Proposed Data Collection Submitted for Public Comment and Recommendations, 36555-36556 [2021-14754]
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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 Day–21–1100; Docket No. CDC–2021–
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. CDC–2021–
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, 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
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,
khammond on DSKJM1Z7X2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
17:26 Jul 09, 2021
Jkt 253001
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, 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 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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
36555
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
E:\FR\FM\12JYN1.SGM
12JYN1
36556
Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
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.
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 SelfInterview (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
(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
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Persons eligible for
study.
Enrolled participants ......
Phase 1 Consent .................................................
2,334
1
15/60
584
Phase
Phase
Phase
Phase
Enrollment Survey .................................
Consent .................................................
HIV Symptom and Care survey ............
Behavioral Survey .................................
1,867
50
50
50
1
1
9
1
30/60
15/60
5/60
30/60
934
13
38
25
Total ........................
..............................................................................
........................
........................
........................
1,594
1
2
2
2
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–21–1242]
Agency Forms Undergoing Paperwork
Reduction Act Review
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Strengthening
U.S. Response to Resistant Gonorrhea
(SURRG) 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
September 30, 2020 to obtain comments
from the public and affected agencies.
VerDate Sep<11>2014
17:26 Jul 09, 2021
Jkt 253001
CDC received one non-substantive
comment 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,
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 www.reginfo.gov/public/
do/PRAMain. 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
Strengthening U.S. Response to
Resistant Gonorrhea (SURRG) (OMB
Control No. 0920–1242, Exp. 9/30/
2021)—Revision—National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
E:\FR\FM\12JYN1.SGM
12JYN1
]]>Agencies
[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36555-36556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14754]
[[Page 36555]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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, 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 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, 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 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
[[Page 36556]]
(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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
---------------------------------------------------------------
Total...................................... ....................................... .............. .............. .............. 1,594
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
