Notice2023-11264
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 26, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 88 Issue 102 (Friday, May 26, 2023)</title>
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[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34156-34158]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-11264]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-1080]
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 February 17, 2023 to obtain comments from
the public and affected agencies. CDC received one comment 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,
[[Page 34157]]
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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. 2/29/
2024)--Extension--National Center for HIV, Viral Hepatitis, STD, TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC) requests OMB
approval to continue collecting information for HIV Outpatient Study
(HOPS). The study is based on a prospective longitudinal cohort of
adults 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 an 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 (W-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 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.
OMB approval is requested for three years. The estimated number of
participants in the annual behavioral assessment is 2,700 respondents.
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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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in 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 Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2023-11264 Filed 5-25-23; 8:45 am]
BILLING CODE 4163-18-P
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