Branded Prescription Drug Fee; Correction (IRS final rule

Official source: Federal Register (GovInfo) (https://www.govinfo.gov/content/pkg/FR-2014-09-26/pdf/2014-22929.pdf), retrieved 2026-10-03. U.S. Government work (17 U.S.C. § 105).

Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Rules and Regulations 57783

§ 122.15 [Amended]

1. The listing of user fee airports in § 122.15(b) is amended as follows:
a. Add, in alphabetical order, in the ‘‘Location’’ column ‘‘Santa Ana, California’’ and add on the same line, in the ‘‘Name’’ column ‘‘John Wayne Airport.’’; and
b. In the ‘‘Name’’ column adjacent to the listing in the ‘‘Location’’ column of ‘‘Mesa, Arizona’’, remove ‘‘Williams Gateway Airport.’’ and add in its place ‘‘Phoenix-Mesa Gateway Airport.’’

Dated: September 22, 2014. R. Gil Kerlikowske, Commissioner, U.S. Customs and Border Protection.

[FR Doc. 2014–22939 Filed 9–25–14; 8:45 am]

BILLING CODE 9111–14–P

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 51

[TD 9684]

RIN 1545–BJ39

Branded Prescription Drug Fee; Correction

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Correcting amendment.

SUMMARY: This 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.

DATES: This correction is effective September 26, 2014 and applicable beginning July 28, 2014.

FOR FURTHER INFORMATION CONTACT: Celia Gabrysh, at (202) 317–6855 (not a toll free number).

SUPPLEMENTARY INFORMATION:

Background

The final regulations (TD 9684) that are the subject of this correction is under section 9008 of the Patient Protection and Affordable Care Act.

Need for Correction

As published, the final regulations (TD 9684) contains errors that may prove to be misleading and are in need of clarification.

to provide the customs services. To implement this provision, generally, the airport seeking the designation as a user fee airport or that airport’s authority agrees to pay a flat fee for which the users of the airport are to reimburse the airport/airport authority. The airport/ airport authority agrees to set and periodically review the charges to ensure that they are in accord with the airport’s expenses.

The regulation pertaining to user fee airports is 19 CFR 122.15. It addresses the procedures for obtaining permission to land at a user fee airport, the grounds for withdrawal of a user fee designation and includes the list of user fee airports designated by the Commissioner of CBP in accordance with 19 U.S.C. 58b.

Periodically, CBP updates the list of user fee airports at 19 CFR 122.15(b) to reflect those that have been recently designated by the Commissioner and other changes, such as a name change for a listed user fee airport. On April 15, 2012, the Commissioner of CBP signed a MOA approving the designation of user fee status for the John Wayne Airport. This document updates the list of user fee airports by adding John Wayne Airport in Santa Ana, California to the list.

On September 17, 2007, the Williams Gateway Airport Authority approved the renaming of the Williams Gateway Airport in Mesa, Arizona to the Phoenix-Mesa Gateway Airport. This name change went into effect on October 15, 2007. This document updates the list of user fee airports to reflect the renaming of the Williams Gateway Airport to the Phoenix-Mesa Gateway Airport.

II. Statutory and Regulatory Requirements

A. Inapplicability of Public Notice and Delayed Effective Date Requirements

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. This final rule updates the list of user fee airports to add an airport that has already been designated by the Commissioner of CBP in accordance with 19 U.S.C. 58b as a user fee airport and to reflect a name change for one of the listed airports. These amendments are conforming changes to update the list of user fee airports. Therefore, notice and comment for this rule is unnecessary because the rule has no substantive impact, is technical in nature, and it relates only to management, organization, procedure,

and practice. For the same reasons, pursuant to 5 U.S.C. 553(d)(3), a delayed effective date is not required.

B. The Regulatory Flexibility Act and Executive Order 12866

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. This amendment does not meet the criteria for a ‘‘significant regulatory action’’ as specified in Executive Order 12866, as supplemented by Executive Order 13563.

C. Unfunded Mandates Reform Act of 1995

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

D. Executive Order 13132

The rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

E. Signing Authority

This document is limited to technical amendments of CBP regulations. Accordingly, it is being signed under the authority of 19 CFR 0.1(b).

List of Subjects in 19 CFR Part 122

Air carriers, Aircraft, Airports, Customs duties and inspection, Freight.

Amendments to Regulations

For the reasons set forth above, part 122, Code of Federal Regulations (19 CFR part 122) is amended as set forth below:

PART 122—AIR COMMERCE REGULATIONS

1. The authority citation for Part 122 continues to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66, 1431, 1433, 1436, 1448, 1459, 1590, 1594, 1623, 1624, 1644, 1644a, 2071 note.

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57784 Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Rules and Regulations

List of Subjects in 26 CFR Part 51

Drugs, Reporting and recordkeeping requirements.

