Cardiovascular Outcome Claim Supplement Submission

GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims

Documents and Forms

Document Name Document Type
0670 GFI Labeling for Cardiovascular Outcome claims March 2011.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-ou Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Cardiovascular Outcome Claim Supplement Submission	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0670 GFI Labeling for Cardiovascular Outcome claims March 2011.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims	No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 4	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	4	3	1
Annual IC Time Burden (Hours)	80	60	20
Annual IC Cost Burden (Dollars)	6,120	6,120	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.