[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18853-18855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07424]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-15BFV]
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
[[Page 18854]]
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 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 2,474 hours incurred by 530 participants. There are no costs
to the respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (hours)
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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 up 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. 2016-07424 Filed 3-31-16; 8:45 am]
BILLING CODE 4163-18-P