Zika Postpartum Emergency Response Survey (ZPER) - Puerto Rico 2017

Forms and Documents

Document Name	Status
Telephone Follow-Up Survey Form and Instruction	New
Hospital-based Survey for Fathers Form and Instruction	New
Hospital-based Survey for Mothers Form and Instruction	New
SSA - Emergency Zika Package ZPER 12MAY2017.docx Supporting Statement A	2017-05-15
Att 6 PRAMS IRB approval.docx Supplementary Document	2017-05-15
Att 10 Sampling_ZPER_Protocol_031317.docx Supplementary Document	2017-05-15
Att 5b Telephone Introductory Script and Informed Consent_Spanish.docx Supplementary Document	2017-05-15
Att 5a Telephone Introductory Script and Informed Consent_English.docx Supplementary Document	2017-05-15
Att 4b Telephone Survey Introductory Letter_Spanish.docx Supplementary Document	2017-05-15
Att 4a Telephone Survey Introductory Letter_English.docx Supplementary Document	2017-05-15
Att 3b Hospital-based Informed Consent _Spanish.docx Supplementary Document	2017-05-15
Att 3a Hospital-based Informed Consent_English_OMB_final.docx Supplementary Document	2017-05-15
SSB - Emergency Zika Package_ZPER 12MAY2017.docx Supporting Statement B	2017-05-15
Zika-ZPER-March2017-OMB Memo.pdf Supplementary Document	2017-04-19
60dFRN - published.pdf Supplementary Document	2017-04-19
Att 1 - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2017-04-19

IC Document Collections

IC ID	Document Title	Status
226839	Telephone Follow-Up Survey Form and Instruction	New
226838	Hospital-based Survey for Fathers Form and Instruction	New
226837	Hospital-based Survey for Mothers Form and Instruction	New

ICR Details

OMB Control No: 0920-1183	ICR Reference No: 201704-0920-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 17ABC
Title: Zika Postpartum Emergency Response Survey (ZPER) - Puerto Rico 2017
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: 05/16/2017
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/15/2017
	Date Received in OIRA: 05/15/2017
Terms of Clearance: This emergency clearance is approved for 3 months with the understanding that more than three months are needed to conduct the full collection. The agency will accordingly immediately publish a 60 day FRN to begin the process for standard ICR review and approval for the longer-term collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	6 Months From Approved
Responses	8,062	0	0
Time Burden (Hours)	2,536	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this collection is to conduct population-based assessments of utilization of Zika virus prevention strategies and resource needs for pregnant and postpartum women, and newborn infants in Puerto Rico. It will include a hospital-based survey of mothers and fathers to obtain information on the prenatal period. A follow-up telephone survey in the postpartum period will be used to evaluate the ongoing needs of mother and infants in the postpartum period.

Emergency Justfication: Emergency approval is requested for this collection since for the following reasons. In January 2017, The Health Resources and Services Administration (HRSA) provided funding to various agencies in the Puerto Rico Department of Health to address the issues of screening, access, and coordination of care for women, children and families. However, while there is a critical need to provide services for infants who have been affected by Zika during the early postpartum period, there is currently no population-based information available about health care for young infants born to women in Puerto Rico who were pregnant in the first year of the Zika outbreak. While clinical data is available, it is limited to those who seek and receive services. There is an urgent critical need for data on accessibility and utilization of postpartum and newborn services – especially for women and infants affected by Zika, as well as adherence to prevention strategies. To fill this gap, in January 2017, the Puerto Rico Department of Health was funded by the Centers for Disease Control to collect population based data to inform these efforts. The goal of this information collection, planned to begin in April 2017, is to gather scientifically valid and current information from the mothers previously surveyed immediately postpartum in the hospital by re-contacting them by phone 2-10 months after delivery to assess,; 1) their access to and utilization of health care services for themselves and their infants, and 2) their use of measures to avoid Zika infection, including use of postpartum contraception to prevent unintended pregnancies that might otherwise be affected by Zika. Additionally, as the outbreak continues, there is a need to reassess the effectiveness of emergency response efforts from the first season and to determine where additional efforts and resources are needed in subsequent seasons. Because fathers play a critical role in the health and well-being of their infants, there is also a need to assess their knowledge and contribution to prevention efforts and access to and adherence to recommended care. To address these needs, a second cohort of women will be surveyed 1) immediately postpartum using a hospital-based survey, 2) approximately a year following the initial ZPER survey, and 3) fathers who are present will also be surveyed. Moreover, given the increasing need to assess prevention strategies and resource needs for newborn infants, along with the effectiveness of efforts to prevent rapid repeat pregnancies that are unintended among postpartum women as the number of infants potentially exposed to Zika during pregnancy rises, this second cohort of women will also be re-contacted by telephone for a follow up survey to assess health behaviors and health care needs of postpartum mothers and their infants as it relates to Zika prevention strategies and resource gaps for mothers and newborns.

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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 18460	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: 3

IC Title	Form No.	Form Name
Hospital-based Survey for Mothers	NA, NA, NA, NA	ZPER Maternal Hospital-based Questionnaire - Spanish ,   Maternal Hospital-based Questionnaire - English Screenshot ,   ZPER Maternal Hospital-based Questionnaire - English ,   ZPER Maternal Hospital-based Questionnaire - Spanish Screenshot
Hospital-based Survey for Fathers	NA, NA	Hospital-based Survey for Fathers - English ,   Hospital-based Survey for Fathers - Spanish
Telephone Follow-Up Survey	NA, NA, NA, NA	ZPER Telephone Follow-Up Survey - English Phone Format ,   ZPER Telephone Follow-Up Survey - English Phone Format ,   ZPER Telephone Follow-Up Survey - English ,   ZPER Telephone 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	8,062	0	0	8,062	0	0
Annual Time Burden (Hours)	2,536	0	0	2,536	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 0920-17ABC is a New Emergency Clearance Request related to the Zika Virus outbreak.

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Annual Cost to Federal Government: $400,587

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: 05/15/2017

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