New SOPs

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⚠️ Notice: This information collection may be referencing outdated material.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 New SOPs Form and Instruction
3356 Establishment Regirstation and Listing for HCT/Ps FORM FDA 3356.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	New SOPs	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(a) 21 CFR 1271.160(b)(2)&(d)(1) 21 CFR 1271.180(a) 21 CFR 1271.85(b)(2) 21 CFR 1271.190(d)(1) 21 CFR 1271.200(b) 21 CFR 1271.200(c) 21 CFR 1271.230(a)&(c) 21 CFR 1271.250(a) 21 CFR 1271.265(e)&(f) 21 CFR 1271.270(b)&(d) 21 CFR 1271.290(b)(1) 21 CFR 1271.320(a)

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 Regirstation 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: 218	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	218	218
Annual IC Time Burden (Hours)	10,464	10,464
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.