82 FR 34611 - Branded Prescription Drug Fee
DEPARTMENT OF THE TREASURY
Internal Revenue Service Federal Register Volume 82, Issue 142 (July 26, 2017)
Internal Revenue Service
Federal Register Volume 82, Issue 142 (July 26, 2017)
| Page Range | 34611-34612 | |
| FR Document | 2017-15643 |
[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)] [Rules and Regulations] [Pages 34611-34612] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15643] ----------------------------------------------------------------------- DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 51 [TD 9823] RIN 1545-BM26 Branded Prescription Drug Fee AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Final regulations and removal of temporary regulations. ----------------------------------------------------------------------- SUMMARY: This document contains final regulations that define the term controlled group for purposes of the branded prescription drug fee. The final regulations supersede and adopt the text of temporary regulations that define the term controlled group. The final regulations affect persons engaged in the business of manufacturing or importing certain branded prescription drugs. DATES: Effective Date: The final regulations are effective July 24, 2017. Applicability Date: For dates of applicability, see Sec. 51.11(b) of the final regulations. FOR FURTHER INFORMATION CONTACT: Rachel S. Smith at (202) 317-6855 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The branded prescription drug fee was enacted by section 9008 of the Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, 124 Stat. 1029 (2010) (collectively the ACA). Section 9008 did not amend the Internal Revenue Code (Code) but cross-references specific Code sections. On July 28, 2014, temporary regulations (TD 9684) relating to the fee on branded prescription drugs were published in the Federal Register (79 FR 43631) (2014 temporary regulations). A notice of proposed rulemaking (REG-123286-14) cross-referencing the temporary regulations was published in the Federal Register on the same day (79 FR 43699). The 2014 temporary regulations provided a definition of the term controlled group that was broader than the definition of the term controlled group in Sec. 51.2T(e)(3) of the temporary regulations (TD 9544) published in the Federal Register (76 FR 51245) on August 18, 2011 (2011 temporary regulations). Neither the Department of the Treasury (Treasury Department) nor the Internal Revenue Service (IRS) received any written comments with respect to the notice of proposed rulemaking and no public hearing was requested or held. The final regulations adopt the proposed regulations without change and the 2014 temporary regulations are removed. Explanation of Provisions The 2011 temporary regulations defined the term controlled group to mean a group of at least two covered entities that are treated as a single employer under section 52(a), 52(b), 414(m), or 414(o) of the Code. The 2014 temporary regulations defined the term controlled group more broadly to mean a group of two or more persons, including at least one person that is a covered entity, that is treated as a single employer under section 52(a), 52(b), 414(m), or 414(o) of the Code. These final regulations adopt the definition of controlled group contained in the 2014 temporary regulations without change. The broader definition of the term controlled group in the 2014 temporary regulations and these final regulations is supported by the statutory language and is consistent with the way in which controlled group rules based on similar statutory language are applied, including how the term controlled group is defined in Sec. 57.2(c)(1) for purposes of the health insurance providers fee under section 9010 of the ACA. Consistent with the preamble to the 2014 temporary regulations, the Treasury Department and the IRS continue to expect that the broader definition of the term controlled group in the final regulations will primarily affect the scope of joint and several liability for the fee and will not otherwise affect the administration of the fee. The 2014 temporary regulations applied beginning on January 1, 2015 (i.e., starting with 2015 sales years), and are effective until July 24, 2017. These final regulations apply on and after July 24, 2017. Because both the 2014 temporary regulations and these final regulations provide the same definition of controlled group for purposes of section 9008 of the ACA, that definition applies continuously beginning with the 2015 sales year and 2017 fee year. Special Analyses Certain IRS regulations, including these, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. Because the final regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking that preceded the final regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. No comments were received on the proposed regulations. Drafting Information The principal author of these final regulations is Rachel S. Smith, Office of the Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and the Treasury Department participated in their development. List of Subjects in 26 CFR Part 51 Drugs, Reporting and recordkeeping requirements. Adoption of Amendments to the Regulations Accordingly, 26 CFR part 51 is amended as follows: PART 51--BRANDED PRESCRIPTION DRUG FEE 0 Paragraph 1. The authority citation for part 51 is revised to read as follows: Authority: 26 U.S.C. 7805; sec. 9008, Pub. L. 111-148, 124 Stat. 119. Section 51.8 also issued under 26 U.S.C. 6302(a). [[Page 34612]] Section 51.6302-1 also issued under 26 U.S.C. 6302(a). 