2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2014.

This document contains final and temporary regulations relating to the application of the straddle rules to a debt instrument. The temporary regulations clarify that a taxpayer's obligation under a debt instrument can be a position in personal property that is part of a straddle. The temporary regulations primarily affect taxpayers that issue debt instruments that provide for one or more payments that reference the value of personal property or a position in personal property. The text of these temporary regulations also serves as the text of the proposed regulations (REG-111753-12) set forth in the Proposed Rules section in this issue of the Federal Register.

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

The Coast Guard is temporarily changing the enforcement period of a special local regulation for one specific recurring marine event in the Fifth Coast Guard District. This regulation applies only to the Hampton Bay Days Festival, which consists of a Fireworks Display held at multiple locations along the Hampton River, Hampton, Virginia. This special local regulation is necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic on portions of the Hampton River near Hampton, Virginia during the event.

The Coast Guard is establishing a temporary safety zone on Presque Isle Bay, Erie, PA. This safety zone is intended to restrict vessels from a portion of Presque Isle Bay during the Perry 200 Fireworks display. This temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a fireworks display.

This Notice provides NHTSA's finding that a waiver of the Buy America requirements is appropriate for the purchase of Combi Navette infant car seats by the Maryland Highway Safety Office (MHSO), using Federal grant funds. NHTSA has determined that a waiver is appropriate because there are no comparable car seats produced in the United States that are designed to seat infants under four pounds.

The Coast Guard is establishing a safety zone on the navigable waters of Oceanside Harbor in Oceanside, California for the 2013 Oceanside Tiki Swim on the morning of September 29, 2013. This temporary safety zone is necessary to provide for the safety of the participants, crew, spectators, participating vessels, and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port or his designated representative.

The Coast Guard is establishing a temporary safety zone on Presque Isle Bay, Erie, PA. This safety zone is intended to restrict vessels from a portion of Presque Isle Bay during the Tall Ships Erie 2013 Fireworks Show. This temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a fireworks display.

In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.

The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that required data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. A copy of the proposed ICR can be obtained by contacting the office listed below in the addresses section of this notice.

The Rural Housing Service is correcting a notice published on August 14, 2013, (78 FR 49460-49467). This action is taken to correct two ``submission deadline'' dates.

Following receipt of a request on August 2, 2013 from the Senate Committee on Finance and the House Committee on Ways and Means (Committees) under section 332(g) of the Tariff Act of 1930 (19 U.S.C. 1332(g)), the U.S. International Trade Commission (Commission) instituted investigation No. 332-543, Trade, Investment, and Industrial Policies in India: Effects on the U.S. Economy.

The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public. On March 22, 2010, the Office of the Comptroller of the Currency, Board of Governors of the Federal Reserve System, Federal Deposit Insurance Corporation, and National Credit Union Administration (the agencies) published in the Federal Register a joint final notice (75 FR 13656) implementing the guidance effective on May 21, 2010. The Guidance reiterates the process that institutions should follow to appropriately identify, measure, monitor, and control their funding and liquidity risk. In particular, the Guidance re- emphasizes the importance of cash flow projections, diversified funding sources, stress testing, a cushion of liquid assets, and a formal well- developed contingency funding plan (CFP) as primary tools for measuring and managing liquidity risk. The agencies expect all financial institutions \1\ to manage liquidity risk using processes and systems that are commensurate with the institution's complexity, risk profile, and scope of operations. Liquidity risk management processes and plans should be well documented and available for supervisory review. Failure to maintain an adequate liquidity risk management process is considered an unsafe and unsound practice.

The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public. Section 701.36 of the NCUA Rules and Regulations regulates ownership of fixed assets by federal credit unions. This rule ensures that federal credit unions do not undertake undue risk related to fixed assets. Specifically, section 701.36 limits the aggregate amount of fixed assets, defines the duration for which property can be held before it must be occupied or disposed and, defines prohibited transactions. This information collection enables NCUA to evaluate waiver requests of these limitations.

This notice announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS) Publication 201-2, Personal Identity Verification (PIV) of Federal Employees and Contractors. FIPS 201-2 includes clarifications to existing text, additional text in cases where there were ambiguities, adaptation to changes in the environment since the publication of FIPS 201-1, and specific changes requested by Federal agencies and implementers.

Pursuant to Section 102(2)(c) of the National Environmental Policy Act (NEPA) of 1969, as implemented by the Council on Environmental Quality regulations (40 Code of Federal Regulations parts 1500-1508), the Department of the Navy (DoN) announces its intent to prepare an Environmental Impact Statement (EIS) for EA-18G Growler airfield operations at Naval Air Station (NAS) Whidbey Island, Washington. The EIS will evaluate the potential environmental effects associated with the introduction of two additional EA-18G Growler expeditionary squadrons (10 aircraft) and the addition of three EA-18G Growler aircraft to the Fleet Replacement Squadron (FRS) when added to baseline conditions, including ongoing EA-18G Growler airfield operations, at NAS Whidbey Island's Ault Field and Outlying Landing Field (OLF) Coupeville.