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

Human Cells, Tissues, and Cellular and Tissue-Based Products

Documents and Forms

Document Name Document Type
eHCTERS Screenshots_07 11 2023.docx Other-eHCTERS Screenshot
eHCTERS Screenshots_07 11 2023.docx Other-eHCTERS 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-eHCTERS Screenshot			eHCTERS Screenshots_07 11 2023.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,531	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	8,387,822	-300,922	8,688,744
Annual IC Time Burden (Hours)	2,237,107	-136,726	2,373,833
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.