Source: http://www.law.cornell.edu/cfr/text/26/51.5T
Timestamp: 2014-12-20 01:17:42
Document Index: 609405522

Matched Legal Cases: ['art 51', '§ 51', 'art 51', 'arts 51', '§ 51', 'arts 51', '§ 6302', '§ 7805', 'art 51', 'art 51']

26 CFR 51.5T - Fee calculation (temporary). | LII / Legal Information Institute
CFR › Title 26 › Chapter I › Subchapter D › Part 51 › Section 51.5T 26 CFR 51.5T - Fee calculation (temporary).
There are 3 Updates appearing in the Federal Register for 26 CFR 51. View below or at eCFR (GPOAccess)
§ 51.5T
Fee calculation (temporary).
Fee components—
For every fee year, the IRS will calculate a covered entity's total fee as described in this section. For each fee year after 2011, the IRS will determine a covered entity's total fee by applying, if applicable, the adjustment amount described in paragraph (e) of this section to the entity's allocated fee described in paragraph (d) of this section.
Calculation of branded prescription drug sales.
Each covered entity's allocated fee for any fee year is equal to an amount that bears the same ratio to the applicable amount as the covered entity's branded prescription drug sales taken into account during the sales year bears to the aggregate branded prescription drug sales of all covered entities taken into account during the sales year.
Applicable amount.
The applicable amounts for fee years are—
Sales taken into account.
A covered entity's branded prescription drug sales taken into account during any calendar year are as follows:
Covered entity's branded prescription drug sales during the calendar year that are:
Percentage of branded prescription drug sales taken into account is
Not more than $5,000,000
Determination of branded prescription drug sales.
The IRS will compile each covered entity's branded prescription drug sales for each Program by NDC. Each NDC will be attributed to the covered entity that owns the NDC as of the end of the day on December 31st of the sales year. For a covered entity that is a controlled group, this includes all NDCs that a member of the covered entity owns as of the end of the day on December 31st of the sales year. For this purpose, the IRS may revise the list of NDCs as a result of information received in the dispute resolution process, and the data the IRS uses to produce the final fee calculation will include any revisions provided by the Agencies at the completion of the dispute resolution process. Each covered entity's branded prescription drug sales will be reduced by its Medicare Part D rebates and Medicaid state supplemental rebate amounts in the following manner. If CMS has the rebate information for these Programs for a sales year, CMS will report to the IRS branded prescription drug sales net of rebates. If CMS does not have the rebate information for these programs for a sales year, the IRS will reduce the branded prescription drug sales reported for these Programs by rebates reported by the covered entities on Forms 8947.
Determination of sales taken into account.
For each sales year and for each covered entity, the IRS will calculate sales taken into account. The resulting number is the numerator of the ratio described in paragraph (d)(1) of this section.
For each sales year, the IRS will calculate the aggregate branded prescription drug sales taken into account for all covered entities. The resulting number is the denominator of the ratio described in paragraph (d)(2) of this section.
Allocated fee calculation.
For each covered entity for each fee year, the IRS will calculate the entity's allocated fee by multiplying the applicable amount from paragraph (a)(2) of this section by a fraction—
The numerator of which is the covered entity's branded prescription drug sales taken into account during the sales year (described in paragraph (c)(1) of this section); and
The denominator of which is the aggregate branded prescription drug sales taken into account for all covered entities during the same year (described in paragraph (c)(2) of this section).
Adjustment amount.
For each fee year after 2011, in addition to the allocated fee computed under paragraph (d) of this section, the IRS will also calculate an adjustment amount that reflects the difference between the allocated fee determined for the covered entity in the immediately preceding fee year, using data from the second calendar year preceding that fee year, and what the allocated fee would have been for that entity for the immediately preceding fee year using data from the calendar year immediately preceding that fee year. For example, for 2012, the adjustment amount for a covered entity will be the difference between the entity's 2011 allocated fee, using 2009 data, and what the 2011 allocated fee would have been using 2010 data. Although the adjustment reflects a revision of the prior year's fee based on data from the year immediately preceding the prior fee year, the adjustment is only taken into account by adding it to or subtracting it from the allocated fee computed under paragraph (d) of this section for the current fee year to arrive at the total fee for the current fee year.
