Administrative Changes for Any Manufacturer

Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0915-0327 can be found here:

Documents and Forms

Document Name Document Type
Form 1 Administrative Changes for Any Manufacturer Form
1 340B Manufacturer Change Form-Revised 340B Manufacturer Change Form-Revised.docx Form

Information Collection (IC) Details

IC Title:	Administrative Changes for Any Manufacturer	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	1	340B Manufacturer Change Form-Revised	340B Manufacturer Change Form-Revised.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 350	Number of Respondents for Small Entity: 120

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	350	350
Annual IC Time Burden (Hours)	175	175
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.