Branded Prescription Drug Fee; Correction (IRS final rule

Official source: Federal Register (GovInfo) (https://www.govinfo.gov/content/pkg/FR-2011-09-28/pdf/2011-24911.pdf), retrieved 2026-10-03. U.S. Government work (17 U.S.C. § 105).

Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations 59897

(2) * - - A form 2848 must be filed with the error report;

Par. 4. Section 51.8T is amended by revising paragraph (a)(2) to read as follows.

§ 51.8T Notification and payment of fee (temporary).

(a) * - (2) After the 2011 fee year, the covered entity’s adjustment amount

calculated as described in § 51.5T(e);

LaNita VanDyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration).

[FR Doc. 2011–24903 Filed 9–27–11; 8:45 am]

BILLING CODE 4830–01–P

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 51

[TD 9544]

RIN 1545–BK34

Branded Prescription Drug Fee; Correction

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Correction to temporary regulations.

SUMMARY: This document contains corrections to temporary regulations that were published in the Federal Register on Thursday, August 18, 2011. The temporary regulations 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.

DATES: This correction is effective on September 28, 2011 and applies to any fee on branded prescription drug sales that is due on or after September 30, 2011.

FOR FURTHER INFORMATION CONTACT: Celia Gabrysh, (202) 435–3130 (not a toll free number).

SUPPLEMENTARY INFORMATION:

Background

Need for Correction

As published August 18, 2011 (76 FR 51245), the temporary regulations (TD 9544) contains errors that may prove to

Northern District of Florida, Pensacola Division. Bayou Lawn & Landscape Services, et al. (Bayou) v. Solis, et al., Civil Docket No. 11–445. The Bayou plaintiffs’ claims are similar to the LFA plaintiffs’ claims, and they also seek to preliminarily and permanently enjoin the Department’s implementation of the Wage Rule.

The Administrative Procedure Act, at 5 U.S.C. 705, provides that ‘‘[w]hen an agency finds that justice so requires, it may postpone the effective date of action taken by it, pending judicial review.’’ In consideration of the two pending challenges to the Wage Rule and its new effective date, and the possibility that, in response to the CATA plaintiffs’ motion, the litigation will be transferred to another court, the Department is postponing the effective date of the rule from September 30, 2011, until November 30, 2011. This delay will allow the Department to mount an appropriate defense of the rule, and will allow for the orderly resolution of the various claims pending in two Federal courts. The delay will permit the various courts involved in the litigation to determine the appropriate venue for the resolution of all claims, and allow the Department to avoid the possibility of administering the H–2B program under potentially conflicting court orders. In the interest of administering a nationwide program in a uniform fashion during the pending litigation, the Department has determined that, in the interest of justice, a delay in the effective date is necessary.

Signed at Washington, DC, this 22nd day of September, 2011. Jane Oates, Assistant Secretary for Employment and Training.

[FR Doc. 2011–24969 Filed 9–26–11; 4:15 pm]

BILLING CODE 4510–FP–P

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 51

[TD 9544]

RIN 1545–BK34

Branded Prescription Drug Fee; Correction

AGENCY: Internal Revenue Service (IRS), Treasury.

ACTION: Correcting amendment.

SUMMARY: This document contains corrections to temporary regulations (TD 9544) that were published in the

Federal Register on Thursday, August 18, 2011. The temporary regulations 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.

DATES: This correction is effective on September 28, 2011 and applies to any fee on branded prescription drug sales that is due on or after September 30, 2011.

FOR FURTHER INFORMATION CONTACT: Celia Gabrysh, (202) 622–3130 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

Need for Correction

As published August 18, 2001 (76 FR 51245), the tempoary regulations (TD 9544) contains errors that may prove to be misleading and are in need of clarification.

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 51.2T is amended by revising paragraph (k)(1) to read as follows:

§ 51.2T Explanation of terms (temporary).

- - - (k) Orphan drugs —(1) In general. Except as provided in paragraph (k)(2) of this section, the term orphan drug means any branded prescription drug for which any person claimed a section 45C credit and that credit was allowed for any taxable year.

Par. 3. Section 51.7T is amended by revising the last sentence of paragraph (c)(2) to read as follows.

§ 51.7T Dispute resolution process (temporary).

- - - (c) * -

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59898 Federal Register / Vol. 76, No. 188 / Wednesday, September 28, 2011 / Rules and Regulations

be misleading and are in need of clarification.

