Notice2021-26003
Agency Forms Undergoing Paperwork Reduction Act Review
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
November 30, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 86 Issue 227 (Tuesday, November 30, 2021)</title>
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[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Notices]
[Pages 67952-67953]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-26003]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-1100]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Identification of Behavioral and Clinical
Predictors of Early HIV Infection (Project DETECT)'' to the Office of
Management and Budget (OMB) for review and approval. CDC previously
published a ``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on July 12, 2021 to obtain comments from the
public and affected agencies. CDC did not receive comments related to
the previous notice. This notice serves to allow an additional 30 days
for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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 instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
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, Viral Hepatitis, STD, and TB Prevention (NCHHSTP),
Division of HIV Prevention (DHP) requests a three-year Extension for an
existing 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 and 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 clinic 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
(``discordant'') will be considered to have a potential early HIV
infection. Nucleic acid 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 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
[[Page 67953]]
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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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Persons eligible for study............ Phase 1 Consent......... 2,334 1 15/60
Enrolled participants................. Phase 1 Enrollment 1,867 1 30/60
Survey.
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.
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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. 2021-26003 Filed 11-29-21; 8:45 am]
BILLING CODE 4163-18-P
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