Information Collection

Cardiovascular Outcome Claim Supplement Submission

IC 251540 under ICR 202202-0910-001 · OMB 0910-0572.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0572 can be found here:

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

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.