Recordkeeping; developing and updating plan

Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products

Documents and Forms

Document Name Document Type
GFI Planning for High Absenteeism 0675.pdf www.fda.gov/downloads/Drugs/.../Guidances/UCM196497.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Recordkeeping; developing and updating plan	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 211; 211.100 (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			GFI Planning for High Absenteeism 0675.pdf	https://www.fda.gov/downloads/Drugs/.../Guidances/UCM196497.pdf	No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 70	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	70	0	70
Annual IC Time Burden (Hours)	17,500	-17,500	35,000
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.