[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63512-63513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-1100]


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 ``Identification of Behavioral and Clinical 
Predictors of Early HIV Infection (Project DETECT)'' 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 August 21, 2018 to obtain comments from the 
public and affected agencies. CDC received one (1) 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, 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 or send an email to [email protected]. 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

    Identification of Behavioral and Clinical Predictors of Early HIV 
Infection (Project DETECT) (OMB No. 0920-1100, Exp. 2/28/2019)--
Extension--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC requests a three-year OMB approval to continue information 
collection for ``Project DETECT,'' an ongoing research study conducted 
by the University of Washington (UW). Study sites initiated information 
collection in 2016 and CDC is requesting OMB approval for three 
additional years (2019-2022). The study is designed to (1) identify 
behavioral and clinical predictors of early HIV infection, and (2) 
characterize the performance of new HIV tests for detecting established 
and early HIV infection at the point of care (POC), relative to each 
other and to currently used gold standard, non-POC tests.
    The primary study population is persons at high risk for, or 
diagnosed with HIV infection, many of whom will be men who have sex 
with men (MSM)

[[Page 63513]]

because the majority of new HIV infections occur each year among this 
population. In each year of the study, an average of 1,667 participants 
will be recruited from the Public Health--Seattle and King County 
(PHSKC) STD Clinic, which serves as the primary study site, and an 
additional 200 persons will be enrolled from other clinics in the 
greater Seattle area. Information collection 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.
    CDC will use findings to update guidelines for HIV testing and 
diagnosis in the United States. The guidelines will help HIV test 
providers choose which HIV tests to use, and target tests appropriately 
to persons at different levels of risk. Findings will also be 
disseminated through articles in peer-reviewed journals and the 
technical assistance provided by CDC to grantees that provide HIV 
testing and diagnostic services.
    There are no changes to the previously approved information 
collection instruments or burden estimates. The participation of 
respondents is voluntary and there are no costs to respondents other 
than their time. The total estimated annualized burden for the proposed 
project is 2,110 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Persons eligible for study............  Phase 1 Consent.........           2,334               1           15/60
Enrolled participants.................  Phase 1 Enrollment                 1,667               1           45/60
                                         Survey A.
                                        Phase 1 Enrollment                   200               1           60/60
                                         Survey B.
                                        Phase 2 Consent.........              50               1           15/60
                                        Phase 2 HIV Symptom and               50               9            5/60
                                         Care survey.
                                        Phase 2 Behavioral                    50               1           30/60
                                         Survey.
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2018-26634 Filed 12-7-18; 8:45 am]
 BILLING CODE 4163-18-P