2017 – Federal Register Recent Federal Regulation Documents

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order embodied in the consent agreementthat would settle these allegations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' The intent of this draft guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GIF) #210 entitled ``The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' This draft guidance describes the process for adding a new animal drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index). The Index consists of a list of legally marketed unapproved new animal drugs for minor species that meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

This notice lists the membership of the National Institute of Standards and Technology Performance Review Board (NIST PRB) and supersedes the list published on September 8, 2016.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on August 10, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Broadcom Limited of San Jose, California and Avago Technologies General IP (Singapore) Pte. Ltd. of Singapore. An amended complaint was filed on August 16, 2017, and supplements to the amended complaint were filed on August 30, 2017. The amended complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain wireless audio systems and components thereof by reason of infringement of U.S. Patent No. 6,684,060 (``the '060 patent''). The amended complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The U.S. Environmental Protection Agency (EPA or the agency) is taking final action to amend the Standards and Practices for All Appropriate Inquiries to update an existing reference to a standard practice revised by ASTM International, a widely recognized standards development organization. Specifically, this final rule amends the All Appropriate Inquiries Rule to reference ASTM International's E2247-16 ``Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process for Forestland or Rural Property'' and allow for its use to satisfy the statutory requirements for conducting all appropriate inquires under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

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

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

We (U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 (PRA), and as a part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. As a Federal agency, we may not conduct or sponsor and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Puerto Rico (FEMA-4336-DR), dated 09/10/2017. Incident: Hurricane Irma. Incident Period: 09/05/2017 and continuing.

This is a Notice of the Presidential declaration of a major disaster for the State of Florida (FEMA-4337-DR), dated September 10, 2017.