2011-24903. Branded Prescription Drug Fee; Correction

AGENCY:

Internal Revenue Service (IRS), Treasury.

ACTION:

Correcting amendment.

SUMMARY:

This document contains corrections to temporary regulations (TD 9544) 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, 2001 (76 FR 51245), the tempoary regulations (TD 9544) contains errors that may prove to be misleading and are in need of clarification.

List of Subjects in 26 CFR Part 51

• Drugs
• Reporting and recordkeeping requirements

Correction of Publication

Accordingly, 26 CFR part 51 is corrected by making the following correcting amendments:

PART 51—BRANDED PRESCRIPTION DRUG FEE

Paragraph 1. The authority citation for part 51 continues to read in part as follows:

Authority: 26 U.S.C. 7805 * * *

Par. 2. Section 51.2T is amended by revising paragraph (k)(1) to read as follows:

§ 51.2T

Explanation of terms (temporary).

* * * * *

(k) Orphan drugs—(1) In general. Except as provided in paragraph (k)(2) of this section, the term orphan drug means any branded prescription drug for which any person claimed a section 45C credit and that credit was allowed for any taxable year.

* * * * *

Par. 3. Section 51.7T is amended by revising the last sentence of paragraph (c)(2) to read as follows.

§ 51.7T

Dispute resolution process (temporary).

* * * * *

(c) * * *

(2) * * * A form 2848 must be filed with the error report;

* * * * *

Par. 4. Section 51.8T is amended by revising paragraph (a)(2) to read as follows.

§ 51.8T

Notification and payment of fee (temporary).

(a) * * *

(2) After the 2011 fee year, the covered entity's adjustment amount

calculated as described in § 51.5T(e);

* * * * *

LaNita VanDyke,

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