Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP)

Forms and Documents

Document Name	Status
Infant Follow-Up Questionnaire Form and Instruction	New
Infant Enrollment and Delivery Questionnaire Form and Instruction	New
Pregnant Women Follow-Up Questionnaire Form and Instruction	New
Pregnant Women Symptom Questionnaire Form and Instruction	New
Pregnant Women Enrollment Questionnaire Form and Instruction	New
Pregnant Women Screening Form Form and Instruction	New
OMB_Part B_ZIRP_full_v1_clean.docx Supporting Statement B	2017-07-07
OMB_Part A_ZIRP_full_v1_clean.docx Supporting Statement A	2017-07-07
Att E1- 7005 IRB Submission Approval.docx Supplementary Document	2017-07-07
Att D3 - Agreement to abide by data restrictions.docx Supplementary Document	2017-07-07
Att D2 - FTE Non-disclosure agreement.docx Supplementary Document	2017-07-07
Att D1 - Assurance of Confidentiality.docx Supplementary Document	2017-07-07
deb lubar signed memo.pdf Supplementary Document	2017-07-07
Att B - 60-day notice.pdf Supplementary Document	2017-07-07
Att A - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2017-07-07

IC Document Collections

IC ID	Document Title	Status
227422	Infant Follow-Up Questionnaire Form and Instruction	New
227421	Infant Enrollment and Delivery Questionnaire Form and Instruction	New
227420	Pregnant Women Follow-Up Questionnaire Form and Instruction	New
227419	Pregnant Women Symptom Questionnaire Form and Instruction	New
227418	Pregnant Women Enrollment Questionnaire Form and Instruction	New
227417	Pregnant Women Screening Form Form and Instruction	New

ICR Details

OMB Control No: 0920-1189	ICR Reference No: 201706-0920-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17NF
Title: Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 07/10/2017
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/10/2017
	Date Received in OIRA: 07/10/2017
Terms of Clearance: As the information collection is scheduled to last for 15 months, CDC will submit a full Information Collection Request within 3 months after getting emergency approval

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	6 Months From Approved
Responses	6,000	0	0
Time Burden (Hours)	785	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Emergency ZIRP study aims to determine the prevalence and duration of ZIKV RNA persistence in pregnant women infected with ZIKV and their congenitally exposed infants. Information from the ZIRP Puerto Rico study will provide the data needed to establish ZIKV testing guidance for pregnant women and congenitally exposed infants, and will also provide information to assess the association between persistent ZIKV RNA in pregnant women or infants and adverse outcomes.

Emergency Justfication: Currently, the Centers for Disease Control and Prevention (CDC) and the PRDH recommend that all pregnant women living in areas with active ZIKV transmission such as Puerto Rico, be tested for ZIKV. Limited data from human studies also suggest that pregnant women have persistent detection of ZIKV RNA in serum. Even less is known about persistent detection of ZIKV RNA in infants. One case study reported persistent ZIKV RNA detection in a male child born in Brazil at 40 weeks gestation with brain abnormalities. The increasing number of cases and stage of the outbreak in Puerto Rico provides an opportunity to collect actionable information on a shorter timeframe than is possible elsewhere. This study is expected to provide critical scientific information to help the United States prepare for the unprecedented challenges posed by Zika and possible clinical guidelines related to ZIKV RNA testing. Because information collection is scheduled to last for 15 months, CDC will submit a full Information Collection Request within 3 months after getting emergency approval.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. 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:
	82 FR 18462	04/19/2017
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
Infant Enrollment and Delivery Questionnaire	NA, NA	Infant Enrollment and Delivery Questionnaire - English ,   Infant Enrollment and Delivery Questionnaire - Spanish
Infant Follow-Up Questionnaire	NA, NA	Infant Follow-Up Questionnaire - English ,   Infant Follow-Up Questionnaire - Spanish
Pregnant Women Screening Form	NA, NA	Pregnant Women Screening Form - English ,   Pregnant Women Screening Form - Spanish
Pregnant Women Enrollment Questionnaire	NA, NA	Pregnant Women Enrollment Questionnaire - English ,   Pregnant Women Enrollment Questionnaire - Spanish
Pregnant Women Symptom Questionnaire	NA, NA	Pregnant Women Symptom Questionnaire - English ,   Pregnant Women Symptom Questionnaire - Spanish
Pregnant Women Follow-Up Questionnaire	NA, NA	Pregnant Women Follow-Up Questionnaire - English ,   Pregnant Women Follow-Up Questionnaire - 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	6,000	0	0	6,000	0	0
Annual Time Burden (Hours)	785	0	0	785	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 0920-17NF - Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP) is a New Emergency Clearance Request.

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Annual Cost to Federal Government: $1,333,820

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: 07/10/2017

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