Notice2021-14754
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 12, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 130 (Monday, July 12, 2021)</title>
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[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36555-36556]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14754]
[[Page 36555]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-21-1100; Docket No. CDC-2021-0066]
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 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.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0066 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments
to <a href="http://Regulations.gov">Regulations.gov</a>.
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, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
<a href="/cdn-cgi/l/email-protection#2847454a684b4c4b064f475e"><span class="__cf_email__" data-cfemail="d1bebcb391b2b5b2ffb6bea7">[email protected]</span></a>.
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 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 agency's 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 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/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 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-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 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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(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 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
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Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
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Persons eligible for study..................... Phase 1 Consent........................ 2,334 1 15/60 584
Enrolled participants.......................... Phase 1 Enrollment Survey.............. 1,867 1 30/60 934
Phase 2 Consent........................ 50 1 15/60 13
Phase 2 HIV Symptom and Care survey.... 50 9 5/60 38
Phase 2 Behavioral Survey.............. 50 1 30/60 25
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Total...................................... ....................................... .............. .............. .............. 1,594
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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. 2021-14754 Filed 7-9-21; 8:45 am]
BILLING CODE 4163-18-P
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