82 FR 3 pg. 1356 - Delegation of Authority Under Title III, Part D, Section 340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA)
Type: NOTICEVolume: 82Number: 3Page: 1356
Page: 1356FR document: [FR Doc. 2016-31944 Filed 1-4-17; 8:45 am]
Agency: Health and Human Services Department
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Delegation of Authority Under Title III, Part D, Section 340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA)
Notice is hereby given that I have delegated to the Inspector General, Office of Inspector General, the authority vested in the Secretary of Health and Human Services under Title III, Part D, Section 340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA), as amended, to impose sanctions in the form of civil monetary penalties against manufacturers that knowingly and intentionally charge a 340B covered entity a price for purchase of a drug that exceeds the maximum applicable ceiling price as defined by section 340B(a)(1) of the PHSA. In accordance with section 340B(d)(1)(B)(vi)(II) of the PHSA, such sanctions shall not exceed $5,000 for each instance of overcharging a 340B covered entity that may have occurred. This authority may be redelegated. This delegation excludes the authority to issue regulations.
I have affirmed and ratified any actions taken by the Inspector General, or subordinates, that involved the exercise of the authority delegated herein prior to the effective date of the delegation.
This delegation became effective upon date of signature.
Authority:
42 U.S.C. 256b(d)(1)(B)(vi)
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-31944 Filed 1-4-17; 8:45 am]
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