Information Collection

Recordkeeping - Radiopharmaceutical Compounding and Repackaging GFI, Biological Products GFI

IC 267943 under ICR 202405-0910-002 · OMB 0910-0858.

Documents and Forms

Document Name Document Type
Compounding-and-Repackaging-of-Radiopharmaceuticals-by-State-Licensed-Nuclear-Pharmacies (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

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Recordkeeping - Radiopharmaceutical Compounding and Repackaging GFI, Biological Products GFI	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			Compounding-and-Repackaging-of-Radiopharmaceuticals-by-State-Licensed-Nuclear-Pharmacies (2024).pdf		Yes	No	Printable Only
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: 15	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	400	400
Annual IC Time Burden (Hours)	25	25
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.