[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]

[Notices]

[Pages 26053-26055]

From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]

[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., MSD74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

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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 startup 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 

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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 wellestablished 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

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 Study of the ``Persistence of Ebola Virus (EBOV) in Body Fluids of EVD Survivors in Sierra Leone''

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 Average

 Number of Number of burden per Total burden

 Type of respondents Form name respondents responses per response (in (in hrs.)

 respondent hrs.)

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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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 Total..................... ................ .............. .............. .............. 2,474

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 ``Assessment of Public Knowledge, Attitudes, and Practices Relating to EVD Prevention and Medical Care in

 Guinea''

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 Average

 Number of Number of burden per Total burden

 Type of respondents Form name respondents responses per response (in (in hrs.)

 respondent hrs.)

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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.

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 Total..................... ................ .............. .............. .............. 5,184

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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. 2015-10541 Filed 5-5-15; 8:45 am]

 BILLING CODE 4163-18-P

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