List of all ICR documents REVISED

List of all ICR documents REVISED.docx

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

List of all ICR documents REVISED

OMB: 0915-0327

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IC Title

Form Name

  1.  340B Program Registrations & Certifications for Hospitals

340B Registration DSH-Revised

Cert state or local government-Revised

Public OWNERSHIP-Revised

340B Registration Children's Hospital-Revised

Public OWNERSHIP Revised

340B Registration Free Standing Cancer-Revised

340B Registration Rural Referral Centers and Sole Community Hospitals (Orphan Drug)

340B Registration-CAH Revised

  1. Certification to Enroll Hospitals' Outpatient facilities to 340B Program

340B Registration-Outpatient Facility-Revised

  1.  Hospital Annual Recertification

Hospital Recertification-DSH

Recert-Critical Access; Sole-community; Rural-Referral centers (Orphan Drug)

Recert-Free standing Cancer Hospital (Orphan Drug)-Revised

  1.  340B Registration for all other covered entities

340BRegistration-Covered Entities All Other-Revised


  1.  Annual Recertification for Community Health Centers

Community Health Center Recert


  1.  Annual Recertification for STD & TB

STD-Recertification

TB-Recertification

  1.  Annual Recertification for Other Entities

RW-Recert

  1.  Administrative Change Form

340B Participant Change Request Revised

  1.  Contract Pharmacy Registration Form

Contract Pharmacy Registration-Revised

Contract Pharmacy Termination

  1.  Administrative Changes for Any Manufacturer

340B Manufacturer Change Form-Revised

  1.  Pharmaceutical Pricing Agreement

Manu-Pharma Pricing Agreement (PPA)

  1. Manufacturer Data Required to Verify 340B Ceiling Price Calculations

Manufacturer Data Fields for 340B Ceiling Price

  1. Registrations for Community Health Centers

340B Registration-Covered Entities – Community Health Center


  1. Registrations for STD/TB Clinics

340BRegistration-Covered Entities STD-Revised

340BRegistration-Covered Entities TB-Revised

  1. Pharmaceutical Pricing Agreement Addendum

PPA Addendum form


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AuthorLeah Baskin
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File Created2021-01-24

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