[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]

[Notices]

[Pages 27311-27313]

From the Federal Register Online via the Government Publishing Office [http://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., MSD74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

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 startup 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 

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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

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 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

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 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

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