💊Overview of 340B Drug Pricing Program Compliance Requirements
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327-Revision
Summary
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agencies
- Health and Human Services Department
- Health Resources and Services Administration
Business Impact
$$$ - High
The regulation requires covered entities in the 340B Drug Pricing Program to ensure compliance with numerous statutory requirements, indicating a significant regulatory burden that could affect their operational costs and financial planning. Additionally, businesses that are drug manufacturers must comply with agreements mandating participation in the program, influencing their pricing strategies and revenue models.