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2015-06-17
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340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
Proposed Rules
D09002ee1c1805ce1
D09002ee1c1805d77
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.'' This proposed rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The proposed rule sets forth the calculation of the ceiling price and application of civil monetary penalties.
80 FR 34583
https://www.govinfo.gov/app/details/FR-2015-06-17/2015-14648
2015-14648
fr17jn15-13
RIN 0906-AA89
4165-15-P
https://www.govinfo.gov/app/details/FR-2015-06-17/2015-14648
https://www.govinfo.gov/content/pkg/FR-2015-06-17/html/2015-14648.htm
https://www.govinfo.gov/content/pkg/FR-2015-06-17/pdf/2015-14648.pdf
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340b Drug Pricing Program
6 p.
34583
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80 FR 34583
Code of Federal Regulations
Title 42 Part 10
42 CFR Part 10
Regulation Identification Number 0906-AA89
RIN 0906-AA89
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Federal Register Vol. 80, Issue
PRORULE
2015-14648
DEPARTMENT OF HEALTH AND HUMAN SERVICES
2015-08-17
4165-15-P
2015-14648
Notice of proposed rulemaking.
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.'' This proposed rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The proposed rule sets forth the calculation of the ceiling price and application of civil monetary penalties.
Submit comments on or before August 17, 2015.
CDR Krista Pedley, Director, OPA, HSB, HRSA, 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857, or by telephone at 301-594-4353.
Biologics
Business and Industry
Diseases
Drugs
Health
Health Care
Health Facilities
Hospitals
340b Drug Pricing Program
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties
,
340BCMPNPRM@hrsa.gov
http://www.HHS.gov/regulations
http://www.regulations.gov
Federal Register
Vol. 80, no. 116
Office of the Federal Register, National Archives and Records Administration
2015-06-17
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307 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-06-17
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr17jn15
https://www.govinfo.gov/app/details/FR-2015-06-17
https://www.govinfo.gov/content/pkg/FR-2015-06-17/pdf/FR-2015-06-17.pdf
https://www.govinfo.gov/content/pkg/FR-2015-06-17/xml/FR-2015-06-17.xml
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FR-2015-06-17
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