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

Forms and Documents

Document Name	Status
Form 0920-1199 Telephone Follow-Up Survey (New Version) Form and Instruction	New
Telephone Follow-Up Survey Form and Instruction	Modified
Hospital-based Survey for Fathers/Partners Form and Instruction	Modified
Hospital-based Survey for Mothers Form and Instruction	Modified
PRAMS-ZPER (1199) Change Request_122117docx_Clean.docx Justification for No Material/Nonsubstantive Change	2018-01-04
SSB - Emergency Zika Package ZPER_081717_DRH_clean.docx Supporting Statement B	2017-08-18
SSA - Emergency Zika Package ZPER_081717_DRH_clean.docx Supporting Statement A	2017-08-18
Att 10 Sampling ZPER Protocol_6_20_17.docx Supplementary Document	2017-08-11
Att 6 PRAMS IRB approval.docx Supplementary Document	2017-08-11
Att 5b Telephone Introductory Scripts and Consent_Spanish_062017.docx Supplementary Document	2017-08-11
Att 5a Telephone Introductory Scripts and Consent_English_062017.docx Supplementary Document	2017-08-11
Att 4bTelephone Survey Introductory Letter_Spanish_062017.docx Supplementary Document	2017-08-11
Att 4a Telephone Survey Introductory Letter_English_062017.docx Supplementary Document	2017-08-11
Att 3h - Hospital based FATHER-PARTNER ASSENT (SPANISH).doc Supplementary Document	2017-08-11
Att 3g - Hospital based FATHER-PARTNER ASSENT (ENGLISH).doc Supplementary Document	2017-08-11
Att 3f - Hospital based FATHER-PARTNER CONSENT (SPANISH).doc Supplementary Document	2017-08-11
Att 3e - Hospital based FATHER-PARTNER CONSENT (ENGLISH).doc Supplementary Document	2017-08-11
Att 3d - Hospital based MATERNAL ASSENT (SPANISH).doc Supplementary Document	2017-08-11
Att 3c - Hospital based MATERNAL ASSENT (ENGLISH).doc Supplementary Document	2017-08-11
Att 3b - Hospital based MATERNAL CONSENT (SPANISH).doc Supplementary Document	2017-08-11
Att 3a - Hospital based MATERNAL CONSENT (ENGLISH).doc Supplementary Document	2017-08-11
Att 2 - 60-Day FRN.pdf Supplementary Document	2017-08-08
Att 1 - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2017-08-08

IC Document Collections

IC ID	Document Title	Status
229601	Telephone Follow-Up Survey (New Version) Form and Instruction	New
227894	Telephone Follow-Up Survey Form and Instruction	Modified
227893	Hospital-based Survey for Fathers/Partners Form and Instruction	Modified
227892	Hospital-based Survey for Mothers Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1199	ICR Reference No: 201712-0920-013
Status: Historical Active	Previous ICR Reference No: 201708-0920-008
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1199
Title: Zika Postpartum Emergency Response Survey (ZPER), Puerto Rico, 2017
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/18/2018
	Date Received in OIRA: 01/04/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	09/30/2018	09/30/2018
Responses	5,950	0	7,850
Time Burden (Hours)	1,679	0	2,462
Cost Burden (Dollars)	0	0	0

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Abstract: The ZPER study will assess utilization of Zika virus prevention strategies and resource needs of pregnant and postpartum women, and newborn infants in Puerto Rico. A hospital-based survey of mothers and fathers will obtain information on the prenatal period. A follow-up telephone survey period will assess ongoing needs of mothers and infants in the postpartum period. This Change Request is to modify a subset of existing questions to assess the impact and available resources for pregnant and postpartum women and infants in relation to recent hurricanes in addition to Zika.The study will continue to collect data that was initially approved as 0920-1199.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. 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 18464	04/19/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 39438	08/18/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Telephone Follow-Up Survey (New Version)	0920-1199, 0920-1199	ZPER Telephone Follow-Up Questionnaire - English ,   ZPER Telephone Follow-Up Questionnaire - Spanish
Hospital-based Survey for Fathers/Partners	NA, NA	IN-HOSPITAL PARTNER SURVEY: English version ,   IN-HOSPITAL PARTNER SURVEY: Spanish version
Telephone Follow-Up Survey	NA, NA	ZPER Telephone Follow-up Questionnaire – English phone version ,   ZPER Telephone Follow-up Questionnaire – Spanish phone version
Hospital-based Survey for Mothers	NA, NA	IN-HOSPITAL MATERNAL SURVEY: English version ,   IN-HOSPITAL MATERNAL SURVEY: Spanish version

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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	5,950	7,850	0	-1,900	0	0
Annual Time Burden (Hours)	1,679	2,462	0	-783	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: Non-Substantive Change Request to approved 0920-1199 collection adds a new version of Telephone Follow-Up survey and reduces the number of Respondents due to disruption from Hurricanes Irma and Maria.

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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

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.     Yes

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: 01/04/2018

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