DDR Product Data Specifications (CMS-367c)

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⚠️ Notice: This information collection may be referencing outdated material.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
CMS-367_Instructions_to_Labelers_August 2019_Final.pdf Instruction
CMS-367c Product Data 367c_August 2019_Final.pdf Form
367c_August 2019_Track Changes.docx CMS-367c - Track Changes IC Document
Form Record Specification Crosswalk 367c_August 2019.xlsx CMS-367c - Crosswalk IC Document
CMS-367_Instructions_to_Labelers_August 2019_Track Changes.docx Instructions - Track Changes IC Document
Form Record Specification Crosswalk of Instructions Document December 2019.xlsx Instructions - Crosswalk IC Document

Information Collection (IC) Details

IC Title:	DDR Product Data Specifications (CMS-367c)	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	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			CMS-367_Instructions_to_Labelers_August 2019_Final.pdf		Yes	Yes	Fillable Fileable
Form	CMS-367c	Product Data	367c_August 2019_Final.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 743	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	743	133	610
Annual IC Time Burden (Hours)	32,321	-314	32,635
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
CMS-367c - Track Changes	367c_August 2019_Track Changes.docx	12/12/2019
CMS-367c - Crosswalk	Form Record Specification Crosswalk 367c_August 2019.xlsx	12/12/2019
Instructions - Track Changes	CMS-367_Instructions_to_Labelers_August 2019_Track Changes.docx	12/12/2019
Instructions - Crosswalk	Form Record Specification Crosswalk of Instructions Document December 2019.xlsx	12/12/2019

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