Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

Forms and Documents

Document Name	Status
0584__Change Request Memo_Aug. 2019.doc Justification for No Material/Nonsubstantive Change	2019-08-27
0584_Supporting Statement_2019.doc Supporting Statement A	2019-07-19

IC Document Collections

IC ID	Document Title	Status
6307	Guidance for Reagents for Detection of Specific Novel Influenza A Viruses Other-Guidance; Class II Special Controls Guidance Document: Rea	Modified

ICR Details

OMB Control No: 0910-0584	ICR Reference No: 201908-0910-018
Status: Active	Previous ICR Reference No: 201907-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Guidance for Reagents for Detection of Specific Novel Influenza A Viruses
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/05/2019
	Date Received in OIRA: 08/27/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	08/31/2022	08/31/2022
Responses	2	0	2
Time Burden (Hours)	30	0	30
Cost Burden (Dollars)	0	0	0

---

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. The information collection described above is a measure that FDA determined to be necessary to provide reasonable assurance of safety and effectiveness of Novel Influenza A Reagents.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 7904	03/05/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 34190	07/17/2019
Did the Agency receive public comments on this ICR? No

---

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

---

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	2	0	0	0	0
Annual Time Burden (Hours)	30	30	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:

---

Annual Cost to Federal Government: $0

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

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.     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

---

Common Form ICR:  No

---

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: 08/27/2019

---