Submission to Docket Number FDA-2008-D-0150

Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims

OMB: 0910-0670

IC ID: 193929

Documents and Forms
Document Name
Document Type
Other-Guidance
Information Collection (IC) Details

View Information Collection (IC)

Submission to Docket Number FDA-2008-D-0150
 
No Modified
 
Voluntary
 
5 CFR 1320.3(c)(2) 21 CFR 201.56&201.57

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance FINAL GUIDANCE 0670 Hypertension 8-28-13.pdf Yes No Printable Only

Health Consumer Health and Safety

 

1 0
   
Private Sector Businesses or other for-profits
 
   25 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 1 0 0 0 0 1
Annual IC Time Burden (Hours) 10 0 0 0 0 10
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

© 2024 OMB.report | Privacy Policy