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
Main Study 3 & 6 Month Follow-Up Questionnaire - Female Form	New
Main Study Survivor Follow-Up Questionnaire - Female Form	New
Main Study Survivor Questionnaire - Female Form	New
Main Study 3 & 6 Month Follow-Up Questionnaire - Male Form	New
Main Study Survivor Follow-Up Questionnaire - Male Form	New
Main Study Survivor Questionnaire - Male Form	New
3 & 6 Month Follow-Up Questionnaire - Pilot Form	New
Surnivor Follow-Up Questionnaire - Pilot Form	New
Survivor Questionnaire - Pilot Form	New
Intake Form Form	New
Ebola Sierra Leone_SSA-15BFV_11APR2016_30NOVrev_CLEAN.docx Supporting Statement A	2016-12-01
Attachment7b - Counselling Script - Female.pdf Supplementary Document	2016-04-19
Attachment7a - Counselling Script - Male.pdf Supplementary Document	2016-04-19
Attachment3_Participant Study ID Card.pdf Supplementary Document	2016-04-19
Attachment2d_Re-Consent Form - Main Study.pdf Supplementary Document	2016-04-19
Attachment2c_Re-Consent Form - Pilot Study.pdf Supplementary Document	2016-04-19
Attachment2b_Consent Form-Main Study.docx Supplementary Document	2016-04-19
Attachment2a_Consent Form -PilotStudy.docx Supplementary Document	2016-04-19
IRB Approval APR2017.docx Supplementary Document	2016-04-15
SSB-15BFV-031516.docx Supporting Statement B	2016-04-15
AppndxE Sierra-Leone-Minimum-Wage.pdf Supplementary Document	2016-03-29
AppndxC-PublicComments.docx Supplementary Document	2016-03-29
AppndxB-60DayFRN.pdf Supplementary Document	2016-03-29
AppndxA 42 USC 241 PH Service Act Section 301.pdf Supplementary Document	2016-03-29

IC Document Collections

IC ID	Document Title	Status
221134	Laboratory Results Form Form	New
221133	Main Study 3 & 6 Month Follow-Up Questionnaire - Female Form	New
221132	Main Study Survivor Follow-Up Questionnaire - Female Form	New
221131	Main Study Survivor Questionnaire - Female Form	New
221127	Main Study 3 & 6 Month Follow-Up Questionnaire - Male Form	New
221126	Main Study Survivor Follow-Up Questionnaire - Male Form	New
221125	Main Study Survivor Questionnaire - Male Form	New
221123	3 & 6 Month Follow-Up Questionnaire - Pilot Form	New
221122	Surnivor Follow-Up Questionnaire - Pilot Form	New
221120	Survivor Questionnaire - Pilot Form	New
221100	Intake Form Form	New

ICR Details

OMB Control No: 0920-1149	ICR Reference No: 201603-0920-013
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15BFV
Title: Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease Survivors in Sierra Leone
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/02/2016
	Date Received in OIRA: 04/25/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	12 Months From Approved
Responses	8,240	0	0
Time Burden (Hours)	1,836	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: This study is designed to assess the presence and duration of infectious Ebola virus (EBOV) in semen, vaginal fluids, and other body fluids of Ebola Virus Disease (EVD) and its relation to humoral immune response in survivors in Sierra Leone, which will help inform EBOV transmission prevention strategies during EVD outbreaks. Data will provide health care and public health practitioners working on the Ebola response with insight into how long EBOV persists in body fluids other than blood. This information is needed in order to understand transmission risk of EBOV to others in the community from survivors for whom the virus is no longer active in blood.

---

Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 56993	09/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 19608	04/05/2016
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Intake Form	NA	Intake Form
Survivor Questionnaire - Pilot	NA	Survivor Questionnaire (Initial Study Visit and Follow-up) - Male/Female Pilot
Surnivor Follow-Up Questionnaire - Pilot	NA	Survivor Questionnaire (Initial Study Visit and Follow-up) Male/Female - Pilot
3 & 6 Month Follow-Up Questionnaire - Pilot	NA, NA	3 and 6 Mopnth Follow-Up Questionnaire for Men ,   3 and 6 Mopnth Follow-Up Questionnaire for Women
Main Study 3 & 6 Month Follow-Up Questionnaire - Female	NA	3 & 6 Month Follow-Up Questionnaire for Women
Laboratory Results Form	NA	Laboratory Results Form
Main Study Survivor Follow-Up Questionnaire - Male	NA	Follow-Up Visit Questionnaire for Men
Main Study Survivor Questionnaire - Female	NA	Baseline Questionnaire for Women
Main Study Survivor Follow-Up Questionnaire - Female	NA	Follow-Up Visit Questionnaire for Women
Main Study Survivor Questionnaire - Male	NA	Baseline Questionnaire for Men
Main Study 3 & 6 Month Follow-Up Questionnaire - Male	NA	3 & 6 Month Follow-Up Questionnaire for Men

---

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	8,240	0	0	8,240	0	0
Annual Time Burden (Hours)	1,836	0	0	1,836	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 is an Existing ICR without OMB Control Number. Increase in Burden Hours is the result of the continuation of studies that began as an Emergency ICR.

---

Annual Cost to Federal Government: $1,450,505

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

---

Common Form ICR:  No

---

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: 04/25/2016

---