“General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, Forms FDA 356h and 2567”
(OMB Control Number 0910-0338)
CHANGE REQUEST (83-C)
Date: February 28, 2014
In brief, we are proposing a change to FDA Form # 356h. The only update to this form since OMB’s approval in mid-January, has been the addition of the following:
Field 29 – Establishment contact information:
- ‘Country’ in Establishment Contact Information – this is a single text box; some establishment contacts are not in the US, so the country text box allows them to provide the information where the contact is located.
- ‘N/A’ for ‘Is the site ready for inspection?’ – this is a selection box to check/uncheck; for establishments with a status of inactive or withdrawn, the ‘N/A’ box would be applicable.
Since the release in November 2012, we soon realized that we needed this on the form. The burden of time is minimal, and combined is less than a minute at most.
We hope to release the revised form in March.
| File Type | application/msword |
| Author | O'Donoghue, Amie |
| Last Modified By | Mizrachi, Ila |
| File Modified | 2014-02-28 |
| File Created | 2014-02-28 |