Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice

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⚠️ Notice: This information collection may be referencing outdated material.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
Form FDA-3356 Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice Form
FDA-3356 FDA-3356 FDA-3356.pdf Form
FDA-3356 FDA-3356 FDA-3356.pdf Form

Information Collection (IC) Details

IC Title:	Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 1271.47(d)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	FDA-3356	FDA-3356	FDA-3356.pdf		Yes	Yes	Printable Only
Form	FDA-3356	FDA-3356	FDA-3356.pdf		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,009	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1,009	1,009
Annual IC Time Burden (Hours)	1,009	1,009
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.