Title 26 published on 2013-04-01The following are only the Rules published in the Federal Register after the published date of Title 26.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2014-09-26; vol. 79 # 187 - Friday, September 26, 201479 FR 57783 - Branded Prescription Drug Fee; Correction
typeregulations.gov FR Doc.2014-22929 RIN1545-BJ39 TD9684 DEPARTMENT OF THE TREASURY, Internal Revenue Service Correcting amendment. This correction is effective September 26, 2014 and applicable beginning July 28, 2014. 26 CFR Part 51 SummaryThis document contains corrections to final 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.
79 FR 57783 - Branded Prescription Drug Fee; Correction
typeregulations.gov FR Doc.2014-22930 RIN1545-BJ39 TD9684 DEPARTMENT OF THE TREASURY, Internal Revenue Service Final regulations, temporary regulations, and removal of temporary regulations; correction. This correction is effective September 26, 2014 and applicable beginning July 28, 2014. 26 CFR Parts 51 and 602 SummaryThis 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.
2014-07-28; vol. 79 # 144 - Monday, July 28, 201479 FR 43631 - Branded Prescription Drug Fee
typeregulations.gov FR Doc.2014-17697 RIN1545-BJ39 TD9684 DEPARTMENT OF THE TREASURY, Internal Revenue Service Final regulations, temporary regulations, and removal of temporary regulations. Effective Date: These regulations are effective on July 28, 2014. Applicability Date: For dates of applicability, see §§ 51.11, 51.11T, and 51.6302-1(b). 26 CFR Parts 51 and 602 SummaryThis document contains final regulations that provide guidance on the annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. 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. This document also withdraws the Branded Prescription Drug Fee temporary regulations and contains new temporary regulations regarding the definition of controlled group that apply beginning on January 1, 2015. The final regulations and the new temporary regulations affect persons engaged in the business of manufacturing or importing certain branded prescription drugs. The text of the temporary regulations in this document also serves as the text of proposed regulations set forth in a notice of proposed rulemaking (REG-123286-14) on this subject in the Proposed Rules section in this issue of the Federal Register .
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 26 - INTERNAL REVENUE CODE§ 6302 - Mode or time of collection§ 7805 - Rules and regulations
Statutes at Large124 Stat. 119
Title 26 published on 2013-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 26 CFR 51 after this date.2014-09-26; vol. 79 # 187 - Friday, September 26, 201479 FR 57783 - Branded Prescription Drug Fee; Correction
79 FR 57853 - Branded Prescription Drug Fee; Correction
typeregulations.gov FR Doc.2014-22928 RIN1545-BM26 REG-123286-14 DEPARTMENT OF THE TREASURY, Internal Revenue Service Correction to a notice of proposed rulemaking by cross- reference to temporary regulations. Written or electronic comments and requests for a public hearing for the notice of proposed rulemaking by cross-reference to temporary regulations published at 79 FR 43699, June 28, 2014, are still being accepted and must be received by October 27, 2014. 26 CFR Part 51 SummaryThis document contains corrections to a notice of proposed rulemaking by cross-reference to temporary regulations (REG-123286-14) that was published in the Federal Register on Monday, July 28, 2014 (79 FR 43699). The proposed regulations relate to the branded prescription drug fee. The proposed regulations modify the definition of controlled group for purposes of the branded prescription drug fee.
79 FR 43699 - Branded Prescription Drug Fee
typeregulations.gov FR Doc.2014-17698 RIN1545-BM26 REG-123286-14 DEPARTMENT OF THE TREASURY, Internal Revenue Service Notice of proposed rulemaking by cross-reference to temporary regulations. Comments and requests for a public hearing must be received by October 27, 2014. 26 CFR Part 51 SummaryIn 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.