[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27313-27314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11510]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-15JX]
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 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
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. Clinical data are
abstracted on ongoing basis from the medical records of adult HIV-
infected HOPS study participants, who also complete an optional seven
minute telephone/web-based behavioral assessment as part of their
annual clinic visit.
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
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 estimate consenting 450 new participants per year across all
HOPS study sites (50 participants at each of the 9 sites). The consent
process takes approximately 15 minutes to complete.
Medical record abstractions will be completed on all eligible
participants. All eligible participants will be offered the opportunity
to participate in an optional short survey that will take approximately
seven minutes.
Participation of respondents is voluntary. There is no cost to the
respondents other than their time. The estimated annual burden hours
are 405.
Estimated Annualized Burden Hours
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Number of Avg. burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
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HOPS study Patients.................. Behavioral survey........ 2,500 1 7/60
HOPS Study Patients.................. Consent form............. 450 1 15/60
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[[Page 27314]]
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. 2015-11510 Filed 5-12-15; 8:45 am]
BILLING CODE 4163-18-P