Assessment to Estimate the Effect of Community-Wide Vector Control Initiatives on Zika Virus Transmission in Puerto Rico, 2016

Forms and Documents

Document Name	Status
Refusal Demographics Form Form and Instruction	New
Individual specimen collection of blood, urine, and saliva Form	Unchanged
Individual Questionnaire Form and Instruction	Modified
Household Questionnaire Form and Instruction	Unchanged
0920-1137 change request.docx Justification for No Material/Nonsubstantive Change	2016-09-26
Revised SSB Vector Control Initiatives_PR 12SEP2016.docx Supporting Statement B	2016-09-12
Emergency Zika SSA - Vector Control Initiatives in PR_OMB 09 21 2016_RMB_FINAL.docx Supporting Statement A	2016-09-27
Att I - Household Tracking Form.docx Supplementary Document	2016-08-31
Att F - Assent for Children aged 5-14 SPANISH.docx Supplementary Document	2016-08-31
Att F - Assent for Children aged 5-14.docx Supplementary Document	2016-08-31
Att E - Adult Consent Form SPANISH.docx Supplementary Document	2016-08-31
Att E - Adult Consent Form.docx Supplementary Document	2016-08-31
Att D - Household and Individual Consent Form SPANISH (002).docx Supplementary Document	2016-08-31
Att D - Household and Individual Consent Form.docx Supplementary Document	2016-08-31
Att C - 6901 CDC IRB Approval Memo_New-Expedited 8 2 16.docx Supplementary Document	2016-08-31
Att B - 60-Day FRN.docx Supplementary Document	2016-08-31
Emergency Review Request Memo - Signed.pdf Supplementary Document	2016-08-31

IC Document Collections

IC ID	Document Title	Status
223708	Refusal Demographics Form Form and Instruction	New
223493	Individual specimen collection of blood, urine, and saliva Form	Unchanged
223311	Individual Questionnaire Form and Instruction	Modified
223310	Household Questionnaire Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1137	ICR Reference No: 201609-0920-018
Status: Historical Active	Previous ICR Reference No: 201608-0920-013
Agency/Subagency: HHS/CDC	Agency Tracking No: 16BFB
Title: Assessment to Estimate the Effect of Community-Wide Vector Control Initiatives on Zika Virus Transmission in Puerto Rico, 2016
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: 09/13/2016
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/28/2016
	Date Received in OIRA: 09/27/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2017	03/31/2017	03/31/2017
Responses	1,800	0	1,700
Time Burden (Hours)	646	0	643
Cost Burden (Dollars)	0	0	0

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Abstract: Household-based cluster investigations have not yet been conducted during ZIKV outbreaks in Puerto Rico or elsewhere. Such investigations would enable enhanced case finding and subsequent extrapolation of current rates of under-reporting of ZIKV disease cases (due either to lack of presentation for care, clinical misdiagnosis, or failure for cases to be reported), description of the symptomatology of infected individuals, and elucidation of risk factors for infection among the individuals included in the investigation, which may or may not be the same as those amongst the larger population. Findings from both passive surveillance data and household-based cluster investigations may provide a more informed interpretation of the community-wide patterns of ZIKV infections, and will be used to develop or refine messaging to the public and medical communities to improve case-seeking behavior and case reporting.

Emergency Justfication: Emergency Clearance is requested to; 1) Conduct household-based cluster investigations in areas with and without ongoing community-wide vector control (e.g., aerial spraying) activities, and 2) Compare trends in ZIKV disease cases reported to the Passive Arboviral Diseases Surveillance System (PADSS) in areas with and without ongoing community-wide vector control activities (e.g., aerial spraying). Findings will be used to develop or refine messaging to the public and medical communities to improve case-seeking behavior and case reporting, respectively. It is not expected that this project will take longer than six months.

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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: 4

IC Title	Form No.	Form Name
Individual Questionnaire	NA, NA	Zika Investigation - Individual Interview Form SPANISH ,   Zika Investigation - Individual Interview Form ENGLISH
Household Questionnaire	NA, NA	Zika Investigation - Household Interview Form ENGLISH ,   Zika Investigation - Household Interview Form SPANISH
Individual specimen collection of blood, urine, and saliva	NA, NA, NA, NA	Adult Consent Form - English ,   Adult Consent Form - Spanish ,   Assent Children 5-14 - English ,   Assent Children 5-14 - Spanish
Refusal Demographics Form	NA	PR Zika Investigation –Refusal Demographics Form

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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	1,800	1,700	0	100	0	0
Annual Time Burden (Hours)	646	643	0	3	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: Non-Substantive Change includes addition of new Form to collect information regarding the demographics of those who refuse to participate in the collection.

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Annual Cost to Federal Government: $8,502

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: 09/27/2016

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