Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534

Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0938-0578 can be found here:

Documents and Forms

Document Name Document Type
Form CMS-367a Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 Form
CMS-367 Instructions to Labelers.doc Instruction
CMS-367a DDR Quarterly Pricing Data CMS-367a instrument.doc Form
CMS-367b DDR Monthly Pricing Data CMS-367b instrument.doc Form
CMS-367c DDR Drug Product Data CMS-367c instrument.doc Form
CMS-367d Medicaid Drug Rebate Agreement CMS-367d instrument.doc Form
367Relevant Statute.doc Relevant Statute IC Document
CMS-367 disclosure statement.doc Disclosure Statement IC Document

Information Collection (IC) Details

IC Title:	Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534	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:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	CMS-367a	DDR Quarterly Pricing Data	CMS-367a instrument.doc	Yes	Yes	Fillable Fileable
Form	CMS-367b	DDR Monthly Pricing Data	CMS-367b instrument.doc	Yes	Yes	Fillable Fileable
Form	CMS-367c	DDR Drug Product Data	CMS-367c instrument.doc	Yes	Yes	Fillable Fileable
Form	CMS-367d	Medicaid Drug Rebate Agreement	CMS-367d instrument.doc	Yes	Yes	Fillable Fileable
Instruction			CMS-367 Instructions to Labelers.doc	No	No	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 540	Number of Respondents for Small Entity: 100

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	8,640	6,360	2,280
Annual IC Time Burden (Hours)	106,272	51,492	54,780
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
Relevant Statute	367Relevant Statute.doc
Disclosure Statement	CMS-367 disclosure statement.doc

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