| 2013 (old version) |
2014 (new version) |
Type of Change |
Reason for Change |
Burden Change |
| Filler (367a) |
Blank |
Rev |
The filler field wasn't being used, so we are deleting it. |
No |
| Filler (367b) |
5i Threshold |
Rev |
The filler field wasn't being used, so we are replacing it with the 5i Threshold field, which is required as part of the Affordable Care Act. |
1 hour per reporting period |
| DESI Indicator (367c) |
COD Status and FDA Application Number/OTC Monograph Number |
Rev |
The DESI Indicator field is no longer relevant to the Medicaid Drug Rebate Program and is being replaced with the new Covered Outpatient Drug Status field and the associated FDA Application Number/OTC Monograph Number field. |
One-time burden of 5 hours per labeler |
| Blank |
5i Drug Indicator and 5i Route of Administration (367c) |
Rev |
In accordance with the Affordable Care Act, the 5i Drug Indicator and 5i Route of Administration fields are being added. |
One-time burden of 2.5 hours per labeler |
| Blank |
ACA Baseline AMP (367c) |
Rev |
In accordance with the Affordable Care Act, the voluntary ACA Baseline AMP is being added. |
Negligible because not every labeler will report it, nor will it be reported for every drug |
| Blank |
Reactivation Date |
Rev |
To ensure more accurate product data reporting and allow labelers to report a date on which a terminated NDC is reintroduced to the market, the voluntary Reactivation Date field is being added. |
Negligible because not every labeler will report it, nor will it be reported for every drug |
| Blank |
Legal Contact Email Address (367d) |
Rev |
To provide each labeler with the option to submit an alternate email address as part of their reported contact information. |
Negligible because not every labeler will report it. |
| Blank |
Invoice Contact Email Address (367d) |
Rev |
To provide each labeler with the option to submit an alternate email address as part of their reported contact information. |
Negligible because not every labeler will report it. |