Zika Emergency Package III: Persistence of Zika virus in semen and urine of adult men with confirmed Zika virus infection

Forms and Documents

Document Name	Status
Follow-Up Survey Form and Instruction	Unchanged
Introductory Survey Form and Instruction	Unchanged
0920-1109 non-sub change request.docx Justification for No Material/Nonsubstantive Change	2016-04-12
Att. L -- Phone script from State health department.docx Supplementary Document	2016-04-12
Att. K -- Letter from state health department.docx Supplementary Document	2016-04-12
Att. J2 -- IRB Amendment.docx Supplementary Document	2016-04-12
SSA zika emergency III 28MAR2016.docx Supporting Statement A	2016-03-28
Att. J -- IRB approval.docx Supplementary Document	2016-03-28
Att. I -- Thank You and Test Results.docx Supplementary Document	2016-03-28
Att. H -- FAQs.docx Supplementary Document	2016-03-28
Att. G -- General Instructions.docx Supplementary Document	2016-03-28
Att. F -- Copy of Consent Form.docx Supplementary Document	2016-03-28
Att. E -- Instructions for Sample Collection.docx Supplementary Document	2016-03-28
Att. B -- 60-Day FRN.docx Supplementary Document	2016-03-28
Att. A -- Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2016-03-28
Emergency request memo to OMB.pdf Supplementary Document	2016-03-28
SSB zika emergency III 12APR2016.docx Supporting Statement B	2016-04-12

IC Document Collections

IC ID	Document Title	Status
220786	Follow-Up Survey Form and Instruction	Unchanged
220785	Introductory Survey Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1109	ICR Reference No: 201604-0920-004
Status: Historical Active	Previous ICR Reference No: 201603-0920-011
Agency/Subagency: HHS/CDC	Agency Tracking No: 16ABI
Title: Zika Emergency Package III: Persistence of Zika virus in semen and urine of adult men with confirmed Zika virus infection
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 03/30/2016
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/13/2016
	Date Received in OIRA: 04/13/2016
Terms of Clearance: Approved consistent with the understanding that associated collections extending beyond 6 months will be submitted to OMB as a non-emergency information collection request for formal review.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	09/30/2016	09/30/2016
Responses	3,250	0	3,250
Time Burden (Hours)	58	0	58
Cost Burden (Dollars)	0	0	0

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Abstract: Information on the frequency and duration of Zika virus shedding in semen and urine is needed urgently to inform public health recommendations for infected men and their partners. The purpose of this study is to enroll adult men with confirmed Zika virus infection and collect serial specimens of semen and urine. This study will fill gaps in the scientific knowledge base for Zika virus regarding the occurrence, persistence, and transmissibility of Zika virus in urine and semen.

Emergency Justfication: Zika virus is an arthropod-borne flavivirus that has recently emerged in the Americas. Maternal infection has been linked to congenital microcephaly, fetal loss, and other adverse reproductive health outcomes. Although spread primarily by mosquitoes, recent reports have highlighted the potential for sexual transmission of Zika virus through the semen of infected men. The purpose of this study is to enroll adult men with confirmed Zika virus infection and collect serial specimens of semen and urine. This study will fill gaps in the scientific knowledge base for Zika virus regarding the occurrence, persistence and transmissibility of Zika virus in urine and semen. This is a prospective, descriptive cohort study that allows for determining the persistence of shedding Zika virus in semen and urine through serial specimen collection from individuals with confirmed Zika virus.The results of this study will be of great relevance to provide evidence-based information to circumvent Zika virus transmission. Results and analysis will be used to update and refine relevant counseling messages and recommendations as well as provide understanding for future Zika virus outbreaks..

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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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Follow-Up Survey	NA	Follow-Up Survey
Introductory Survey	NA	Verbal Script for Consent and Introductory Survey

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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	3,250	3,250	0	0	0	0
Annual Time Burden (Hours)	58	58	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: Submission of 09290-16YE is a New Emergency ICR.

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Annual Cost to Federal Government: $36,397

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: 04/13/2016

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