Correction of Publication

Accordingly, the temporary regulations (TD 9544), that are the subject of FR Doc. 2011–21011, are corrected as follows:

On page 51247, column 3, in the preamble, under the paragraph heading ‘‘IV. Information Provided by the Agencies’’, line 6 of the third full paragraph of the column, the language ‘‘with a specific HCPCS Code. CMS’’ is corrected to read ‘‘with a specific Healthcare Common Procedure Coding System (HCPCS) Code. CMS’’.
On page 51248, column 2, in the preamble, under the paragraph heading ‘‘VI. Notice of Preliminary Fee Calculation’’, line 5 from the bottom of the column, the language ‘‘9008 (a)(2); the aggregate branded’’ is corrected to read ‘‘9008 (b)(2); the aggregate branded’’.
On page 51248, column 3, under the paragraph heading ‘‘VIII. Notification and Payment of Fee’’, line 1 of the paragraph, the language ‘‘Section 9008(a) provides that the’’ is corrected to read ‘‘Section 9008(a)(2) provides that the’’
On page 51248, column 3, under the paragraph heading ‘‘VIII. Notification and Payment of Fee’’, line 4 from the bottom of the column, the language ‘‘section 9008(a)(2); the aggregate’’ is corrected to read ‘‘section 9008(b)(2); the aggregate’’
On page 51255, column 1, in the signature block line 2, the language ‘‘Deputy Commissioner for Services and Enforcement.’’ is corrected to read ‘‘Acting Deputy Commissioner for Services and Enforcement.’’

LaNita VanDyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, Procedure and Administration.

[FR Doc. 2011–24911 Filed 9–27–11; 8:45 am]

BILLING CODE 4830–01–P

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 51

[REG–112805–10]

RIN 1545–BJ39

Branded Prescription Drug Fee; Correction

AGENCY: Internal Revenue Service (IRS), Treasury.

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

SUMMARY: This document contains a correction to a notice of proposed rulemaking that was published in the Federal Register on Thursday, August 18, 2011. The proposed regulation provides guidance relating to the branded prescription drug fee imposed by the Affordable Care Act.

FOR FURTHER INFORMATION CONTACT: Celia Gabrysh, (202) 622–3130 (not a toll free number).

SUPPLEMENTARY INFORMATION:

Need for Correction

As published August 18, 2011 (76 FR 51310), the notice of proposed rulemaking (REG–112805–10) contains errors that may prove to be misleading and are in need of clarification.

Correction of Publication

Accordingly, the notice of proposed rulemaking (REG–112805–10), that was the subject of FR Doc. 2011–21012, is corrected as follows:

On Page 51311, column 2, under the part heading PART 51—BRANDED PRESCRIPTION DRUGS, the last line of the first paragraph, the language ‘‘this issue of the Federal Register .]’’ is corrected to read ‘‘this issue of the Federal Register ].’’.
On page 51311, column 2, under the part heading PART 51—BRANDED PRESCRIPTION DRUGS, the first line of the last paragraph, the language ‘‘[The text of proposed § 51.6302–1 is’’ is corrected to read ‘‘[The text of proposed paragraphs (a) and (b) of § 51.6302–1 is’’.
On page 51311, column 2, under the part heading PART 51—BRANDED PRESCRIPTION DRUGS, the last line of the last paragraph, the language ‘‘Register.]’’ is corrected to read ‘‘Register].’’
On page 51311, column 2, in the signature block, the language ‘‘Sarah Hall Ingram, Deputy Commissioner for Services and Enforcement.’’ is corrected to read ‘‘Sarah Hall Ingram, Acting Deputy Commissioner for Services and Enforcement.’’

LaNita VanDyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, Procedure and Administration.

[FR Doc. 2011–24913 Filed 9–27–11; 8:45 am]

BILLING CODE 4830–01–P

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG–2009–0996

Special Local Regulation, Hydroplane Races, Lake Sammamish, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

SUMMARY: The Coast Guard will enforce the Special Local Regulation, Hydroplane Races within the Captain of the Port Puget Sound Area of Responsibility for the 2011 Fall Championship hydroplane event in Lake Sammamish, WA from 11 a.m. until 4:30 p.m. from September 30, 2011 through October 2, 2011. This action is necessary to restrict vessel movement in the vicinity of the race courses thereby ensuring the safety of participants and spectators during these events. During the enforcement period non-participant vessels are prohibited from entering the designated race areas. Spectator craft entering, exiting or moving within the spectator area must operate at speeds which will create a minimum wake.

DATES: The regulations in 33 CFR 100.1308 will be enforced from 11 a.m. until 4:30 p.m. each day from September 30, 2011 through October 2, 2011.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice, call or e-mail Ensign Anthony P. LaBoy, Sector Puget Sound Waterways Management Division, Coast Guard; telephone 206–217–6323, e-mail SectorPugetSoundWWM@uscg.mil.

SUPPLEMENTARY INFORMATION: The Coast Guard is providing notice of enforcement of the Special Local Regulation for Hydroplane Races within the Captain of the Port Puget Sound Area of Responsibility 33 CFR 100.1308. The Lake Sammamish area, 33 CFR 100.1308(a)(3) will be enforced from 11 a.m. until 4:30 p.m. from September 30, 2011 through October 2, 2011. These regulations can be found in the March 29, 2011 issue of the Federal Register (76 FR 17341).

Under the provisions of 33 CFR 100.1308, the regulated area shall be closed for the duration of the event to all vessel traffic not participating in the event and authorized by the event sponsor or Coast Guard Patrol Commander.

When this special local regulation is enforced, non-participant vessels are

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