[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 <a href="/cdn-cgi/l/email-protection#5f30323d1f3c3b3c71383029"><span class="__cf_email__" data-cfemail="06696b644665626528616970">[email protected]</span></a>.
    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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
HOPS study Patients...........  Consent form....             450               1           15/60             113
HOPS Study Patients...........  Behavioral                 2,500               1            7/60             292
                                 survey.
                                                 ---------------------------------------------------------------
    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


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