82 FR 12508 - 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 42 (March 6, 2017)

In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled ``340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation,'' published in the January 5, 2017, Federal Register. This document announces that the effective date is delayed until March 21, 2017.

[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Rules and Regulations]
[Pages 12508-12509]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 10

RIN 0906-AA89


340B Drug Pricing Program Ceiling Price and Manufacturer Civil 
Monetary Penalties; Delay of Effective Date

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Final rule; delay of effective date.

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SUMMARY: In accordance with the memorandum of January 20, 2017, from 
the Assistant to the President and Chief of Staff, entitled 
``Regulatory Freeze Pending Review,'' this action temporarily delays 
for 60 days from the date of the memorandum the effective date of the 
final rule titled ``340B Drug Pricing Program Ceiling Price and 
Manufacturer Civil Monetary Penalties Regulation,'' published in the 
January 5, 2017, Federal Register. This document announces that the 
effective date is delayed until March 21, 2017.

DATES: Effective date: This regulation is effective March 3, 2017. The 
effective date of the final rule published in the January 5, 2017, 
Federal Register (82 FR 1210), is delayed until March 21, 2017. 
Compliance date: HHS recognizes that the effective date falls in the 
middle of a quarter. As such, HHS plans to begin enforcing the 
requirements of this final rule at the start of the next quarter, which 
begins April 1, 2017.

FOR FURTHER INFORMATION CONTACT: CAPT Krista Pedley, Director, Office 
of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), HRSA, 5600 
Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 
301-594-4353.

SUPPLEMENTARY INFORMATION: The January 20, 2017 memorandum from the 
Assistant to the President and Chief of Staff, titled ``Regulatory 
Freeze Pending Review,'' published in the Federal

[[Page 12509]]

Register on January 24, 2017 (82 FR 8346) instructed federal agencies 
to delay the effective date of rules published in the Federal Register, 
but which have not yet taken effect, for a period of 60 days from the 
date of the memorandum. The final rule sets forth the calculation of 
the 340B ceiling price and application of civil monetary penalties 
(CMPs). The effective date of that rule, which would have been March 6, 
2017, is now March 21, 2017. The temporary delay in the effective date 
of this final rule is necessary to give Department officials the 
opportunity for further review and consideration of new regulations, 
consistent with the Assistant to the President and Chief of Staff's 
memorandum.

    Dated: February 23, 2017.
James Macrae,
Acting Administrator, Health Resources and Services Administration.
    Approved: March 1, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-04337 Filed 3-2-17; 11:15 am]
BILLING CODE 4160-15-P