Information Collection

Submission of Administrative Changes for Any Manufacturer

IC 203460 under ICR 202601-0915-001 · OMB 0915-0327.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 5 340B Manufacturer Change Form.pdf Submission of Administrative Changes for Any Manufacturer	Form
5 340B Manufacturer Change Form.pdf 340B Manufacturer Change Form.docx.pdf	Form
340B Manufacturer Change Form Redline.pdf 340B Manufacturer Change Form Redline	IC Document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

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
Form	5				Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 471

Number of Respondents for Small Entity: 161

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	471	121	350
Annual IC Time Burden (Hours)	236	61	175
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
340B Manufacturer Change Form Redline		01/08/2026

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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