United States and Global Human Influenza Surveillance in at-Risk Settings (NIAID)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 33 Attachment 17 Form15a QC Checklist	Form	New	Available
Form 32 Attachment 16 Form 14a 10% Data Accuracy Report	Form	New	Available
Form 31 Attachment 15 Form 13a Enrollment Report	Form	New	Available
Form 30 Attachment 14 Form 12a Subject Checklist	Form	New	Available
Form 29 Attachmnt 13 Form 11a Subject Withdrawal Form	Form	New	Available
Form 28 Attachment 12 Form 10a Chart Review -Inpatient Hospitalization	Form	New	Available
Form 27 Attachment 11 Form9a ED Chart Review	Form	New	Available
Form 26 Attachment 9 Form 7a Enrollment Speciment Collection	Form	New	Available
Form 25 Attachment 2 Representative Informed Consent Form	Form	New	Available
Form 24 Attachment 10 Form 8a Follow Up Assessment	Form	New	Available
Form 23 Attachment 8 Form 6a Medical History	Form	New	Available
Form 22 Attachment 7 Form 5a Current Symptoms	Form	New	Available
Form 21 Attachment 6 Form 4a Demographic and Exposure Information	Form	New	Available
Form 20 Attachment 5 Form 3a Subject Indentification	Form	New	Available
Form 19 Attachment 4 Form 2a Eligibility Checklist	Form	New	Available
Form 18 Attachment 2 Representative Informed Consent Form	Form	New	Available
Form 17 Attachment 2 Representative Informed Consent Form	Form	New	Available
Form 16 Attachment 10 Form 8a Follow Up Assessment	Form	New	Available
Form 15 Attachment 8 Form 6a Medical History	Form	New	Available
Form 14 Attachment 7 Form 5a Current Symptoms	Form	New	Available
Form 13 Attachment 6 Form 4a Demographic and Exposure Information	Form	New	Available
Form 12 Attachment 5 Form 3a Subject Indentification	Form	New	Available
Form 11 Attachment 4 Form 2a Eligibility Checklist	Form	New	Available
Form 10 Attachment 3 Form 1a Screening and Enrollment Log	Form	New	Available
Form 9 Attachment 2 Representative Informed Consent Form	Form and Instruction	New	Available
Form 8 Attachment 10 Form 8a Follow Up Assessment	Form	New	Available
Form 7 Attachment 8 Form 6a Medical History	Form	New	Available
Form 6 Attachment 7 Form 5a Current Symptoms	Form	New	Available
Form 5 Attachment 6 Form 4a Demographic and Exposure Information	Form	New	Available
Form 4 Attachment 5 Form 3a Subject Indentification	Form	New	Available
Form 3 Attachment 4 Form 2a Eligibility Checklist	Form	New	Available
Form 2 Attachment 3 Form 1a Screening and Enrollment Log	Form	New	Available
Form 1 Attachment 2 Representative Informed Consent Form	Form and Instruction	New	Available
Influenza Sub-Study Template Example 2 26 2016.doc	Supplementary Document	Uploaded 2016-03-22	Available
USGHIS_Statement B_GENERIC_OMB_2-26-16.docx	Supporting Statement B	Uploaded 2016-03-22	Available
NIAID 30-day notice.pdf	Supplementary Document	Uploaded 2015-09-21	Available
USGHIS_Statement A_GENERIC_OMB2-FINAL.docx	Supporting Statement A	Uploaded 2016-03-22	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
218301	Study Staff Form 15a QC Checklist	Form	New	Attachment 17 Form15a QC Checklist
218300	Study Staff Form 14a 10% Data accuracy report	Form	New	Attachment 16 Form 14a 10% Data Accuracy Report
218299	Study Staff Form 13a Enrollment Report	Form	New	Attachment 15 Form 13a Enrollment Report
218298	Study Staff Form 12a Subject Checklist	Form	New	Attachment 14 Form 12a Subject Checklist
218297	Study Staff Form 11a Subject Withdrawl Form	Form	New	Attachmnt 13 Form 11a Subject Withdrawal Form
218296	Study Staff Form 10a Chart Review Inpatient Hospitalization	Form	New	Attachment 12 Form 10a Chart Review -Inpatient Hospitalization
218295	Study Staff Form 9a ED Chart Review	Form	New	Attachment 11 Form9a ED Chart Review
218294	Study Staff Form 7a Enrollment Specimen Collection	Form	New	Attachment 9 Form 7a Enrollment Speciment Collection
218293	Study Staff Informed Consent Form	Form	New	Attachment 2 Representative Informed Consent Form
218292	Household Surveillance patients Form 8a Follow Up Assessment	Form	New	Attachment 10 Form 8a Follow Up Assessment
218291	Household Surveillance patients Form 6a Medical History	Form	New	Attachment 8 Form 6a Medical History
218290	Household Surveillance patients Form 5a Current Symptoms	Form	New	Attachment 7 Form 5a Current Symptoms
218289	Household Surveillance patients Form 4a Demographic and Exposure Information	Form	New	Attachment 6 Form 4a Demographic and Exposure Information
218288	Household Surveillance patients Form 3a Subject Indentification	Form	New	Attachment 5 Form 3a Subject Indentification
218287	Household Surveillance patients Form 2a Eligibility Checklist	Form	New	Attachment 4 Form 2a Eligibility Checklist
218286	Household Surveillance patients Form 1a Screening and enrollment log	Form	New	Attachment 2 Representative Informed Consent Form
218285	Household Surveillance patients Informed Consent Form	Form	New	Attachment 2 Representative Informed Consent Form
218284	Human Animal-interface patients, Form 8a Follow Up Assessment	Form	New	Attachment 10 Form 8a Follow Up Assessment
218283	Human Animal-interface patients, 6a Medical History	Form	New	Attachment 8 Form 6a Medical History
218282	Human Animal-interface patients, Form 5a Current Symptoms	Form	New	Attachment 7 Form 5a Current Symptoms
218281	Human Animal-interface patients, Form 4a Demographic and Exposure Information	Form	New	Attachment 6 Form 4a Demographic and Exposure Information
218280	Human Animal-interface patients, Form 3a Subject Identification	Form	New	Attachment 5 Form 3a Subject Indentification
218279	Human Animal interface patients Form 2a Eligibility Checklist	Form	New	Attachment 4 Form 2a Eligibility Checklist
218278	Human Animal interface patients Form 1a Screening and enrollment log	Form	New	Attachment 3 Form 1a Screening and Enrollment Log
218277	Human Animal interface patients Informed Consent Form	Form and Instruction	New	Attachment 2 Representative Informed Consent Form
218253	Hospital/care setting patients, Form 8a Follow Up Assessment	Form	New	Attachment 10 Form 8a Follow Up Assessment
218252	Hospital/care setting patients, Form 6a Medical History	Form	New	Attachment 8 Form 6a Medical History
218250	Hospital/care setting patients, Form 5a Current Symptoms	Form	New	Attachment 7 Form 5a Current Symptoms
218249	Hospital/care setting patients, Form 4a Demographic and Exposure Information	Form	New	Attachment 6 Form 4a Demographic and Exposure Information
218248	Hospital/care setting patients, Form 3a Subject Identification	Form	New	Attachment 5 Form 3a Subject Indentification
218247	Hospital/care setting patients, Form 2a Eligibility Checklist	Form	New	Attachment 4 Form 2a Eligibility Checklist
218246	Hospital/care setting patients, Form 1a Screening and enrollment log	Form	New	Attachment 3 Form 1a Screening and Enrollment Log
218245	Hospital/care setting patients, Informed Consent	Form and Instruction	New	Attachment 2 Representative Informed Consent Form

