| 2014 (old version) |
2016 (new version) |
Type of Change |
Reason for Change |
Burden Change |
| Blank |
Initial Drug Available for LE (367a) |
Rev |
In accordance with section 447.509(a)(4) of the final rule, CMS-2345-F, the Initial Drug Available for LE data definition and valid values are being added. |
20 hours per labeler per quarter (this burden change also includes the reporting of the Initial Drug field) |
| Blank |
Initial Drug (367a) |
Rev |
In accordance with section 447.509(a)(4) of the final rule, CMS-2345-F, the Initial Drug data definition and valid values are being added. |
20 hours per labeler per quarter (this burden change also includes the reporting of the Initial Drug Available for LE field) |
| Blank |
Line Extension Drug Indicator (367c) |
Rev |
In accordance with section 447.509(a)(4) of the final rule, CMS-2345-F, the Line Extension data definition and valid values are being added. |
26 hours per labeler |