Internal Revenue Bulletin: 2011-40 |
October 3, 2011 |
Table of Contents
- Rev. Rul. 2011-21
- T.D. 9544
- AGENCY:
- ACTION:
- SUMMARY:
- DATES:
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- Paperwork Reduction Act
- Background
- Statutory provisions
- IRS guidance
- Explanation of Provisions
- I. Overview
- II. Explanation of terms
- A. Manufacturer or importer
- B. Designated entity
- C. Orphan drug sales
- III. Information requested from covered entities
- IV. Information provided by the Agencies
- V. Fee calculation including adjustment
- VI. Notice of preliminary fee calculation
- VII. Dispute resolution process
- VIII. Notification and payment of fee
- IX. Tax treatment of fee
- X. Refund claims
- Availability of IRS documents
- Special Analyses
- Adoption of Amendments to the Regulations
- Drafting Information
- T.D. 9543
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