Correction of Publication

Accordingly, 26 CFR part 51 is corrected by making the following correcting amendments:

PART 51—BRANDED PRESCRIPTION DRUG FEE

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

Authority: 26 U.S.C. 7805 * -

Par. 2. Section 51.4 is corrected by revising paragraphs (b)(2)(i)(A) and (B) (b)(2)(ii) through (iv), and (c)(4)(i)(D) to read as follows:

§ 51.4 Information provided by the Agencies.

- - - (b) * - (2) * - (i) * - (A) Any direct and indirect remuneration (DIR) (within the meaning of paragraph (b)(2)(ii) of this section), which includes any DIR reported on the PDE records at the point of sale and any DIR reported on a Detailed DIR Report (within the meaning of a paragraph (b)(2)(iii) of this section); and

(B) Any coverage gap discount amount (within the meaning of paragraph (b)(2)(iv) of this section).

(ii) Direct and indirect remuneration. For purposes of paragraph (b)(2)(i)(A) of this section, the term direct and indirect remuneration (DIR) has the same meaning as found in the definition of actually paid in 42 CFR 423.308.

(iii) Detailed DIR Report. For purposes of paragraph (b)(2)(i)(A) of this section, the term Detailed DIR Report means the report containing any DIR (within the meaning of paragraph (b)(2)(ii) of this section) that is collected yearly from Part D sponsors at the NDC level.

(iv) Coverage gap discount amount. For purposes of paragraph (b)(2)(i)(B) of this section, the term coverage gap discount amount means a 50-percent manufactured-paid discount on certain drugs under the Coverage Gap Discount Program described in section 1860D– 14A of the Social Security Act. (c) * - (4) * - (i) * - (D) Those entities (if any) identified in paragraph (c)(4)(i)(C) of this section that

are manufacturing branded prescription drugs assigned to the HCPCS code.

Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration).

[FR Doc. 2014–22929 Filed 9–25–14; 8:45 am]

BILLING CODE 4830–01–P

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 51 and 602

[TD 9684]

RIN 1545–BJ39

Branded Prescription Drug Fee; Correction

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Final regulations, temporary regulations, and removal of temporary regulations; correction.

SUMMARY: This 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.

DATES: This correction is effective September 26, 2014 and applicable beginning July 28, 2014.

FOR FURTHER INFORMATION CONTACT: Celia Gabrysh, at (202) 317–6855 (not a toll free number).

SUPPLEMENTARY INFORMATION:

Background

The final regulations, temporary regulations, and removal of temporary regulations (TD 9684) that are the subject of this correction is under section 9008 of the Patient Protection and Affordable Care Act.

Need for Correction

As published, the final regulations, temporary regulations, and removal of temporary regulations (TD 9684) contain errors that may prove to be misleading and are in need of clarification.

Correction of Publication

Accordingly, the final regulations, temporary regulations, and removal of temporary regulations (TD 9684), that are the subject of FR Doc. 2014–17697, are corrected as follows:

On page 43634, second column, in the preamble, in the footnotes, the last line of the column, the language ‘‘Hightower v. Commissioner, T.C. Memo 1982–559.’’ is corrected to read ‘‘Hightower v. Commissioner, T.C. Memo. 1982–559.’’.
On page 43634, third column, in the preamble, the sixth line of the third full paragraph, the language ‘‘10, CC;PSI:B7, Room 5314, 1111’’ is corrected to read ‘‘10, CC:PSI:B7, Room 5314, 1111’’.
On page 43637, second column, in the preamble, the third line of the first full paragraph, the language ‘‘the IFF and CRF be excluded from VA’’ is corrected to read ‘‘the Industrial Funding Fee (IFF) and the Cost Recovery Fee (CRF) be excluded from VA’’ .
On page 43637, second column, in the preamble, under the paragraph heading ‘‘ Department of Defense ’’, the third and fourth lines of the second full paragraph, the language ‘‘the Industrial Funding Fee (IFF) and the Cost Recovery Fee (CRF) be excluded’’ is corrected to read ‘‘IFF and the CRF be excluded’’ .
On page 43638, third column, in the preamble, under the paragraph heading ‘‘ Availability of IRS Documents ’’, the first and second lines, the language ‘‘The IRS notices, the revenue procedure, and the temporary’’ is corrected to read ‘‘The IRS notices and the temporary’’.

Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration).

[FR Doc. 2014–22930 Filed 9–25–14; 8:45 am]

BILLING CODE 4830–01–P

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 301

[TD 9687]

RIN 1545–BL08

Awards for Information Relating to Detecting Underpayments of Tax or Violations of the Internal Revenue Laws; Correction

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Correcting amendments.

SUMMARY: This document contains corrections to final regulations (TD 9687) that were published in the Federal Register on Tuesday, August 12, 2014 (79 FR 47246). The final

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