[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Rules and Regulations]
[Page 59897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24903]



Internal Revenue Service

26 CFR Part 51

[TD 9544]
RIN 1545-BK34

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, (202) 622-3130 (not a 
toll-free number).



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:


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:

Sec.  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.

Sec.  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.

Sec.  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 Sec.  51.5T(e);
* * * * *

LaNita VanDyke,
Chief, Publications and Regulations Branch, Legal Processing Division, 
Associate Chief Counsel (Procedure and Administration).
[FR Doc. 2011-24903 Filed 9-27-11; 8:45 am]