Mailing of Important Information About Drugs - 21 CFR 200.5

Guidance for Industry and Food and Drug Administration Staff on 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⚠️ Notice: This information collection may be referencing outdated material.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
GUIDANCE DHCP 9-3-13.doc Other-Guidance

Information Collection (IC) Details

IC Title:	Mailing of Important Information About Drugs - 21 CFR 200.5	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

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-Guidance			GUIDANCE DHCP 9-3-13.doc		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 25	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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	30	30
Annual IC Time Burden (Hours)	3,000	3,000
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.