Zika Emergency Package V: Assessment of Interventions Intended to Protect Pregnant Women in Puerto Rico from Zika virus Infections

Forms and Documents

Document Name	Status
Telephone Interview of Cases and Controls Form and Instruction	Modified
Follow-Up Telephone Interview Form and Instruction	Unchanged
Initial Telephone Interview Form and Instruction	Unchanged
0920-1118 Non-sub Change Request.docx Justification for No Material/Nonsubstantive Change	2016-07-14
Statement A 24 JUN2016.revised.docx Supporting Statement A	2016-06-27
Attachment H.Logic Model of Puerto Rico Zika Response Activities.pptx Supplementary Document	2016-06-17
Attachment G.IRB determination letter for project 2.pdf Supplementary Document	2016-06-17
Attachment F.Projet 1.IRB letter of determination.pdf Supplementary Document	2016-06-17
Statement B 16JUN2016 FINAL.docx Supporting Statement B	2016-06-17
Emergency Review Request Memo - Zika 5 SIGNED.pdf Supplementary Document	2016-06-10
Att. B - Draft 60-Day FRN.docx Supplementary Document	2016-06-10
Att. A - Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2016-06-10

IC Document Collections

IC ID	Document Title	Status
222028	Telephone Interview of Cases and Controls Form and Instruction	Modified
221889	Follow-Up Telephone Interview Form and Instruction	Unchanged
221888	Initial Telephone Interview Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1118	ICR Reference No: 201607-0920-003
Status: Historical Active	Previous ICR Reference No: 201606-0920-019
Agency/Subagency: HHS/CDC	Agency Tracking No: 16ATJ
Title: Zika Emergency Package V: Assessment of Interventions Intended to Protect Pregnant Women in Puerto Rico from Zika virus Infections
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 06/17/2016
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/14/2016
	Date Received in OIRA: 07/14/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	12/31/2016	12/31/2016
Responses	2,900	0	2,900
Time Burden (Hours)	892	0	892
Cost Burden (Dollars)	0	0	0

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Abstract: CDC requests an Emergency Clearance to collect data for six months. The goal of this project is to find out if interventions are reaching pregnant women and having the intended effects along with getting feedback from pregnant women about the Zika prevention activities that have been implemented (e.g., Zika education sessions and prevention kits, vector control services, and communication activities). Findings will be used to improve the delivery of interventions and to inform decisions about future Zika prevention activities for pregnant women in Puerto Rico.

Emergency Justfication: CDC needs this assessment to ensure that Zika prevention activities effectively educate, equip, and encourage women to participate in as many Zika prevention behaviors as possible. On-going evaluation is an important part of this program because it can reveal novel ways that women protect themselves from Zika, how effective the distribution of the Zika Prevention Kit has been in Puerto Rico, perceived severity and susceptibility to Zika, pregnant women’s self-efficacy in protecting themselves from Zika after the interventions have been implemented, as well as the extent to which target populations are using contents of the Zika Prevention Kit.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: 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

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
Initial Telephone Interview	NA, NA	Initial Telephone Interview - ENGLISH 27JUN2016 ,   Initial Telephone Interview - SPANISH 27JUN2016
Follow-Up Telephone Interview	NA, NA	Follow-Up Interview - Spanish ,   Follow-Up Interview - English
Telephone Interview of Cases and Controls	NA, NA	Case-Control Interview - English 13JUL2016 ,   Case-Control Interview - Spanish 13JUL2016

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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	2,900	2,900	0	0	0	0
Annual Time Burden (Hours)	892	892	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $60,829

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: 07/14/2016

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