ICR Details

OMB Control No: 0925-0737	ICR Reference No: 201509-0925-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: United States and Global Human Influenza Surveillance in at-Risk Settings (NIAID)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/24/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/30/2015
Terms of Clearance: Approved consistent with the understanding that each sub-study submitted under this generic umbrella will include a complete justification for the incentive proposed (e.g., travel to data collection site, blood draw), including relevant supporting evidence that the requested amount is necessary.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved
Responses	9,015	0	0
Time Burden (Hours)	52,002	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In order to capture samples and information from the 2014-2015 influenza season, which featured a rare drift variant of influenza, we filed an emergency OMB paperwork reduction act clearance request for surveillance and information collection to be conducted at the Johns Hopkins University in a hospital setting. We received approval on 04/23/2015 under OMB control number 0925-0715, expiration date 10/31/2015. The hospital was able to collect some samples and information from the end of last influenza season, giving us critical information on an important new variant influenza strain. The study at Johns Hopkins University will need to continue to collect samples and information in the upcoming influenza seasons in order to identify if the draft variant from last season remains in circulation, to identify any additional novel circulating influenza strains, and to draw important conclusions on the risk to public health of circulating influenza viruses. We anticipate using the generic clearance we seek here to continue that study and capture information and samples from the upcoming 2015-2016 influenza season. We also anticipate future studies in other at-risk settings

