[Federal Register Volume 86, Number 4 (Thursday, January 7, 2021)]
[Notices]
[Pages 1112-1114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-1080]


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 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 14, 2020 to obtain comments from 
the public and affected agencies. CDC did not receive 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;

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    (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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 No. 0920-1080, Exp. 9/30/
2021)--Extension--National Center for HIV/AIDS, 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 OMB 
approval to continue collecting information for HIV Outpatient Study 
(HOPS). The study is based on a prospective longitudinal cohort of 
adults living with HIV in outpatient care at eight well-established 
private HIV care practices and university-based clinics in the U.S. The 
HOPS study sites are located in six cities: Tampa, Florida; Washington, 
DC; Stony Brook, New York; Chicago, Illinois; Denver, Colorado; and 
Philadelphia, Pennsylvania. The study currently collects information on 
a maximum of 2,700 outpatients per year. A portion of HOPS participants 
are lost to follow-up each year (most due to transferring out of the 
HOPS clinics), and our target goal is to enroll up to 450 new 
participants (50-60 per site) annually. Patients are approached during 
one of their routine clinic visits and invited to participate in the 
HOPS.
    There are two sources of information for the HOPS. First, clinical 
data are abstracted on ongoing basis from the medical records of study 
participants. Medical records provide 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); and all 
laboratory values, including CD4+ T lymphocyte (CD4+) cell counts, 
plasma HIV-RNA determinations, and genotype, phenotype, and trophile 
results. Clinic charts also provide data about visit frequency, AIDS, 
and death. Medical records abstraction is conducted by trained study 
staff and does not impose ongoing burden on HOPS participants, however, 
CDC does account for burden associated with the initial study consent 
and orientation process. The estimated burden per response is 15 
minutes.
    The second source of HOPS information is the annual behavioral 
assessment, an optional activity scheduled in conjunction with the 
participant's annual clinic visit. For convenience, the behavioral 
assessment can be completed in either of two modes: A brief Telephone 
Audio-Computer Assisted Self-Interview (T-ACASI) survey or an identical 
Web-based Audio-Computer Assisted Self-Interview (ACASI). Data 
collection includes: 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. The estimated burden per response is seven minutes.
    The core areas of HOPS research extending through the present HIV 
treatment era include (i) investigating and characterizing (new) 
problems associated with long-term HIV infection and its treatments 
using the longitudinal cohort data, (ii) monitoring death rates and 
causes of death, (iii) characterizing the optimal patient management 
strategies to reduce HIV related morbidity and mortality (e.g., 
effectiveness of antiretroviral therapies and other clinical 
interventions), (iv) assessing sexual and drug use behaviors and other 
patient reported outcomes that supplement data from chart abstraction, 
and (v) 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 multiyear 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.
    OMB approval is requested for three years. The estimated number of 
participants in the annual behavioral assessment will increase from 
2,500 respondents to 2,700 respondents, resulting in an increase of 23 
burden hours. There are no changes to the information collection forms 
or methods. Participation is voluntary and there are no costs to 
respondents other than their time. The total estimated annualized 
burden is 428 hours.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
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HOPS study Patients...................  Behavioral survey.......           2,700               1            7/60
HOPS Study Patients...................  Consent form............             450               1           15/60
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-00003 Filed 1-6-21; 8:45 am]
BILLING CODE 4163-18-P