Information Collection

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

IC 208657 under ICR 201610-0910-007 · OMB 0910-0754.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
GFI Dear Heath Care Provider 0754 Guidance.pdf www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm233769.pdf	Other-Agency Guidance

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.