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

Forms and Documents

Document Name	Status
Parents of ZIKV-positive Infant - Infant Follow-Up Questionnaire Form and Instruction	New
Parents of ZIKV-positive Infants - Infant Enrollment and Delivery Questionnaire Form and Instruction	New
Zika-positive Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction	New
Zika-positive Pregnant Women - Pregnant Women Symptom Questionnaire Form and Instruction	New
Zika-positive Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction	New
Zika-positive Pregnant Women - Pregnant Women Screening Form Form and Instruction	New
Part B_ZIRP_CLEAN.docx Supporting Statement B	2017-11-08
Part A_ZIRP_CLEAN.docx Supporting Statement A	2017-11-08
List of Attachments.docx Supplementary Document	2017-10-31
Att E3-Amendment #1 approval.docx Supplementary Document	2017-10-31
Att E2- UPR IRB approval.pdf Supplementary Document	2017-10-31
Att E1- 7005 IRB Submission Approval.docx Supplementary Document	2017-10-31
Att D3 - Agreement to abide by restrictions.docx Supplementary Document	2017-10-31
Att D2 - FTE Nondisclosure.DOCX Supplementary Document	2017-10-31
Att D1 - Assurance of Confidentiality Zika Surveillance.doc Supplementary Document	2017-10-31
60 Day FRN.pdf Supplementary Document	2017-10-31
Att A- Section 301_PHS_Act (42 U.S.C. 241).docx Supplementary Document	2017-10-31

IC Document Collections

IC ID	Document Title	Status
228861	Parents of ZIKV-positive Infant - Infant Follow-Up Questionnaire Form and Instruction	New
228859	Parents of ZIKV-positive Infants - Infant Enrollment and Delivery Questionnaire Form and Instruction	New
228856	Zika-positive Pregnant Women - Pregnant Women Follow-Up Questionnaire Form and Instruction	New
228854	Zika-positive Pregnant Women - Pregnant Women Symptom Questionnaire Form and Instruction	New
228852	Zika-positive Pregnant Women - Pregnant Women Enrollment Questionnaire Form and Instruction	New
228847	Zika-positive Pregnant Women - Pregnant Women Screening Form Form and Instruction	New

ICR Details

OMB Control No: 0920-1217	ICR Reference No: 201710-0920-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17AZX
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: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/09/2018
	Date Received in OIRA: 11/13/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	24 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: This study is a part of an ongoing public health emergency response related to the Zika virus outbreak in Puerto Rico. Results of the ZIRP Puerto Rico study will provide critical data in establishing guidance for testing in pregnant women and congenitally exposed infants with exposure to ZIKV. It will also provide information on the association between persistent ZIKV RNA in pregnant women and adverse outcomes or infection in infants that can enable health care. This New ICR will continue the work initiated in Emergency Collection Request, OMB # 0920-1189.

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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
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 51839	11/08/2017
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
Zika-positive Pregnant Women - Pregnant Women Screening Form	NA	ZIRP: Pregnant Woman Screening Form
Zika-positive Pregnant Women - Pregnant Women Follow-Up Questionnaire	NA	ZIRP - Pregnant Woman Follow-Up Questionnaire
Zika-positive Pregnant Women - Pregnant Women Enrollment Questionnaire	NA	ZIRP - Pregnant Woman Enrollment Questionnaire
Zika-positive Pregnant Women - Pregnant Women Symptom Questionnaire	NA	ZIRP - Pregnant Woman Symptom Questionnaire
Parents of ZIKV-positive Infant - Infant Follow-Up Questionnaire	NA	ZIRP - Infant Follow-Up Questionnaire
Parents of ZIKV-positive Infants - Infant Enrollment and Delivery Questionnaire	NA	ZIRP - Infant Baseline and Delivery Questionnaire

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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: 0920-17AZX - Zika Virus RNA Persistence in Pregnant Women and Congenitally Exposed Infants in Puerto Rico (ZIRP) is being submitted as a New ICR to continue collection of data originally approved as an 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? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 11/13/2017

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