Information Collection

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

IC 6263 under ICR 202609-0910-001 · OMB 0910-0543.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
eHCTERS Screenshots_07 11 2023.docx	Other-eHCTERS Screenshot

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Unchanged

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 1271

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
Other-eHCTERS Screenshot					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 %

table that charts list of burden
	Requested	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	8,387,822	8,387,822
Annual IC Time Burden (Hours)	2,237,107	2,237,107
Annual IC Cost Burden (Dollars)	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.

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