82 FR 1356 - Delegation of Authority Under Title III, Part D, Section 340B(d)(1)(B)(vi) of the Public Health Service Act (PHSA)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 82, Issue 3 (January 5, 2017)

[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Page 1356]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31944]


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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]
 BILLING CODE 4165-15-P