Small Biotech Exception

Negotiation Program Drug Selection for Initial Price Applicability Year 2028 (CMS-10844) - IRA

Documents and Forms

Document Name Document Type
Form CMS-10844 Small Biotech Exception Form and Instruction
CMS-10844 Negotiation Program Drug Selection Information Collectio CMS-10844 Initial Price Applicability Year 2028_ Negotiation Program Drug Selection Information Collection Forms.docx Form and Instruction
CMS-10844 Initial Price Applicability Year 2028_Negotiation Program Drug Selection Information Collection Forms redline of proposed changes.docx Track change - Negotiation Program Drug Selection Information Collection Forms IC Document

Information Collection (IC) Details

IC Title:	Small Biotech Exception	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	CMS-10844	Negotiation Program Drug Selection Information Collection Forms	CMS-10844 Initial Price Applicability Year 2028_ Negotiation Program Drug Selection Information Collection Forms.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 30	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	30	21	9
Annual IC Time Burden (Hours)	292	218	74
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
Track change - Negotiation Program Drug Selection Information Collection Forms	CMS-10844 Initial Price Applicability Year 2028_Negotiation Program Drug Selection Information Collection Forms redline of proposed changes.docx	09/30/2025

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.