June 5, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The previous guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,'' issued on November 18, 2015, has been withdrawn.

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Rhode Island. This revision updates Rhode Island Air Pollution Control Regulations (APCRs) for volatile organic compound (VOC) emissions, nitrogen oxide (NOx) emissions, sulfur content in fuel requirements and associated general definitions. The intended effect of this action is to propose approval of the revised regulations. This action is being taken under the Clean Air Act.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

On April 13, 2018, the Environmental Protection Agency (EPA) published a direct final rule approving the updated delegation of EPA authority for implementation and enforcement of certain New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAPs) for all sources (both part 70 and non-part 70 sources) to the New Mexico Environmental Department (NMED). EPA stated in the direct final rule that if EPA received relevant adverse comments by May 14, 2018, EPA would publish a timely withdrawal in the Federal Register. EPA received an adverse comment on May 14, 2018, and accordingly is withdrawing the direct final rule.

The Department of Commerce (Commerce) determines that countervailable subsidies are not being provided to producers and exporters of citric acid and certain citrate salts (citric acid) from Thailand. The period of investigation is January 1, 2016, through December 31, 2016. In addition, we determine that critical circumstances do not exist with respect to imports of the subject merchandise.

The Department of Commerce (Commerce) determines that citric acid and certain citrate salts (citric acid) from Thailand are being, or are likely to be, sold in the United States at less than fair value (LTFV) during the period of investigation (POI) April 1, 2016, through March 31, 2017. In addition, we determine that critical circumstances exist with respect to certain imports of the subject merchandise.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. A 60-day Federal Register Notice was published in the Federal Register on February 9, 2018 (83 FR 5791). There were 23 public comments. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on January 10, 2018 (83 FR 1264), and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Department of Justice, Office on Violence Against Women (OVW) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register allowing for a 60 day comment period.

Notice is hereby given that NMFS Northeast Fisheries Science Center, Woods Hole, MA (Responsible Party: John Hare), has applied in due form for a permit to conduct research on four species of pinnipeds.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 to Regulatory Guide (RG) 1.207, ``Guidelines for Evaluating the Effects of Light-Water Reactor Water Environments in Fatigue Analyses of Metal Components.'' This RG describes methods and procedures that the staff of the NRC considers acceptable for use in determining the acceptable fatigue lives of components evaluated by a cumulative usage factor calculation in accordance with the fatigue design provisions in Section III, ``Rules for Construction of Nuclear Power Plant Components,'' of the American Society of Mechanical Engineers Boiler and Pressure Vessel Code to account for the effects of light-water reactor water environments.

In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the National Space Council Users' Advisory Group (UAG).

The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when agencies no longer need them for current Government business. The records schedules authorize agencies to preserve records of continuing value in the National Archives of the United States and to destroy, after a specified period, records lacking administrative, legal, research, or other value. NARA publishes notice in the Federal Register for records schedules in which agencies propose to destroy records they no longer need to conduct agency business. NARA invites public comments on such records schedules.

NMFS and the Western Pacific Fishery Management Council (Council) will convene a Western Pacific Stock Assessment Review (WPSAR) of a draft 2018 benchmark stock assessment for main Hawaiian Islands Kona crab.