1271.10(b)(2), 1271.21(c)(ii) and 1271.25(c) - Are my HCT/Ps regulated solely under Section 361 of the PHS Act?/When do I register?/What info. is required for registration?

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⚠️ Notice: This information collection may be referencing outdated material.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 3356 1271.10(b)(2), 1271.21(c)(ii) and 1271.25(c) - Are my HCT/Ps regulated solely under Section 361 of the PHS Act?/When do I register?/What info. is required for registration? Form and Instruction
3356 Establishment Registration and Listing for HCT/Ps FORM FDA 3356.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	1271.10(b)(2), 1271.21(c)(ii) and 1271.25(c) - Are my HCT/Ps regulated solely under Section 361 of the PHS Act?/When do I register?/What info. is required for registration?	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 1271.10(b)(2) 21 CFR 1271.21(c)(ii) 21 CFR 1271.25(c)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3356	Establishment Registration and Listing for HCT/Ps	FORM FDA 3356.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 3,737	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-3,737	3,737
Annual IC Time Burden (Hours)	-1,869	1,869
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.