October 6, 2016 – Federal Register Recent Federal Regulation Documents

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 Federal Communication Commission (FCC or Commission, or the Agency) proposes to add one new, consolidated system of records, FCC/OMD-25, Financial Operations Information System (FOIS) to its inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a) as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of records maintained by the agency (5 U.S.C. 552a(e)(4)). FCC/OMD-25 will consolidate the three system of records, FCC/OMD-6, Financial Accounting Systems (FAS), FCC/ OMD-9, Commission Registration System (CORES), and FCC/OMD-19, Denial of Federal Benefits (Drug Debarment List), and also add new and/or updated information that pertains to the mission and activities of the FCC's Financial Operations (FO) organization in the Office of Managing Director, which are associated with the Commission's financial and budgetary operations, programs, activities, and transactions, and the related telecommunications functions. Upon approval of FCC/OMD-25, the Commission will cancel FCC/OMD-6, FCC/OMD-9, and FCC/OMD-19.

The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-557 and 731-TA-1312 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of stainless steel sheet and strip from China, provided for in subheadings 7219.13.00, 7219.14.00, 7219.23.00, 7219.24.00, 7219.32.00, 7219.33.00, 7219.34.00, 7219.35.00, 7219.90.00, 7220.12.10, 7220.12.50, 7220.20.10, 7220.20.60, 7220.20.70, 7220.20.80, 7220.20.90, and 7220.90.00 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce to be subsidized and sold at less-than-fair-value.

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.