2006 proposed fee schedule - American Society of Clinical Oncology

e. Revised Format for Submitting ASP Data
244
As specified in the April 6, 2004 interim final rule,
manufacturers are required to report the ASP data to us in
Microsoft Excel using the specified template. As discussed
above, the current template does not provide adequate
instructions for manufacturers to report both the ASP and
the WAC. Therefore, in a separate information collection
notice that will be published at or about the same time as
this proposed rule, we will propose to revise the ASP
reporting format to accommodate submission of both the ASP
and the WAC. We will also propose to collect the following
additional information:
• Drug name.
• Package size (strength of product, volume per item,
and number of items per NDC).
• Expiration date for last lot manufactured.
• Date the NDC was first marketed (for products first
marketed on or after October 1, 2005).
• Date of first sale for products first sold on or after
October 1, 2005.
We are mentioning the separate information collection
notice in this proposed rule in order to broaden public
awareness of the separate notice. The separate notice will
be posted at http://www.cms.hhs.gov/regulations/pra/. The