Voluntary 340B Repository Data Element Reporting Requirements

[IRA Collection] Medicare Prescription Drug Inflation Rebate Program: Sections 11101 and 11102 of the Inflation Reduction Act (IRA) (CMS-10930)

Documents and Forms

Document Name Document Type
Form CMS-10930 Voluntary 340B Repository Data Element Reporting Requirements Form
340B Repository Data Elements Reporting Instruction_11.18.25 508.docx Instruction
CMS-10930 - PRA Disclosure Statement_clean_11.19.25docx.docx Other-PRA Disclosure Statement
CMS-10930 340B Repository Data Elements Reporting Example Form 340B Repository Data Elements Reporting Example Form_11.18.25 508.xlsx Form
340B Repository Data Elements Reporting Example Form_redlines_11.18.25 508.xlsx Redline: 340B Repository Data Elements Reporting Example Form IC Document
340B Data Elements Reporting Instructions_redline_11.18.25 508.docx Redline: 340B Repository Data Elements Reporting Instructions IC Document
Crosswalk - 340B Repository Data Elements Reporting Example Form_11.18.25 508.docx Crosswalk: 340B Repository Data Elements Reporting Example Form IC Document
Crosswalk - 340B Repository Data Elements Reporting Instructions_11.18.25 508.docx Crosswalk: 340B Repository Data Elements Reporting Instructions IC Document

Information Collection (IC) Details

IC Title:	Voluntary 340B Repository Data Element Reporting Requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	CMS-10930	340B Repository Data Elements Reporting Example Form	340B Repository Data Elements Reporting Example Form_11.18.25 508.xlsx	Yes	Yes	Fillable Fileable
Instruction			340B Repository Data Elements Reporting Instruction_11.18.25 508.docx	Yes	No	Printable Only
Other-PRA Disclosure Statement			CMS-10930 - PRA Disclosure Statement_clean_11.19.25docx.docx	Yes	No	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,600	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Not-for-profit institutions, Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	10,400	10,400
Annual IC Time Burden (Hours)	83,200	83,200
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
Redline: 340B Repository Data Elements Reporting Example Form	340B Repository Data Elements Reporting Example Form_redlines_11.18.25 508.xlsx	11/21/2025
Redline: 340B Repository Data Elements Reporting Instructions	340B Data Elements Reporting Instructions_redline_11.18.25 508.docx	11/21/2025
Crosswalk: 340B Repository Data Elements Reporting Example Form	Crosswalk - 340B Repository Data Elements Reporting Example Form_11.18.25 508.docx	11/21/2025
Crosswalk: 340B Repository Data Elements Reporting Instructions	Crosswalk - 340B Repository Data Elements Reporting Instructions_11.18.25 508.docx	11/21/2025

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