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

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 19090	04/09/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 56477	09/18/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 33

table that charts list of burden

IC Title	Form No.	Form Name
Hospital/care setting patients, Form 1a Screening and enrollment log	2	Attachment 3 Form 1a Screening and Enrollment Log
Hospital/care setting patients, Form 2a Eligibility Checklist	3	Attachment 4 Form 2a Eligibility Checklist
Hospital/care setting patients, Form 3a Subject Identification	4	Attachment 5 Form 3a Subject Indentification
Hospital/care setting patients, Form 4a Demographic and Exposure Information	5	Attachment 6 Form 4a Demographic and Exposure Information
Hospital/care setting patients, Form 5a Current Symptoms	6	Attachment 7 Form 5a Current Symptoms
Hospital/care setting patients, Form 8a Follow Up Assessment	8	Attachment 10 Form 8a Follow Up Assessment
Hospital/care setting patients, Informed Consent	1	Attachment 2 Representative Informed Consent Form
Hospital/care setting patients, Form 6a Medical History	7	Attachment 8 Form 6a Medical History
Household Surveillance patients Form 1a Screening and enrollment log	18	Attachment 2 Representative Informed Consent Form
Household Surveillance patients Form 2a Eligibility Checklist	19	Attachment 4 Form 2a Eligibility Checklist
Household Surveillance patients Form 3a Subject Indentification	20	Attachment 5 Form 3a Subject Indentification
Household Surveillance patients Form 4a Demographic and Exposure Information	21	Attachment 6 Form 4a Demographic and Exposure Information
Household Surveillance patients Form 5a Current Symptoms	22	Attachment 7 Form 5a Current Symptoms
Household Surveillance patients Form 6a Medical History	23	Attachment 8 Form 6a Medical History
Household Surveillance patients Form 8a Follow Up Assessment	24	Attachment 10 Form 8a Follow Up Assessment
Household Surveillance patients Informed Consent Form	17	Attachment 2 Representative Informed Consent Form
Human Animal interface patients Form 1a Screening and enrollment log	10	Attachment 3 Form 1a Screening and Enrollment Log
Human Animal interface patients Form 2a Eligibility Checklist	11	Attachment 4 Form 2a Eligibility Checklist
Human Animal interface patients Informed Consent Form	9	Attachment 2 Representative Informed Consent Form
Human Animal-interface patients, Form 3a Subject Identification	12	Attachment 5 Form 3a Subject Indentification
Human Animal-interface patients, Form 4a Demographic and Exposure Information	13	Attachment 6 Form 4a Demographic and Exposure Information
Human Animal-interface patients, 6a Medical History	15	Attachment 8 Form 6a Medical History
Human Animal-interface patients, Form 5a Current Symptoms	14	Attachment 7 Form 5a Current Symptoms
Human Animal-interface patients, Form 8a Follow Up Assessment	16	Attachment 10 Form 8a Follow Up Assessment
Study Staff Form 10a Chart Review Inpatient Hospitalization	28	Attachment 12 Form 10a Chart Review -Inpatient Hospitalization
Study Staff Form 11a Subject Withdrawl Form	29	Attachmnt 13 Form 11a Subject Withdrawal Form
Study Staff Form 12a Subject Checklist	30	Attachment 14 Form 12a Subject Checklist
Study Staff Form 13a Enrollment Report	31	Attachment 15 Form 13a Enrollment Report
Study Staff Form 14a 10% Data accuracy report	32	Attachment 16 Form 14a 10% Data Accuracy Report
Study Staff Form 15a QC Checklist	33	Attachment 17 Form15a QC Checklist
Study Staff Form 7a Enrollment Specimen Collection	26	Attachment 9 Form 7a Enrollment Speciment Collection
Study Staff Form 9a ED Chart Review	27	Attachment 11 Form9a ED Chart Review
Study Staff Informed Consent Form	25	Attachment 2 Representative Informed Consent Form

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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	9,015	0	0	9,015	0	0
Annual Time Burden (Hours)	52,002	0	0	52,002	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: This is a new generic submission.

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Annual Cost to Federal Government: $715,551

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: 09/30/2015

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