GFI: Dear Healthcare Provider Letter; Improving Communication of Important Safety Information

GFI: Dear Health Care Provider Letters; Improving Communication of Important Safety Information

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0754 can be found here:

Documents and Forms

Document Name Document Type
GFI Dear Heath Care Provider 0754 Guidance.pdf www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm233769.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	GFI: Dear Healthcare Provider Letter; Improving Communication of Important Safety Information	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 200.5

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			GFI Dear Heath Care Provider 0754 Guidance.pdf	http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm233769.pdf	No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 18	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 50 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	25	-5	30
Annual IC Time Burden (Hours)	2,500	-500	3,000
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.