60 day FRN

63513

Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices
because the majority of new HIV
infections occur each year among this
population. In each year of the study, an
average of 1,667 participants will be
recruited from the Public Health—
Seattle and King County (PHSKC) STD
Clinic, which serves as the primary
study site, and an additional 200
persons will be enrolled from other
clinics in the greater Seattle area.
Information collection 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 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
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.
CDC will use findings to update
guidelines for HIV testing and diagnosis
in the United States. The guidelines will
help HIV test providers choose which
HIV tests to use, and target tests
appropriately to persons at different
levels of risk. Findings will also be
disseminated through articles in peerreviewed journals and the technical
assistance provided by CDC to grantees
that provide HIV testing and diagnostic
services.
There are no changes to the
previously approved information
collection instruments or burden
estimates. The participation of
respondents is voluntary and there are
no costs to respondents other than their
time. The total estimated annualized
burden for the proposed project is 2,110
hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Number of
respondents

Form name

Persons eligible for study ...............................
Enrolled participants .......................................

Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.

Phase
Phase
Phase
Phase
Phase
Phase

1
1
1
2
2
2

Consent ...........................................
Enrollment Survey A ........................
Enrollment Survey B ........................
Consent ...........................................
HIV Symptom and Care survey ......
Behavioral Survey ...........................

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

[FR Doc. 2018–26634 Filed 12–7–18; 8:45 am]

[60Day–19–0017; Docket No. CDC–2018–
0109]

BILLING CODE 4163–18–P

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:

VerDate Sep<11>2014

17:10 Dec 07, 2018

Jkt 247001

PO 00000

Frm 00048

Fmt 4703

Sfmt 4703

2,334
1,667
200
50
50
50

Number of
responses per
respondent
1
1
1
1
9
1

Average
burden per
response
(in hours)
15/60
45/60
60/60
15/60
5/60
30/60

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 Application for Training (OMB
Control No. 0920–0017). The Training
and Continuing Education Online
(TCEO) system is used in the
management of the accreditation

SUMMARY:

E:\FR\FM\10DEN1.SGM

10DEN1

63514

Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices

process for non-federal educators who
develop public health and healthcare
educational activities and for nonfederal health professionals who seek
continuing education necessary to
maintain professional licensures and
certifications. This request for revision
is to add new questions to the TCEO
New Participant Registration, a new
TCEO Post-Course Evaluation, and a
new TCEO Follow-up Evaluation. Both
new evaluation tools will improve the
quality of educational activities. Each
TCEO tool ensures compliance with
accreditation requirements.
DATES: CDC must receive written
comments on or before February 8,
2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0109 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Acting Lead,
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 Jeffery 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.

VerDate Sep<11>2014

17:10 Dec 07, 2018

Jkt 247001

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; and
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.
5. Assess information collection costs.
Proposed Project
Application for Training (OMB
Control No. 0920–0017, Exp 06/30/
2019)—Revision—Division of Scientific
Education and Professional
Development (DSEPD), Center for
Surveillance, Epidemiology and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
DSEPD requests a three-year Revision
to the Training and Continuing
Education Online (TCEO) system, which
will comprise four data collection and
management tools. Requested revisions
are (1) to add questions to the existing
TCEO New Participant Registration and
(2) to introduce a Post-Course
Evaluation and a Follow-Up Evaluation.
No changes are requested for the
existing TCEO Proposal Tool.
TCEO provides access to CDC
educational activities that offer
continuing education to public health
and healthcare professionals (learners)
to maintain their professional licensures
and certifications. Licensures and
certifications are mandatory for certain
health professionals to provide services
that prevent and mitigate illness and
save lives. Employees of hospitals,
universities, medical centers, state and
local health departments, and federal
agencies participate in CDC’s accredited
educational activities to learn about
current public health and healthcare
practices. CDC is accredited by seven
accreditation organizations to provide
continuing education for public health
and healthcare professionals.

