Persistence of Zika virus in semen and urine of adult men in the United States with confirmed Zika virus infection

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Follow-Up Survey - Spanish	Form and Instruction	New	Available
Follow-Up Survey - English	Form and Instruction	New	Available
First Follow-Up Survey - Spanish	Form and Instruction	New	Available
First Follow-Up Survey - English	Form and Instruction	New	Available
Study of Zika Virus Shedding in Semen and Urine of Adult Men - Phone Script and Consent - Spanish	Form and Instruction	New	Available
Study of Zika Virus Shedding in Semen and Urine of Adult Men - Phone Script and Consent - English	Form and Instruction	New	Available
SSB Zika USA Shedding Study_09 26 2016 OMB_SHedits092816.docx	Supporting Statement B	Uploaded 2016-10-05	Available
SSA Zika USA Shedding Study_10042016 OMB.docx	Supporting Statement A	Uploaded 2016-10-05	Available
Certificate_of_Translation_CDC_SPANISH_05 05 2016.pdf	Supplementary Document	Uploaded 2016-06-28	Available
Att. J -- IRB approval.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. L -- Phone script from state health department ESP.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. L -- Phone script from State health department.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. K -- Letter from state health department ESP.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. K -- Letter from state health department.docx	Supplementary Document	Uploaded 2016-06-28	Repair queued
Att. I -- Thank You and Test Results ESP.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. I -- Thank You and Test Results.docx	Supplementary Document	Uploaded 2016-06-28	Repair queued
Att. H -- FAQs ESP.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. H -- FAQs.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. G -- General Instructions ESP.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. G -- General Instructions.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. F -- Copy of Consent Form ESP.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. F -- Copy of Consent Form.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. E -- Instructions for sample collection ESP.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. E -- Instructions for Sample Collection.docx	Supplementary Document	Uploaded 2016-06-28	Available
Att. B2 -- Public Comment.pdf	Supplementary Document	Uploaded 2016-06-28	Available
Att. B1 -- 60-day FRN.pdf	Supplementary Document	Uploaded 2016-06-28	Available
Att. A -- Section 301 of the Public Health Service Act (42 USC 241).pdf	Supplementary Document	Uploaded 2016-06-28	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
222242	Follow-Up Survey	Form and Instruction	New	Follow-Up Survey - Spanish
222242	Follow-Up Survey	Form and Instruction	New	Follow-Up Survey - English
222242	Follow-Up Survey	Form and Instruction	New	First Follow-Up Survey - Spanish
222242	Follow-Up Survey	Form and Instruction	New	First Follow-Up Survey - English
222241	Introductory Survey	Form and Instruction	New	Study of Zika Virus Shedding in Semen and Urine of Adult Men - Phone Script and Consent - Spanish
222241	Introductory Survey	Form and Instruction	New	Study of Zika Virus Shedding in Semen and Urine of Adult Men - Phone Script and Consent - English

ICR Details

OMB Control No: 0920-1139	ICR Reference No: 201606-0920-018
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-16ASR
Title: Persistence of Zika virus in semen and urine of adult men in the United States with confirmed Zika virus infection
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/05/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/13/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	12 Months From Approved
Responses	3,250	0	0
Time Burden (Hours)	133	0	0
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 is an extension of the Emergency Request that was previously approved by OMB, and will fill gaps in the scientific knowledge base for Zika virus regarding the occurrence, persistence, and transmissibility of Zika virus in urine and semen.

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

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:
	81 FR 26231	05/02/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 44866	07/11/2016
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Follow-Up Survey	NA, NA, NA, NA	First Follow-Up Survey - English ,   First Follow-Up Survey - Spanish ,   Follow-Up Survey - English ,   Follow-Up Survey - Spanish
Introductory Survey	NA, NA	Study of Zika Virus Shedding in Semen and Urine of Adult Men - Phone Script and Consent - English ,   Study of Zika Virus Shedding in Semen and Urine of Adult Men - Phone Script and Consent - Spanish

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ICR Summary of Burden

table that charts list 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	0	0	3,250	0	0
Annual Time Burden (Hours)	133	0	0	133	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 0920-16ASR is a NEW ICR for continuation of a previously OMB-approved Emergency package.

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Annual Cost to Federal Government: $94,003

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: 07/13/2016

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