• On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation Reduction Act (IRA).  
• The data solicited concerns certain manufacturer-specific data and data regarding therapeutic alternatives that CMS will consider in negotiating a maximum fair price for selected drugs.
• CMS specifically solicits comments regarding (1) the necessity and utility of the information collection; (2) whether the burden estimate is accurate and justified; and (3) how to ensure the information collected is high quality, clear and useful.
• Comments to the 60-Day Notice must be submitted by May 22, 2023. A second notice will likely be published in the Federal Register this summer, which will have a 30-day comment period (the “30-Day Notice”). 
• The data elements are also described in a separate guidance document, for which comments are due on April 14, 2023.

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Background on the Paperwork Reduction Act
This ICR Form was issued by CMS pursuant to the clearance procedures required by the Paperwork Reduction Act (PRA) – a federal law that was enacted to reduce the burden imposed by the federal government on private businesses and citizens and to maximize the usefulness of the information collected.  The PRA applies to CMS’ requirement to consider certain manufacturer-specific data, as the PRA is triggered whenever an agency asks for answers to identical questions, or seeks to impose identical reporting or recordkeeping requirements, from 10 or more “members of the public”—defined to include both individuals and businesses.

As such, CMS must comply with the clearance procedures in the PRA that require the agency to publish an ICR for comment twice in the Federal Register. The first notice provides the public 60 days to submit comments regarding issues such as: (1) the necessity and utility of the information collection; (2) whether the burden estimate is accurate and justified; and (3) how to ensure the information collected is high quality, clear and useful (the “60-Day Notice”). The 30-Day Notice will include all the information from the 60-Day Notice and any changes the agency made from public comments.

Proposed Information to be Collected
For manufacturer-specific data, CMS intends to collect from Primary Manufacturers the following information:

• Non-FAMP data for the selected drug;
• Research and development costs of the Primary Manufacturer for the selected drug and the extent to which the Primary Manufacturer has recouped research and development costs;
• Current unit costs of production and distribution of the selected drug;
• Prior federal financial support for novel therapeutic discovery and development with respect to the selected drug;
• Data on pending and approved patent applications, exclusivities recognized by the Food and Drug Administration (FDA), and applications and approvals under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act; and
• Market data and revenue and sales volume data for the selected drug. 

For evidence about therapeutic alternatives, CMS intends to collect Primary Manufactures (as part of their larger data submission) and separately from members of the public the following information:

• The extent to which such selected drug represents a therapeutic advance as compared to existing therapeutic alternatives and the costs of such existing therapeutic alternatives;
• Prescribing information approved by the FDA for such selected drug and therapeutic alternatives to such drug;
• Comparative effectiveness of such selected drug and therapeutic alternatives to such drug, taking into consideration the effects of such drug and therapeutic alternatives to such drug on specific populations, such as individuals with disabilities, the elderly, the terminally ill, children, and other patient populations; and
• The extent to which such selected drug and therapeutic alternatives to such drug address unmet medical needs for a condition for which treatment or diagnosis is not addressed adequately by available therapy.

Estimated Burden for Primary Manufacturers
CMS estimated the burden for each Primary Manufacturer to provide this information to CMS, where the estimated time and cost burdens would be 500 hours and $515,885, respectively, for a Primary Manufacturer (the “base estimate”).  CMS also provided a low and high estimate that halved and doubled both the time and costs of the base estimate “to illustrate the possible variability for this burden estimate[.]"