[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 56995]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Type of         Number of       Number of      burden per     Total  burden
           Form name               respondent       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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.
                               ---------------------------------------------------------------------------------
    TOTALS....................  ................  ..............  ..............  ..............           2,474
----------------------------------------------------------------------------------------------------------------


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