June 1, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information in the FDA publication, ``Approved Drug Products With Therapeutic Equivalence Evaluations'' (commonly known as the ``Orange Book''). We are soliciting comments on the types of patents currently listed in the Orange Book and the impact that any change to current patent listing practices may have on drug product development. This notice is not intended to communicate our regulatory expectations on these issues but is instead intended to seek early input from the public to inform further regulatory action if determined to be appropriate.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Orange BookQuestions and Answers.'' This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). This guidance provides answers to commonly asked questions FDA has received from interested parties regarding the Orange Book.

NOAA and the State of Connecticut (State) intend to prepare a Draft Environmental Impact Statement (DEIS) and Draft Management Plan (DMP) for the proposed Connecticut National Estuarine Research Reserve (NERR). The DEIS will consider the human and environmental consequences of federally designating the State's proposed site and alternatives, and identify a final boundary. The DMP will provide a framework for operating the proposed site if approved by NOAA and will include plans for administration, research, education, and facilities.

As required by the Federal Advisory Committee Act, the Department of State gives notice of a virtual meeting of the Advisory Committee on International Postal and Delivery Services.

The Department of State announces the renewal of the Charter for the Defense Trade Advisory Group (DTAG) for another two years. The DTAG advises the Department on its support for and regulation of defense trade to help ensure the foreign policy and national security of the United States continue to be protected and advanced, while helping to reduce unnecessary impediments to legitimate exports in order to support the defense requirements of U.S. friends and allies. It is the only Department of State advisory committee that addresses defense trade related topics. The DTAG will remain in existence for two years after the filing date of the Charter unless terminated sooner. The DTAG is authorized by the Federal Advisory Committee Act.

The U.S. Army Corps of Engineers, New York District, Planning Division is notifying interested parties that it is withdrawing the Notice of Intent (NOI) to develop an EIS for the NYNJHAT Coastal Storm Risk Management (CSRM) Feasibility Study. The NOI to Prepare an EIS was published in the Federal Register on January 13, 2020.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Fish and Wildlife Service (Service), are proposing a new information collection in use without Office of Management and Budget (OMB) approval.

The New England Fishery Management Council (Council) is scheduling a public meeting via webinar of its Groundfish Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

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 meeting of the Connecticut Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EDT) on Monday, June 22, 2020. The purpose of the meeting is for the Advisory Committee to begin planning its first civil rights project for its new appointment term.

The Department of Labor (DOL) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, ``Pre-Hearing Statement.'' This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).

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 that the Michigan Advisory Committee (Committee) will hold a meeting via teleconference on Friday, June 19, 2020, at 2:00 p.m. Eastern Time, for the purpose of discussing civil rights issues in the state.

The Advisory Committee on Construction Safety and Health (ACCSH) will meet July 1, 2020, by teleconference and WebEx. In conjunction with the ACCSH meeting, ACCSH Workgroups will also meet by teleconference and WebEx on June 30, 2020.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of a docket to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public regarding practical steps and successful approaches to establish a rare disease clinical trials network.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on April 24, 2020, under section 337 of the Tariff Act of 1930, as amended, on behalf of Kirsch Research and Development, LLC, of Simi Valley, California. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and/or the sale within the United certain synthetic roofing underlayment products and components thereof States after importation of certain synthetic roofing underlayment products and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,765,251 (``the '251 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add Global Expedited Package Services Non-Published Rates 15 (GEPS-NPR 15) to the Competitive Products List.

The United States Postal Service\TM\ (USPS\TM\) is proposing to revise a Customer Privacy Act Systems of Records. These updates are being made to facilitate the implementation of web-based conferencing applications.

The Board of Overseers of the Malcolm Baldrige National Quality Award (Board of Overseers) and the Judges Panel of the Malcolm Baldrige National Quality Award (Judges Panel) will meet in open session on Thursday, June 11, 2020, from 11:00 a.m. to 4:00 p.m. Eastern time. The Board of Overseers, appointed by the Secretary of Commerce, reports the results of the Malcolm Baldrige National Quality Award (Award) activities to the Director of the National Institute of Standards and Technology (NIST) each year, along with its recommendations for the improvement of the Award process. The Judges Panel, also appointed by the Secretary of Commerce, ensures the integrity of the Award selection process and recommends Award recipients to the Secretary of Commerce. The purpose of this meeting is to discuss and review information received from the National Institute of Standards and Technology and from the Chair of the Judges Panel. The agenda will include: Baldrige Program Update, Baldrige Foundation Update, Baldrige Judges Panel Update, Ethics Review, Baldrige Award Process, and New Business/Public Comment.

The Commission is acknowledging a recent filing by the Postal Service that it has entered into the Inbound Competitive Multi-Service Agreement with Foreign Postal Operators (FPOs). This notice informs the public of the filing, invites public comment, and takes other administrative steps.

NMFS announces a public meeting of the Permanent Advisory Committee (PAC) to advise the U.S. Commissioners to the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC) on July 7, 2020. Meeting topics are provided under the SUPPLEMENTARY INFORMATION section of this notice.