60 day FRN

69683

Federal Register / Vol. 80, No. 217 / Tuesday, November 10, 2015 / Notices
important work. There is no cost to the
respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Total burden
(in hrs.)

Form name

U.S. healthcare facilities ...................

300

12

3/60

180

U.S. healthcare facilities ...................

Occupational Health Safety Network
(OHSN).
Enrollment form ................................

300

1

1/60

5

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

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

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

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

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

185

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. 2015–28474 Filed 11–9–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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.

Centers for Disease Control and
Prevention

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.

[60Day–16–16CM; Docket No. CDC–2015–
0097]

FOR FURTHER INFORMATION CONTACT:

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 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. CDC is requesting a new
three-year approval for ‘‘The
Cooperative Re-engagement Controlled
Trial (CoRECT)’’ information
collections.

SUMMARY:

Written comments must be
received on or before January 11, 2016.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0097 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
DATES:

asabaliauskas on DSK5VPTVN1PROD with NOTICES

Average
burden per
response
(in hrs.)

Number of
responses per
respondent

Number of
respondents

Type of respondents

VerDate Sep<11>2014

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Jkt 238001

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: 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 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

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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
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
The Cooperative Re-engagement
Controlled Trial (CoRECT)—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
new three-year OMB approval for
information collection for a new
research study entitled ‘‘The
Cooperative Re-engagement Controlled
Trial (CoRECT)’’. The purpose of the
study is to evaluate a combined health
department and clinic intervention to
improve engagement in HIV care.

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69684

Federal Register / Vol. 80, No. 217 / Tuesday, November 10, 2015 / Notices

Increasing the number of people living
with HIV who access HIV care and
achieve viral load suppression
addresses one of the priorities of the
National HIV/AIDS Strategy.
The CoRECT Study data collection is
comprised of six core components: 1.
Electronic clinic data abstraction
(Electronic Medical Record (EMR)
abstraction will be conducted by project
clinic staff at each project clinic to
develop the clinic-based ‘‘Out of Care’’
list; 2. electronic surveillance data
abstraction (Electronic surveillance data
abstraction will be conducted by project
health department staff at each health
department to develop the health
department based ‘‘Out of Care’’ list); 3.
a ‘‘Barriers to Care’’ survey (These
surveys will provide information
regarding barriers to accessing
healthcare (e.g., transportation, financial
assistance, housing, substance abuse
services, etc.); 4. ‘‘Standard of Care’’
survey (Investigators will administer
this survey to clinic managers, at
baseline and every six months during
the study period to assess how the
delivery of health services has evolved
over time) 5. Preliminary Case
Investigations form (a listing of potential
out-of-care patients will be reviewed to
determine those who appear to be outof-care, as determined by study
eligibility, versus those who meet
criteria for exclusion); and 6) Case
Conference form (project health
department staff will determine if

(i) People diagnosed with HIV and
linked to care are engaging medical care
(i.e., attending their enrollment
appointment and returning for followup medical appointments); and (ii)
people who have disengaged from HIV
care (i.e., have missed medical
appointments and have not been seen in
clinic for more than 6 months) are able
to efficiently re-engage in care. There
have been no randomized controlled
studies using a Data-to-Care approach to
identify and re-engage out of care
persons. Controlled studies such as the
CoRECT study are critical to determine
the effectiveness of HIV prevention
interventions.
The CoRECT study is a randomized
controlled trial that seeks to establish a
data-sharing partnership between health
departments and HIV care clinical
providers to identify HIV-infected
persons who are out of care and
evaluate an intervention that aims to
have randomized participants: (a) Link
to an HIV clinic; (b) remain in HIV
medical care; (c) achieve HIV viral load
suppression within 12 months; and (d)
achieve durable HIV viral load
suppression over 18 months.
The study is funded by CDC through
cooperative agreements with the
Connecticut State Department of Public
Health (in collaboration with Yale
University School of Medicine), the
Massachusetts State Department of
Public Health, and the Philadelphia
Department of Public Health.

potentially eligible patients met criteria
for inclusion in the study and if so
randomization will occur).
Prospective data collection will
provide information about participant’s
baseline characteristics including sex,
race/ethnicity, HIV exposure risk
category, CD4 and viral load test results,
date of first clinic visit, and insurance
status.
HIV antiretroviral therapy (ART) can
durably suppress the plasma HIV viral
load, which improves individual
survival and dramatically reduces
further HIV transmission. Increasing the
number of people living with HIV who
access HIV care and achieve viral load
suppression is a priority of the National
HIV/AIDS Strategy. Within the
continuum of HIV care in the United
States, improvements in linkage to and
retention in effective care provide the
greatest opportunity to improve rates of
HIV viral suppression. It is estimated
that of the 1.2 million persons living
with HIV in 2011, only 40% were
engaged in HIV medical care and only
30% achieved viral suppression.
HIV clinical trials with enhanced case
management have demonstrated that
interventions provided by the health
department can improve linkage to HIV
care and interventions provided by the
clinic can improve retention in HIV
care. Although linkage to care has
improved in many health department
jurisdictions, being linked to care is not
enough. There is a need to ensure that:

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Study Coordinator .............................

Electronic transmittal of surveillance
variables.
Electronic transmittal of clinical variables.
Barriers to Care Survey ...................
Standard of Care Survey .................
Case Conference Session ...............
Case Conference Session ...............

Clinic data manager ..........................
CoRECT study Participants ..............
Clinical Nurse Coordinator ................
Clinic data manager ..........................
CoRECT study Coordinator (health
department).
CoRECT study Coordinator (health
department).
Clinic Data Manager .........................

asabaliauskas on DSK5VPTVN1PROD with NOTICES

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

Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Type of respondent

3

4

1

12

46

4

1

184

1,200
46
46
3

1
2
12
12

30/60
45/60
1
1

600
69
552
36

Preliminary Case Investigation ........

3

12

1

36

Preliminary Case Investigation ........

3

12

1

36

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

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

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

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

1,525

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. 2015–28471 Filed 11–9–15; 8:45 am]
BILLING CODE 4163–18–P

VerDate Sep<11>2014

19:41 Nov 09, 2015

Total
burden hours

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