Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
340B Program Registrations amp; Certifications for Children's Hospitals Removed 0 0 0 Form 1 340B Registration Children's Hospital -Revised
Form 2 Cert state or local government-Revised
Form 3 Public Ownership-Revised.docx
340B Program Registrations amp; Certifications for Free Standing Cancer Hospitals Removed 0 0 0 Form 1 340B Registration Free Standing Cancer-Revised
340B Program Registrations amp; Certifications for Rural Referral Hospitals Removed 0 0 0 Form 1 340B Registration Rural Referral and Sole Community Hospitals (Orphan Drug)-REVISED
340B Program Registrations amp; Certifications for Sole Community Hospitals Removed 0 0 0 Form 1 340B Registration Rural Referral and Sole Community Hospitals (Orphan Drug)-REVISED
340B Program Registrations and Certifications for Critical Access Hospitals Removed 0 0 0 Form 1 340B Registration-CAH-Revised
340B Program Registrations and Certifications for Hospitals Modified 194 388 0 Form 1 340B Registration DSH-Revised
Form 2 Cert state or local government-Revised.docx
Form 3 Public Ownership-Revised
Form 4 340B Registration Children's Hospital
Form 5 340B Registration Free Standing Cancer
Form 6 340B Registration Rural Referral and Sole Community Hospitals (Orphan Drug) Revised
Form 7 340B Registration-CAH-Revised.docx
340B Registration for all other covered entities Modified 405 405 0 Form and Instruction 1 340BRegistration-Covered Entities All Other-Revised
Administrative Change Form Unchanged 9396 4698 0 Form and Instruction 1 340B Participant Change Request-Revised
Administrative Changes for Any Manufacturer Unchanged 350 175 0 Form 1 340B Manufacturer Change Form-Revised
Annual Recertificaion for STD amp; TB Unchanged 3123 781 0 Form 1 STD-Recertification
Form 2 TB-Recertification
Annual Recertification for Community Health Centers Modified 6020 1505 0 Form 1 Conmmunity Health Center Recert
Annual Recertification for Other Entities Modified 4899 1225 0 Form 2 RW-Recertification-Revised
Certification to Enroll Hospitals' Outpatient facilities to 340B Program Modified 5576 2788 0 Form and Instruction 1 3 340B Registration-Outpatient Facility Revised
Contract Pharmacy Registration Form Modified 8790 8790 0 Form 1 Contract Pharmacy Registration-Revised
Form 2 Contract Pharmacy Termination
Hospital Annual Recertification Unchanged 12804 3201 0 Form 2 Recert-Critical Access; Sole-community; Rural-Referral centers (Orphan Drug)-Revised
Form 1 Public Ownership-Revised.docx
Form 3 Recert-Free standing Cancer Hospital (Orphan Drug)-Revised.pdf
Manufacturer Data Required to Verify 340 B Ceiling Price Calculations Unchanged 2400 1200 0 Form 1 Manufacturer Data Fields for 340B Ceiling Price - FINAL VERSION
Pharmaceutical Pricing Agreement Unchanged 200 200 0 Form and Instruction 1 Manufacturer Pharma Pricing Agreement (PPA)
Pharmaceutical Pricing Agreement Addendum New 620 310 0 Form 1 DRAFT PPA Addendum (FINAL REVISED).docx
Instruction
Registrations for Community Health Centers New 1281 1281 0 Form and Instruction 1 340BRegistration-Covered Entities - Community Health Center.docx
Registrations for STD/TB Clinics New 647 647 0 Form and Instruction 1 340BRegistration-Covered Entities STD-Revised
Form and Instruction 2 340BRegistration-Covered Entities TB-Revised
Total burden requested under this ICR: 56705 27594 0  
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