Information Collection

Recordkeeping - Radiopharmaceutical Compounding and Repackaging GFI, Biological Products GFI

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

Documents and Forms

Documents and forms in this information collection
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

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	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 %

table that charts list of burden
	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

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.