Crosswalk

CROSSWALK DOCUMENT FOR CMS 10110
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1

FORM#
Supporting
Statement A

CHANGE
Supporting document
details were updated to
reflect more accurate
estimates of burden and
the number of respondents.
• The number of
respondents was
increased to 300
from 180.

2

Addendum A

Added 2 new FDA approval CMS revised this field to better
types to the drop down list
classify drug and biological
of the FDA Approval Type
products.
column in Addendum A to
identify more FDA approval
types. Corresponding field
instructions on tab 2 of
Addendum A “Column
Instructions” were also
revised to reflect this
update.

3

Addendum A

FDA
Approval
Type
Deleted descriptive data
field.
Descriptive Data
Corrected

RATIONALE
CMS revised the cost burden and
reporting estimates to allow for an
increase in the number of
respondents due to growth in the
number of Part B drugs, more
niche drugs from smaller
manufacturers, and payments for
ESRP, OTP, etc.

This field is no longer necessary.