[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 56993-56995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23572]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-15-15BFV; Docket No. CDC-2015-0085]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
[[Page 56994]]
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 the proposed
information collection request entitled ``A Study of Viral Persistence
in Ebola Virus Disease (EVD) Survivors''. The purpose of this
information collection 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. ``Persistence of Ebola Virus in Body Fluids of
Ebola Virus Disease (EVD) Survivors in Sierra Leone''. This information
collection will be the first systematic examination of the post-
recovery persistence of Ebola virus and the risks of transmission from
a cohort of convalescent Ebola survivors during close or intimate
contact.
DATES: Written comments must be received on or before November 20,
2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0085 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
Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease
(EVD) Survivors in Sierra Leone--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 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.
``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. This activity is currently approved by OMB for emergency use
under OMB Control Number 0920-1064--Persistence of Ebola Virus (EBOV)
in Body Fluids of EVD Survivors in Sierra Leone, which expires on
November 30, 2015. 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 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 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
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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 estimated annualized burden hours are 2,474.
Estimated Annualized Burden Hours
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Average
Type of Number of Number of burden per Total burden
Form name respondent respondents responses per response (in hours
respondent hours)
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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.
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TOTALS.................... ................ .............. .............. .............. 2,474
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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. 2015-23572 Filed 9-18-15; 8:45 am]
BILLING CODE 4163-18-P