Information Collection

Radiopharmaceutical Compounding GFI

IC 232156 under ICR 202405-0910-002 · OMB 0910-0858.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
CDER NEW Compound Radiopharms GFI 2018.pdf	Other-Agency Guidance
21 USC 353a Pharmacy compounding.pdf	Other-Statutory Authority
21 USC 353b Outsourcing Facilities.pdf	Other-Statutory Authority

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance	CDER NEW Compound Radiopharms GFI 2018.pdf	No		Printable Only
Other-Statutory Authority	21 USC 353a Pharmacy compounding.pdf	Yes	Yes	Fillable Fileable
Other-Statutory Authority	21 USC 353b Outsourcing Facilities.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 10

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
	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-250	250
Annual IC Time Burden (Hours)	-13	13
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.