Factors Influencing the Transmission of Influenza

Forms and Documents

Document Name	Status
Form 0920-0888 Medical Testing Form and Instruction	Modified
Form 0920-0888 Health Questionnaire Form	Modified
Informed Consent Form	Modified
Influenza Study - PIA.PDF Supplementary Document	2017-12-15
30dy FRN (published).pdf Supplementary Document	2017-12-15
Attachment 7 - IRB approval for study.pdf Supplementary Document	2017-12-15
Attachment 2 - 60-day Federal Register Notice.pdf Supplementary Document	2017-12-15
Attachment 1 - Legislation Authorizing Data Collection.docx Supplementary Document	2017-12-15
Influenza Section B 2017-06-21.docx Supporting Statement B	2017-12-15
Influenza Section A 2017-12-15 Lindsley changes.docx Supporting Statement A	2017-12-15

IC Document Collections

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

ICR Details

OMB Control No: 0920-0888	ICR Reference No: 201708-0920-017
Status: Active	Previous ICR Reference No: 201405-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0888 17RT
Title: Factors Influencing the Transmission of Influenza
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/02/2018
	Date Received in OIRA: 12/19/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved
Responses	450	0	0
Time Burden (Hours)	148	0	0
Cost Burden (Dollars)	0	0	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.

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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:
	82 FR 12360	03/02/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 43542	09/18/2017
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Initial Verbal Screening
Informed Consent	none	Consent
Health Questionnaire	0920-0888	Health Questionnaire
Medical Testing	0920-0888	Medical Testing

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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	450	0	0	450	0	0
Annual Time Burden (Hours)	148	0	0	148	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 reinstatement with change. Work under the previous approval showed that patients infected with influenza virus produce airborne particles containing viable airborne influenza virus during both breathing and coughing, but that breathing may generate more airborne infectious material than coughing over time. However, this work was hampered because the amounts of influenza virus in almost all of the aerosol samples were below the limit of quantification.

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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.     Yes

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.     Yes

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: 12/19/2017

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