[Federal Register Volume 83, Number 162 (Tuesday, August 21, 2018)]
[Notices]
[Pages 42301-42303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-18-1100; Docket No. CDC-2018-0070]


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 Identification of Behavioral and 
Clinical Predictors of Early HIV Infection (Project DETECT), which 
collects information from people testing for HIV in order to compare 
the performance characteristics of new point of care HIV tests for 
detection of early HIV infection and to identify behavioral and 
clinical predictors of early HIV infection.

DATES: CDC must receive written comments on or before October 22, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0070 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: To request more information on the proposed 
project or to obtain a copy of the information collection plan and 
instruments, contact Jeffery M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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

    Identification of Behavioral and Clinical Predictors of Early HIV 
Infection (Project DETECT)--(OMB No. 0920-1100 Exp: 2/29/2019)--
Extension--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

[[Page 42302]]

Background and Brief Description

    CDC provides guidelines for HIV testing and diagnosis for the 
United States, as well as technical guidance for its grantees. The 
purpose of this project is to assess characteristics of HIV testing 
technologies to update these guidance documents to reflect the latest 
available testing technologies, their performance characteristics, and 
considerations regarding their use. Specifically, CDC will describe 
behavioral and clinical characteristics of persons with early infection 
to help HIV test providers (including CDC grantees) choose which HIV 
tests to use, and target tests appropriately to persons at different 
levels of risk. This information will be disseminated primarily through 
guidance documents and articles in peer-reviewed journals.
    The primary study population will be persons at high risk for or 
diagnosed with HIV infection, many of whom will be men who have sex 
with men (MSM) because the majority of new HIV infections occur each 
year among this population. The goals of the project are to: (1) 
Characterize the performance of new HIV tests for detecting established 
and early HIV infection at the point of care, relative to each other 
and to currently used gold standard, non-POC tests, and (2) identify 
behavioral and clinical predictors of early HIV infection.
    Project DETECT will enroll 1,667 persons annually at the primary 
study site clinic in Seattle, and an additional 200 persons will be 
enrolled from other clinics in the greater Seattle area. The study will 
be conducted in two phases.
    Phase 1: After a clinic client consents to participate, he/she will 
be assigned a unique participant ID and will then undergo testing with 
the seven new HIV tests under study. While awaiting test results, 
participants will undergo additional specimen collections and complete 
the Phase 1 Enrollment Survey.
    Phase 2: All Phase 1 participants whose results on the seven tests 
under investigation are not in agreement with one another 
(``discordant'') will be considered to have a potential early HIV 
infection. Nucleic amplification testing that detects viral nucleic 
acids will be conducted to confirm an HIV diagnosis and rule out false 
positives. Study investigators expect that each year, 50 participants 
with discordant test results will be invited to participate in serial 
follow-up specimen collections to assess the time point at which all 
HIV test results resolve and become concordant positive (indicating 
enrollment during early infection) or concordant negative (indicating 
one or more false-positive test results in Phase 1).
    The follow-up schedule will consist of up to nine visits scheduled 
at regular intervals over a 70-day period. At each follow-up visit, 
participants will be tested with the new HIV tests and additional oral 
fluid and blood specimens will also be collected for storage and use in 
future HIV test evaluations at CDC. Participants will be followed up 
only to the point at which all their test results become concordant. At 
each time point, participants will be asked to complete the Phase 2 HIV 
Symptom and Care survey that collects information on symptoms 
associated with early HIV infection as well as access to HIV care and 
treatment since the last Phase 2 visit. When all tests become 
concordant (i.e., at the last Phase 2 visit) participants will complete 
the Phase 2 behavioral survey to identify any behavioral changes during 
follow-up. Of the 50 Phase 2 participants; it is estimated that no more 
than 26, annually, will have early HIV infection.
    All data for the proposed information collection will be collected 
via an electronic Computer Assisted Self- Interview (CASI) survey. 
Participants will complete the surveys on an encrypted computer, with 
the exception of the Phase 2 Symptom and Care survey, which will be 
administered by a research assistant and then electronically entered 
into the CASI system. Data to be collected via CASI include questions 
on sociodemographic characteristics, medical care, HIV testing, pre-
exposure prophylaxis, antiretroviral treatment, sexually transmitted 
diseases (STD) history, symptoms of early HIV infection, substance use 
and sexual behavior.
    Data from the surveys will be merged with HIV test results and 
relevant clinical data using the unique identification (ID) number. 
Data will be stored on a secure server managed by the University of 
Washington Department of Medicine Information Technology (IT) Services.
    The participation of respondents is voluntary. There is no cost to 
the respondents other than their time. The total estimated annual 
burden hours for the proposed project are 2,110 hours.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of respondents                               Form name                   respondents    responses per   response  (in    (in hours)
                                                                                                            respondent        hours)
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Persons eligible for study.....................  Phase 1 Consent........................           2,334               1           15/60             584
Enrolled participants..........................  Phase 1 Enrollment Survey A............           1,667               1           45/60           1,250
                                                 Phase 1 Enrollment Survey B............             200               1           60/60             200
                                                 Phase 2 Consent........................              50               1           15/60              13
                                                 Phase 2 HIV Symptom and Care survey....              50               9            5/60              38
                                                 Phase 2 Behavioral Survey..............              50               1           30/60              25
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           2,110
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Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-17980 Filed 8-20-18; 8:45 am]
BILLING CODE 4163-18-P