80 FR 26053 - 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 87 (May 6, 2015)

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 two information collections titled ``Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease (EVD) Survivors in Sierra Leone'' and ``Assessment of Public Knowledge, Attitudes, and Practices (KAPs) Relating to EVD Prevention and Medical Care in Guinea.'' The purpose of these information collections is to gather the necessary information for the CDC and the international community to begin the activities necessary to reach the goal of zero new EVD cases throughout West Africa. Once that goal is reached, the 42-day countdown to declare West Africa Ebola-free can begin. Similar requests for public comment will be published as new information collections are proposed in the effort to meet the international goal of zero new EVD cases.

[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26053-26055]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15AEP; Docket No. CDC-2015-0029]


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 two information 
collections titled ``Persistence of Ebola Virus in Body Fluids of Ebola 
Virus Disease (EVD) Survivors in Sierra Leone'' and ``Assessment of 
Public Knowledge, Attitudes, and Practices (KAPs) Relating to EVD 
Prevention and Medical Care in Guinea.'' The purpose of these 
information collections is to gather the necessary information for the 
CDC and the international community to begin the activities necessary 
to reach the goal of zero new EVD cases throughout West Africa. Once 
that goal is reached, the 42-day countdown to declare West Africa 
Ebola-free can begin. Similar requests for public comment will be 
published as new information collections are proposed in the effort to 
meet the international goal of zero new EVD cases.

DATES: Written comments must be received on or before July 6, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0029 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 Projects

    A Study of Viral Persistence in Ebola Virus Disease (EVD) Survivors 
and an Assessment of Public Knowledge, Attitudes, and Practices 
Relating to EVD Prevention and Medical Care--New--National Center for 
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Much progress has been made in the year since the CDC first 
responded to the Ebola outbreak in West Africa, but the agency's 
efforts must continue until there are zero new cases of Ebola virus 
disease (EVD). As the CDC's 2014 Ebola

[[Page 26054]]

