[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Notices]
[Pages 67952-67953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26003]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-1100]


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 July 12, 2021 to obtain comments from the 
public and affected agencies. CDC did not receive comments 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 Control No. 0920-1100, Exp. 1/31/
2022)--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 (CDC), National 
Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Division of HIV Prevention (DHP) requests a three-year Extension for an 
existing data collection titled ``Identification of Behavioral and 
Clinical Predictors of Early HIV Infection (Project DETECT).''
    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 and 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), transgender women, minorities, and persons who inject 
drugs (PWIDs) because the majority of new HIV infections occur each 
year among these populations. 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-point-of-care (POC) tests, and 
(2) identify behavioral and clinical predictors of early HIV infection.
    Project DETECT will enroll 1,867 persons annually from two study 
sites (Seattle and Baltimore). 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 
up to 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 acid 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 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 to collect 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

[[Page 67953]]

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 awardee's 
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 1,594 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Persons eligible for study............  Phase 1 Consent.........           2,334               1           15/60
Enrolled participants.................  Phase 1 Enrollment                 1,867               1           30/60
                                         Survey.
                                        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,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-26003 Filed 11-29-21; 8:45 am]
BILLING CODE 4163-18-P