80 FR 67757 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 212 (November 3, 2015)

[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67757-67759]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27888]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-15AEZ]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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

[[Page 67758]]

instruments, call (404) 639-7570 or send an email to [email protected]. 
Written comments and/or suggestions regarding the items contained in 
this notice should be directed to the Attention: CDC Desk Officer, 
Office of Management and Budget, Washington, DC 20503 or by fax to 
(202) 395-5806. Written comments should be received within 30 days of 
this notice.

Proposed Project

    Identification of Behavioral and Clinical Predictors of Early HIV 
Infection (Project DETECT)--New--National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    CDC provides guidelines for HIV testing and diagnosis for the 
United States, as well as technical guidance for its grantees. CDC will 
use the HIV testing data collected for this project to update these 
guidance documents to reflect the latest available testing 
technologies, their performance characteristics, and considerations 
regarding their use. Specifically, CDC will describe the information on 
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 primarily be disseminated 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 7 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 7 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 estimate 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 socio-demographics, medical care, HIV testing, pre-exposure 
prophylaxis, antiretroviral treatment, sexually transmitted disease 
(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 ID number. Data will be stored 
on a secure server managed by the University of Washington Department 
of Medicine IT Services. The participation of respondents is voluntary. 
There is no cost to the respondents other than their time. The total 
annual burden hours are 2,110.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Number of      Average burden
          Type of respondents                   Form name           Number of    responses per     per response
                                                                   respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------



[[Page 67759]]

Leroy A. Richardson,
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. 2015-27888 Filed 11-2-15; 8:45 am]
 BILLING CODE 4163-18-P