2015-10541. 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.

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., MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

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 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 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 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 well-established 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, Boké, Mamou, Labé, Faranah, Kankan, N'zérékoré). 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

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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Pilot participants	Survivor Questionnaire	80	1	30/60	40
Pilot participants	Survivor Follow-up Questionnaire	80	12	10/60	160
Module A male participants	Survivor Questionnaire	175	1	30/60	88
Module A male participants	Survivor Follow-up Questionnaire	175	12	10/60	350
Module A female participants	Survivor Questionnaire	175	1	30/60	88
Module A female participants	Survivor Follow-up Questionnaire	175	12	10/60	350
Module B female participants	Survivor Questionnaire	100	1	30/60	50
Module B female participants	Survivor Follow-up Questionnaire	100	12	10/60	200
Data manager	Laboratory Results Form	1	6,890	10/60	1,148
Total					2,474

“Assessment of Public Knowledge, Attitudes, and Practices Relating to EVD Prevention and Medical Care in Guinea”

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Household Members	Information Collection Instrument—Household	5,120	1	1	5,120
Village or Neighborhood Leaders	Information Collection Instrument—Leader	128	1	30/60	64
Total					5,184

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.