Assessment of a Preventive Service Program in the Context of a Zika Virus Outbreak in Puerto Rico

Forms and Documents

Document Name	Status
30-month Follow-up Survey for Z-CAN patients who did not complete the 18-month Follow-up Survey Form and Instruction	New
30-month Follow-up Survey for Z-CAN patients who completed the 18-month Follow-up Survey Form and Instruction	New
18-month Follow-up Survey for Z-CAN patients Form and Instruction	New
Att I Referenced articles.pdf Supplementary Document	2018-07-20
Att G Consent_Online Survey_18_30_ZCAN women (Eng and Span).docx Supplementary Document	2018-07-20
Att F Invitation_Online Survey_18_30_ZCAN women (Eng and Span).docx Supplementary Document	2018-07-20
Att E Interim contacts with ZCAN women (Eng and Span).docx Supplementary Document	2018-07-20
Att D-2 UPR IRB approval letter.pdf Supplementary Document	2018-07-20
Att D-1 CDC IRB approval letter.pdf Supplementary Document	2018-07-20
Att C Privacy Act Determination.pdf Supplementary Document	2018-07-20
Att B-1 60-day FRN March 30 2018.pdf Supplementary Document	2018-07-20
Att A-Section 301 of the PHS Act.pdf Supplementary Document	2018-07-20
SSB_Z-CAN_07022018.docx Supporting Statement B	2018-07-20
SSA_Z-CAN_07022018.docx Supporting Statement A	2018-07-20

IC Document Collections

IC ID	Document Title	Status
232335	30-month Follow-up Survey for Z-CAN patients who did not complete the 18-month Follow-up Survey Form and Instruction	New
232334	30-month Follow-up Survey for Z-CAN patients who completed the 18-month Follow-up Survey Form and Instruction	New
232333	18-month Follow-up Survey for Z-CAN patients Form and Instruction	New

ICR Details

OMB Control No: 0920-1241	ICR Reference No: 201806-0920-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18TH
Title: Assessment of a Preventive Service Program in the Context of a Zika Virus Outbreak in Puerto Rico
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: 08/22/2018
	Date Received in OIRA: 07/23/2018
Terms of Clearance: Approved consistent with the understanding that CDC - in collaboration with the University of Puerto Rico - is confident that the internet access in Puerto Rico necessary to conduct this information collection is now stable and sufficient.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	24 Months From Approved
Responses	1,840	0	0
Time Burden (Hours)	259	0	0
Cost Burden (Dollars)	1,875	0	0

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Abstract: The purpose of this project is to assess the implementation and associated outcomes of the Zika Contraception Access Network (Z-CAN), an initiative that provided patient-centered services to reproductive-aged women in Puerto Rico who chose to delay or avoid pregnancy while local Zika virus transmission was ongoing. Online surveys will be conducted with women who have received services through Z-CAN. The specific aims are to assess: (1) prevention strategy adherence among Z-CAN patients at approximately 18 months after receipt of program services; and (2) prevention strategy adherence, patient satisfaction, and unmet need for services among Z-CAN patients at approximately 30 months after receipt of program services. Findings will be used to improve services and determine the program’s potential for replication/adaptation during other emergency responses.

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Authorizing Statute(s): US Code: 42 USC 301 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
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 13752	03/30/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 34588	07/20/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
30-month Follow-up Survey for Z-CAN patients who completed the 18-month Follow-up Survey	n/a	Screenshots of the 30-month Follow-up Survey (Version A for Z-CAN patients who completed the 18-month Follow-up Survey)
18-month Follow-up Survey for Z-CAN patients	n/a	Screenshots of the 18-month Follow-up Survery for Z-CAN patients ages 18+
30-month Follow-up Survey for Z-CAN patients who did not complete the 18-month Follow-up Survey	n/a	Screenshots of the 30-month Follow-up Survey (Version B for Z-CAN patients who did not complete the 18-month Follow-up Survey)

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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	1,840	0	0	1,840	0	0
Annual Time Burden (Hours)	259	0	0	259	0	0
Annual Cost Burden (Dollars)	1,875	0	0	1,875	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: Z-CAN patients will be asked to respond to online surveys at approximately 18 and 30 months after their initial Z-CAN visit. Since women’s satisfaction with their contraceptive method and continued use of that method may vary over time, it is important to assess these outcomes, as well as unmet need for services and reproductive health outcomes over a longer period including after the end of Z-CAN. Some concerns may only become apparent with longer-term assessment, such as changes in utilization or satisfaction with chosen contraceptive methods, whether women are readily able to access services they are eligible for from a Z-CAN provider during or after the program (i.e., no-cost removal of intrauterine devices and implants), and ongoing unmet needs for services after the program. Collecting this information from Z-CAN patients less frequently will preclude this assessment.

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Annual Cost to Federal Government: $706,784

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.     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: 07/23/2018

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