Notice2023-03322
Proposed Data Collection Submitted for Public Comment and Recommendations
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
February 17, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled HIV Outpatient Study (HOPS). HOPS is a CDC data collection for standardized HIV clinical and behavioral data at private HIV care practices and university-based U.S. clinics participating in the HOPS program.
Full Text
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<title>Federal Register, Volume 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10336-10337]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03322]
[[Page 10336]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-1080; Docket No. CDC-2023-0010]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: 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 the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled HIV Outpatient Study (HOPS). HOPS is a CDC data collection for
standardized HIV clinical and behavioral data at private HIV care
practices and university-based U.S. clinics participating in the HOPS
program.
DATES: CDC must receive written comments on or before April 18, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0010 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road,
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118;
Email: <a href="/cdn-cgi/l/email-protection#016e6c63416265622f666e77"><span class="__cf_email__" data-cfemail="c2adafa082a1a6a1eca5adb4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.
Proposed Project
HIV Outpatient Study (HOPS) (OMB Control No. 0920-1080, Exp. 02/29/
2024)--Extension--National Center for HIV, 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 (CDC) requests a
three-year approval for the HIV Outpatient Study (HOPS) data
collection. HOPS is a prospective longitudinal cohort of patients in
HIV care at eight 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 an ongoing
basis from the medical records of adult 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 for
persons living with HIV; and (iv) investigating disparities in the HIV
care continuum by various demographic factors. In recent years, 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. 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.
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); and all laboratory values, including CD4+
Tlymphocyte (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.
[[Page 10337]]
CDC anticipates that 450 new HOPS study participants will be
recruited annually into HOPS from a pool of patients with HIV currently
in HIV-care at the eight aforementioned clinics (50-60 patients per
site). Patients are approached during one of their routine clinic
visits to participate in HOPS. Patients interested in participating in
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 2,700
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. CDC request OMB approval
for an estimated 428 annual burden hours. There is no cost to the
respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hr) (in hr)
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HOPS Study Patients........... Behavioral 2,700 1 7/60 315
survey.
HOPS Study Patients........... Consent form.... 450 1 15/60 113
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Total..................... ................ .............. .............. .............. 428
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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. 2023-03322 Filed 2-16-23; 8:45 am]
BILLING CODE 4163-18-P
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