Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

Forms and Documents

Document Name	Status
Specific Novel Influenza A Viruses guidance.pdf Supplementary Document	2013-03-14
0584--Guidance for Reagents for Detection of Specific Novel Influenza A Viruses SS.doc Supporting Statement A	2013-03-14

IC Document Collections

IC ID	Document Title	Status
6307	Guidance for Reagents for Detection of Specific Novel Influenza A Viruses	Modified

ICR Details

OMB Control No: 0910-0584	ICR Reference No: 201303-0910-002
Status: Historical Active	Previous ICR Reference No: 201001-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: 19128
Title: Guidance for Reagents for Detection of Specific Novel Influenza A Viruses
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/23/2013
	Date Received in OIRA: 03/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2016	36 Months From Approved	04/30/2013
Responses	20	0	20
Time Burden (Hours)	300	0	300
Cost Burden (Dollars)	0	0	0

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Abstract: OMB clearance is being sought for an information collection that has been established as a special control for the class II device type, Novel Influenza A Reagents. This classification results from the review of a request from a device sponsor (CDC) for a diagnostic test intended to diagnose influenza subtype H5 (Asian lineage), commonly known as avian flu. This classification permits the legal distribution of this device, and the information collection addressed here plays a significant role in providing a reasonable assurance of the safety and effectiveness of this device and of similar future devices. Specifically, the information collection asks sponsors to obtain and analyze data postmarket to ensure the continued reliability of the device, given the propensity of influenza viruses to mutate and the potential for changes in disease prevalence. This involves collecting data on the clinical performance of the device under new prevalence conditions if there is a change in prevalence of influenza caused by the specific novel virus that the device is intended to detect, as compared to the prevalence of this virus when the clinical studies described in the 510(k) were conducted.

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Authorizing Statute(s): US Code: 21 USC 360c Name of Law: Sec 513 Classification of Devices Intended for Human Use
  

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:
	77 FR 58997	09/25/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 15952	03/13/2013
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

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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	20	20	0	0	0	0
Annual Time Burden (Hours)	300	300	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 03/20/2013

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