Branded Prescription Drug Fee; Correction, 57784 [2014-22930]
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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.
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*
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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
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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:
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*
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*
(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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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