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Registrations and Recertifications for Entities other than Hospitals
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
OMB: 0915-0327
IC ID: 190347
OMB.report
HHS/HSA
OMB 0915-0327
ICR 202601-0915-001
IC 190347
( )
Documents and Forms
Document Name
Document Type
Form 2.1
Registrations and Recertifications for Entities other than Hospitals
Form
2.1 340B Registration CHC and FQHCLA.pdf
340B Registration-Community Health Center.docx.pdf
Form
2.2 340B Registration STD and TB.pdf
340B Registration-STD.TB.pdf
Form
2.3 340B Registration-Covered Entities All Other Non-Hospita
340B Registration-Covered Entities All Other.docx.pdf
Form
2.4 340B Recertfication STD and TB.pdf
340B Recertfication-STD.TB.pdf
Form
2.5 340B Recertification CHC and FQHCLA.pdf
340B Recertification-Community Health Center and Look alike.pdf
Form
2.6 340B Recertification Covered Entities All Other Non-Hosp
340B Recertification-Covered Entities All Other.pdf
Form
340B Registration-Community Health Center Redline.pdf
340B Registration-Community Health Center Redline
IC Document
340B Registration-Covered Entities All Other Redline.docx.pdf
340B Registration-Covered Entities All Other Redline.docx
IC Document
340B Registration-STD.TB Redline.pdf
340B Registration-STD.TB Redline
IC Document
340B Recertfication-STD Redline.pdf
340B Recertfication-STD Redline
IC Document
340B Recertification-Community Health Center and Look alike Redline.pdf
340B Recertification-Community Health Center and Look alike Redline
IC Document
340B Recertification-Covered Entities All Other redline.pdf
340B Recertification-Covered Entities All Other redline
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Registrations and Recertifications for Entities other than Hospitals
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
2.1
340B Registration CHC and FQHCLA.pdf
340B Registration-Community Health Center.docx.pdf
Yes
Yes
Fillable Fileable
Form
2.2
340B Registration STD and TB.pdf
340B Registration-STD.TB.pdf
Yes
Yes
Fillable Fileable
Form
2.3
340B Registration-Covered Entities All Other Non-Hospitals.pdf
340B Registration-Covered Entities All Other.docx.pdf
Yes
Yes
Fillable Fileable
Form
2.4
340B Recertfication STD and TB.pdf
340B Recertfication-STD.TB.pdf
Yes
Yes
Fillable Fileable
Form
2.5
340B Recertification CHC and FQHCLA.pdf
340B Recertification-Community Health Center and Look alike.pdf
Yes
Yes
Fillable Fileable
Form
2.6
340B Recertification Covered Entities All Other Non-Hospital..pdf
340B Recertification-Covered Entities All Other.pdf
Yes
Yes
Fillable Fileable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Health Care Services
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
12,527
Number of Respondents for Small Entity:
1,308
Affected Public:
Private Sector
Private Sector:
Not-for-profit institutions
Percentage of Respondents Reporting Electronically:
100 %
Requested
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
24,267
0
5,114
0
0
19,153
Annual IC Time Burden (Hours)
7,372
0
1,302
0
0
6,070
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
340B Registration-Community Health Center Redline
340B Registration-Community Health Center Redline.pdf
01/08/2026
340B Registration-Covered Entities All Other Redline.docx
340B Registration-Covered Entities All Other Redline.docx.pdf
01/08/2026
340B Registration-STD.TB Redline
340B Registration-STD.TB Redline.pdf
01/08/2026
340B Recertfication-STD Redline
340B Recertfication-STD Redline.pdf
01/08/2026
340B Recertification-Community Health Center and Look alike Redline
340B Recertification-Community Health Center and Look alike Redline.pdf
01/08/2026
340B Recertification-Covered Entities All Other redline
340B Recertification-Covered Entities All Other redline.pdf
01/08/2026
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.