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Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and Prevention 60 Day211100; Docket No. CDC2021
0066

Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention CDC, Department of Health and Human Services HHS.
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease Control and Prevention CDC, as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995.
This notice invites comment on a proposed information collection project titled Identification of Behavioral and Clinical Predictors of Early HIV
Infection Project DETECT, which collects information from people testing for HIV in order to compare the performance characteristics of new point of care HIV tests for detection of early HIV infection and to identify behavioral and clinical predictors of early HIV infection.
DATES: CDC must receive written comments on or before September 10, 2021.
SUMMARY:

You may submit comments, identified by Docket No. CDC2021
0066 by any of the following methods:
Federal eRulemaking Portal:
Regulations.gov. Follow the instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600
Clifton Road NE, MSD74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.
Please note: Submit all comments 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 Jeffrey M. Zirger, Information Collection Review Office,
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ADDRESSES:

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Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS
D74, Atlanta, Georgia 30329; phone:
4046397570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 PRA
44 U.S.C. 35013520, 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 the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agencys estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected;
4. 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 submissions of responses; and 5. Assess information collection costs.
Proposed Project Identification of Behavioral and Clinical Predictors of Early HIV
Infection Project DETECTOMB
Control No. 09201100, Exp. 1/31/
2022ExtensionNational 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 three-year Extension for a data collection titled Identification of
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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 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-pointof-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 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 test 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
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