Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
0584_Guidance_2019.pdf Other-Guidance; Class II Special Con

Information Collection (IC) Details

View Information Collection (IC)

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 800.820.100 21 CFR 800.820.30

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			0584_Guidance_2019.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: 1	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	2	-18	20
Annual IC Time Burden (Hours)	30	-270	300
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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.