Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease Survivors in Sierra Leone

Forms and Documents

Document Name	Status
Laboratory Results Form Form	New
FEMALE Participants Follow-Up Questionnaire - Module B Form and Instruction	New
FEMALE Participants Survivor Questionnaire - Module B Form and Instruction	New
FEMALE Participants Follow-Up Questionnaire - Module A Form and Instruction	New
FEMALE Participants Survivor Questionnaire - Module A Form and Instruction	New
MALE Participants Follow-Up Questionnaire - Module A Form and Instruction	New
MALE Participants Survivor Questionnaire - Module A Form and Instruction	New
PILOT Participants Follow-Up Questionnaire Form and Instruction	New
PILOT Participants Survivor Questionnaire Form and Instruction	New
Study Intake Form Form	New
20150518 SupptngStmntB-BodyFluidsSL_clean.docx Supporting Statement B	2015-05-18
20150518 SupptngStmntA-BodyFluidsSL_clean.docx Supporting Statement A	2015-05-18
OMBEmerRqustMemo EBOVPersist 20150518.pdf Supplementary Document	2015-05-18
Att8_CounsellingScript.docx Supplementary Document	2015-05-18
Att4_ParticipantStudyIDCard.pptx Supplementary Document	2015-05-18
Att3_ConsentFormModuleB.docx Supplementary Document	2015-05-18
Att2_ConsentFormPilotModuleA.docx Supplementary Document	2015-05-18
AppndxC Sierra-Leone-Minimum-Wage.pdf Supplementary Document	2015-05-18
AppndxB HmnSubjcts Revw-Apprvls.docx Supplementary Document	2015-05-18
AppndxA 42 USC 241 PH Service Act Section 301.pdf Supplementary Document	2015-05-18

IC Document Collections

IC ID	Document Title	Status
216625	Laboratory Results Form Form	New
216624	FEMALE Participants Follow-Up Questionnaire - Module B Form and Instruction	New
216623	FEMALE Participants Survivor Questionnaire - Module B Form and Instruction	New
216622	FEMALE Participants Follow-Up Questionnaire - Module A Form and Instruction	New
216621	FEMALE Participants Survivor Questionnaire - Module A Form and Instruction	New
216620	MALE Participants Follow-Up Questionnaire - Module A Form and Instruction	New
216619	MALE Participants Survivor Questionnaire - Module A Form and Instruction	New
216618	PILOT Participants Follow-Up Questionnaire Form and Instruction	New
216617	PILOT Participants Survivor Questionnaire Form and Instruction	New
216616	Study Intake Form Form	New

ICR Details

OMB Control No: 0920-1064	ICR Reference No: 201505-0920-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15AIR
Title: Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease Survivors in Sierra Leone
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 05/20/2015
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/20/2015
	Date Received in OIRA: 05/19/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	6 Months From Approved
Responses	9,050	0	0
Time Burden (Hours)	2,092	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This research study investigates the persistence of Ebola virus in different body fluids in a cohort of survivors in order to target and refine public health interventions to arrest ongoing spread of disease in Sierra Leone. It will monitor survivors at different points of convalescence ranging from the time of discharge from an Ebola Treatment Unit up to 30 weeks.

Emergency Justfication: The potential public health impact of EBOV transmission by contact with body fluids other than blood from convalescent EVD survivors is substantial. Given large numbers of survivors from the current outbreak in West Africa, even a small percentage of survivors who transmit EBOV to their sex partners, children, or other contacts could prolong clusters of infection or spread EBOV to new communities. The purpose of this study is to assess the presence and duration of infectious EBOV in semen, vaginal fluids, and other body fluids of EVD survivors in Sierra Leone, which is critically important in understanding potential risk of EBOV transmission from survivors.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 26053	05/06/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
MALE Participants Follow-Up Questionnaire - Module A	None	Follow-Up Questionnaire
FEMALE Participants Survivor Questionnaire - Module A	None	Survivor Questionnaire - Pilot/A/B
Study Intake Form	None	Study Intake Form
FEMALE Participants Survivor Questionnaire - Module B	None	Survivor Questionnaire - Pilot/A/B
FEMALE Participants Follow-Up Questionnaire - Module B	None	Follow-Up Questionnaire
PILOT Participants Survivor Questionnaire	None	Survivor Questionnaire - Pilot/A/B
PILOT Participants Follow-Up Questionnaire	None	Follow-Up Questionnaire
MALE Participants Survivor Questionnaire - Module A	None	Survivor Questionnaire - Pilot/A/B
FEMALE Participants Follow-Up Questionnaire - Module A	None	Follow-Up Questionnaire
Laboratory Results Form	None	Laboratory Results Form

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	9,050	0	0	9,050	0	0
Annual Time Burden (Hours)	2,092	0	0	2,092	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Submission of 0920-15AIR is a New Emergency ICR Request

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Annual Cost to Federal Government: $905,083

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/19/2015

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