Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0543 can be found here:

Documents and Forms

Document Name Document Type
0543 blood and tisse Est Reg Screenshot.pdf Other-Screenshot

Information Collection (IC) Details

IC Title:	Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 1271

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Screenshot			0543 blood and tisse Est Reg Screenshot.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,929	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	8,688,744	1,421,160	7,267,584
Annual IC Time Burden (Hours)	2,373,833	305,369	2,068,464
Annual IC Cost Burden (Dollars)	0	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.