Information Collection

Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not After December 31, 2021)

IC 271324 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⚠️ Notice: This information collection may be referencing outdated material.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

Document Name Document Type
Form CMS-10844 Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not 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

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not After December 31, 2021)	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-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: 2	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 Agency Discretion
Annual Number of Responses for this IC	2	2
Annual IC Time Burden (Hours)	32	32
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.