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Federal forms, ICRs, and supporting documents

Information Collection

1271.10(b)(1) and 1271.21(b) - Are my HCT/P's Regulated Solely Under Section 361 of the PHS Act and the regulations in This Part and if so What Must I Do?

IC 6263 under ICR 201401-0910-008 · OMB 0910-0543.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0543 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3356 1271.10(b)(1) and 1271.21(b) - Are my HCT/P's Regulated Solely Under Section 361 of the PHS Act and the regulations in This Part and if so What Must I Do?	Form and Instruction
3356 Establishment Registration & Listing for HCT/Ps FORM FDA 3356.pdf	Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

1271.10(b)(1) and 1271.21(b) - Are my HCT/P's Regulated Solely Under Section 361 of the PHS Act and the regulations in This Part and if so What Must I Do?

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 1271.21(b) 21 CFR 1271.10(b)(1)

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
Form and Instruction	3356	Establishment Registration & Listing for HCT/Ps	FORM FDA 3356.pdf		No	No	Fillable Fileable Signable

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2,706

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses for this IC	2,706	0	0	-2,023,318	0	2,026,024
Annual IC Time Burden (Hours)	1,353	0	0	-1,905,095	0	1,906,448
Annual IC Cost Burden (Dollars)	0	0	0	0	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.