Information Collection

Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

IC 6307 under ICR 202204-0910-009 · OMB 0910-0584.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0584 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Reagents for Detection of Specific Novel Influenza A Viruses - Class II Special Controls Guidance for Industry and FDA Staff _ 6	Other-Guidance: Class II Special Con
Reagents for Detection of Specific Novel Influenza A Viruses - Class II Special Controls Guidance for Industry and FDA Staff _ 6	Other-Guidance: Class II Special Con

IC Title:

Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 866.3332

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance: Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses; Guidance for Industry and FDA Staff			Reagents for Detection of Specific Novel Influenza A Viruses - Class II Special Controls Guidance for Industry and FDA Staff _ 6.22.23.pdf		Yes	No	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 12

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

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	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	24	22	2
Annual IC Time Burden (Hours)	360	330	30
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.