August 12, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled ``Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.

This action finalizes amendments to new source performance standards (NSPS) for the Oil and Natural Gas Sector. On March 23, 2015, the Environmental Protection Agency (EPA) re-proposed its definition of ``low pressure gas well'' for notice and comment to correct a procedural defect with its prior rulemaking that included this definition. The EPA also proposed to amend the NSPS to remove provisions concerning storage vessels connected or installed in parallel and to revise the definition of ``storage vessel.'' This action finalizes the definition of ``low pressure gas well'' and the amendments to the storage vessel provisions.

The Environmental Protection Agency (EPA) is proposing to approve the State Implementation Plan (SIP) revision submitted by the State of Florida through the Florida Department of Environmental Protection (FDEP) on May 1, 2015. This SIP revision seeks to make changes to the SIP to remove certain Stage I vapor control requirements and to make administrative changes to the SIP that would remove gasoline vapor control rules that no longer serve a regulatory purpose, including rules related to the Stage II vapor control requirements for new and upgraded gasoline dispensing facilities in Broward, Miami-Dade, and Palm Beach Counties (hereinafter referred to as the ``Southeast Florida Area''). EPA has preliminarily determined that Florida's May 1, 2015, SIP revision is approvable because it is consistent with the Clean Air Act (CAA or Act). In the Final Rules Section of this Federal Register, EPA is approving the State's implementation plan revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule.

The National Park Service is reopening the public comment period for the proposed rule to amend its regulations to authorize agreements between the National Park Service and federally recognized Indian tribes to allow the gathering and removal of plants or plant parts by designated tribal members for traditional purposes. Reopening the comment period for 45 days will allow more time for the public to review the proposal and submit comments.

The Department of Commerce (``Department'') is conducting an administrative review of the antidumping duty order on polyethylene terephthalate film, sheet, and strip (``PET film'') from the People's Republic of China (``PRC'') for the period of review (``POR'') November 1, 2013, through October 31, 2014. This review covers four PRC companies.\1\ The Department is rescinding the review with respect to Fuwei Films (Shandong) Co., Ltd. (``Fuwei Films''), Sichuan Dongfang Insulating Material Co., Ltd. (``Dongfang''), and Tianjin Wanhua Co., Ltd. (``Wanhua''). Further, the Department preliminarily finds that Shaoxing Xiangyu Green Packing Co., Ltd. (``Green Packing'') is part of the PRC-wide entity.