80 FR 69683 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 217 (November 10, 2015)

Page Range		69683-69684
FR Document		2015-28471

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.

Federal Register, Volume 80 Issue 217 (Tuesday, November 10, 2015)

[Federal Register Volume 80, Number 217 (Tuesday, November 10, 2015)]
[Notices]
[Pages 69683-69684]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

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


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 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.

DATES: 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 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 
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.

[[Page 69684]]

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 out-of-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 
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: (i) People diagnosed with HIV 
and linked to care are engaging medical care (i.e., attending their 
enrollment appointment and returning for follow-up 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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per  response   Total  burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Study Coordinator.............  Electronic                     3               4               1              12
                                 transmittal of
                                 surveillance
                                 variables.
Clinic data manager...........  Electronic                    46               4               1             184
                                 transmittal of
                                 clinical
                                 variables.
CoRECT study Participants.....  Barriers to Care           1,200               1           30/60             600
                                 Survey.
Clinical Nurse Coordinator....  Standard of Care              46               2           45/60              69
                                 Survey.
Clinic data manager...........  Case Conference               46              12               1             552
                                 Session.
CoRECT study Coordinator        Case Conference                3              12               1              36
 (health department).            Session.
CoRECT study Coordinator        Preliminary Case               3              12               1              36
 (health department).            Investigation.
Clinic Data Manager...........  Preliminary Case               3              12               1              36
                                 Investigation.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           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

69684 Federal Register / Vol. 80, No. 217 / Tuesday, November 10, 2015 / Notices

Increasing the number of people living potentially eligible patients met criteria (i) People diagnosed with HIV and
with HIV who access HIV care and for inclusion in the study and if so linked to care are engaging medical care
achieve viral load suppression randomization will occur). (i.e., attending their enrollment
addresses one of the priorities of the Prospective data collection will appointment and returning for follow-
National HIV/AIDS Strategy. provide information about participant’s up medical appointments); and (ii)
The CoRECT Study data collection is baseline characteristics including sex, people who have disengaged from HIV
comprised of six core components: 1. race/ethnicity, HIV exposure risk care (i.e., have missed medical
Electronic clinic data abstraction category, CD4 and viral load test results, appointments and have not been seen in
(Electronic Medical Record (EMR) date of first clinic visit, and insurance clinic for more than 6 months) are able
abstraction will be conducted by project status. to efficiently re-engage in care. There
clinic staff at each project clinic to HIV antiretroviral therapy (ART) can have been no randomized controlled
develop the clinic-based ‘‘Out of Care’’ durably suppress the plasma HIV viral studies using a Data-to-Care approach to
list; 2. electronic surveillance data load, which improves individual identify and re-engage out of care
abstraction (Electronic surveillance data survival and dramatically reduces persons. Controlled studies such as the
abstraction will be conducted by project further HIV transmission. Increasing the CoRECT study are critical to determine
health department staff at each health number of people living with HIV who the effectiveness of HIV prevention
department to develop the health access HIV care and achieve viral load interventions.
department based ‘‘Out of Care’’ list); 3. suppression is a priority of the National The CoRECT study is a randomized
a ‘‘Barriers to Care’’ survey (These HIV/AIDS Strategy. Within the controlled trial that seeks to establish a
surveys will provide information continuum of HIV care in the United data-sharing partnership between health
regarding barriers to accessing States, improvements in linkage to and departments and HIV care clinical
healthcare (e.g., transportation, financial retention in effective care provide the providers to identify HIV-infected
assistance, housing, substance abuse greatest opportunity to improve rates of persons who are out of care and
services, etc.); 4. ‘‘Standard of Care’’ HIV viral suppression. It is estimated evaluate an intervention that aims to
survey (Investigators will administer that of the 1.2 million persons living have randomized participants: (a) Link
this survey to clinic managers, at with HIV in 2011, only 40% were to an HIV clinic; (b) remain in HIV
baseline and every six months during engaged in HIV medical care and only medical care; (c) achieve HIV viral load
the study period to assess how the 30% achieved viral suppression. suppression within 12 months; and (d)
delivery of health services has evolved HIV clinical trials with enhanced case achieve durable HIV viral load
over time) 5. Preliminary Case management have demonstrated that suppression over 18 months.
Investigations form (a listing of potential interventions provided by the health The study is funded by CDC through
out-of-care patients will be reviewed to department can improve linkage to HIV cooperative agreements with the
determine those who appear to be out- care and interventions provided by the Connecticut State Department of Public
of-care, as determined by study clinic can improve retention in HIV Health (in collaboration with Yale
eligibility, versus those who meet care. Although linkage to care has University School of Medicine), the
criteria for exclusion); and 6) Case improved in many health department Massachusetts State Department of
Conference form (project health jurisdictions, being linked to care is not Public Health, and the Philadelphia
department staff will determine if enough. There is a need to ensure that: Department of Public Health.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total
Type of respondent Form name responses per
respondents response burden hours
respondent (in hours)

Study Coordinator ............................. Electronic transmittal of surveillance 3 4 1 12
variables.
Clinic data manager .......................... Electronic transmittal of clinical vari- 46 4 1 184
ables.
CoRECT study Participants .............. Barriers to Care Survey ................... 1,200 1 30/60 600
Clinical Nurse Coordinator ................ Standard of Care Survey ................. 46 2 45/60 69
Clinic data manager .......................... Case Conference Session ............... 46 12 1 552
CoRECT study Coordinator (health Case Conference Session ............... 3 12 1 36
department).
CoRECT study Coordinator (health Preliminary Case Investigation ........ 3 12 1 36
department).
Clinic Data Manager ......................... Preliminary Case Investigation ........ 3 12 1 36
Total ........................................... ........................................................... ........................ ........................ ........................ 1,525

Leroy A. Richardson,
asabaliauskas on DSK5VPTVN1PROD with NOTICES

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

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Document Created: 2018-03-01 11:24:39
Document Modified: 2018-03-01 11:24:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before January 11, 2016.
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]
FR Citation		80 FR 69683

80 FR 69683 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 217 (November 10, 2015)

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