Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0670 can be found here:

Documents and Forms

Document Name Document Type
hypert guidance.doc guidance IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Guidance for Industry Hypertension Indication: Drug labeling for Cardiovascular Outcome Claims	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 5 CFR 1320.3(c)(2)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 25 %

	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1	1
Annual IC Time Burden (Hours)	10	10
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
guidance	hypert guidance.doc	07/06/2010

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.