Monitoring & Evaluation for the Zika Contraception Access Network (Z-CAN)

Forms and Documents

Document Name	Status
Online Survey - 12 month Follow-Up - Patients 18 years or older Form and Instruction	New
Online Survey - 6 month Follow-Up - Patients 18 years or older Form and Instruction	New
Online Survey - Z-CAN Staff Form and Instruction	New
Online Survey - Z-CAN Physician Form and Instruction	New
Semi-structured Individual Interview - Z-CAN Staff Form and Instruction	New
Semi-structured Individual Interview - Z-CAN Physicians Form and Instruction	New
Focus Group Guide - Women 18 years or older / able to conceive Form and Instruction	New
Focus Group Screener - Women 18 years or older / able to conceive Form and Instruction	New
Emergency Review Request Memo - Final.pdf Supplementary Document	2017-02-08
09-20-0136 57FR62812 SORN.txt Supplementary Document	2017-02-08
Att Q Consent_Online Survey_ZCAN women.docx Supplementary Document	2017-02-08
Att P-4 Invitation_Online Survey_ZCAN women (Span).docx Supplementary Document	2017-02-08
Att P-3 Invitation_Online Survey_ZCAN women (Eng).docx Supplementary Document	2017-02-08
Att P-2 Interim contact_Online Survey_ZCAN women (Span).docx Supplementary Document	2017-02-08
Att P-1 Interim contact_Online Survey_ZCAN women (Eng).docx Supplementary Document	2017-02-08
Att O-2 2 week survey NRD_amended.pdf Supplementary Document	2017-02-08
Att O-1 2 week survey NRD.pdf Supplementary Document	2017-02-08
Att M-2 Consent_Online Survey_Staff.docx Supplementary Document	2017-02-08
Att M-1 Consent_Online Survey_Physicians.docx Supplementary Document	2017-02-08
Att L-4 Invitation_Survey_Staff (Span).docx Supplementary Document	2017-02-08
Att L-3 Invitation_Survey_Staff (Eng).docx Supplementary Document	2017-02-08
Att L-2 Invitation_Survey_Physicians (Span).docx Supplementary Document	2017-02-08
Att L-1 Invitation_Survey_Physicians (Eng).docx Supplementary Document	2017-02-08
Att J-2 Consent_Interview_Staff.docx Supplementary Document	2017-02-08
Att J-1 Consent_Interview_Physicians.docx Supplementary Document	2017-02-08
Att I-4 Invitation_Interview_Staff (Span).docx Supplementary Document	2017-02-08
Att I-3 Invitation_Interview_Staff (Eng).docx Supplementary Document	2017-02-08
Att I-2 Invitation_Interview_Physicians (Span).docx Supplementary Document	2017-02-08
Att I-1 Invitation_Interview_Physicians (Eng).docx Supplementary Document	2017-02-08
Att G Consent_FGD ZCAN women.docx Supplementary Document	2017-02-08
Att E-2 Recruitment flyer (Span).pdf Supplementary Document	2017-02-08
Att E-1 Recruitment flyer (Eng).docx Supplementary Document	2017-02-08
Att D-2 UPR IRB approval_qual.pdf Supplementary Document	2017-02-08
Att D-1 CDC IRB approval letter.pdf Supplementary Document	2017-02-08
Att C Privacy Act Determination.pdf Supplementary Document	2017-02-08
Att B 60-day FRN 1 25 2017.docx Supplementary Document	2017-02-08
SSB_Emergency Zika_Z-CAN 07FEB2017.docx Supporting Statement B	2017-02-08
SSA_Emergency Zika_Z-CAN 07FEB2017.docx Supporting Statement A	2017-02-08
Att A-Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2017-02-07

IC Document Collections

IC ID	Document Title	Status
225613	Online Survey - 12 month Follow-Up - Patients 18 years or older Form and Instruction	New
225612	Online Survey - 6 month Follow-Up - Patients 18 years or older Form and Instruction	New
225611	Online Survey - Z-CAN Staff Form and Instruction	New
225610	Online Survey - Z-CAN Physician Form and Instruction	New
225609	Semi-structured Individual Interview - Z-CAN Staff Form and Instruction	New
225608	Semi-structured Individual Interview - Z-CAN Physicians Form and Instruction	New
225607	Focus Group Guide - Women 18 years or older / able to conceive Form and Instruction	New
225606	Focus Group Screener - Women 18 years or older / able to conceive Form and Instruction	New

