[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Proposed Rules]
[Pages 51310-51311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21012]
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 51
[REG-112805-10]
RIN 1545-BJ39
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 imposed by the Affordable Care Act
(ACA). The 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: Written and electronic comments and requests for a public
hearing must be received by November 16, 2011.
ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG-112805-10), room
5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions may be hand-delivered Monday through
Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-
112805-10), Courier's Desk, Internal Revenue Service, 1111 Constitution
Avenue, NW., Washington, DC, or sent electronically via the Federal
eRulemaking Portal at http://www.regulations.gov (IRS REG-112805-10).
FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulations,
Celia Gabrysh at (202) 622-3130; concerning submissions of comments and
requests for a hearing Richard.A.Hurst@irscounsel.treas.gov, (202) 622-
7180 (not toll free numbers).
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act
The collection of information contained in this notice of proposed
rulemaking has been approved by the Office of Management and Budget in
accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d))
and assigned control number 1545-2209.
Comments on the collection of information should be sent to the
Office of Management and Budget, Attn: Desk Officer for the Department
of the Treasury, Office of Information and Regulatory Affairs,
Washington, DC 20503, with copies to the Internal Revenue Service,
Attn: IRS Reports Clearance Officer, SE:W:CAR:MP:T:T:SP, Washington, DC
20224. Comments on the collection of information should be received by
October 17, 2011. Comments are specifically requested concerning:
Whether the proposed collection of information is necessary for the
proper performance of the functions of the Internal Revenue Service,
including whether the information will have practical utility;
The accuracy of the estimated burden associated with the proposed
collection of information;
How the quality, utility, and clarity of the information to be
collected may be enhanced;
How the burden of complying with the proposed collection of
information may be minimized, including through the application of
automated collection techniques or other forms of information
technology; and
Estimates of capital or start-up costs of operation, maintenance,
and purchase of service to provide information.
The collection of information in this proposed regulation is in
Sec. 51.7. This information is necessary to evaluate whether an error
report regarding a preliminary fee calculation is valid and justifies
an adjustment to the preliminary fee calculation. The likely
respondents are manufacturers and importers of branded prescription
drugs.
Estimated total annual reporting and/or recordkeeping burden: 1800
hours.
Estimated annual burden per respondent/recordkeeper: 40 hours.
Estimated number of respondents and/or recordkeepers: 45.
Estimated frequency of responses: Annually.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless the collection of
information displays a valid control number.
Books or records relating to a collection of information must be
retained as long as their contents may become material in the
administration of any internal revenue law. Generally, tax returns and
tax return information are confidential, as required by 26 U.S.C. 6103.
Background
Temporary regulations in the Rules and Regulations section of this
issue of the Federal Register add a new part, part 51, to subchapter D,
Miscellaneous
[[Page 51311]]
Excise Taxes. Part 51 provides guidance on the annual fee imposed on
covered entities engaged in the business of manufacturing or importing
branded prescription drugs by section 9008 of the ACA. The text of
those regulations also serves as the text of these proposed
regulations. The preamble to the temporary regulations explains the new
part.
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. It is hereby
certified that the collection of information in these regulations will
not have a significant economic impact on a substantial number of small
entities. This certification is based on the fact that these
regulations primarily affect large corporations. Thus, Treasury
Department and the IRS do not expect a substantial number of small
entities to be effected. Therefore, 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 written comments (a signed original
and eight (8) copies) or electronic comments that are submitted timely
to the IRS. Comments are requested on all aspects of the proposed
regulations. In addition, the IRS and the Treasury Department
specifically request comments on the clarity of the proposed
regulations and how they may be made easier to understand. All comments
will be available for public inspection and copying. 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 Department
participated in their development.
List of Subjects in 26 CFR Part 51
Drugs, Reporting and recordkeeping requirements.
Proposed Amendments to the Regulations
Accordingly, and under the authority of 26 U.S.C. 7805 (sec. 9008,
Pub. L. 111-347 (124 Stat. 119)), 26 CFR part 51 is proposed to be
added to read as follows:
PART 51--BRANDED PRESCRIPTION DRUGS
[The text of proposed Sec. Sec. 51.1 through 51.11 is the same as
the text of Sec. Sec. 51.1T through 51.11T published elsewhere in this
issue of the Federal Register.]
[The text of proposed Sec. 51.6302-1 is the same as the text of
paragraphs (a) and (b) of Sec. 51.6302-1T published elsewhere in this
issue of the Federal Register.]
Sarah Hall Ingram,
Deputy Commissioner for Services and Enforcement.
[FR Doc. 2011-21012 Filed 8-15-11; 11:15 am]
BILLING CODE 4830-01-P