[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Proposed Rules]
[Pages 43699-43700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17698]


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DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 51

[REG-123286-14]
RIN 1545-BM26


Branded Prescription Drug Fee

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Notice of proposed rulemaking by cross-reference to temporary 
regulations.

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SUMMARY: In the Rules and Regulations section of this issue of the 
Federal Register, the IRS is issuing temporary regulations relating to 
the branded prescription drug fee. This fee was enacted by section 9008 
of the Patient Protection and Affordable Care Act, as amended by 
section 1404 of the Health Care and Education Reconciliation Act of 
2010, and the Health Care and Reconciliation Act of 2010 (collectively 
the ACA). The proposed regulations modify the definition of controlled 
group for purposes of the branded prescription drug fee. The proposed 
regulations affect persons engaged in the business of manufacturing or 
importing certain branded prescription drugs. The text of the temporary 
regulations also serves as the text of the proposed regulations.

DATES: Comments and requests for a public hearing must be received by 
October 27, 2014.

ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG-123286-14), Room 
5205, Internal Revenue Service, PO Box 7604, Ben Franklin Station, 
Washington, DC 20044. Submissions may be hand-delivered to: 
CC:PA:LPD:PR Monday through Friday between the hours of 8 a.m. and 4 
p.m. to: CC:PA:LPD:PR (REG-123286-14), Courier's Desk, Internal Revenue 
Service, 1111 Constitution Avenue NW., Washington, DC, or sent 
electronically via the Federal eRulemaking Portal at 
www.regulations.gov (IRS REG-123286-14).

FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulations, 
Celia Gabrysh, (202) 317-6855; concerning submissions of comments and 
request for a hearing, Oluwafunmilayo Taylor, (202) 317-6901 (not toll-
free calls).

SUPPLEMENTARY INFORMATION: 

Background

    Temporary regulations in the Rules and Regulations section of this 
issue of the Federal Register amend Sec. Sec.  51.2(e)(3) and 51.11(c) 
of the Branded Prescription Drug Fee Regulations, 26 CFR Part 51. The 
text of those regulations also serves as the text of these proposed 
regulations. The preamble to the temporary regulations explains the 
amendment.

Special Analyses

    It has been determined that this notice of proposed rulemaking is 
not a significant regulatory action as defined in Executive Order 
12866, as supplemented by Executive Order 13563. Therefore, a 
regulatory flexibility assessment is not required. It also has been 
determined that section 553(b) of the Administrative Procedure Act (5 
U.S.C. chapter 5) does not apply to these regulations. Because these 
regulations do not impose a collection of information on small 
entities, a Regulatory Flexibility Analysis under the Regulatory 
Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to 
section 7805(f) of the Internal Revenue Code, this notice of proposed 
rulemaking has been submitted to the Chief Counsel for Advocacy of the 
Small Business Administration for comment on its impact on small 
business.

Comments and Requests for a Public Hearing

    Before these proposed regulations are adopted as final regulations, 
consideration will be given to any comments that are submitted timely 
to the IRS as prescribed in this preamble under the ``Addresses'' 
heading. Comments are requested on all aspects of the proposed 
regulations. All comments will be available at www.regulations.gov or 
upon request. A public hearing may be scheduled if requested in writing 
by any person that timely submits written comments. If a public hearing 
is scheduled, notice of the date, time, and place for the hearing will 
be published in the Federal Register.

Drafting Information

    The principal author of these regulations is Celia Gabrysh, Office 
of Associate Chief Counsel (Passthroughs and Special Industries). 
However, other personnel from the IRS and the Treasury

[[Page 43700]]

Department participated in their development.

List of Subjects in 26 CFR Part 51

    Drugs, Reporting and recordkeeping requirements.

Proposed Amendments to the Regulations

    Accordingly, 26 CFR part 51 is proposed to be amended as follows:

PART 51--BRANDED PRESCRIPTION DRUGS

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

    Authority: Authority: 26 U.S.C. 7805; sec. 9008, Public Law 111-
347 (124 Stat. 119).
* * * * *
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) [The text of proposed Sec.  51.2(e)(3) is the same as the text 
of Sec.  51.2T(e)(3) published elsewhere in this issue of the Federal 
Register.]
0
Par. 3. Section 51.11 is amended by revising paragraph (c) to read as 
follows:


Sec.  51.11  Effective/applicability date.

* * * * *
    (c) [The text of proposed Sec.  51.11(c) is the same as the text of 
Sec.  51.11T(c) published elsewhere in this issue of the Federal 
Register.]

John Dalrymple,
Deputy Commissioner for Services and Enforcement.
[FR Doc. 2014-17698 Filed 7-24-14; 4:15 pm]
BILLING CODE 4830-01-P