February 2019 – Federal Register Recent Federal Regulation Documents

Under the Endangered Species Act, we, the U.S. Fish and Wildlife Service, invite the public to comment on a federally listed American burying beetle incidental take permit (ITP) application. The applicant anticipates American burying beetle take as a result of impacts to Oklahoma habitat the species uses for breeding, feeding, and sheltering. The take would be incidental to the applicant's activities associated with oil and gas well field and pipeline infrastructure (gathering, transmission, and distribution), including geophysical exploration (seismic), construction, maintenance, operation, repair, decommissioning, and reclamation. If approved, the permit would be issued under the approved American Burying Beetle Amended Oil and Gas Industry Conservation Plan (ICP) Endangered Species Act Section 10(a)(1)(B) Permit Issuance in Oklahoma.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Nonbinding Feedback After Certain FDA Inspections of Device Establishments.'' The FDA Reauthorization Act of 2017 (FDARA) mandated that FDA issue draft guidance specifying how FDA provides nonbinding feedback to the owner, operator, or agent in charge of a device establishment after an inspection of such establishment within 45 days of FDA's receipt of a request for such feedback if the request meets certain statutory criteria. This draft guidance describes FDA's proposed approach for providing nonbinding feedback, including the procedures for requesting nonbinding feedback and FDA's review of requests for nonbinding feedback. This draft guidance is not final nor is it in effect at this time.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a briefing meeting of the Connecticut Advisory Committee to the Commission will convene at 10:00 a.m. (EST) on Tuesday, April 2, 2019, in Room 1D of the Legislative Office Building, 300 Capitol Avenue, Hartford, CT. The purpose of the briefing is for the committee to examine the civil rights implications of the prosecutorial appointment process in Connecticut.

The Commission has changed the date for transmittal of its report to the USTR in these investigations from January 24, 2018 to February 28, 2019 due to the lapse of appropriation between December 22, 2018 and January 25, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Competitive Generic Therapies.'' On August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), was signed into law. Under FDARA, a section was added to the FD&C Act that established a new process to designate, and expedite the development and review of, certain drugs intended for submission or submitted in an abbreviated new drug application (ANDA) and for which there is ``inadequate generic competition.'' This draft guidance provides a description of the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating a drug as a CGT. This draft guidance also includes information on the actions FDA may take to expedite the development and review of an ANDA for a drug designated as a CGT. This draft guidance also provides information on how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for drugs designated as CGTs.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Department of Commerce (Commerce) preliminarily determines that Novolipetsk Steel (NLMK) did not make a bona fide sale during the period of review (POR) December 1, 2016, through November 30, 2017; therefore, we are preliminarily rescinding this administrative review. Interested parties are invited to comment on the preliminary results of this review.

The Department of Commerce (Commerce) determines that Daejin Steel Co. (Daejin), Koram Inc. (Koram), and Korea Wire Co. Ltd. (Kowire) made sales of certain steel nails (steel nails) from the Republic of Korea (Korea) at less than normal value during the period of review (POR), July 1, 2016, through June 30, 2017.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request the reinstatement of an information collection associated with the National Animal Health Reporting System.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request the reinstatement of an information collection associated with the Animal and Plant Health Inspection Service's Student Outreach Program.

On December 27, 2018, NMFS published a proposed rule in the Federal Register to implement annual limits on commercial catch of Pacific bluefin tuna (Thunnus orientalis) in the eastern Pacific Ocean (EPO) for 2019 and 2020. Comments were due by January 16, 2019. However, due to a lapse in appropriations, the link to the public comment portal provided in the proposed rule was not active. Consequently, NMFS is reopening the public comment period for an additional 15 calendar days.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

We, the U.S. Fish and Wildlife Service, invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA). With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The ESA also requires that we invite public comment before issuing permits for any activity otherwise prohibited by the ESA with respect to any endangered species.