[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27311-27313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11511]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15AEZ; Docket No. CDC-2015-0028]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
information collection entitled Identification of Behavioral and 
Clinical Predictors of Early HIV Infection (Project DETECT).

DATES: Written comments must be received on or before July 13, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0028 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted 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 the 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and

[[Page 27312]]

maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

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

    The Centers for Disease Control and Prevention (CDC), National 
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Division of HIV/AIDS Prevention (DHAP) requests a 3-year approval for a 
new data collection called ``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. 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 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 socio-demographics, 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 2,111 hours.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of      Avg. burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)         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           1,251
Enrolled participants..........................  Phase 1 Enrollment Survey B............             200               1               1             200
Enrolled participants..........................  Phase 2 Consent........................              50               1           15/60              13
Enrolled participants..........................  Phase 2 HIV Symptom and Care Survey....              50               9            5/60              38
Enrolled participants..........................  Phase 2 Behavioral Survey..............              50               1           30/60              25
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           2,111
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[[Page 27313]]

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. 2015-11511 Filed 5-12-15; 8:45 am]
 BILLING CODE 4163-18-P