PO 00000

Frm 00049

Fmt 4703

Sfmt 4703

CDC and CDC-funded educational
activities include classroom study,
conferences, and electronic learning (elearning). The TCEO Proposal expedites
submission, review, and accreditation
processes for these CDC and CDCfunded educational activities. The
information collected from educational
developers provides CDC with the
information necessary to meet
accreditation requirements. CDC
reviews proposals to ensure compliance
with requirements and awards
continuing education when activities
meet accreditation standards. The
educational activities that can offer
continuing education are then added to
TCEO for learners to access.
Accreditation organizations require a
method of tracking learners who
complete an educational activity and
some require collection of professionspecific data, among other requirements.
CDC requires health professionals who
seek continuing education to establish
an account by completing the TCEO
New Participant Registration. CDC relies
on this electronic form to collect
information needed to coordinate
learner registrations for educational
activities.
The proposed inclusion of two new
evaluation tools is required by
accreditation organizations to ensure
compliance with accreditation
standards. Public health professionals
will be required to take the TCEO Postcourse Evaluation after they have
participated in an educational activity
and before they can earn continuing
education. Health professionals who
have received continuing education for
the activity will be encouraged to
complete the TCEO Follow-up
Evaluation when a link is sent to them
from TCEO by email. Reports on
responses to both tools will be
submitted to accreditation organizations
when they conduct audits or when CDC
requests renewal of accreditation. Both
new tools provide information to help
CDC improve the quality of its
educational activities.
Proposed changes not only ensure
that CDC is in compliance with
accreditation requirements, changes will
improve the quality of educational
activities, while continuing to offer
accredited educational activities at no
cost to learners. Because of the
increasing demand for accredited
educational activities that offer free CE
for licensures and certifications, TCEO
experiences a continued increase in
educational activities completed each
year by registered learners. Every year,
the number of times learners complete
steps to earn continuing education
increases by approximately 15%. The

E:\FR\FM\10DEN1.SGM

10DEN1

63515

Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices
two new evaluation tools will be shared
with all learners who complete
educational activities in TCEO, causing
the annual burden estimate to increase
significantly. The annual burden table

has been updated to reflect the new
TCEO Post-course Evaluation (66,667
burden hours) and the new TCEO
Follow-up Evaluation (2,000 burden
hours), for a total of 85,934 burden

hours that include all four TCEO tools.
There are no costs to respondents other
than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

Educational Developers (Health Educators).
Public Health and Health Care Professionals (Learners).
Public Health and Health Care Professionals (Learners).
Public Health and Health Care Professionals (Learners).

TCEO Proposal ................................

Total ...........................................

Total burden
(in hours)

1

5

600

TCEO New Participant Registration

200,000

1

5/60

16,667

TCEO Post-course Evaluation .........

200,000

2

10/60

66,667

TCEO Follow-up Evaluation .............

20,000

2

3/60

2,000

...........................................................

420,120

........................

........................

85,934

[FR Doc. 2018–26637 Filed 12–7–18; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–18PR]

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 The World
Trade Center Health Program (WTCHP):
Impact Assessment and Strategic
Planning for Translational Research
(Part 1, Formative Research: Focus
Groups) 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 March 15,
2018 to obtain comments from the
public and affected agencies. The
WTCHP is administered by the CDC/
National Institute for Occupational
Safety and Health (NIOSH). 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

17:10 Dec 07, 2018

Average
burden per
response
(in hours)

120

Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention (CDC).

VerDate Sep<11>2014

Number of
responses per
respondent

Jkt 247001

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 or
send an email to [email protected]. 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
The World Trade Center Health
Program: Impact Assessment and
Strategic Planning for Translational
Research (Part 1, Formative Research:

PO 00000

Frm 00050

Fmt 4703

Sfmt 4703

Focus Groups)—New—National
Institute for Occupational Safety and
Health (NIOSH), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The World Trade Center Health
Program (WTCHP) was established by
the James Zadroga 9/11 Health and
Compensation Act of 2010, Public Law
111–347 (hereafter referred to as ‘‘the
Zadroga Act’’). Under subtitle C, the
Zadroga Act requires the establishment
of a research program on health
conditions resulting from the 9/11
terrorist attacks. The Research to Care
(RTC) model is the strategic framework
employed by the WTCHP to prioritize,
conduct, and assess research that
informs excellence in clinical care for
the population of responders and
survivors affected by the 9/11 attacks in
New York City. It is the focus of this
assessment.
The RTC model assumes the
collective involvement of different
WTCHP stakeholders, including
members, researchers, clinicians, and
program administrators. It accounts for
a variety of inputs that can affect the
progress and impact of WTCHP
research. These inputs include people
and organizations (e.g., program
members, providers, clinical centers of
excellence, extramural researchers, and
program staff), resources (e.g.,
technology, data centers, the NYC 9/11
Health Registry) and regulatory rules,
principally the Zadroga Act. The
program supports activities such as
research prioritization, conduct of
research, delivery of medical care, and
iterative assessments of the translation
of research to improvements in health
care services and chronic disease

E:\FR\FM\10DEN1.SGM

10DEN1