[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Rules and Regulations]
[Pages 57783-57784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22929]


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DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 51

[TD 9684]
RIN 1545-BJ39


Branded Prescription Drug Fee; Correction

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Correcting amendment.

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SUMMARY: This document contains corrections to final regulations (TD 
9684) that were published in the Federal Register on Monday, July 28, 
2014 (79 FR 43631). The final regulations provide guidance on the 
annual fee imposed on covered entities engaged in the business of 
manufacturing branded prescription drugs.

DATES: This correction is effective September 26, 2014 and applicable 
beginning July 28, 2014.

FOR FURTHER INFORMATION CONTACT: Celia Gabrysh, at (202) 317-6855 (not 
a toll free number).

SUPPLEMENTARY INFORMATION: 

Background

    The final regulations (TD 9684) that are the subject of this 
correction is under section 9008 of the Patient Protection and 
Affordable Care Act.

Need for Correction

    As published, the final regulations (TD 9684) contains errors that 
may prove to be misleading and are in need of clarification.

[[Page 57784]]

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

0
Paragraph 1. The authority citation for part 51 continues to read in 
part as follows:

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


0
Par. 2. Section 51.4 is corrected by revising paragraphs (b)(2)(i)(A) 
and (B) (b)(2)(ii) through (iv), and (c)(4)(i)(D) to read as follows:


Sec.  51.4  Information provided by the Agencies.

* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (A) Any direct and indirect remuneration (DIR) (within the meaning 
of paragraph (b)(2)(ii) of this section), which includes any DIR 
reported on the PDE records at the point of sale and any DIR reported 
on a Detailed DIR Report (within the meaning of a paragraph (b)(2)(iii) 
of this section); and
    (B) Any coverage gap discount amount (within the meaning of 
paragraph (b)(2)(iv) of this section).
    (ii) Direct and indirect remuneration. For purposes of paragraph 
(b)(2)(i)(A) of this section, the term direct and indirect remuneration 
(DIR) has the same meaning as found in the definition of actually paid 
in 42 CFR 423.308.
    (iii) Detailed DIR Report. For purposes of paragraph (b)(2)(i)(A) 
of this section, the term Detailed DIR Report means the report 
containing any DIR (within the meaning of paragraph (b)(2)(ii) of this 
section) that is collected yearly from Part D sponsors at the NDC 
level.
    (iv) Coverage gap discount amount. For purposes of paragraph 
(b)(2)(i)(B) of this section, the term coverage gap discount amount 
means a 50-percent manufactured-paid discount on certain drugs under 
the Coverage Gap Discount Program described in section 1860D-14A of the 
Social Security Act.
    (c) * * *
    (4) * * *
    (i) * * *
    (D) Those entities (if any) identified in paragraph (c)(4)(i)(C) of 
this section that are manufacturing branded prescription drugs assigned 
to the HCPCS code.
* * * * *

Martin V. Franks,
Chief, Publications and Regulations Branch, Legal Processing Division, 
Associate Chief Counsel (Procedure and Administration).
[FR Doc. 2014-22929 Filed 9-25-14; 8:45 am]
BILLING CODE 4830-01-P