30-Day Crosswalk

Negotiation Data Elements and Drug Price Negotiation Process Information Collection Request (ICR) for Initial Price Applicability Year 2027

Crosswalk of Changes Between the 30-Day and Final Documents^*

Location of Edits	Summary of Changes (Included for 30-day Comment Period)	Type of Change	Explanation of Changes	Burden Change (Yes/No)
Supporting Statement
Background, Outside Consultation and Burden Estimates	Included discussion of final revisions	Modify	Technical Updates	No
Information Collection Request (ICR) Forms
ICR Form – Negotiation Data Elements
Section C	Revised instructions for Questions 1, 2b, 3d, 4c, and 5a regarding adjustments for inflation and cost of capital Revised instructions for Questions 1, 2a, 3a, 4a, and 5c regarding adjustments for inflation and cost of capital	Modify	Revisions made in response to comments received from the ICR 30-Day Comment Period	No
Question 27	Instructions revised to clarify that respondent should list the applicable question numbers and also indicate which question the response applies to within the free text field	Modify	Technical Updates	No
Section I	Added clarifying instructions to Question 28 regarding the applicability of the options and sub-question regarding manufacturer affiliation for a Primary Manufacturer Added clarification to instructions for patient- and caregiver-focused questions that respondents should address their experience related to the selected drug and its therapeutic alternatives Revised title of Question 45 to include “Additional” Revised instructions for Question 61 to specify that respondents will select, not click, applicable questions	Modify	Technical Updates and revisions made in response to comments received from the ICR 30-Day Comment Period	No
Question 62	Instructions revised to clarify that respondent should list the applicable question numbers and indicate which question the response applies to within the free text field	Modify	Technical Updates	No
ICR Form – Drug Price Negotiation Process
Question 1	Revised “counteroffer price” to “proposal for the MFP”	Modify	Technical Update	No

*Question numbering matches final document.

1