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| HHS/HRSA | RIN: 0906-AA93 | Publication ID: Spring 2011 |
| Title: ●340B Civil Monetary Penalties for Covered Entities | |
| Abstract: The purpose of this rulemaking is to implement an enhancement to the 340B Program. It amends section 340B of the Public Health Service Act to impose sanctions, in appropriate cases as determined by the Secretary, additional to those to which covered entities are subject under subsection (a)(5)(D), through one or more of the following actions: (i) Where a covered entity knowingly and intentionally violates subsection (a)(5)(B), the covered entity shall be required to pay a monetary penalty to a manufacturer or manufacturers in the form of interest on sums for which the covered entity is found liable under subsection (a)(5)(D), (ii) where the Secretary determines a violation of subsection (a)(5)(B) was systematic and egregious as well as knowing and intentional, removing the covered entity from the drug discount program under this section and disqualifying the entity from re-entry into such program for a reasonable period of time to be determined by the Secretary; and (iii) referring matters to appropriate Federal authorities within the Food and Drug Administration, the Office of Inspector General of Department of Health and Human Services, or other Federal agencies for consideration of appropriate action under other Federal statutes, such as the Prescription Drug Marketing Act (21 U.S.C. 353). | |
| Agency: Department of Health and Human Services(HHS) | Priority: Info./Admin./Other |
| RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: Sec 340B PHS Act (42 USC 256b), as amended | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Bradford Lang Public Health Analyst/Health Care System Bureau Department of Health and Human Services Health Resources and Services Administration 5600 Fishers Lane, Room 10C-03, Rockville, MD 20857 Phone:301 443-2671 Fax:301 594-4982 Email: blang@hrsa.gov |
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