0 Par. 2. Section 51.2 is amended by revising paragraph (e)(3) to read as follows: Sec. 51.2 Explanation of terms. * * * * * (e) * * * (3) Controlled group. The term controlled group means a group of two or more persons, including at least one person that is a covered entity, that is treated as a single employer under section 52(a), 52(b), 414(m), or 414(o). * * * * * Sec. 51.2T [Removed] 0 Par. 3. Section 51.2T is removed. 0 Par. 4. Section 51.11 is amended by revising the section heading and paragraph (b) and removing paragraph (c) to read as follows: Sec. 51.11 Applicability date. * * * * * (b) Section 51.2(e)(3) applies on and after July 24, 2017. Sec. 51.11T [Removed] 0 Par. 5. Section 51.11T is removed. Kirsten Wielobob, Deputy Commissioner for Services and Enforcement. Approved: July 17, 2017. Tom West, Tax Legislative Counsel. [FR Doc. 2017-15643 Filed 7-24-17; 4:15 pm] BILLING CODE 4830-01-P
![Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Rules and Regulations 34611
the amount of the specified premiums Patient Protection and Affordable Care Treasury Department and the IRS
minus the advance credit payments Act, Public Law 111–148, 124 Stat. 119 continue to expect that the broader
attributable to the specified premiums. (2010), as amended by section 1404 of definition of the term controlled group
(b) Additional guidance. The the Health Care and Education in the final regulations will primarily
Secretary may provide by publication in Reconciliation Act of 2010, Public Law affect the scope of joint and several
the Federal Register or in the Internal 111–152, 124 Stat. 1029 (2010) liability for the fee and will not
Revenue Bulletin (see § 601.601(d)(2) of (collectively the ACA). Section 9008 did otherwise affect the administration of
this chapter) additional guidance on not amend the Internal Revenue Code the fee.
coordinating the deduction allowed (Code) but cross-references specific The 2014 temporary regulations
under section 162(l) and the credit Code sections. applied beginning on January 1, 2015
provided under section 36B. On July 28, 2014, temporary (i.e., starting with 2015 sales years), and
(c) Applicability date. This section regulations (TD 9684) relating to the fee are effective until July 24, 2017. These
applies for taxable years beginning after on branded prescription drugs were final regulations apply on and after July
December 31, 2013. published in the Federal Register (79 24, 2017. Because both the 2014
FR 43631) (2014 temporary regulations). temporary regulations and these final
§ 1.162(l)–1T [Removed] A notice of proposed rulemaking (REG– regulations provide the same definition
■ Par. 11. Section 1.162(l)–1T is 123286–14) cross-referencing the of controlled group for purposes of
removed. temporary regulations was published in section 9008 of the ACA, that definition
the Federal Register on the same day applies continuously beginning with the
Kirsten B. Wielobob, (79 FR 43699). The 2014 temporary 2015 sales year and 2017 fee year.
Deputy Commissioner for Services and regulations provided a definition of the
Enforcement. term controlled group that was broader Special Analyses
Approved: July 14, 2017. than the definition of the term Certain IRS regulations, including
Thomas West, controlled group in § 51.2T(e)(3) of the these, are exempt from the requirements
Tax Legislative Counsel. temporary regulations (TD 9544) of Executive Order 12866, as
[FR Doc. 2017–15642 Filed 7–24–17; 4:15 pm] published in the Federal Register (76 supplemented and reaffirmed by
BILLING CODE 4830–01–P FR 51245) on August 18, 2011 (2011 Executive Order 13563. Therefore, a
temporary regulations). regulatory impact assessment is not
Neither the Department of the required. Because the final regulations
DEPARTMENT OF THE TREASURY Treasury (Treasury Department) nor the do not impose a collection of
Internal Revenue Service (IRS) received information on small entities, the
Internal Revenue Service any written comments with respect to Regulatory Flexibility Act (5 U.S.C.
the notice of proposed rulemaking and chapter 6) does not apply. Pursuant to
26 CFR Part 51 no public hearing was requested or section 7805(f) of the Code, the notice
held. The final regulations adopt the of proposed rulemaking that preceded
[TD 9823]
proposed regulations without change the final regulations was submitted to
RIN 1545–BM26 and the 2014 temporary regulations are the Chief Counsel for Advocacy of the
removed. Small Business Administration for
Branded Prescription Drug Fee
Explanation of Provisions comment on its impact on small
AGENCY: Internal Revenue Service (IRS), The 2011 temporary regulations business. No comments were received
Treasury. defined the term controlled group to on the proposed regulations.
