2011-24911. Branded Prescription Drug Fee; Correction

AGENCY:

Internal Revenue Service (IRS), Treasury.

ACTION:

Correction to temporary regulations.

SUMMARY:

This document contains corrections to temporary regulations that were published in the Federal Register on Thursday, August 18, 2011. The temporary regulations provide guidance on the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. This fee was enacted by section 9008 of the Patient Protection and Affordable Care Act, as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010.

DATES:

This correction is effective on September 28, 2011 and applies to any fee on branded prescription drug sales that is due on or after September 30, 2011.

FOR FURTHER INFORMATION CONTACT:

Celia Gabrysh, [phone] (not a toll free number).

SUPPLEMENTARY INFORMATION:

Background

Need for Correction

As published August 18, 2011 (76 FR 51245), the temporary regulations (TD 9544) contains errors that may prove to be misleading and are in need of clarification.

Correction of Publication

Accordingly, the temporary regulations (TD 9544), that are the subject of FR Doc. 2011-21011, are corrected as follows:

1. On page 51247, column 3, in the preamble, under the paragraph heading “IV. Information Provided by the Agencies”, line 6 of the third full paragraph of the column, the language “with a specific HCPCS Code. CMS” is corrected to read “with a specific Healthcare Common Procedure Coding System (HCPCS) Code. CMS”.

2. On page 51248, column 2, in the preamble, under the paragraph heading “VI. Notice of Preliminary Fee Calculation”, line 5 from the bottom of the column, the language “9008 (a)(2); the aggregate branded” is corrected to read “9008 (b)(2); the aggregate branded”.

3. On page 51248, column 3, under the paragraph heading “VIII. Notification and Payment of Fee”, line 1 of the paragraph, the language “Section 9008(a) provides that the” is corrected to read “Section 9008(a)(2) provides that the”

4. On page 51248, column 3, under the paragraph heading “VIII. Notification and Payment of Fee”, line 4 from the bottom of the column, the language “section 9008(a)(2); the aggregate” is corrected to read “section 9008(b)(2); the aggregate”

5. On page 51255, column 1, in the signature block line 2, the language “Deputy Commissioner for Services and Enforcement.” is corrected to read “Acting Deputy Commissioner for Services and Enforcement.”

LaNita VanDyke,

Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, Procedure and Administration.