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

Forms and Documents

Document Name	Status
Form 1a Form1a Screening and Enrollment Form and Instruction	New
ATTACHMENT 27 - 7 Day Emergency Federal Register Notice.pdf Supplementary Document	2015-04-22
Attachment 26_HIPPA Waiver.pdf Supplementary Document	2015-04-22
Attachment 25_Manual Operating Procedure_CGMH.docx Supplementary Document	2015-04-22
Attachment 24_Manual Operating Procedures JHU.docx Supplementary Document	2015-04-22
Attachment 23_Appointment Reminder Card_CGMH.docx Supplementary Document	2015-04-22
Attachment 22_Appointment Reminder Card JHU.docx Supplementary Document	2015-04-22
Attachment 2_Clinical Protocol 14-0076_IRB Approved.docx Supplementary Document	2015-04-22
ATTACHMENT 1 - Memo Requesting Emergency Exemption.doc Supplementary Document	2015-04-22
JHCEIRS_Statement B 0416_revised_MD_clean.docx Supporting Statement B	2015-04-22
JHCEIRS_Statement A 0416_revised_MD2_clean.docx Supporting Statement A	2015-04-22

IC Document Collections

IC ID	Document Title	Status
216245	Form1a Screening and Enrollment Form and Instruction	New

ICR Details

OMB Control No: 0925-0715	ICR Reference No: 201504-0925-005
Status: Historical Active	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
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: 04/23/2015
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/23/2015
	Date Received in OIRA: 04/22/2015
Terms of Clearance: Approved consistent with the understanding that NIH will submit a full package for the larger ongoing study within three months.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2015	6 Months From Approved
Responses	600	0	0
Time Burden (Hours)	1,500	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The collection of the information required for the study "Human Influenza Surveillance of Health Care Centers in the United States and Taiwan" directly ties to the core mission of NIAID and NIH. The surveillance that will be conducted under this protocol (Attachment 2) will permit timely identification of Influenza viruses with pandemic potential, as well as variant seasonal influenza virus strains such as those resulting from antigenic drift; complementary clinical research will assess serologic and immunologic correlates of infection and disease severity. The sites that will be developed in the US and Taiwan will provide the US government with capacities to respond appropriately to emerging and re-emerging influenza strains. This study will provide information to better understand influenza in the human population in close to real time by utilizing advanced molecular testing methods which permit triaging (or selection) of sample for more in-depth analysis. The knowledge gained will be utilized to enhance health and reduce illness due to influenza infection.

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.

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Authorizing Statute(s): US Code: 42 USC 285f 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
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

IC Title	Form No.	Form Name
Form1a Screening and Enrollment	6a, 3a, 7a, 11a, 12a, 13a, 14a, 15a, 2a, 1a, 4a, 5a, 8a, 9a, 10a	Screening and Enrollment ,   Eligibility Checklist ,   Subject Identification ,   Demographic and Exposure Information ,   Current Symptoms ,   Medical History ,   Enrollment Specimen Collection ,   Follow Up Assessment ,   ED Chart Review ,   Chart Review - Inpatient Hospitalization ,   Subject Withdrawl Form ,   Subject Checklist ,   Enrollment Report ,   10% Data Accuracy Report ,   QC Checklist

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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	600	0	0	600	0	0
Annual Time Burden (Hours)	1,500	0	0	1,500	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: emergency exemption

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Annual Cost to Federal Government: $709,551

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 04/22/2015

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