Information Collection

Small Biotech Exception with CGDP Agreement (Submitting Manufacture Not Acquired After December 31, 2021)

IC 259843 under ICR 202410-0938-001 · OMB 0938-1443.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0938-1443 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form CMS-10844 Small Biotech Exception with CGDP Agreement (Submitting Manufacture Not Acquired After December 31, 2021)	Form and Instruction
CMS-10844 Small Biotech Exception and Biosimilar Delay Information CMS-10844 IPAY 2027 SBE Biosim Delay 30-day ICR Forms.docx	Form and Instruction
CMS-10844 Small Biotech Exception and Biosimilar Delay Information CMS-10844 IPAY 2027 SBE Biosim Delay 30-day ICR Forms.docx	Form and Instruction

IC Title:

Small Biotech Exception with CGDP Agreement (Submitting Manufacture Not Acquired After December 31, 2021)

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:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	CMS-10844	Small Biotech Exception and Biosimilar Delay Information Collection Request	CMS-10844 IPAY 2027 SBE Biosim Delay 30-day ICR 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: 9

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	9	0	9
Annual IC Time Burden (Hours)	74	18	56
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.