Cardiovascular Outcome Claim Supplement Submission

Labeling Requirements for Human Prescription Drug and Biological Products

Documents and Forms

Document Name Document Type
GFI_Hypertension Indication_ Drug Labeling for Cardiovascular Outcome Claims.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-ou Instruction
GFI_Hypertension Indication_ Drug Labeling for Cardiovascular Outcome Claims.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-ou Instruction

Information Collection (IC) Details

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

Is this a Common Form? No		IC Status: New

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
Instruction			GFI_Hypertension Indication_ Drug Labeling for Cardiovascular Outcome Claims.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims	Yes	Yes	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
Annual Number of Responses for this IC	4	4
Annual IC Time Burden (Hours)	80	80
Annual IC Cost Burden (Dollars)	6,120	6,120

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.