expired in 5/96. Therefore, any collections since that date have
been in violation of the Paperwork Reduction Act. The collection is
approved on the condition that FDA add a burden statement, in
accordance with the Paperwork Reduction Act, to the form. FDA shall
send the revised form to OMB prior to its release.
Inventory as of this Action
FDA-2567 is completed by manufacturers
of biological products when applying for a license for new product,
when updating labeling information on a licensed biological
product, or when an amended label or package insert is generated
for a licensed product.