (OMB Control No. 0920-0573, 
Expires 02/29/2016)--Revision--National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Data collected as part of the National HIV Surveillance System 
(NHSS) are the primary data used to monitor the impact of HIV infection 
in the United States. The NHSS provides critical data that are used to 
describe the incidence and prevalence of HIV disease and the 
characteristics of infected persons. HIV surveillance data are used 
widely at the local, state and national levels for planning, evaluation 
and allocation of funding for HIV prevention and care programs.
    The NHSS has been updated periodically as science, technology, and 
our understanding of HIV has evolved. CDC in collaboration with health 
departments in the 50 states, the District of Columbia, and U.S. 
dependent areas, conducts national surveillance for cases of HIV 
infection that includes critical data across the spectrum of HIV 
disease from HIV diagnosis, to stage 3 (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 HIV drug resistance and genetic diversity, as well as 
provide information on perinatal exposures in the United States.
    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 2014, following extensive consultation and peer review, CDC and 
the Council of State and Territorial Epidemiologists (CSTE) revised and 
combined the surveillance case definitions for human immunodeficiency 
virus (HIV) infection into a single case definition for persons of all 
ages. Laboratory criteria for defining a confirmed case now accommodate 
new multi-test algorithms, including criteria for differentiating 
between HIV-1 and HIV-2 infection and for recognizing early HIV 
infection. Clinical (non-laboratory) criteria for defining a case for 
surveillance purposes have been made more practical by eliminating the 
requirement for information about laboratory tests. The surveillance 
case definition is intended primarily for monitoring the HIV infection 
burden and planning for prevention and care on a population level, not 
as a basis for clinical decisions for individual patients. CDC and CSTE 
recommend that all states and territories conduct case surveillance of 
HIV infection using this revised surveillance case definition.
    Modifications to data elements to accommodate the 2014 HIV case 
surveillance definition were approved in the last renewal of OMB 
Control No. 0920-0573. The revisions requested in this extension 
include modifications to currently collected data elements and forms to 
accommodate new testing technologies as well as clinical practice 
guidelines. Specifically, the HIV Testing and Antiretroviral Use 
History section will be revised on the adult/adolescent and pediatric 
case report forms to include new laboratory tests, additional 
information on use of antiretrioviral (ARV) medications for pre-
exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), 
prevention of mother-to-child-transmission among HIV infected women 
during pregnancy, and hepatitis B virus (HBV) treatment. Other changes 
include addition of dates to the address and patient ID fields to 
better track residence information and minor formatting changes to the 
form used for Perinatal HIV Exposure Reporting (PHER).
    The revisions to this request also include the addition of burden 
hours for annual reporting by health departments for the Standards 
Evaluation Report (SER) and Annual Performance Report (APR). Findings 
from these reports are used to improve data quality and ensure the 
accuracy, timeliness, and completeness of the national HIV 
surveillance, as well as to monitor performance and progress in 
achieving both state and national HIV surveillance program objectives. 
Fifty-nine health departments funded for HIV surveillance will report a 
Standards Evaluation Report (SER) and APR annually.
    CDC provides funding for 59 health departments to conduct adult and 
pediatric HIV case surveillance and report information to CDC. Health 
department staff compile information from laboratories, physicians, 
hospitals, clinics and other health care providers to complete adult 
and adolescent and pediatric HIV confidential case reports. Updates to 
case reports are also entered into an electronic database 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., 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 
Molecular HIV Surveillance (MHS), and 35 areas will be reporting data 
as part of 35 health departments will be reporting data collected as 
part of Perinatal HIV Exposure Reporting (PHER) annually. The total 
estimated annual burden hours are 50,504.

[[Page 7802]]



                                        Estimated 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 HIV Case Report..              59           1,061           20/60
Health Departments...................  Pediatric HIV Case                   59               5           20/60
                                        Report.
Health Departments...................  Case Report Evaluations              59             107           20/60
Health Departments...................  Case Report Updates....              59           1,576            2/60
Health Departments...................  Laboratory Updates.....              59           6,303            1/60
Health Departments...................  HIV Incidence                        25           2,288           10/60
                                        Surveillance (HIS).
Health Departments...................  Molecular HIV                        53             829            5/60
                                        Surveillance (MHS).
Health Departments...................  Perinatal HIV Exposure               35             114           30/60
                                        Reporting (PHER).
Health Departments...................  Annual Reporting:                    59               1               8
                                        Standards Evaluation
                                        Report (SER).
Health Departments...................  Annual Reporting:                    59               1              42
                                        Annual Performance
                                        Report (APR).
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-03046 Filed 2-12-16; 8:45 am]
BILLING CODE 4163-18-P