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

Forms and Documents

Forms and supporting documents for this ICR

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

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
228861	Parents of ZIKV-positive Infant - Infant Follow-Up Questionnaire	Form and Instruction	New	ZIRP - Infant Follow-Up Questionnaire
228859	Parents of ZIKV-positive Infants - Infant Enrollment and Delivery Questionnaire	Form and Instruction	New	ZIRP - Infant Baseline and Delivery Questionnaire
228856	Zika-positive Pregnant Women - Pregnant Women Follow-Up Questionnaire	Form and Instruction	New	ZIRP - Pregnant Woman Follow-Up Questionnaire
228854	Zika-positive Pregnant Women - Pregnant Women Symptom Questionnaire	Form and Instruction	New	ZIRP - Pregnant Woman Symptom Questionnaire
228852	Zika-positive Pregnant Women - Pregnant Women Enrollment Questionnaire	Form and Instruction	New	ZIRP - Pregnant Woman Enrollment Questionnaire
228847	Zika-positive Pregnant Women - Pregnant Women Screening Form	Form and Instruction	New	ZIRP: Pregnant Woman Screening Form

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
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/13/2017
Terms of Clearance:

table that charts list comparision

	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

table that charts list of burden

IC Title	Form No.	Form Name
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
Zika-positive Pregnant Women - Pregnant Women Enrollment Questionnaire	NA	ZIRP - Pregnant Woman Enrollment Questionnaire
Zika-positive Pregnant Women - Pregnant Women Follow-Up Questionnaire	NA	ZIRP - Pregnant Woman Follow-Up Questionnaire
Zika-positive Pregnant Women - Pregnant Women Screening Form	NA	ZIRP: Pregnant Woman Screening Form
Zika-positive Pregnant Women - Pregnant Women Symptom Questionnaire	NA	ZIRP - Pregnant Woman Symptom Questionnaire

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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	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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