Developing a counteroffer submission per selected drug

Drug Price Negotiation Process under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849) - (IRA)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0938-1452 can be found here:

Documents and Forms

Document Name Document Type
Form CMS-10849 Developing a counteroffer submission per selected drug Form and Instruction
CMS-10849 Counteroffer Form clean_Negotiation Offer Exchange ICR Form and Certification_508 FINAL.pdf Form and Instruction
CMS-10849 Counteroffer Form Final Package_Negotiation Offer Exchange ICR Form and Certification_clean.docx Form and Instruction

Information Collection (IC) Details

IC Title:	Developing a counteroffer submission per selected drug	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

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-10849	Counteroffer Form	Final Package_Negotiation Offer Exchange ICR Form and Certification_clean.docx		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 10	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to New Statute
Annual Number of Responses for this IC	10	10
Annual IC Time Burden (Hours)	2,043	2,043
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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