CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Survey of County-Level Surveillance Records of Aedes aegypti and Aedes albopictus	Form and Instruction	Modified	Available
Infant Health Follow-Up Form	Form and Instruction	Modified	Available
Assessment at Delivery Form	Form and Instruction	Modified	Available
Clinical Inquiries Database	Form and Instruction	Modified	Available
Maternal Health History Form	Form and Instruction	Modified	Available
Clinical Inquiries Database	Form and Instruction	Modified	Available
Att. D -- Overview Letter - Revised 31MAR2016_OMB.docx	Supplementary Document	Uploaded 2016-04-07	Available
0920-1101 Non-sub Change Request_4_7_16 FINAL.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2016-04-07	Available
Att. S -- CSTE Case Definition.pdf	Supplementary Document	Uploaded 2016-04-07	Available
0920-1101 Non-sub Change Request_4_7_16.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2016-04-07	Available
Att. R -- Fact sheet for Health Departments.docx	Supplementary Document	Uploaded 2016-04-07	Available
Att. Q -- Fact sheet for pediatric healthcare providers.docx	Supplementary Document	Uploaded 2016-04-07	Available
Att. P -- Fact sheet for obstetric healthcare providers.docx	Supplementary Document	Uploaded 2016-04-07	Available
Att. N -- Pregnancy Registry Information Sheet.docx	Supplementary Document	Uploaded 2016-04-07	Available
Att. M -- IRB determination.pdf	Supplementary Document	Uploaded 2016-04-07	Available
Att. C -- Website Information - Zika Virus Disease and Pregnancy Registry 31MAR2016.docx	Supplementary Document	Uploaded 2016-04-01	Available
Att. M -- IRB determination.pdf	Supplementary Document	Uploaded 2016-04-07	Available
Att. R -- Definitions for case inclusion.docx	Supplementary Document	Uploaded 2016-03-31	Available
Att. Q -- CSTE Case Definition.pdf	Supplementary Document	Uploaded 2016-03-31	Available
Att. P -- Fact Sheet for Health Care Providers.pdf	Supplementary Document	Uploaded 2016-03-31	Available
Att. O -- Developmental Milestones for Infant.docx	Supplementary Document	Uploaded 2016-03-31	Available
Att. N -- Pregnancy Registry Information Sheet Revised 31MAR2016.pdf	Supplementary Document	Uploaded 2016-03-31	Available
Att. D -- Overview Letter - Revised 31MAR2016.docx	Supplementary Document	Uploaded 2016-03-31	Available
0920-1101 Non-sub Change Request.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2016-03-31	Available
Att. B -- 60-Day FRN - ZIKA.docx	Supplementary Document	Uploaded 2016-02-18	Available
Zika Emergency 1_SSB_non sub change CLEAN.docx	Supporting Statement B	Uploaded 2016-03-31	Available
Zika Emergency 1 SSA non sub change CLEAN_4_7_16.docx	Supporting Statement A	Uploaded 2016-04-07	Available
Att. M -- IRB Approval Pregnancy Registry.pdf	Supplementary Document	Uploaded 2016-02-12	Available
Att. L -- IRB Approval Mosquito survey.pdf	Supplementary Document	Uploaded 2016-02-12	Available
Att. K -- IRB Approval Call Center.pdf	Supplementary Document	Uploaded 2016-02-12	Available
Att. A -- 42 USC 241.pdf	Supplementary Document	Uploaded 2016-02-12	Available
Signed memo 021616.pdf	Supplementary Document	Uploaded 2016-02-12	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
220152	Survey of County-Level Surveillance Records of Aedes aegypti and Aedes albopictus	Form and Instruction	Modified
220151	Infant Health Follow-Up Form	Form and Instruction	Modified
220150	Assessment at Delivery Form	Form and Instruction	Modified
220149	Clinical Inquiries Database	Form and Instruction	Modified
220148	Specimen Collection Form	Instruction	Modified
220142	Maternal Health History Form	Form and Instruction	Modified
220140	Clinical Inquiries Database	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1101	ICR Reference No: 201603-0920-014
Status: Historical Active	Previous ICR Reference No: 201602-0920-005
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance
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: 02/18/2016
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/07/2016
	Date Received in OIRA: 04/01/2016
Terms of Clearance: Approved consistent with the understanding that the Agency will submit a new information collection request at the earliest possible date when it is determined that this emergency collection will extend beyond the 6 month clearance period.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	08/31/2016	08/31/2016
Responses	2,520	0	2,520
Time Burden (Hours)	705	0	705
Cost Burden (Dollars)	0	0	0

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Abstract: Non-substantive changes are being made because of the updated Council of State and Territorial Epidemiologists (CSTE) case definitions for confirmed and probable Zika virus disease and congenital Zika virus infection. Because of the updated CSTE case definitions, participation in the pregnancy registry is no longer voluntary. Estimates of annualized burden hours for this change request remain the same.

Emergency Justfication: CDC cannot reasonably comply with the normal clearance procedures because CDC researchers need to begin surveillance activities related to the zika virus outbreak as quickly as possible. CDC needs to initiate these surveillance activities right away in order to increase the health security of the United States. Therefore, CDC requests a 180-day emergency clearance to operate a call center in the Emergency Operations Center to field clinical inquiries from physicians, health departments, and the general public; formulate a register for pregnant women to monitor the frequency and types of adverse birth outcomes for women infected with zika virus during pregnancy; and carry out a mosquito surveillance survey distributed to vector control professionals, entomologists, and public health biologists in order to gather information on the distribution of Aedes aegypti and Ae. Albopictus, the vectors that transmit zika virus.

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

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: 7

table that charts list of burden

IC Title	Form No.	Form Name
Maternal Health History Form	NA	Pregnancy and Zika Virus Disease Surveillance Form
Survey of County-Level Surveillance Records of Aedes aegypti and Aedes albopictus	NA	CDC Survey of County-Level Surveillance Records of Aedes aegypti and Aedes albopictus from 2000 - Present
Clinical Inquiries Database	NA	2016 Zika Virus Inquiry Log
Assessment at Delivery Form	NA	Pregnancy and Zika virus disease surveillance form - Neonate Assessment
Infant Health Follow-Up Form	NA	Pregnancy and Zika Virus Disease Surveillance Form - Infant Follow-Up 2 / 6 / 12 Month
Specimen Collection Form
Clinical Inquiries Database	NA	2016 Zika Virus Inquiry Log

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ICR Summary of Burden

table that charts list 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	2,520	2,520	0	0	0	0
Annual Time Burden (Hours)	705	705	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: $127,840

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: 04/01/2016

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