Skip to Content

We invite you to try out our new beta eCFR site at We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!


Branded Prescription Drug Fee; Correction

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Internal Revenue Service (IRS), Treasury.


Correcting amendment.


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.


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

Start Further Info


Celia Gabrysh, at (202) 317-6855 (not a toll free number).

End Further Info End Preamble Start Supplemental Information



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.

Start List of Subjects Start Printed Page 57784

List of Subjects in 26 CFR Part 51

  • Drugs
  • Reporting and recordkeeping requirements
End List of Subjects

Correction of Publication

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

Start Part


End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

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:

End Amendment Part
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.

* * * * *
Start Signature

Martin V. Franks,

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

End Signature End Supplemental Information

[FR Doc. 2014-22929 Filed 9-25-14; 8:45 am]