Information Collection

Disclosure - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI, Biological Products GFI,

IC 267944 under ICR 202405-0910-002 · OMB 0910-0858.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
CompoundingandRepackagingofRadiopharmaceuticalsbyOF (2024).pdf	Other-Agency Guidance
Repackaging-of-Certain-Human-Drug-Products-by-Pharmacies-and-Outsourcing-Facilities (2024).pdf	Other-Agency Guidance
Mixing--Diluting--or-Repackaging-Biological-Products-Outside-the-Scope-of-an-Approved-Biologics-License-Application (2024).pdf	Other-Agency Guidance

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

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	CompoundingandRepackagingofRadiopharmaceuticalsbyOF (2024).pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	Repackaging-of-Certain-Human-Drug-Products-by-Pharmacies-and-Outsourcing-Facilities (2024).pdf	Yes	Yes	Fillable Fileable
Other-Agency Guidance	Mixing--Diluting--or-Repackaging-Biological-Products-Outside-the-Scope-of-an-Approved-Biologics-License-Application (2024).pdf	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 28

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1,801	1,801
Annual IC Time Burden (Hours)	1,009	1,009
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.