[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)]
[Notices]
[Pages 19608-19609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-15BFV]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    A Study of Viral Persistence in Ebola Virus Disease
    (EVD) Survivors--Existing Information Collection Without an OMB 
Control Number--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 virus response maintains the 
international goal of zero new EVD cases in 2015, the agency must 
intensify its efforts to identify and prevent every

[[Page 19609]]

potential route of human disease transmission and to understand the 
most current community barriers to reaching that final goal.
    Persistence of Ebola Virus (EBOV) in Body Fluids of EVD Survivors 
in Sierra Leone is 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 is 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, 
World Health Organization, 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 total burden hours requested for the research study in Sierra 
Leone is 1,836 hours. There are no costs to respondents other than 
their time.

                                        Estimated Annualized Burden Hours
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                                                                                                      Average
                                                                      No. of          No. of        burden per
         Type of respondent                   Form name             respondents   responses  per     response
                                                                                     respondent       (hours)
----------------------------------------------------------------------------------------------------------------
Data manager.......................  Intake Form................               1             550           20/60
Pilot participants.................  Survivor Questionnaire.....             100               1           30/60
Pilot participants.................  Survivor Follow-up                      100               5           15/60
                                      Questionnaire.
Pilot participants.................  3 & 6 Month Follow up                   100               2           15/60
                                      Questionnaire.
Main study male participants.......  Survivor Questionnaire.....             120               1           30/60
Main study male participants.......  Survivor Follow-up                      120              12           15/60
                                      Questionnaire.
Main study male participants.......  3 & 6 Month Follow                      120               2           15/60
                                      Questionnaire.
Main study female participants.....  Survivor Questionnaire.....             120               1           30/60
Main study female participants.....  Survivor Follow-up                      120               4           15/60
                                      Questionnaire.
Main study female participants.....  3 & 6 Month Follow up                   120               2           15/60
                                      Questionnaire.
Data manager.......................  Laboratory Results Form....               1           4,250           10/60
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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. 2016-07803 Filed 4-4-16; 8:45 am]
 BILLING CODE 4163-18-P