ACTION: Final regulations and removal of mean a group of at least two covered Drafting Information
temporary regulations. entities that are treated as a single
The principal author of these final
employer under section 52(a), 52(b),
SUMMARY: This document contains final regulations is Rachel S. Smith, Office of
414(m), or 414(o) of the Code. The 2014
regulations that define the term the Associate Chief Counsel
temporary regulations defined the term
controlled group for purposes of the (Passthroughs and Special Industries).
controlled group more broadly to mean
branded prescription drug fee. The final However, other personnel from the IRS
a group of two or more persons,
regulations supersede and adopt the text and the Treasury Department
including at least one person that is a
of temporary regulations that define the participated in their development.
covered entity, that is treated as a single
term controlled group. The final
employer under section 52(a), 52(b), List of Subjects in 26 CFR Part 51
regulations affect persons engaged in the
414(m), or 414(o) of the Code. These Drugs, Reporting and recordkeeping
business of manufacturing or importing
final regulations adopt the definition of requirements.
certain branded prescription drugs.
controlled group contained in the 2014
DATES: temporary regulations without change. Adoption of Amendments to the
Effective Date: The final regulations The broader definition of the term Regulations
are effective July 24, 2017. controlled group in the 2014 temporary
Applicability Date: For dates of Accordingly, 26 CFR part 51 is
regulations and these final regulations is amended as follows:
applicability, see § 51.11(b) of the final supported by the statutory language and
regulations. is consistent with the way in which PART 51—BRANDED PRESCRIPTION
FOR FURTHER INFORMATION CONTACT: controlled group rules based on similar DRUG FEE
pmangrum on DSKBC4BHB2PROD with RULES
Rachel S. Smith at (202) 317–6855 (not statutory language are applied,
a toll-free number). including how the term controlled ■ Paragraph 1. The authority citation
SUPPLEMENTARY INFORMATION: group is defined in § 57.2(c)(1) for for part 51 is revised to read as follows:
purposes of the health insurance Authority: 26 U.S.C. 7805; sec. 9008, Pub.
Background providers fee under section 9010 of the L. 111–148, 124 Stat. 119.
The branded prescription drug fee ACA. Consistent with the preamble to Section 51.8 also issued under 26 U.S.C.
was enacted by section 9008 of the the 2014 temporary regulations, the 6302(a).
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![34612 Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Rules and Regulations
Section 51.6302–1 also issued under 26 persons and vessels from being in the 600-feet of the existing bridge for a
U.S.C. 6302(a). safety zones unless authorized by the three-hour duration during these
■ Par. 2. Section 51.2 is amended by Captain of the Port New York or a operations. NYSDOT stated FDNY was
revising paragraph (e)(3) to read as designated representative. working with the explosives demolition
follows: DATES: This rule is effective without subcontractor and would provide a final
actual notice from July 26, 2017 through exclusion zone limit during these
§ 51.2 Explanation of terms. operations in early May 2017.
December 31, 2017. For the purposes of
* * * * * enforcement, actual notice will be used On May 15, 2017 the contractor
(e) * * * from July 22, 2017 through July 26, notified the Coast Guard that the
(3) Controlled group. The term 2017. distance requested for the exclusion
controlled group means a group of two zone is 1,200 from the existing bridge
or more persons, including at least one ADDRESSES: To view documents during the explosives demolition.
person that is a covered entity, that is mentioned in this preamble as being However, the subcontractor stated this
treated as a single employer under available in the docket, go to http:// is a preliminary distance for discussion
section 52(a), 52(b), 414(m), or 414(o). www.regulations.gov, type USCG–2017– purposes only. The final distance would
0486 in the ‘‘SEARCH’’ box and click not be provided until the contract is
* * * * *
‘‘SEARCH.’’ Click on Open Docket awarded and the subcontractor meets
§ 51.2T [Removed] Folder on the line associated with this with NYSDOT, the general contractor,
rule. security forces, and other stakeholders.
■ Par. 3. Section 51.2T is removed.
FOR FURTHER INFORMATION CONTACT: If Due to this expanded distance and late
■ Par. 4. Section 51.11 is amended by
you have questions on this rule, call or notification the Coast Guard was unable
revising the section heading and email Mr. Jeff Yunker, Sector New York to include this request within the
paragraph (b) and removing paragraph Waterways Management Division; existing bridge demolition rulemaking
(c) to read as follows: telephone 718–354–4195, email (Docket Number USCG–2016–1048) for
§ 51.11 Applicability date. jeff.m.yunker@uscg.mil. this bridge replacement project. The
* * * * * SUPPLEMENTARY INFORMATION: safety zone distance is to ensure that
(b) Section 51.2(e)(3) applies on and persons are not exposed to air
I. Table of Abbreviations overpressure (noise) levels above the
after July 24, 2017.
