[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Notices]
[Pages 43688-43689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-1080]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled [HIV Outpatient Study (HOPS)] to the Office 
of Management and Budget (OMB) for review and approval. CDC previously 
published a ``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on [September 26, 2017] to obtain comments 
from the public and affected agencies. CDC received [2] comments 
related to the previous notice. This notice serves to allow an 
additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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 <a href="/cdn-cgi/l/email-protection#7b1416193b181f18551c140d"><span class="__cf_email__" data-cfemail="137c7e71537077703d747c65">[email protected]</span></a>. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street, NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    HIV Outpatient Study (HOPS) (OMB Control Number 0920-1080, 
Expiration Date 08/31/2018)--REVISION--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 eight 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 eight 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 eight 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

[[Page 43689]]

respondents other than their time. The estimated annual burden hours 
are 405.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of respondents                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
HOPS study Patients................  Behavioral survey (att                2,500               1            7/60
                                      3a,b,9).
HOPS Study Patients................  Consent form (att 4).......             450               1           15/60
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting 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. 2018-18445 Filed 8-24-18; 8:45 am]
BILLING CODE 4163-18-P


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