Factors Influencing the Transmission of Influenza

Forms and Documents

Document Name	Status
Initial Verbal Screening Form and Instruction	Modified
Health Questionnaire Form	Modified
Attachment 7 - IRB Approval of Continuation.pdf Supplementary Document	2021-02-18
Attachment 2 - Federal Register Notice.pdf Supplementary Document	2021-02-18
Attachment 1 - Authorizing Legislation.docx Supplementary Document	2021-02-18
Influenza Section B_2021-2-16.docx Supporting Statement B	2021-02-18
Influenza Section A_2021-2-18.docx Supporting Statement A	2021-02-18

IC Document Collections

IC ID	Document Title	Status
228011	Initial Verbal Screening Form and Instruction	Modified
196083	Medical Testing Other-Summary of Medical Tests	Modified
196082	Health Questionnaire Form	Modified
196081	Informed Consent Other-Informed Consent	Modified

ICR Details

OMB Control No: 0920-0888	ICR Reference No: 202101-0920-010
Status: Received in OIRA	Previous ICR Reference No: 201708-0920-017
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0888
Title: Factors Influencing the Transmission of Influenza
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 02/23/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2021
Responses	450	450
Time Burden (Hours)	148	148
Cost Burden (Dollars)	2,137	0

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Abstract: The purpose of this study is to gain a better understanding of the production of infectious aerosols by patients with influenza, and to compare this to the levels of biomarkers in the blood of these patients. To do this, aerosols produced by volunteer subjects with influenza will be collected and tested for influenza virus, and the levels of influenza infection-associated microRNA molecules will be measured in blood samples from these subjects. PCR assays specific to SARS-CoV-2 will also be done to distinguish influenza patients from Covid-19 patients.

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Authorizing Statute(s): US Code: 29 USC 669 Name of Law: 1970 OSHA
  

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:
	85 FR 64475	10/13/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 10969	02/23/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Initial Verbal Screening	n/a	Script for Initial Verbal Screening
Informed Consent
Health Questionnaire	n/a	Health Questionnaire for study "Factors Influencing the Transmission of Influenza"
Medical Testing

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ICR Summary of Burden

	Total Request	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	450	450	0	0	0	0
Annual Time Burden (Hours)	148	148	0	0	0	0
Annual Cost Burden (Dollars)	2,137	0	0	2,137	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $80,429

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? Yes

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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: 02/23/2021

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