CFR Code of Federal Regulations
140 decibel impact guidelines under
§ 51.11T [Removed] COTP Captain of the Port New York OSHA regulations codified at 29 CFR
■ Par. 5. Section 51.11T is removed. DHS Department of Homeland Security 1910.95 Table G–16—PERMISSIBLE
FDNY New York City Fire Department NOISE EXPOSURES, Footnote 1. The
Kirsten Wielobob, FR Federal Register Coast Guard proposes to make this rule
Deputy Commissioner for Services and NPRM Notice of proposed rulemaking enforceable through December 31, 2017,
Enforcement. NYSDOT New York State Department of and to a greater distance (2,000 feet)
Approved: July 17, 2017. Transportation than currently requested (1,200 feet), as
OSHA Occupational Safety and Health a contingency for any unforeseen delays
Tom West,
Administration or revisions to the bridge approach
Tax Legislative Counsel. § Section
[FR Doc. 2017–15643 Filed 7–24–17; 4:15 pm] U.S.C. United States Code
spans demolition schedule or safety
requirements based upon the final
BILLING CODE 4830–01–P
II. Background Information and FDNY safety requirements.
Regulatory History The Coast Guard is making this
temporary rule effective less than 30
DEPARTMENT OF HOMELAND The Coast Guard issued a Bridge days after publication in the Federal
SECURITY Permit dated August 21, 2013 approving Register pursuant to authority under
the location and construction of the section 4(a) of the Administrative
Coast Guard Kosciuszko Bridge across Newtown Procedure Act (APA) (5 U.S.C. 553(d)).
Creek, mile 2.1, between the Boroughs This provision authorizes an agency to
33 CFR Part 165 of Queens and Brooklyn, NY. On April make a rule effective less than 30 days
[Docket Number USCG–2017–0486] 25, 2017, NYSDOT notified the Coast after publication for good cause. We are
Guard that the contractor requires a issuing this rule, and under 5 U.S.C.
RIN 1625–AA00 short term closure of Newtown Creek for 553(d)(3), the Coast Guard finds that
the energetic felling of the existing good cause exists for making it effective
Safety Zone; Kosciuszko Bridge
Kosciuszko Bridge approach spans over less than 30 days after publication in the
Approach Spans Demolition, Newtown
land using shaped charges. The shaped Federal Register because waiting 30
Creek, Brooklyn and Queens, NY
charges make multiple precise cuts in days would be impracticable and
AGENCY: Coast Guard, DHS. the steel bridge spans at the same contrary to the public interest. It is
ACTION: Temporary final rule. instant. This allows the approach spans impracticable and contrary to the public
to fall directly to the ground below. interest to provide a full 30-days notice
SUMMARY: The Coast Guard is There will be no debris field outside of because this rule must be effective on
establishing a temporary safety zone on the limits of the bridge. The tentative, July 22 or 23, 2017 to limit delays to
the navigable waters of Newtown Creek, primary demolition dates are the early NYSDOT and contractor schedules as
pmangrum on DSKBC4BHB2PROD with RULES
NY within 2,000 feet of the existing morning hours of July 22 or 23, 2017. part of this $555 million dollar
Kosciuszko Bridge at mile 2.1. This The tentative back-up dates for these infrastructure improvement project.
action is necessary to provide for the operations are the early morning hours FDNY requires the contractor to conduct
safety of life on these navigable waters of July 29 or 30, August 5 or 6, and the explosives demolition in the early
during the explosives demolition of the August 12 or 13, 2017. To ensure public morning hours on a weekend to reduce
approach spans on each adjacent safety the contractor requested the the impact to vehicle traffic on the
shoreline. This rulemaking prohibits USCG establish a safety zone within bridge. This time frame is also expected
VerDate Sep<11>2014 13:33 Jul 25, 2017 Jkt 241001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\26JYR1.SGM 26JYR1](https://thefederalregister.org/doc/82_FR_34753/page/2.svg)
Document Created: 2017-07-26 01:30:13
Document Modified: 2017-07-26 01:30:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final regulations and removal of temporary regulations. | |
| Dates | Effective Date: The final regulations are effective July 24, 2017. | |
| Contact | Rachel S. Smith at (202) 317-6855 (not a toll-free number). | |
| FR Citation | 82 FR 34611 | |
| RIN Number | 1545-BM26 | |
| CFR Associated | Drugs and Reporting and Recordkeeping Requirements |
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