Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

Documents and Forms

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

Information Collection (IC) Details

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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:

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 %

	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

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