Human Influenza Surveillance of Health Care Centers in the United States and Taiwan (NIAID)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form Attachment 7 Data Submission forms	Form and Instruction	New	Repair queued
Attachment 15 Emegency FRN published 2.26.2015.pdf	Supplementary Document	Uploaded 2015-03-30	Repair queued
Attachment 1 - Memo Requesting Emergency Exemption.doc	Supplementary Document	Uploaded 2015-03-30	Available
JHCEIRS_Statement B 323revised_MD.doc	Supporting Statement B	Uploaded 2015-03-27	Repair queued
JHCEIRS_support_stmt_A 03272015_with PCB changes.docx	Supporting Statement A	Uploaded 2015-03-27	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
215891	Data Submission forms	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201503-0925-010
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Human Influenza Surveillance of Health Care Centers in the United States and Taiwan (NIAID)
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: 03/31/2015
OIRA Conclusion Action: Improperly submitted	Conclusion Date: 04/07/2015
	Date Received in OIRA: 03/30/2015
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		6 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This study will identify individuals with influenza through focused surveillance in key region of the United States and Taiwan, rapidly identify circulating influenza strains to identify those with pandemic potential and create an invaluable bank of human samples from patients with influenza to characterize the basis of severe disease - a critical knowledge gap impacting effectiveness of decision-making around patient care. An emergency clearance was requested to allow NIH to go into the field ASAP due to the seasonality of the flu.

Emergency Justfication: This is a request for an emergency clearance of the “Human Influenza Surveillance of Health Care Centers in the United States and Taiwan Study” on the grounds that this is essential to the mission of The National Institute of Allergy and Infectious Diseases (NIAID) and that NIAID cannot reasonably comply with the normal clearance procedures and this would likely prevent or substantially disrupt the collection of information (5CFR 1320.13, see Attachment 1- Memo requesting Emergency Exemption). In addition, prevention of the study would cause public harm through the loss of critically needed information to understand the nature of the virus strains causing influenza during this year of increased influenza activity. The information gathered is critical for public health preparedness measures for the next influenza season, because characterizing current influenza virus strains effects the choice of next year’s influenza vaccine strains and helps determine effective treatment strategies by assessing the degree of antiviral resistance present in current influenza virus strains. The planned start date for the study March 31, 2015.

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Authorizing Statute(s): US Code: 42 USC 285f Name of Law: National Institute of Allergy and Infectious Diseases
  

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:
	80 FR 10494	02/26/2015
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Data Submission forms	Attachment 7	Clinical Data Forms

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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: This is a new data collection ( emergncy)

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Annual Cost to Federal Government: $709,551

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: 03/30/2015

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