September 27, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Dilip Patel and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Patel for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Patel was convicted of a conspiracy to commit a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Patel's debarment, FDA considered the relevant factors listed in the FD&C Act. Patel failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Environmental Protection Agency (EPA) is notifying the public that we have received negative declarations from Minnesota pertaining to the presence of Commercial and Industrial Solid Waste Incineration (CISWI) units and Other Solid Waste Incineration (OSWI) units in Minnesota. The Minnesota Pollution Control Agency (MPCA) submitted its CISWI negative declaration by letter dated February 3, 2017, and its OSWI negative declaration by letter dated June 21, 2017. MPCA notified EPA in its negative declaration letters that there are no CISWI or OSWI units subject to the requirements of the Clean Air Act (Act) currently operating in Minnesota.

On August 27, 2018, the Department of Commerce (Commerce) published its preliminary determination in the less-than-fair-value investigation of large diameter welded pipe (welded pipe) from Greece in the Federal Register. Commerce is amending this preliminary determination to correct a significant ministerial error.

The Environmental Protection Agency (EPA) is proposing to update the regulations that were originally promulgated in 1998 to implement the NOX SIP Call. In place of the current requirement for states to include provisions in their state implementation plans (SIPs) under which certain emissions sources must monitor their mass emissions of nitrogen oxides (NOX) according to 40 CFR part 75, the proposed amendments would allow states to include alternate forms of monitoring requirements in their SIPs. The amendments would also rescind the findings of interstate pollution transport obligations with respect to the 1997 8-hour ozone national ambient air quality standards (NAAQS) under the NOX SIP Call that have been stayed by EPA since 2000. Other revisions would remove additional obsolete provisions and clarify the remaining regulations but would not substantively alter any current regulatory requirements.

The Environmental Protection Agency has submitted an information collection request (ICR), ``State Program Adequacy Determination (Renewal).'' (EPA ICR No. 1608.08, OMB Control No. 2050- 0152) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through September 30, 2018. Public comments were previously requested via the Federal Register on May 08, 2018 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

We are adopting a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 2000 and FALCON 2000EX airplanes. This AD was prompted by reports of metallic debris found in the wing slat piccolo tubes; investigation revealed that the debris originated from the flow guide of the ball joint of the wing anti-ice valve. This AD requires repetitive inspections for metallic debris and damage of the flow guide of the ball joint of the wing anti-ice valve, and related investigative and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.