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

Forms and Documents

Document Name	Status
Form 33 Study Staff Form 15a QC Checklist Form	New
Form 32 Study Staff Form 14a 10% Data accuracy report Form	New
Form 31 Study Staff Form 13a Enrollment Report Form	New
Form 30 Study Staff Form 12a Subject Checklist Form	New
Form 29 Study Staff Form 11a Subject Withdrawl Form Form	New
Form 28 Study Staff Form 10a Chart Review Inpatient Hospitalization Form	New
Form 27 Study Staff Form 9a ED Chart Review Form	New
Form 26 Study Staff Form 7a Enrollment Specimen Collection Form	New
Form 25 Study Staff Informed Consent Form Form	New
Form 24 Household Surveillance patients Form 8a Follow Up Assessment Form	New
Form 23 Household Surveillance patients Form 6a Medical History Form	New
Form 22 Household Surveillance patients Form 5a Current Symptoms Form	New
Form 21 Household Surveillance patients Form 4a Demographic and Exposure Information Form	New
Form 20 Household Surveillance patients Form 3a Subject Indentification Form	New
Form 19 Household Surveillance patients Form 2a Eligibility Checklist Form	New
Form 18 Household Surveillance patients Form 1a Screening and enrollment log Form	New
Form 17 Household Surveillance patients Informed Consent Form Form	New
Form 16 Human Animal-interface patients, Form 8a Follow Up Assessment Form	New
Form 15 Human Animal-interface patients, 6a Medical History Form	New
Form 14 Human Animal-interface patients, Form 5a Current Symptoms Form	New
Form 13 Human Animal-interface patients, Form 4a Demographic and Exposure Information Form	New
Form 12 Human Animal-interface patients, Form 3a Subject Identification Form	New
Form 11 Human Animal interface patients Form 2a Eligibility Checklist Form	New
Form 10 Human Animal interface patients Form 1a Screening and enrollment log Form	New
Form 9 Human Animal interface patients Informed Consent Form Form and Instruction	New
Form 8 Hospital/care setting patients, Form 8a Follow Up Assessment Form	New
Form 7 Hospital/care setting patients, Form 6a Medical History Form	New
Form 6 Hospital/care setting patients, Form 5a Current Symptoms Form	New
Form 5 Hospital/care setting patients, Form 4a Demographic and Exposure Information Form	New
Form 4 Hospital/care setting patients, Form 3a Subject Identification Form	New
Form 3 Hospital/care setting patients, Form 2a Eligibility Checklist Form	New
Form 2 Hospital/care setting patients, Form 1a Screening and enrollment log Form	New
Form 1 Hospital/care setting patients, Informed Consent Form and Instruction	New
Influenza Sub-Study Template Example 2 26 2016.doc Supplementary Document	2016-03-22
USGHIS_Statement B_GENERIC_OMB_2-26-16.docx Supporting Statement B	2016-03-22
NIAID 30-day notice.pdf Supplementary Document	2015-09-21
USGHIS_Statement A_GENERIC_OMB2-FINAL.docx Supporting Statement A	2016-03-22

IC Document Collections

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

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
	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.

	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

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

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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	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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