[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10336-10337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) 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: [email protected].

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.

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    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
                                                 ---------------------------------------------------------------
    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