OMB control number
GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims
OMB 0910-0670 · HHS/FDA.
OMB 0910-0670
The information supports Agency guidance intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. The appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling.
The latest form for GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims expires 2022-12-31 and is listed under ICR 201911-0910-010.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0670 GFI Hypertension Indication SSA 2019.pdf | Supporting Statement A |
 Cardiovascular Outcome Claim Supplement Submission |
Other-Agency Guidance |
| Submission to Docket Number FDA-2008-D-0150 |
Other-Guidance |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201911-0910-010 | Extension without change of a currently approved collection | 2019-12-05 | Approved without change | |
| 201610-0910-011 | Extension without change of a currently approved collection | 2016-11-08 | Approved without change | |
| 201309-0910-001 | Extension without change of a currently approved collection | 2013-09-10 | Approved without change | |
| 201007-0910-004 | New collection (Request for a new OMB Control Number) | 2010-07-26 | Approved without change |
OMB Details
Submission to Docket Number FDA-2008-D-0150
Federal Enterprise Architecture: Health - Consumer Health and Safety