[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 506-507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30889]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-15-15JX]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC), as part of
its continuing effort 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. To request more information on the below
proposed project or to obtain a copy of the information collection plan
and instruments, call 404-639-7570 or send comments to LeRoy
Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an
email to [email protected].
Comments submitted in response to this notice will be summarized
and/or included in the request for Office of Management and Budget
(OMB) approval. 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. Written comments should be received within 60
days of this notice.
Proposed Project
HIV Outpatient Study (HOPS)--New--National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention requests a three-
year approval for the HIV Outpatient Study data collection activity.
The HIV Outpatient Study (HOPS) is a prospective longitudinal cohort of
HIV-infected outpatients at nine well-established private HIV care
practices and university-based U.S. clinics, in Tampa, Florida;
Washington, DC; Stony Brook, New York; Chicago, Illinois; Denver,
Colorado; and Philadelphia, Pennsylvania.
Clinical data are abstracted on ongoing basis from the medical
records of adult HIV-infected HOPS study participants, who also
complete an optional telephone/Web-based behavioral assessment as part
of their annual clinic visit, which on average takes about seven
minutes. Before enrolling in this study, all potential study
participants will undergo an informed consent process (including
signing of a written informed consent) which is estimated to take 15
minutes.
The core areas of HOPS research extending through the present HIV
treatment era include (i) monitoring death rates and causes of death,
(ii) characterizing the optimal patient management strategies to reduce
HIV-related morbidity and mortality (e.g., effectiveness of
antiretroviral therapies and other clinical interventions), (iii)
monitoring of sexual and drug use behaviors to inform Prevention with
Positives, and (iv) investigating disparities in the HIV care continuum
by various demographic factors. In recent years, the HOPS has been
[[Page 507]]
instrumental in bringing attention to emerging issues in chronic HIV
infection with actionable opportunities for prevention, including
cardiovascular disease, fragility fractures, renal and hepatic disease,
and cancers. The HOPS remains an important source for multi-year trend
data concerning conditions and behaviors for which data are not readily
available elsewhere, including: Rates of opportunistic illnesses, rates
of comorbid conditions (e.g., hypertension, obesity, diabetes) and
antiretroviral drug resistance.
Data will be collected through medical record abstraction by
trained abstractors and by telephone or internet-based, computer-
assisted interviews at nine funded study sites in six U.S. cities.
Collection of data abstracted from patient medical records provides
data in five general categories: Demographics and risk behaviors for
HIV infection; symptoms; diagnosed conditions (definitive and
presumptive); medications prescribed (including dose, duration, and
reasons for stopping); all laboratory values, including CD4+ T-
lymphocyte (CD4+) cell counts, plasma HIV-RNA determinations, and
genotype, phenotype, and trophile results. Data on visit frequency,
AIDS, and death are acquired from the clinic chart.
Data collected using a brief Telephone Audio-Computer Assisted
Self-Interview (T-ACASI) survey or an identical Web-based Audio-
Computer Assisted Self-Interview (ACASI) include: Age, sex at birth,
use of alcohol and drugs, cigarette smoking, adherence to
antiretroviral medications, types of sexual intercourse, condom use,
and disclosure of HIV status to partners.
We anticipate that 450 new HOPS study participants will be
recruited annually into the HOPS from a pool of HIV-infected
individuals currently in HIV-care at the nine aforementioned clinics
(50 patients per site). Patients are approached during one of their
routine clinic visits to participate in the HOPS. Patients interested
in participating in the HOPS are given detailed information about the
nature of the study and provided with written informed consent that
must be completed prior to enrollment.
The 450 newly enrolled participants each year will be added to the
database of existing participants such that approximately 2,500
participants will be seen in the HOPS each year. Medical record
abstractions will be completed on all HOPS participants, and impose no
direct burden on HOPS study participants.
Participation of respondents is voluntary. There is no cost to the
respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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HOPS study Patients........... Consent form.... 450 1 15/60 113
HOPS Study Patients........... Behavioral 2,500 1 7/60 292
survey.
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Total..................... ................ .............. .............. .............. 405
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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. 2014-30889 Filed 1-5-15; 8:45 am]
BILLING CODE 4163-18-P