Branded Prescription Drug Fee; Correction, 57784 [2014-22930]

Download as PDF 57784 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Rules and Regulations List of Subjects in 26 CFR Part 51 Drugs, Reporting and recordkeeping requirements. 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). Correction of Publication Accordingly, 26 CFR part 51 is corrected by making the following correcting amendments: [FR Doc. 2014–22929 Filed 9–25–14; 8:45 am] BILLING CODE 4830–01–P PART 51—BRANDED PRESCRIPTION DRUG FEE DEPARTMENT OF THE TREASURY Paragraph 1. The authority citation for part 51 continues to read in part as follows: ■ Internal Revenue Service 26 CFR Parts 51 and 602 Authority: 26 U.S.C. 7805 * * * [TD 9684] 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: ■ § 51.4 Information provided by the Agencies. asabaliauskas on DSK5VPTVN1PROD with RULES * 17:52 Sep 25, 2014 Jkt 232001 Branded Prescription Drug Fee; Correction Internal Revenue Service (IRS), Treasury. ACTION: Final regulations, temporary regulations, and removal of temporary regulations; correction. AGENCY: * * * * (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 VerDate Sep<11>2014 RIN 1545–BJ39 This document contains corrections to final regulations, temporary regulations, and removal of temporary 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: SUMMARY: Background The final regulations, temporary regulations, and removal of temporary 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, temporary regulations, and removal of temporary regulations (TD 9684) contain errors that may prove to be misleading and are in need of clarification. Correction of Publication Accordingly, the final regulations, temporary regulations, and removal of temporary regulations (TD 9684), that are the subject of FR Doc. 2014–17697, are corrected as follows: PO 00000 Frm 00082 Fmt 4700 Sfmt 4700 1. On page 43634, second column, in the preamble, in the footnotes, the last line of the column, the language ‘‘Hightower v. Commissioner, T.C. Memo 1982–559.’’ is corrected to read ‘‘Hightower v. Commissioner, T.C. Memo. 1982–559.’’. 2. On page 43634, third column, in the preamble, the sixth line of the third full paragraph, the language ‘‘10, CC;PSI:B7, Room 5314, 1111’’ is corrected to read ‘‘10, CC:PSI:B7, Room 5314, 1111’’. 3. On page 43637, second column, in the preamble, the third line of the first full paragraph, the language ‘‘the IFF and CRF be excluded from VA’’ is corrected to read ‘‘the Industrial Funding Fee (IFF) and the Cost Recovery Fee (CRF) be excluded from VA’’ . 4. On page 43637, second column, in the preamble, under the paragraph heading ‘‘Department of Defense’’, the third and fourth lines of the second full paragraph, the language ‘‘the Industrial Funding Fee (IFF) and the Cost Recovery Fee (CRF) be excluded’’ is corrected to read ‘‘IFF and the CRF be excluded’’ . 5. On page 43638, third column, in the preamble, under the paragraph heading ‘‘Availability of IRS Documents’’, the first and second lines, the language ‘‘The IRS notices, the revenue procedure, and the temporary’’ is corrected to read ‘‘The IRS notices and the temporary’’. Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. 2014–22930 Filed 9–25–14; 8:45 am] BILLING CODE 4830–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [TD 9687] RIN 1545–BL08 Awards for Information Relating to Detecting Underpayments of Tax or Violations of the Internal Revenue Laws; Correction Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendments. AGENCY: This document contains corrections to final regulations (TD 9687) that were published in the Federal Register on Tuesday, August 12, 2014 (79 FR 47246). The final SUMMARY: E:\FR\FM\26SER1.SGM 26SER1

Agencies

[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Rules and Regulations]
[Page 57784]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22930]


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DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 51 and 602

[TD 9684]
RIN 1545-BJ39


Branded Prescription Drug Fee; Correction

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Final regulations, temporary regulations, and removal of 
temporary regulations; correction.

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SUMMARY: This document contains corrections to final regulations, 
temporary regulations, and removal of temporary 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, temporary regulations, and removal of 
temporary 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, temporary regulations, and 
removal of temporary regulations (TD 9684) contain errors that may 
prove to be misleading and are in need of clarification.

Correction of Publication

    Accordingly, the final regulations, temporary regulations, and 
removal of temporary regulations (TD 9684), that are the subject of FR 
Doc. 2014-17697, are corrected as follows:
    1. On page 43634, second column, in the preamble, in the footnotes, 
the last line of the column, the language ``Hightower v. Commissioner, 
T.C. Memo 1982-559.'' is corrected to read ``Hightower v. Commissioner, 
T.C. Memo. 1982-559.''.
    2. On page 43634, third column, in the preamble, the sixth line of 
the third full paragraph, the language ``10, CC;PSI:B7, Room 5314, 
1111'' is corrected to read ``10, CC:PSI:B7, Room 5314, 1111''.
    3. On page 43637, second column, in the preamble, the third line of 
the first full paragraph, the language ``the IFF and CRF be excluded 
from VA'' is corrected to read ``the Industrial Funding Fee (IFF) and 
the Cost Recovery Fee (CRF) be excluded from VA'' .
    4. On page 43637, second column, in the preamble, under the 
paragraph heading ``Department of Defense'', the third and fourth lines 
of the second full paragraph, the language ``the Industrial Funding Fee 
(IFF) and the Cost Recovery Fee (CRF) be excluded'' is corrected to 
read ``IFF and the CRF be excluded'' .
    5. On page 43638, third column, in the preamble, under the 
paragraph heading ``Availability of IRS Documents'', the first and 
second lines, the language ``The IRS notices, the revenue procedure, 
and the temporary'' is corrected to read ``The IRS notices and the 
temporary''.

Martin V. Franks,
Chief, Publications and Regulations Branch, Legal Processing Division, 
Associate Chief Counsel (Procedure and Administration).
[FR Doc. 2014-22930 Filed 9-25-14; 8:45 am]
BILLING CODE 4830-01-P