[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 <a href="/cdn-cgi/l/email-protection#51033832393023357f107f192423222511382322323e243f22343d7f25233430227f363e27"><span class="__cf_email__" data-cfemail="7d2f141e151c0f19533c5335080f0e093d140f0e1e1208130e181153090f181c0e531a120b">[email protected]</span></a>, (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


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