Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study)

Forms and Documents

Document Name	Status
Contact Information Form Form and Instruction	New
Shedding Eligibility Form Form and Instruction	New
Questionnaire for Men in Semen Study Form and Instruction	New
Shedding Questionnaire - Asymptomatics Form and Instruction	New
Shedding Questionnaire - Symptomatics Form and Instruction	New
Shedding Questionnaire - Public Health Personnel Form and Instruction	New
Contact Information Form Form	Removed
Shedding Eligibility Form and Instruction	Removed
Baseline and Follow-Up Questionnaire - Asymptomatic Form and Instruction	Removed
Baseline and Follow-Up Questionnaire - Symptomatic Form and Instruction	Removed
Att. L - IRB approval.docx Supplementary Document	2017-07-13
Att. M - Informational Flyer.docx Supplementary Document	2017-07-13
Att. K - Counseling messages.docx Supplementary Document	2017-07-13
Att. J - Laboratory Form.docx Supplementary Document	2017-07-13
Att. I - Protocol for specimen collection ESP.docx Supplementary Document	2017-07-13
Att. I - Protocol for specimen collection.docx Supplementary Document	2017-07-13
Att. F - ZIPER Phone Recruitment Script ESP.docx Supplementary Document	2017-07-13
Att. F - ZIPER Phone Recruitment Script.docx Supplementary Document	2017-07-13
Att. E - Consent forms ESP.docx Supplementary Document	2017-07-13
Att. E - Consent forms.docx Supplementary Document	2017-07-13
Att. C - Model coupon.docx Supplementary Document	2017-07-13
Att. B - 60-day FRN (0920-1140).pdf Supplementary Document	2017-07-13
Att. A - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2017-07-13
SSB_0920-1140_2017_Revision.docx Supporting Statement B	2017-07-13
SSA_0920-1140_13JUL2017.docx Supporting Statement A	2017-07-13

IC Document Collections

IC ID	Document Title	Status
227482	Contact Information Form Form and Instruction	New
227481	Shedding Eligibility Form Form and Instruction	New
227480	Questionnaire for Men in Semen Study Form and Instruction	New
227479	Shedding Questionnaire - Asymptomatics Form and Instruction	New
227478	Shedding Questionnaire - Symptomatics Form and Instruction	New
227477	Shedding Questionnaire - Public Health Personnel Form and Instruction	New
222428	Contact Information Form Form	Removed
222266	Shedding Eligibility Form and Instruction	Removed
222265	Baseline and Follow-Up Questionnaire - Asymptomatic Form and Instruction	Removed
222264	Baseline and Follow-Up Questionnaire - Symptomatic Form and Instruction	Removed

ICR Details

OMB Control No: 0920-1140	ICR Reference No: 201707-0920-005
Status: Historical Active	Previous ICR Reference No: 201606-0920-022
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1140
Title: Zika virus persistence in body fluids of patients with Zika virus infection in Puerto Rico (ZIPER Study)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/15/2017
	Date Received in OIRA: 07/14/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	36 Months From Approved	10/31/2017
Responses	1,302	0	3,400
Time Burden (Hours)	241	0	407
Cost Burden (Dollars)	0	0	0

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Abstract: The ZIPER study will help inform the presence and duration of ZIKV shedding in several body fluids among RT-PCR-positive ZIKV cases from Puerto Rico. It will also provide information regarding the duration of detection of anti-ZIKV IgM antibodies and the time for development of IgG antibodies among the same population. In addition, this study will determine the prevalence of anti-ZIKV, IgM and IgG, and virus shedding in body fluids among household contacts of ZIKV cases. This Revision ICR is being submitted to allow information collection activities to continue with the addition of, 1) a follow-up household visit to determine how many household members of Zika virus-infected participants become infected during the 4 months following initial screening, and 2) a follow-up with men with Zika virus-positive semen specimens to better understand the effect of Zika virus infection on sperm.

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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:
	82 FR 16837	04/06/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 32554	07/14/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Contact Information Form	NA	Contact Information Form
Shedding Questionnaire - Public Health Personnel	NA, NA	Baseline and Follow-Up Questionnaire - English ,   Baseline and Follow-Up Questionnaire - Spanish
Shedding Questionnaire - Symptomatics	NA, NA	Baseline and Follow-Up Questionnaire - English ,   Baseline and Follow-Up Questionnaire - Spanish
Shedding Questionnaire - Asymptomatics	NA, NA	Baseline and Follow-Up Questionnaire - English ,   Baseline and Follow-Up Questionnaire
Questionnaire for Men in Semen Study	NA	Questionnaire for Men in Semen Sub-Study
Shedding Eligibility Form	NA	Eligibility Form
Baseline and Follow-Up Questionnaire - Symptomatic	NA, NA	Baseline and Follow-Up Questionnaire - English 29SEP2016 ,   Baseline and Follow-Up Questionnaire - Spanish 29SEP2016
Shedding Eligibility	NA	Participant Eligibility Form
Contact Information Form	NA	Contact Information Form
Baseline and Follow-Up Questionnaire - Asymptomatic	NA, NA	Baseline and Follow-Up Questionnaire - English 29SEP2016 ,   Baseline and Follow-Up Questionnaire - Spanish 29SEP2016

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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	1,302	3,400	0	-2,098	0	0
Annual Time Burden (Hours)	241	407	0	-166	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Submission of 0920-1140 is a Revision ICR to allow information collection activities to continue with the addition of, 1) a follow-up household visit to determine how many household members of Zika virus-infected participants become infected during the 4 months following initial screening, and 2) a follow-up with men with Zika virus-positive semen specimens to better understand the effect of Zika virus infection on sperm.

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Annual Cost to Federal Government: $109,522

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: 07/14/2017

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