CMS-10110 Proposed Revised Addendum A

Manufacturer's Name

11-Digit National Drug Code

Manufacturer's Average Sales Price

Number of ASP Units

Wholesale Acquisition Cost

Name of Drug or Biological

Strength of the Product

Volume Per Item

Number of Items Per NDC

Expiration Date of Last Lot Sold

Date of First Sale

Number of CAP Units Excluded

FDA Application Number

FDA Final Pre-Marketing Approval Date

FDA Approval Type

Descriptive Data Corrected

Currently collected data elements

Proposed New Data Elements

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0921.

The time required to complete this information collection is estimated to average (40 hours) per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

CMS 10110 approval pending

Expiration Date: _________________.