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2018-11-02
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340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
Proposed Rules
D09002ee1bdb848e6
D09002ee1bdb84963
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HRSA published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After further consideration of the issue, the Department of Health and Human Services (HHS or Department) proposes to cease any further delay of the rule and change the effective date from July 1, 2019, to January 1, 2019.
83 FR 55135
https://www.govinfo.gov/app/details/FR-2018-11-02/2018-24057
2018-24057
fr02no18-18
RIN 0906-AB19
4165-15-P
https://www.govinfo.gov/app/details/FR-2018-11-02/2018-24057
https://www.govinfo.gov/content/pkg/FR-2018-11-02/html/2018-24057.htm
https://www.govinfo.gov/content/pkg/FR-2018-11-02/pdf/2018-24057.pdf
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3 p.
55135
55137
83 FR 55135
Code of Federal Regulations
Title 42 Part 10
42 CFR Part 10
Regulation Identification Number 0906-AB19
RIN 0906-AB19
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Federal Register Vol. 83, Issue
PRORULE
2018-24057
DEPARTMENT OF HEALTH AND HUMAN SERVICES
2018-11-23
4165-15-P
2018-24057
Notice of proposed rulemaking; effective date change.
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HRSA published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HRSA published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After further consideration of the issue, the Department of Health and Human Services (HHS or Department) proposes to cease any further delay of the rule and change the effective date from July 1, 2019, to January 1, 2019.
Submit comments on or before November 23, 2018
CAPT Krista Pedley, Director, OPA, HSB, HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301-594-4353.
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340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties
,
340BCMPNPRM@hrsa.gov
http://www.regulations.gov
Federal Register
Vol. 83, no. 213
Office of the Federal Register, National Archives and Records Administration
2018-11-02
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2018-11-02
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0042-1219
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https://www.govinfo.gov/app/details/FR-2018-11-02
https://www.govinfo.gov/content/pkg/FR-2018-11-02/pdf/FR-2018-11-02.pdf
https://www.govinfo.gov/content/pkg/FR-2018-11-02/xml/FR-2018-11-02.xml
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