Factors Influencing the Transmission of Influenza

Forms and Documents

Document Name	Status
Medical Testing Form and Instruction	Modified
Health Questionnaire Form	Modified
Informed Consent Form	Modified
Attachment 7 - Public Comments and Responses to the 60-day FRN.docx Supplementary Document	2014-05-05
Attachment 6 - Institutional Review Board Approval.docx Supplementary Document	2014-05-05
Attachment 2 - 60-day Federal Register Notice.docx Supplementary Document	2014-05-05
Attachment 1 - Legislation Authorizing Data Collection.docx Supplementary Document	2014-05-05
Section B 2014-04-28.docx Supporting Statement B	2014-05-05
Section A 2014-04-28.docx Supporting Statement A	2014-05-05

IC Document Collections

IC ID	Document Title	Status
196088	Initial Participants (Health Questionnaire) Phase 3 Other-WORD	Removed
196087	Initial Participants (Health Questionnaire) Phase 2 Other-WORD	Removed
196086	Qualified Participants (Testing) Phase 3 Instruction	Removed
196085	Qualified Participants (Testing) Phase 2 Instruction	Removed
196084	Qualified Participants (Informed Consent) Phase 3 Other-WORD	Removed
196083	Medical Testing Form and Instruction	Modified
196082	Health Questionnaire Form	Modified
196081	Informed Consent Form	Modified
196080	Initial Participants (Health Questionnaire) Phase 1 Other-WORD	Removed

ICR Details

OMB Control No: 0920-0888	ICR Reference No: 201405-0920-001
Status: Historical Active	Previous ICR Reference No: 201102-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Factors Influencing the Transmission of Influenza
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/18/2014
	Date Received in OIRA: 05/07/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2017	36 Months From Approved	06/30/2014
Responses	540	0	372
Time Burden (Hours)	150	0	84
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this study is to measure the amount of viable influenza virus in airborne particles that are produced by patients when they cough, and the size and quantity of the particles carrying the virus. A better understanding of the amount of potentially infectious material released by patients and the size of particles carrying the virus will assist in determining the possible role of airborne transmission in the spread of influenza and in devising measures to prevent it. After agreeing to participate, eligible participants provide nasopharyngeal and oropharyngeal swabs and cough into an aerosol particle collection system for testing, as well as complete forms.

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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:
	78 FR 67147	11/08/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 25595	05/05/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Informed Consent	none	Consent
Health Questionnaire	none	Health Questionnaire
Medical Testing	none	Medical Testing
Qualified Participants (Testing) Phase 3
Initial Participants (Health Questionnaire) Phase 2
Initial Participants (Health Questionnaire) Phase 3
Qualified Participants (Informed Consent) Phase 3
Qualified Participants (Testing) Phase 2
Initial Participants (Health Questionnaire) Phase 1

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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	540	372	0	168	0	0
Annual Time Burden (Hours)	150	84	0	66	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Changes in burden are due to increasing the number of participants to achieve an adequate sample size. The forms have been changed so that only three are necessary for this phase of the study.

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Annual Cost to Federal Government: $31,726

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: 05/07/2014

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