[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Pages 56616-56618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20214]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-1080; Docket No. CDC-2020-0098]


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 proposed and/or 
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). The 
Centers for Disease Control and Prevention is requesting a three-year 
extension to the previously approved project to continue collecting 
standardized HIV clinical and behavioral data at private HIV care 
practices and university based U.S. clinics participating in the HOPS.

DATES: CDC must receive written comments on or before November 13, 
2020.

[[Page 56617]]


ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0098 by any of the following methods:
     Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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-D74, Atlanta, Georgia 30329; phone: 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; and
    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.
    5. Assess information collection costs.

Proposed Project

    HIV Outpatient Study (HOPS) (OMB Control No. 0920-1080, Exp. 09/30/
2021)--Extension--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, 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 HIV-infected 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 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 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); 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 anticipate that 450 new HOPS study participants will be 
recruited annually into the HOPS from a pool of HIV-infected 
individuals currently in HIV-care at the nine aforementioned clinics 
(50 patients per site). Patients are approached during one of their 
routine clinic visits to participate in the HOPS. Patients interested 
in participating in the 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 2,500 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. There is no 
cost to the respondents other than their time.

[[Page 56618]]



                                        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                 2,500               1            7/60             292
                                 survey.
HOPS Study Patients...........  Consent form....             450               1           15/60             113
                                                 ---------------------------------------------------------------
    Total.....................  ................             405
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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. 2020-20214 Filed 9-11-20; 8:45 am]
BILLING CODE 4163-18-P