Reporting - Notify FDA of Plan Activation and Deactivation

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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0675 can be found here:

Documents and Forms

Document Name Document Type
GUIDANCE ABSENTEEISM 12-19-13.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Reporting - Notify FDA of Plan Activation and Deactivation	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 211 21 CFR 314.81(b)(1) 21 CFR 600.14 21 CFR 7.40

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			GUIDANCE ABSENTEEISM 12-19-13.pdf		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Previously Approved
Annual Number of Responses for this IC	2	2
Annual IC Time Burden (Hours)	32	32
Annual IC Cost Burden (Dollars)	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.