Formative Assessment Regarding Contraception Use in the U.S. Virgin Islands (USVI) in the Context of Zika

Forms and Documents

Document Name	Status
Semi-structured qualitative focus group interview - Males Form and Instruction	New
Semi-structured qualitative focus group interview - Females Form and Instruction	New
Att F_NCCDPHP Non-Research Determination.pdf Supplementary Document	2016-11-21
Att G_USVI Zika Contraceptive_Consent Form_USVI.docx Supplementary Document	2016-11-21
Att E_Explanation of differences between two zika-related USVI projects.docx Supplementary Document	2016-11-21
Signed Emergency Request Memo_USVI Contraceptive Use Focus Groups.pdf Supplementary Document	2016-11-21
USVI Zika Contraceptive_60-day FRN.docx Supplementary Document	2016-11-21
USVI Zika Contraceptive_SSB-Emergency Zika 11 16 16_clean.docx Supporting Statement B	2016-11-21
USVI Zika Contraceptive_SSA-Emergency Zika 11 16 16_clean.docx Supporting Statement A	2016-11-21
Att A - USVI Zika Contraception _Section 301 of the Public Health Service Act (42 USC 241).pdf Supplementary Document	2016-11-21

IC Document Collections

IC ID	Document Title	Status
224504	Semi-structured qualitative focus group interview - Males Form and Instruction	New
224503	Semi-structured qualitative focus group interview - Females Form and Instruction	New

ICR Details

OMB Control No: 0920-1148	ICR Reference No: 201610-0920-013
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17CP
Title: Formative Assessment Regarding Contraception Use in the U.S. Virgin Islands (USVI) in the Context of Zika
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: 11/23/2016
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/22/2016
	Date Received in OIRA: 11/22/2016
Terms of Clearance: Approved for 3 months. If this collection is anticipated to extend beyond the 3 month emergency clearance, Program will immediately prepare for standard ICR submission to OMB for review and approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2017	6 Months From Approved
Responses	72	0	0
Time Burden (Hours)	144	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this formative assessment is to learn about current knowledge, attitudes, and beliefs regarding contraception use, in general, and related to Zika virus exposure, in particular, among Women of Reproductive Age (WRA) and Men of Reproductive Age (MRA) in the United States Virgin Islands (USVI). The study will explore the perceived barriers to accessing contraception and effective ways to provide messages about the contraceptive methods and services available on the islands.

Emergency Justfication: New data collection activities are required for Zika virus-related studies in the USVI, as the data collected in Puerto Rico are not considered to be directly relevant to USVI populations for multiple reasons. Research has established that contraceptive use is shaped by sociocultural factors (Higgins & Smith, 2016; Institute of Medicine, 1995; Wolifan et al., 2015). The sociocultural landscape in Puerto Rico are inherently different from the USVI, as the language, religious influences, history, and traditions differ significantly. Furthermore, anecdotal information from health care providers have underscored the differences in the health infrastructure and systems that influence access and availability of health services, including contraception, between these island territories. Consequently, findings from data collected in Puerto Rico are not transferrable and/or applicable to the development of messaging and communication strategies within the USVI.

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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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Semi-structured qualitative focus group interview - Females	NA	Focus Group Interview - USVI Females
Semi-structured qualitative focus group interview - Males	NA	Focus Group Interview - USVI Males

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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	72	0	0	72	0	0
Annual Time Burden (Hours)	144	0	0	144	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 0920-17CP is a New Emergency ICR related to the Zika Virus outbreak

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Annual Cost to Federal Government: $16,825

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: 11/22/2016

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