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

Forms and Documents

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

IC Document Collections

IC ID	Document Title	Status
222242	Follow-Up Survey Form and Instruction	New
222241	Introductory Survey Form and Instruction	New

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
	Date Received in OIRA: 07/13/2016
Terms of Clearance:

	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

IC Title	Form No.	Form Name
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
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

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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	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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