October 6, 2016 – Federal Register Recent Federal Regulation Documents

This regulation establishes tolerances for residues of dichlormid in or on all commodities for which there is a tolerance for metolachlor and S-metolachlor. Drexel Chemical Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

NMFS is exchanging unused flathead sole Community Development Quota (CDQ) for yellowfin sole CDQ acceptable biological catch (ABC) reserves in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2016 total allowable catch of yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.

In this document, the Media Bureau (Bureau) dismisses as moot the Application for Review filed jointly by KZLZ, LLC (KZLZ) and Lakeshore Media, LLC, the current and former licensee, respectively, of Station KWCX-FM. While the AFR was pending, KZLZ filed a minor modification application to change the community of license of Station KWCX-FM from Willcox to Tanque Verde, Arizona. Once the requested facility modification to Station KWCX-FM was granted, the assignment at Willcox was deleted, and this in turn rendered moot any Section 307(b) comparison between Davis-Monthan AFB and the deleted Willcox assignment.

We, the U.S. Fish and Wildlife Service (Service), determine threatened species status under the Endangered Species Act of 1973 (Act), as amended, for the Suwannee moccasinshell (Medionidus walkeri), a freshwater mussel species from the Suwannee River Basin in Florida and Georgia. The effect of this regulation will be to add this species to the List of Endangered and Threatened Wildlife.

We, the U.S. Fish and Wildlife Service (Service), propose to designate critical habitat for the Black Warrior waterdog (Necturus alabamensis) under the Endangered Species Act (Act). In total, approximately 1,073 river kilometers (669 river miles) in Blount, Cullman, Etowah, Fayette, Jefferson, Lawrence, Marshall, Tuscaloosa, Walker, and Winston Counties, Alabama, fall within the boundaries of the proposed critical habitat designation. We also announce the availability of a draft economic analysis (DEA) of the proposed critical habitat designation. Elsewhere in this issue of the Federal Register, we propose to list the Black Warrior waterdog as an endangered species under the Act.

We, the U.S. Fish and Wildlife Service (Service), propose to list the Louisiana pinesnake (Pituophis ruthveni), a reptile species from Louisiana and Texas, as a threatened species under the Endangered Species Act (Act). If we finalize this rule as proposed, it would extend the Act's protections to this species.

The Environmental Protection Agency (EPA) is denying a request submitted by California for extension of the attainment date for the 1997 24-hour and annual fine particulate matter (PM2.5) national ambient air quality standards in the San Joaquin Valley Serious PM2.5 nonattainment area.

The Surface Transportation Board (Board or STB) adopts changes to its arbitration procedures to conform to the requirements of the Surface Transportation Reauthorization Act of 2015.

The Environmental Protection Agency (EPA) is finalizing action on five permitting rules submitted as a revision to the Northern Sonoma County Air Pollution Control District (NSCAPCD or District) portion of the applicable state implementation plan (SIP) for the State of California pursuant to requirements under the Clean Air Act (CAA or Act). We are finalizing a limited approval and limited disapproval of two rules; we are finalizing approval of the remaining three permitting rules; and we are deleting three rules. The amended rules govern the issuance of permits for stationary sources, including review and permitting of minor sources, major sources and major modifications under part C of title I of the Act. The limited disapproval actions trigger an obligation for EPA to promulgate a Federal Implementation Plan (FIP) for the specific New Source Review (NSR) program deficiencies unless California submits and we approve SIP revisions that correct the deficiencies within two years of the final action.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.