Exclusion of Orphan Drugs for Certain Covered Entities under 340B Program

Docket ID: HRSA-2011-0001
Agency: Health Resources and Services Administration (HRSA)
Parent Agency: Department of Health and Human Services (HHS)
This final rule provides clarity on orphan drug exclusions for covered entities under the 340B Program.
RIN: 0906-AA94
Impacts and Effects: None
CFR Citation: 42 CFR 10
Priority: Other Significant
UA and Regulatory Plan Information open glossary dialog  
Publication Period: Fall 2013
Agenda Stage of Rulemaking: Completed Action
Major Rule: No
Legal Authorities: 340B PHS Act (42 USC 256b), as amended, sec 215 PHS Act (42 USC 216), as amended, sec 526 FFDC Act (21 USC 360bb), sec 701(a) FFDC Act (21 USC 371(a)
Legal Deadlines: None
Government Levels Affected: No
Federalism Implications: No
Unfunded Mandates: No
Requires Regulatory Flexibility Analysis: No
Small Entities Affected: No
International Impacts: No
Energy Effects: No
Included in Regulatory Plan: No
ActionDateFR Citation
NPRM05/20/201176 FR 29183
NPRM Comment Period End07/19/2011
Final Action07/23/201378 FR 44016
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Type: Rulemaking

Primary Documents

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Comment Period Closed
Jul 19, 2011 11:59 PM ET
Proposed Rule
Posted: 05/20/2011
ID: HRSA-2011-0001-0001

Supporting Documents

No documents available.


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Comments Received*
Regulatory Timeline
Pre Rule
Current Stage
Proposed Rule
Current Stage
Final Rule
Current Stage
Current Stage
Agency Contact
Bradford Lang
Public Health Analyst/Health Care System Bureau
301 443-2671
301 594-4982 (Fax)
5600 Fishers Lane, Room 10C-03, Rockville, MD 20857
Rockville, MD 20857
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