Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in Laboratories

Forms and Documents

Document Name	Status
Rapid Influenza Diagnostic Testing Practices in Laboratories Form	New
Supporting Statement B lw2 rev.docx Supporting Statement B	2011-12-08
Attachment J Cover letter lw2 for the survey.doc Supplementary Document	2011-12-08
Attachment I Phone script for reminder calls.doc Supplementary Document	2011-12-08
Attachment B 60-day FRN.pdf Supplementary Document	2011-12-08
Attachment A Authorizing legislation 42USC241.pdf Supplementary Document	2011-12-08
Supporting Statement A lw2 rev.docx Supporting Statement A	2011-12-08

IC Document Collections

IC ID	Document Title	Status
200422	Rapid Influenza Diagnostic Testing Practices in Laboratories Form	New

ICR Details

OMB Control No: 0920-0924	ICR Reference No: 201112-0920-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in Laboratories
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 without change	Conclusion Date: 02/22/2012
	Date Received in OIRA: 12/12/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	12 Months From Approved
Responses	2,040	0	0
Time Burden (Hours)	1,020	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Thisis a national systematic study investigating RIDT practices in clinical laboratories. RIDT are the only influenza tests that can provide results while the patient is present in facility, thus the appropriate use of the tests and interpretation of the results is critical to the treatment and control of influenza. Understanding the use of RIDT and how the labs report results to emergency and health departments and treatment facilities and what quality assurance practices are used will guide efforts of CDC to develop influenza testing guidelines and training materials for clinicians.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health and Welfare
  

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:
	76 FR 33303	06/08/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 76736	12/08/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Rapid Influenza Diagnostic Testing Practices in Laboratories	none	Rapid Influenza Diagnostic Testing Practices in Laboratories

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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	2,040	0	0	2,040	0	0
Annual Time Burden (Hours)	1,020	0	0	1,020	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 ICR.

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Annual Cost to Federal Government: $65,184

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: 12/12/2011

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