Information Collection

Voluntary 340B Repository Data Element Reporting Requirements

IC 276684 under ICR 202608-0938-007 · OMB 0938-1485.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
340B Repository Data Elements Reporting Instructions_clean_508.pdf	Instruction
340B Repository Data Elements Reporting Instructions_redline.pdf REDLINE: 340B Repository Data Elements Reporting Instructions	IC Document
60-day 340B Repository ICR Crosswalk_clean_508.pdf CROSSWALK: 340B Repository Data Elements Reporting Instructions	IC Document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

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
Instruction					Yes	No	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 14,000

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

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

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Program Change Due to New Statute	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	70,000	45,600	14,000	10,400
Annual IC Time Burden (Hours)	462,000	364,800	14,000	83,200
Annual IC Cost Burden (Dollars)	0	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
REDLINE: 340B Repository Data Elements Reporting Instructions		08/10/2026
CROSSWALK: 340B Repository Data Elements Reporting Instructions		08/10/2026

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

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