Pharmaceutical Pricing Agreement and PPA Addendum

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⚠️ Notice: This information collection may be referencing outdated material.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 6 Pharmaceutical Pricing Agreement and PPA Addendum Form and Instruction
6 Manufacturer PPA and addendum.pdf Manufacturer PPA and addendum..pdf Form and Instruction
Manufacturer PPA and addendum.docx REDLINE Manufacturer PPA and Addendum IC Document

Information Collection (IC) Details

IC Title:	Pharmaceutical Pricing Agreement and PPA Addendum	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
Form and Instruction	6	Manufacturer PPA and addendum.pdf	Manufacturer PPA and addendum..pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 200	Number of Respondents for Small Entity: 70

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	200	-420	620
Annual IC Time Burden (Hours)	200	-110	310
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
REDLINE Manufacturer PPA and Addendum	Manufacturer PPA and addendum.docx	08/12/2019

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