ICR Details

OMB Control No: 0920-1164	ICR Reference No: 201702-0920-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17OA
Title: Monitoring & Evaluation for the Zika Contraception Access Network (Z-CAN)
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: 02/28/2017
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/09/2017
	Date Received in OIRA: 02/09/2017
Terms of Clearance: Three months clearance is granted for this emergency collection. As this collection is anticipated to extend beyond 3 months, CDC will submit a new information collection request to OMB for standard review and approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	6 Months From Approved
Responses	2,237	0	0
Time Burden (Hours)	736	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this collection is to monitor & evaluate the implementation of the Zika Contraception Access Network (Z-CAN) a program designed to increase access to reversible contraceptive methods among reproductive-aged women in Puerto Rico who choose to delay or avoid pregnancy as a primary strategy to reduce Zika-related adverse pregnancy and birth outcomes, and assess patterns of contraceptive use and pregnancy rates after participating in Z-CAN.

Emergency Justfication: The Z-CAN service program to be evaluated began in July 2016. Trainings with providers were completed in September 2016, patient enrollment accelerated in October 2016, and the program is currently expected to end in July 2017. It was recently decided that it is likely that quality improvement would be possible and assessment of the program’s potential for adaptation in other settings would be valuable. To ensure timely data collection, the evaluation should begin at the earliest possible date for program improvement. Patient evaluations, scheduled for 6- and 12-months from enrollment in the Z-CAN program must begin by April 2017 to capture the majority of participants.Findings will be assessed on a rolling basis and information gained will be put to immediate use to affect program improvements. A delayed start would potentially mean this critical information is gathered too late to improve the Puerto Rico program, and too late to determine its suitability for adaptation in other areas with widespread mosquito transmission of the Zika virus during the current outbreak.

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Authorizing Statute(s): None

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: 8

IC Title	Form No.	Form Name
Semi-structured Individual Interview - Z-CAN Staff	NA, NA	Individual Interview Guide - Staff English ,   Individual Interview Guide - Staff Spanish
Online Survey - Z-CAN Physician	NA, NA	Online Survey - Physician English ,   Online Survey Physician Spanish/Screenshot
Online Survey - Z-CAN Staff	NA, NA	Online Survey - Staff English ,   Online Survey - Staff Spanish/Screenshot
Focus Group Screener - Women 18 years or older / able to conceive	NA, NA, NA	Focus Group Screener - Women English ,   Focus Group Screener - Women Spanish ,   Focus Group Screener - Women Screenshot
Semi-structured Individual Interview - Z-CAN Physicians	NA, NA	Individual Interview Guide - Physicians English ,   Individual Interview Guide - Physicians Spanish
Focus Group Guide - Women 18 years or older / able to conceive	NA, NA, NA, NA	Focus Group Guide - Z-CAN Women English ,   Focus Group Guide Z-CAN Women Spanish ,   Focus Group Guide - Non-Z-CAN Women English ,   Focus Group Guide Non-Z-CAN Women Spanish
Online Survey - 6 month Follow-Up - Patients 18 years or older	NA, NA	Onsline Survey - Patient 18 yr 6-month Follow-Up English ,   Onsline Survey - Patient 18 yr 6-month Follow-Up Spanish/Screenshot
Online Survey - 12 month Follow-Up - Patients 18 years or older	NA, NA	Onsline Survey - Patient 18 yr 12-month Follow-Up English ,   Onsline Survey - Patient 18 yr 12-month Follow-Up Spanish/Screenshot

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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	2,237	0	0	2,237	0	0
Annual Time Burden (Hours)	736	0	0	736	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 0920-17OA is a New Emergency Request.

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Annual Cost to Federal Government: $902,969

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: 02/09/2017

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