[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40067-40069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-0920-0573; Docket No. CDC-2015-0054]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
revisions of the National HIV Surveillance System (NHSS) information 
collection. This data collection provides the primary population-based 
data used to describe the epidemiology of HIV in the United States.

DATES: Written comments must be received on or before September 11, 
2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0054 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    National HIV Surveillance System (NHSS) (OMB Control No. 0920-0573, 
Expiration 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

    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. Data collected as part of the 
National HIV Surveillance System (NHSS) are the primary data used to 
monitor the extent and characteristics of the HIV burden in the United 
States. HIV surveillance data are used to describe trends in HIV 
incidence and prevalence and characteristics of infected persons. HIV 
surveillance data are used widely at the federal, state, and local 
levels for planning and evaluating prevention programs and health-care 
services, and allocate funding for prevention and care.
    As science, technology, and our understanding of HIV have evolved, 
the NHSS has been updated periodically. 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

[[Page 40068]]

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 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 multitest algorithms, including criteria for differentiating 
between HIV-1 and HIV-2 infection and for recognizing early HIV 
infection. Clinical (nonlaboratory) 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 this 
information collection. The updates requested in this revision request 
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 identification 
fields to better track residence information and minor formatting 
changes to the form used for Perinatal HIV Exposure Reporting (PHER).
    CDC provides funding for 59 jurisdictions to provide adult and 
pediatric HIV case reports. Health department staff compile information 
from laboratories, physicians, hospitals, clinics and other health care 
providers to complete the HIV and pediatric case reports. CDC estimates 
that, annually, approximately 1,061 adult HIV case reports and 5 
pediatric case reports are processed by each health department.
    These data are recorded using standard case report forms either on 
paper or electronically and entered into the electronic reporting 
system. Updates to case reports are also entered into the reporting 
system by health departments as additional information may be received 
from laboratories, vital statistics, or additional providers. 
Evaluations are also conducted by health departments on a subset of 
case reports (e.g. re-abstraction, validation, de-duplication). CDC 
estimates that on average approximately 107 evaluations of case 
reports, 1,576 updates to case reports and 6,303 updates of laboratory 
test data will be processed by each of the 59 health departments 
annually. Case report information compiled over time by health 
departments is then de-identified and forwarded to CDC on a monthly 
basis to become part of the national HIV surveillance database.
    Supplemental surveillance data are collected in a subset of areas 
to provide additional information necessary to estimate HIV incidence, 
the extent of HIV drug resistance and HIV genetic diversity 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 
providers, and medical records. CDC estimates that on average 2,288 
reports containing incidence data elements will be processed annually 
by each of the 25 health departments funded to collect incidence data; 
829 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 conducting Molecular HIV Surveillance 
(MHS) and 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 Perinatal HIV Exposure 
Reporting (PHER). These supplemental data are also reported monthly to 
CDC.
    The total estimated time burden is 52,204 hours. There is no cost 
to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours)
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Health Departments............  Adult HIV Case                59           1,061           20/60          20,866
                                 Report.
Health Departments............  Pediatric HIV                 59               5           20/60              98
                                 Case Report.
Health Departments............  Case Report                   59             107           20/60           2,104
                                 Evaluations.
Health Departments............  Case Report                   59           1,576            5/60           7,749
                                 Updates.
Health Departments............  Laboratory                    59           6,303            1/60           6,198
                                 Updates.
Health Departments............  HIV Incidence                 25           2,288           10/60           9,533
                                 Surveillance.
Health Departments............  Molecular HIV                 53             829            5/60           3,661
                                 Surveillance
                                 (MHS).
Health Departments............  Perinatal HIV                 35             114           30/60           1,995
                                 Exposure
                                 Reporting
                                 (PHER).
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    Total.....................  ................  ..............  ..............  ..............          52,204
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[[Page 40069]]

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. 2015-17017 Filed 7-10-15; 8:45 am]
 BILLING CODE 4163-18-P