November 17, 2017 – Federal Register Recent Federal Regulation Documents

Due to an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for Approval of Kansas Air Quality State Implementation Plans; Construction Permits and Approvals Program, published in the Federal Register on September 21, 2017. Kansas's SIP revisions included revisions to Kansas' construction permit rules. Specifically, these revisions implemented the revised National Ambient Air Quality Standard (NAAQS) for fine particulate matter; clarified and refined applicable criteria for sources subject to the construction permitting program; updated the construction permitting program fee structure and schedule; and made minor revisions and corrections.

Due to an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for Approval of Implementation Plans; State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard (NAAQS) published in the Federal Register on September 20, 2017. Infrastructure SIPs address the applicable requirements of Clean Air Act (CAA) section 110, which requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by the EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the September 25, 2017 direct final rule that approved the 2011 base year inventory for the Maryland portion of the Philadelphia-Wilmington-Atlantic City marginal nonattainment area for the 2008 8-hour ozone national ambient air quality standard (NAAQS). EPA stated in the direct final rule that if EPA received adverse comments by October 25, 2017, the rule would be withdrawn and not take effect. EPA subsequently received an adverse comment. EPA will address the comment received in a subsequent final action based upon the proposed action also published on September 25, 2017. EPA will not institute a second comment period on this action.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.'' The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.'' The draft guidance, when finalized, will provide stakeholders engaged in the development of regenerative medicine therapies with FDA's current thinking on the expedited development and review of these products. The draft guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as regenerative advanced therapies (which FDA refers to as ``regenerative medicine advanced therapy'' (RMAT) designation); describes how the Center for Biologics Evaluation and Research (CBER) will work with sponsors and encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies being developed to address unmet medical needs in patients with serious or life- threatening diseases or conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff.

In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, the Bureau of Land Management (BLM), Gila District, Tucson Field Office has prepared a Draft Supplemental Environmental Impact Statement (EIS) for the Ray Land Exchange/Plan Amendment and by this Notice is announcing its availability and the opening of the comment period.

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 and 787-9 airplanes. This proposed AD was prompted by reports of failures of the lip heater assemblies of the inlet ice protection system of the cabin air compressor (CAC) due to chafing. This proposed AD would require changing the airplane electrical connectors and the routes of certain wire bundles, and installing new or modified left and right CAC inlet duct assemblies. We are proposing this AD to address the unsafe condition on these products.

The Department of Commerce International Trade Administration (ITA) is seeking input from U.S. stakeholders (companies, private sector organizations and trade associations active in trade-related standards work) on standards, conformity assessment and regulatory trends and challenges in foreign markets and the assistance they require from ITA to effectively address standards-related trade barriers and trends to take advantage of export opportunities. ITA will use this input in reviewing how to improve services and programs to best meet the needs of U.S. stakeholders in the standards area. In addition, ITA will convene an internal summit on how to improve such services and programs on March 6-7, 2018 in Washington, DC, and is soliciting private sector requests for limited opportunities to participate in portions of the summit.

The Bureau of Consumer Financial Protection (Bureau or CFPB) is issuing this final rule establishing regulations creating consumer protections for certain consumer credit products and the official interpretations to the rule. First, the rule identifies it as an unfair and abusive practice for a lender to make covered short-term or longer- term balloon-payment loans, including payday and vehicle title loans, without reasonably determining that consumers have the ability to repay the loans according to their terms. The rule exempts certain loans from the underwriting criteria prescribed in the rule if they have specific consumer protections. Second, for the same set of loans along with certain other high-cost longer-term loans, the rule identifies it as an unfair and abusive practice to make attempts to withdraw payment from consumers' accounts after two consecutive payment attempts have failed, unless the consumer provides a new and specific authorization to do so. Finally, the rule prescribes notices to consumers before attempting to withdraw payments from their account, as well as processes and criteria for registration of information systems, for requirements to furnish and obtain information from them, and for compliance programs and record retention. The rule prohibits evasions and operates as a floor leaving State and local jurisdictions to adopt further regulatory measures (whether a usury limit or other protections) as appropriate to protect consumers.