virus response draws closer to the international goal of zero new EVD 
cases in 2015, the agency must intensify its efforts to identify and 
prevent every potential route of human disease transmission and to 
understand the most current community barriers to reaching that final 
goal.
    The first study, titled ``Persistence of Ebola Virus (EBOV) in Body 
Fluids of EVD Survivors in Sierra Leone,'' will be the first systematic 
examination of the post-recovery persistence of EBOV and the risks of 
transmission from a cohort of convalescent Ebola survivors during close 
or intimate contact. It is important to fully understand how long the 
virus stays active in body fluids other than blood in order to target 
and refine public health interventions to arrest the ongoing spread of 
disease.
    The research study will be comprised of three modules based on the 
body fluids to be studied: A pilot module of adult males (semen) and 
two full modules: Module A of adult men and women repeating collections 
and questionnaires every two weeks (semen, vaginal secretions, and 
saliva, tears, sweat, urine, rectal swab), and Module B of lactating 
adult women repeating collections and questionnaires every three days 
(sweat and breast milk). Participants for each module will be recruited 
by trained study staff from Ebola treatment units (ETUs) and survivor 
registries. Participants will be followed up at study sites in 
government hospitals.
    Specimens will be tested for EBOV ribonucleic acid (RNA) by reverse 
transcription polymerase chain reaction test (RT-PCR) in Sierra Leone 
at the CDC laboratory facility in Bo. All positive RT-PCR samples will 
be sent to CDC Atlanta for virus isolation. Each body fluid will be 
collected until two negative RT-PCR results are obtained. Participants 
will be followed until all their studied body fluids are negative. They 
will receive tokens of appreciation for their participation at the 
initial visit and again at every subsequent follow-up visit [e.g., 
120,000 Leones (approximately $28 US dollars) and a supply of condoms]. 
For Module A, men and women will be recruited in equal numbers for this 
study until more information on gender effects of viral persistence is 
available. A trained study data manager will collect test results for 
all participants in a laboratory results form.
    Results and analyses are needed to update relevant counseling 
messages and recommendations from the Sierra Leone Ministry of Health 
(MoH), WHO, and CDC. The study will provide the most current 
information that is critical to the development of public health 
measures, such as recommendations about sexual activity, breastfeeding, 
and other routine activities and approaches to evaluation of survivors 
to determine whether they can safely resume sexual activity. These 
approaches in turn are expected to reduce the risk of Ebola resurgence 
and mitigate stigma for thousands of survivors. The information is 
likewise critical to reducing the risk that Ebola would be introduced 
in a location that has not previously been affected.
    The second data collection, titled ``Assessment of Public 
Knowledge, Attitudes, and Practices (KAPs) Relating to EVD Prevention 
and Medical Care in Guinea,'' is urgently needed to inform the rapid 
development of an up-to-date national, evidence-based strategy for 
health promotion and social mobilizations to assist the Guinea MoH 
achieve its goal of zero new cases. This will be a nationally 
representative assessment of community-specific KAPs designed to reduce 
prevailing barriers to EVD prevention and control efforts. Despite 
dissemination of basic EVD prevention messages through radio, 
billboards, community meetings, and other means, resistance to EVD 
prevention and control measures continues in many communities. Some 
believe that EVD is transmitted by witchcraft, ``outsiders,'' or health 
workers. Some lack understanding or confidence in control measures. 
Reports of potential resistance include hiding of ill and deceased 
persons, unsafe burial practices, and violence against health workers.
    For this effort, the CDC and the Guinea MoH will work with well-
established African organizations that specialize in household health 
surveys and health promotion. They will collect information from 
representative samples of household members and community leaders 
living in villages and neighborhoods in eight Guinean regions (Conakry, 
Kindia, Bok[eacute], Mamou, Lab[eacute], Faranah, Kankan, 
N'z[eacute]r[eacute]kor[eacute]). No tokens of appreciation will be 
offered to participants in this assessment.
    Previously, a UNICEF-funded EVD-related KAP assessment was 
conducted which did not address perceptions of health education 
activities; reasons for resistance to prevention and control efforts; 
or stigma and discrimination faced by EVD cases, survivors, or 
contacts. For this reason, the CDC Director stressed after his March 
2015 Guinea visit that this new CDC-funded community KAP assessment was 
critical to inform international efforts to get to zero cases in 
Guinea.
    Both information collections will be one-time efforts in these 
participating countries under the authority of Section 301 of the 
Public Health Service Act (42 U.S.C. 241).
    The total burden hours requested for the research study in Sierra 
Leone is 2,474 hours incurred by 530 participants, and for the KAP 
assessment in Guinea, 5,184 hours incurred by 5,248 participants. There 
are no other costs to the respondent other than their time.

Estimated Burden Hours

       Study of the ``Persistence of Ebola Virus (EBOV) in Body Fluids of EVD Survivors in Sierra Leone''
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in      (in hrs.)
                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
Pilot participants............  Survivor                      80               1           30/60              40
                                 Questionnaire.
Pilot participants............  Survivor Follow-              80              12           10/60             160
                                 up
                                 Questionnaire.
Module A male participants....  Survivor                     175               1           30/60              88
                                 Questionnaire.
Module A male participants....  Survivor Follow-             175              12           10/60             350
                                 up
                                 Questionnaire.
Module A female participants..  Survivor                     175               1           30/60              88
                                 Questionnaire.
Module A female participants..  Survivor Follow-             175              12           10/60             350
                                 up
                                 Questionnaire.
Module B female participants..  Survivor                     100               1           30/60              50
                                 Questionnaire.
Module B female participants..  Survivor Follow-             100              12           10/60             200
                                 up
                                 Questionnaire.
Data manager..................  Laboratory                     1           6,890           10/60           1,148
                                 Results Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,474
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[[Page 26055]]


    ``Assessment of Public Knowledge, Attitudes, and Practices Relating to EVD Prevention and Medical Care in
                                                    Guinea''
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in      (in hrs.)
                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
Household Members.............  Information                5,120               1               1           5,120
                                 Collection
                                 Instrument--Hou
                                 sehold.
Village or Neighborhood         Information                  128               1           30/60              64
 Leaders.                        Collection
                                 Instrument--Lea
                                 der.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           5,184
----------------------------------------------------------------------------------------------------------------


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. 2015-10541 Filed 5-5-15; 8:45 am]
 BILLING CODE 4163-18-P