[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
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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