Crosswalk (60day to 30day changes)

Negotiation Program Drug Selection for Initial Price Applicability Year 2028
under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request (ICR):
Crosswalk of Changes Between Initial Price Applicability Year 2028 60-day ICR and Initial Price Applicability Year 2028 30-Day ICR Documents
Location of
Edits

Summary of Changes
(Included for 30-day Comment Period)

Type of
Change

Explanation of
Changes

Burden
Change
(Yes/No)

Modify

No

Modify

Technical updates
related to updating
program guidance
references and to
align with the final
guidance
Technical updates

Modify

Technical update

No

Modify

Technical updates

Yes

Add/Modify

Technical update

No

Modify

Technical updates

No

Add/Modify

Technical updates

No

Supporting Statement – Part A
Throughout

•

Use of
Information
Technology
Federal Register

•

Burden
Estimates

•

•

•
•

Revisions to incorporate reference to the Medicare Drug Price Negotiation
Program: Final Guidance, Implementation of Sections 1191 – 1198 of the Social
Security Act for Initial Price Applicability Year 2028 and Manufacturer
Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028
(hereinafter, the “final guidance”) and to align with definitions and other terms
used in the final guidance
Revisions to capture submission process for Identification and Selection of
Renegotiation-Eligible Drugs ICR Form, which will include a template provided
by CMS to include the questions and tables only
Revisions to capture that the initial price applicability year 2028 materials are
being published for a 30-day comment period
Revisions to update burden estimates to use May 2024 Bureau of Labor
Statistics’ Occupational Employment and Wage Statistics data (from May 2023
data)
Renumbering of tables
Addition of language to capture revisions in the 30-day package

Changes to
Burden
Information Collection Forms
Throughout

•

Section A

•

Revisions to incorporate references to the final guidance and to align with
definitions and other terms used in the final guidance
Small Biotech Exception

•
•

Addition of text to the instruction for Question 2a to clarify that the question
relates to the Submitting Manufacturer, and not the qualifying single source
drug
Addition of the word “mailing” to the Address field for Question 2b
Revisions to instructions and Question 3 for qualifying single source drugs with
distinct combination of active moieties/active ingredients

No

1

Location of
Edits

Summary of Changes
(Included for 30-day Comment Period)

Type of
Change

Explanation of
Changes

Section B

•
•
•

Add/Modify

Technical updates

Section C

•
•

Addition of the word “mailing” to the Address field for Questions 4a and 5b
Addition of the response fields for Labeler Code(s) to Questions 4a and 5b
Revisions to instructions to clarify that Question 5 collects information about
the members of that entity’s controlled group (if any) as of December 31, 2021
that had a Coverage Gap Discount Program Agreement in effect on December
31, 2021
Addition of the word “mailing” to the Address field for Question 6b
Revisions to instructions for Question 6d to clarify the response is intended if
the Submitting Manufacturer held no other New Drug Application(s) and/or
Biologic License Application(s) as of December 31, 2021, other than those for
the qualifying single source drug for which the Submitting Manufacturer seeks
the Small Biotech Exception

Burden
Change
(Yes/No)
No

Add/Modify

Technical update

No

Addition of the word “mailing” to the Address field for Question 1
Addition of an (s) to Active Ingredient in Question 2 to allow for a response with
multiple Active Ingredients
Revisions to the “Reference Product” field in Question 4 to clarify the
information requested in the data field
Revisions to reflect that one manufacturing schedule would have been
submitted to the Food and Drug Administration during its review of the
Biosimilar’s application for licensure
Revisions to the citations provided in Questions 11, 12, and 13

Add/Modify

Technical updates

No

Modify

Technical updates

No

Biosimilar Delay
Section 1

•
•
•

Section 3

•
•

2

Location of
Edits

Summary of Changes
(Included for 30-day Comment Period)

Type of
Change

Explanation of
Changes

Burden
Change
(Yes/No)

Revisions to incorporate references to the final guidance
Revisions to incorporate revisions to defined terms from Appendix A of the final
guidance
Revisions to incorporate instructions for questions also included in the
forthcoming Drug Price Negotiation for Initial Price Applicability Year 2028
under Sections 11001 and 11002 of the Inflation Reduction Act (IRA)
Information Collection Request (CMS-10844, OMB 0938-1452) to provide for
consistency between the two ICRs where applicable, for example, for describing
the reporting time period for prior Federal financial support (Section 3) and for
reporting of units for manufacturer U.S. commercial average net unit price
(Section 5)
Revisions to clarify instructions for submission of responses

Modify

Technical updates

No

Modify

Technical updates

No

Revisions to clarify instructions regarding the 11-digit National Drug Codes
(NDC-11s) for which a Primary Manufacturer should report data in response to
the ICR Form
Revisions to instruction for converting another currency to United States dollars
to clarify which exchange rate to use
Revisions to instructions for inflation adjustments to specify the consumer price
index for all urban consumers
Revisions to Questions 3, 6 and 7 to separate data fields for reporting of
inflation adjusted values
Revisions to Sections 1, 3 and 4 with respect to the periods of time for which
data should be reported
Revisions to Section 1 to clarify instructions for reporting research and
development (R&D) costs and recoupment data
Revisions to instructions to clarify that prior Federal financial support and costs
associated with applying for and receiving foreign approvals may not be
included in Section 3

Modify

Technical update

No

Modify

Technical updates

No

Modify

Revisions to align
with the final
guidance and
technical updates
Revisions to align
with the final
guidance and
technical updates

No

Identification and Selection of Renegotiation-Eligible Drugs
Throughout

•
•
•

Submission
Method
Additional
Instructions

•

Instructions for
Reporting
Monetary
Amounts
Sections 1, 3,
and 4

•

•

•
•
•

Section 1

•
•

Modify

No

3

Location of
Edits

Summary of Changes
(Included for 30-day Comment Period)

Type of
Change

Explanation of
Changes

Section 3

•

Revisions to Section 3 instructions to align with Section 1 regarding the
reporting period for prior Federal financial support

Modify

Section 4

•

Modify

Section 5

•
•

Revisions to Section 4 to clarify the instructions and examples of information to
be submitted
Removal of request to identify the composition of matter patent in Question 9a
Addition of instruction regarding units to be submitted for the data elements
included
Revision to instruction to clarify the NDC-11s that a Primary Manufacturer
should include in response to Section 5
Revision to align the starting date and ending date of the data that may be
submitted in Questions 14 and 15 with sections 130.1.3 and 130.1.4 of the final
guidance
Revisions to add the option to submit visual attachments to Questions 14 and
15 and to include citations in Question 15

Revisions to align
with the final
guidance and
technical updates
Technical updates

Modify

Technical updates

No

Modify

Revisions to align
with the final
guidance and
technical updates

No

•
Section 6

•
•

Burden
Change
(Yes/No)
No

No

4