Data Supplement for Ebola Virus Disease Patients Treated Outside of West Africa

Forms and Documents

Document Name	Status
US/WHO International Clinical Network Ebola Virus Disease Clinical Data Collection Tool Form	New
SupStmnt B US-WHO ClinNetwork EVD ClinDataColl 20150604 clean.docx Supporting Statement B	2015-06-05
SupStmnt A US-WHO ClinNetwork EVD ClinDataColl 20150604 clean.docx Supporting Statement A	2015-06-05
AppndxB Email Invitation V4 20150604.docx Supplementary Document	2015-06-05
AppndxA 42 USC 241 PH Service Act Section 301.pdf Supplementary Document	2015-06-05
EmerRqustMemo US-WHO ClinNetwrk EVD ClinDataColl 20150604 THS.pdf Supplementary Document	2015-06-05

IC Document Collections

IC ID	Document Title	Status
216874	US/WHO International Clinical Network Ebola Virus Disease Clinical Data Collection Tool Form	New

ICR Details

OMB Control No: 0920-1069	ICR Reference No: 201506-0920-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15APQ
Title: Data Supplement for Ebola Virus Disease Patients Treated Outside of West Africa
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: 06/06/2015
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/05/2015
	Date Received in OIRA: 06/05/2015
Terms of Clearance: CDC will submit an extension or revision if it is anticipated that this collection will continue for longer than six months. That decision must be made within two months before the expiration in order to leave sufficient time to prepare the package in an orderly fashion.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	6 Months From Approved
Responses	42	0	0
Time Burden (Hours)	32	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This Emergency Request is to collect clinical data on the presentation, course, and management of patients with Ebola virus disease (EVD) cared for in higher-resource settings outside of West Africa [including in Western Europe and the United States (US), as well as in countries in other regions]. This information collection is necessary to inform the public health response to the ongoing Ebola virus disease outbreak. CDC requests that the following collection of information, "Data Supplement for Ebola Virus Disease Patients Treated Outside of West Africa," be processed in accordance with Section 1320.13 Emergency Processing. CDC seeks to collect this information retrospectively from clinicians who provided medical care for EVD patients. The clinicians and centers caring for these patients are part of a CDC/WHO International Clinical Network on Clinical Management of Ebola Virus Disease Patients that regularly convenes by phone to discuss the real-time management of these patients.

Emergency Justfication: This Emergency Request is to collect clinical data on the presentation, course, and management of patients with Ebola virus disease (EVD) cared for in higher-resource settings outside of West Africa [including in Western Europe and the United States (US), as well as in countries in other regions]. This information collection is necessary to inform the public health response to the ongoing Ebola virus disease outbreak. Due to the urgent need for this information for dissemination to global audiences in a timely manner, the CDC is requesting that OMB approval is granted by June 6, 2015. The CDC cannot reasonably comply with the normal clearance procedures under the Paperwork Reduction Act (PRA) because delays in information collection are likely to result in continued public harm, illness, and possibly death among patients.

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Authorizing Statute(s): US Code: 42 USC 241 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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
US/WHO International Clinical Network Ebola Virus Disease Clinical Data Collection Tool	None	US/WHO Clinical Network EVD Data Collection Tool

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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	42	0	0	42	0	0
Annual Time Burden (Hours)	32	0	0	32	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 0920-15APQ Data Supplement for Ebola Virus Disease Patients Treated Outside of West Africa is a New Emergency ICR.

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Annual Cost to Federal Government: $1,662

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: 06/05/2015

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