March 5, 2020 – Federal Register Recent Federal Regulation Documents

In this document, the Federal Communications Commission (FCC) announces and provides an agenda for the next meeting of the ``Task Force for Reviewing the Connectivity and Technology Needs of Precision Agriculture in the United States'' (the Task Force).

NASA hereby gives notice of its intent to grant a co-exclusive patent license in the United States to practice the invention described and claimed in U.S. Patent Application entitled, ``Method for Simulation of Flow in Fluid Flow Network Having One-Dimensional and Multi-Dimensional Flow Components'', MFS-33798-1, to MODE Technology Group, having its principal place of business in Denver, CO. The fields of use may be limited. The patent rights in these inventions have been assigned to the United States of American as represented by the Administrator of the National Aeronautics and Space Administration. NASA has not yet made a determination to grant the requested license and may deny the requested license even if no objections are submitted within the comment period.

The U.S. Bureau of the Census (Census Bureau) is giving notice of a meeting of the Census Scientific Advisory Committee (CSAC). The Committee will address policy, research, and technical issues relating to a full range of Census Bureau programs and activities, including communications, decennial, demographic, economic, field operations, geographic, information technology, and statistics. CSAC information, including the agenda topics, can be found at the following website: https://www.census.gov/about/cac/sac.html.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB) Chairs. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for INGREZZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.

The Food and Drug Administration (FDA or Agency) announced the completion of the first phase of the enhanced Purple Book on February 24, 2020. FDA is transitioning the current table format ``Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations'' to a searchable, public-facing online database entitled ``Purple Book: Database of FDA-Licensed Biological Products.'' FDA is establishing a docket for public comment to gather stakeholder feedback on the new database to inform the next phase of development.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``The `Deemed To Be a License' Provision of the BPCI Act: Questions and Answers.'' This guidance is intended to provide answers to common questions about FDA's implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's implementation of this statutory provision. This guidance finalizes the draft guidance of the same title issued on December 12, 2018.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

FMCSA announces its decision to exempt eight individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a guidance for industry entitled ``Exocrine Pancreatic Insufficiency Drug ProductsSubmitting NDAs,'' which was issued in 2006. The guidance set forth the Agency's thinking on data and information that may support a new drug application (NDA) for a proposed pancreatic enzyme product (PEP) that contains pancreatin or pancrelipase and is intended for the treatment of exocrine pancreatic insufficiency (EPI). FDA is withdrawing the guidance because an NDA for such a product may not be submitted after March 23, 2020. Sponsors interested in submitting a biologics license application (BLA) for a proposed PEP should contact the Agency with any questions.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of entities whose property and interests in property have been unblocked and removed from the list of Specially Designated Nationals and Blocked Persons.

FMCSA announces its decision to renew exemptions for 95 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirements in one eye.

The Department of Agriculture published a document in the Federal Register of February 28, 2020, pg. 11332, concerning a request for comments on the information collection ``USDA Local and Regional Food Aid Procurement Program'' OMB control number 0551-0046. The document contained incorrect number of respondents and burden hours. The number of respondents should be 8 and the burden hours 31,372 not 22 respondents and 29,172 as published.

The Charter for the Taxpayer Advocacy Panel Committee (TAP), has been renewed for a two-year period beginning February 20, 2020.

The Department of Commerce (Commerce) preliminarily finds that exporters of certain frozen warmwater shrimp (shrimp) from the People's Republic of China (China) sold subject merchandise in the United States at prices below normal value during the period of review (POR) February 1, 2018 through January 31, 2019. We invite all interested parties to comment on these preliminary results.

The Department of Commerce (Commerce) preliminarily determines that Goodluck India Limited (Goodluck) and Tube Investments of India Ltd. (TII) received countervailable subsidies during the period of review (POR), September 25, 2017 through December 31, 2018. Interested parties are invited to comment on these preliminary results.