Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

ICR 201908-0910-018

OMB: 0910-0584

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2019-08-27
Supporting Statement A
2019-07-19
ICR Details
0910-0584 201908-0910-018
Active 201907-0910-012
HHS/FDA CDRH
Guidance for Reagents for Detection of Specific Novel Influenza A Viruses
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/05/2019
Retrieve Notice of Action (NOA) 08/27/2019
  Inventory as of this Action Requested Previously Approved
08/31/2022 08/31/2022 08/31/2022
2 0 2
30 0 30
0 0 0

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.

US Code: 21 USC 360c Name of Law: Sec 513 Classification of Devices Intended for Human Use
  
None

Not associated with rulemaking

  84 FR 7904 03/05/2019
84 FR 34190 07/17/2019
No

1
IC Title Form No. Form Name
Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

  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
No
No

$0
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/27/2019


© 2024 OMB.report | Privacy Policy